Catalogue - ELITech Group · PDF file · 2016-09-12Bestellinformationen Ordering Information All customers may order via our online shop, by e-mail, fax, or telephone. For customers

Catalogue

Food & Water Assays

PCR Cycler Validation

ContractManufacturingNucleic Acid

Extraction

Cell Culture Contamination

ControlDNA Standards &

Cleaning Products

20162017

FactsMinerva Biolabs, founded in 1999, is a privately owned company. Our office and manufacturing fa-cilities are located in Berlin, Germany. The company is part of the Dilarus Group, a privately owned holding company, that is providing product design and communication services to the group mem-bers. Further group members are the Mera Scientific GmbH, a distributor of internationally avaliable molecular diagnostic technologies to the German market, and the Minerva Analytix GmbH, a GMP-certified QC lab for biopharmaceutical and ATMP release testing.

Our AssetsWe serve our customers with our dedicated and well-trained distribution partners in more than 50 countries across the five continents.

We lead in the niche markets with solutions for EP 2.6.7-compliant mycoplasma contamination test-ing, meat identification testing, vegan food control, PCR cycler qualification, and validation standards to give just a selection of our innovative product portfolio. All these products feature the latest PCR technology.

We bring high-value solutions to our customers through our expertise and longstanding experience reflected in our products and contract manufacturing services. If you are looking for an expert and flexible partner for the preparation of your molecular biology kit or reagent, Minerva Biolabs is the right choice. Automated liquid-handling, freeze-drying technology and clean room facilities are avail-able to comply with any customer demand.

We serve academic and industrial cell culture laboratories, quality control units in biopharmaceutical industry as well as food quality professionals providing a service for faster, reliable and stress-free technologies for their specific needs.

We do not stop with single applications like PCR but aim to provide integrated solutions that are required for handling cell cultures contamination-free with our elimination and disinfection reagents, or for operating PCR labs contamination-free with our DNA and RNA removal reagents as well as monitoring tools.

We bring experiences and services to markets that are undersupplied by the major industry players that provide mainly products without support. Customized guidance is our strength as we develop products and apply them routinely in our labs. Based on our experiences, we seek to further improve our products and develop new products to offer innovative solutions to our customer, which keeps Minerva Biolabs on a constant path of growth.

We are highly committed to quality and implemented a quality management system that was certi-fied according to ISO 9001 in the first business year. Since 2007, we conduct our business according to ISO 13485 which enables us to manufacture IVDs according to the in-vitro diagnostic directive. Many customer and authority audits proved the conformity of our quality management system.

Introduction

2 3

Ordering InformationBestellinformationen

All customers may order via our online shop, by e-mail, fax, or telephone. For customers outside of Germany, please contact the Minerva Biolabs’ dis-tributor within your country. If your country does not have an authorized distributor, our online shop will guide you.

Telefon: +49 (0)30 2000437-0Fax: +49 (0)30 2000437-9Web: www.minerva-biolabs.comE-mail: [email protected]: http://shop.minerva-biolabs.com

Information to provide with your order1 Name, telephone number, and e-mail address2 Company/institute3 Shipping and billing address4 Purchase order number5 Catalog number6 Product name, size, and quantity

Terms of paymentTerms of payment is 14 days after receipt of invoice. The goods remain our property until payment of the invoice. The terms and conditions apply.

Our VAT No.DE199467805

Free shipping for qualified ordersWithin Germany, shipping charges are 10.50 Euro for standard shipment. Minerva Biolabs will pay the shipping charges for any order within Germany that totals 300 Euro or more. Please inquire about costs for international shipments at [email protected].

Same day shippingOrders will be shipped the same day until 12 AM, un-less otherwise stated or requested. Non-perishables can be shipped from Monday to Friday. To assure pro-duct integrity, less robust products like polymerases normally are not shipped on Friday. However, please contact Minerva Biolabs for special arrangements.In case of a delay in delivery we will inform you im-mediately. If requested we will send you the confir-mation of your order without delay.Prices are subject to change without notice. Please con-firm current pricing at the time of your order.

For more detailed information, please contact:E-mail: [email protected]: +49 (0)30 2000 4370

Official mailing addressMinerva Biolabs GmbHKoepenicker Strasse 32512555 BerlinGermany

Wir nehmen Ihre Bestellungen gerne über unseren Onlineshop, per E-Mail, per Fax oder telefonisch ent-gegen. Ausländische Kunden können sich direkt an unsere Vertriebspartner wenden. Diese stellen auch Preisinformationen zur Verfügung.

Telefon: +49 (0)30 2000437-0Fax: +49 (0)30 2000437-9Web: www.minerva-biolabs.comE-Mail: [email protected]: http://shop.minerva-biolabs.com

Informationen, die Sie für eine Bestellung benö-tigen1 Ihren Namen, Telefonnummer und E-Mail- Adresse2 Institut/Firma3 Liefer- und ggf. Rechnungsadresse4 ggf. Ihre Auftragsnummer5 Bestellnummer6 Produktname, Packungsgröße und Menge

ZahlungsbedingungenZahlungsziel ist 14 Tage nach Rechnungserhalt ohne Abzug. Die Ware bleibt bis zur vollständigen Bezah-lung unser Eigentum. Es gelten die Allgemeinen Ge-schäftsbedingungen.

Unsere UmsatzsteuernummerDE199467805

Wieviel kostet der Versand?Wir berechnen in Deutschland für alle Versendun-gen regulär 10,50 Euro. Alle Bestellungen mit einem Bestellwert von mehr als 300 Euro sind versandkos-tenfrei. Für Bestellungen aus dem Ausland fallen die effektiven Versandkosten an.

Wann wird die Ware geliefert?Wir liefern Bestellungen bis 12.00 Uhr noch am sel-ben Tag aus. Die Ware trifft innerhalb von 1-3 Werkta-gen bei Ihnen ein. Weniger robuste Produkte, wie z.B. die Polymerasen, werden normalerweise nicht am Freitag versendet, um ihre Integrität zu garantieren.Bitte kontaktieren Sie Minerva Biolabs für besonde-re Vereinbarungen.Bei Lieferverzögerungen werden Sie natürlich umge-hend benachrichtigt. Auf Anfrage senden wir Ihnen unverzüglich eine Auftragsbestätigung zu. Wir behal-ten uns vor, Produktspezifikationen und Preise ohne Vorankündigung zu ändern. Preise und Spezifikatio-nen bestätigen wir gerne auf Anfrage.

Weitere Fragen beantworten wir Ihnen gerne und schnell unter:E-Mail: [email protected]: +49 (0)30 2000 4370

PostanschriftMinerva Biolabs GmbHKöpenicker Straße 325D-12555 Berlin

Für viele unserer Produkte bieten wir ergänzende In-formationen auf unserer Webseite an. Bitte rufen Sie die jeweilige Produktseite auf und achten Sie auf die Einträge an der rechten Seite. Sollten diese Informationen Ihnen nicht weiter-helfen, stehen wir unseren Kunden natürlich gerne

mit einer individuellen und kompetenten Betreu-ung zur Verfügung und unterstützen Sie gerne bei Schwierigkeiten jeglicher Art. Bitte verwenden Sie für Ihre Anfrage unser Formular auf der Webseite http://www.minerva-biolabs.com/de/kontakt.

For many of our products, we are able to provide ad-ditional information on our website. Please access the respective product page and have a look at the links on the right side. If this information does not help you, please contact our support team. They are glad to assist you with an individual and com-

petent support. Please use for your inquiry our form on the website http://www.minerva-biolabs.com/en/contact.

Technische Anfragen Technical Support

4 5

Cell Culture Control

Nucleic Acid Extraction


Food & Water Assays

ContractManufacturing

DNA Standards &Cleaning Products

Cell Culture Contamination Control 8

Introduction 10

Mycoplasma Detection Kits 12Venor®GeM Classic 13Venor®GeM Advance 14Venor®GeM OneStep 15Venor®GeM qEP 16Venor®GeM Sample Preparation Kit 1710CFU™ Mycoplasma Sensitivity Standards 18

Mycoplasma Elimination Reagents 20Mynox® 22Mynox® Gold 23

Onar® Bacteria – Bacteria Detection Kit 24

Decontamination, Disinfection, and Prevention 26ZellShield® 27Mycoplasma-Off™ 28Mycoplasma-Off™ Wipes 29WaterShield™ 30MB Taq DNA Polymerase 31

PCR Cycler Validation 32

Introduction 34PCR Cycler Check™ 35qPCR Cycler Check™ 36Color Compensation Kit 37

Food and Water Testing 38

AquaScreen® 40AquaScreen® FastExtract 42AquaScreen® Legionella species 43AquaScreen® Legionella pneumophila 44AquaScreen® Pseudomonas aeruginosa 45AquaScreen® Escherichia coli 46

Food Control™ 48ExtractNow™ FoodControl 50Food Control™ qPCR 51Food Control™ LFA 52Food Control™ LFA+ 53

Meat ID™ Kits 54ExtractNow™ Meat ID 55Meat ID™ Screen 56Meat ID™ Halal 57

Vegan Control™ Kits 58ExtractNow™ Vegan Control 59Vegan Control™ OneStep 60Vegan Control™ Advance 61

Nucleic Acid Extraction 62

ExtractNow™ Plasmid Mini Kit 64ExtractNow™ DNA Mini Kit 65ExtractNow™ Blood DNA Mini Kit 66ExtractNow™ RNA Mini Kit 67ExtractNow™ CleanUp Kit 68ExtractNow™ Virus DNA/RNA Kit 69

DNA Standards and Cleaning 70

DNA Standards 72Specifity Standards 72Genomic DNA Extracts 72PCR Quantification Standards 7410CFU™ 76

Cleaning 78PCR Clean™ Spray 79PCR Clean™ Wipes 80Lab Clean™ 81WaterShield™ 82

Contract Manufacturing 84

Appendix 88

Licenses & Trademark Information 88

Terms and Conditions 89

Index 92

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Food & Water Assays



Cell Culture Contamination Control

8 9

IncidenceBesides contamination with yeast, fungi and other cell types, the contamination of cell cultures with viruses, bacteria and mycoplasma is widely spread. Up to 87 % of all cell cultures in academic use and up to 4 % in industrial production are contaminated with mycoplasma. Approx. 6 % of all autologous cells used for therapeutic purposes are contaminated with undetected bacteria. The regular use of an-tibiotics in cell culture media suppresses the bacterial growth to a level which is undetectable without a suitable detection method.

ImpactIt is important to keep an eye on these contaminants during routine work for diverse and severe rea-sons: inhibition of cell proliferation up to 50 %, higher infection risk for patients treated with therapeutic cells, unspecific positive results in animal control testing by stimulated immune systems, influence on virus proliferation and infection rates, disturbance of the hybridoma-technique and patch-clamp expe-riments as well as a drastic decrease of electroporation rates. Mycoplasma can constitute up to 50 % of the total protein and 15 - 30 % of the DNA isolated from a cell culture. These impurities will compli-cate any downstream purification processes and cloning experiments.

PreventionUnfortunately, ways of contamination are manifold and even laboratories with best practice are not safe. As mycoplasma are associated with specific host organisms, the source of contamination can be traced, e.g. contamination with Mycoplasma hyorhinis usually occurs by cross contamination from lab to lab and rarely by trypsin used for cell transfer. Trypsin lyses mycoplasma particles within a short time. On the other hand Acholeplasma laidlawii was confirmed as a contaminant of tryptone soya broth used in media products with surprising growth and long term survival abilities. Routine and reliable testing is the only way to prevent the cell culture user from loss and expenses. Not all test methods available on the market are equivalently suitable for specific sample material, show a large detection range or are sensitive enough.

SolutionThe PCR method can easily fulfil the requirements of a modern test system on specificity and robust-ness. The sensitivity of the test method is limited by the low sample volume. To fulfil the sensitivity li-mits based on the culture method (CFU/ml), concentration methods or cell culture enrichment might apply, the later even solving the problem of direct testing methods with DNA from dead mycoplasma. Spiking a cell culture with 10 vital mycoplasma particles gives a strong detectable PCR signal within one week of cultivation; DNA from dead mycoplasma will be digested by DNA nucleases of lysed cells within days of cultivation.

Regulated TestingDue to the sensitive and rapid test principle, PCR is established as the method of choice in research but also for highly regulated testing procedures of pharmaceutical samples, such as in-process release testing or final release testing of vaccines and ATMPs. Based on European Pharmacopoeia 2.6.7, traditional culture methods or indicator cell culture me-thods can be replaced by PCR approaches, if a robust detection limit of 10 CFU/ml is shown. Both, our Venor®GeM Classic and Venor®GeM qEP are validated in compliance with the requirements of the EP 2.6.7. The validation reports are available on request. However, the validation data are for information only, as the EP 2.6.7 states: “Where commercial kits are used ..., documented validation points alrea-dy covered by the kit manufacturer can replace validation by the user. Nevertheless, the performance of the kit with respect to its intended use has to be demonstrated by the user (e.g. detection limit, ro-bustness, cross-detection of other classes of bacteria)”. Please feel free to contact us, if you need assistance, e.g. providing a Validation Plan Template for validating the release testing of ATMP´s.

M. fermentans 3%

M. hominis 5%

M. arginini 17%A. laidlawii 9%

Other 18%

M. hyorhinis 20%

M. orale 23%

M. salivarium 5%

Introduction

10 11




Food & Water Assays



Our Mycoplasma Detection Kits employ PCR technology for rapid and reliable detection of more than 110 Mollicutes species, including Mycoplasma, Acholeplasma and Spiroplasma. All relevant species known as contaminants in various in situ biologicals including cell cultures, culture media, cell preparations and virus stocks are detectable. One of the different types will fit each individual custom-er’s need for a fast, reliable and time-saving routine monitoring!

Mycoplasma Detection Kits

Venor®GeMClassic

Venor®GeMOneStep

Venor®GeMAdvance

Venor®GeM qEP

Kit version Description

Con

vent

iona

l PC

R

y n y n y

qPC

R

Extr

actio

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ontr

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Poly

mer

ase

incl

uded

Rec

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ende

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r re

sear

ch

Rec

omm

ende

d fo

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dust

ry /

phar

ma

Rec

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ende

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sam

ple

quan

tity

EP 2

.6.7

con

form

ity

y low y

y n n y y n low n The pre -casted version o f Venor®GeM is ready- for-gel. Just

add the rehydration buffer and the sample into the pre-casted PCR tubes. After cycling the PCR products can be loaded directly onto a gel, as marker and loa-ding buffer are already included. The best version for time-savers!

y

n

n

y

n

y

y

y

y

n

n

y

high

high

n

y

Venor®GeM OneStep is all-in-one! Do you need a robust and reliable

work-horse? The Venor®GeM OneStep is the best choice as all reagents inclu-ding the polymerase are freeze-dried and only need to be reactivated by adding the rehydration buffer. Best value for money!

qEP stands for qPCR-based, EP 2.6.7 compliant mycoplasma tes-

ting. Venor®GEM qEP can be performed with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and HEX™. Two protocols allow the fast screening of research samples or highly sensitive and robust testing of re-gulated biopharmaceutical samples.

The classical version for gel eva-luation. 15 years of experience,

EP 2.6.7 compliant, always improved and at the state-of-the-art of DNA based mycoplasma detection – the optimal choice for money-savers!

Features

Type of PCR For conventional endpoint PCR

Description Venor®GeM Classic is a basic PCR kit for fast, reliable and time-saving routine monitoring of mycoplasma contamination.

Recommended Use / Scope Applicable in research and industry for direct testing of cell cultures and biologicals. Not recommended for clinical diagnostics.

Kit Components Freeze-dried primer sets and nucleotides10x reaction buffer optimized for MB Taq DNA PolymeraseFreeze-dried positive control DNAFreeze-dried internal amplification control DNA

Package Sizes Primer sets and nucleotides are prepared in aliquots of 25 tests.Cat. No. 11-1025 25 TestsCat. No. 11-1050 50 TestsCat. No. 11-1100 100 TestsCat. No. 11-1250 250 Tests

Result Evaluation Gel electrophoresis at endpoint of PCR

Required Consumables Polymerase. We highly recommend our reliable hot-start MB Taq DNA Polymerase, Cat. No. 53-1050/100/200/250. (SEE PAGE 31), PCR reaction tubes.

Optional for process validation and EP 2.6.7 compliant testing:Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-1905)10CFU™ Sensitivity Standards available for all EP listed mycoplasma species (SEE PAGE 18)

Required Lab Devices Regular PCR cycler, agarose gel electrophoresis and DNA staining system, pipetting equipment, tube centrifuge

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months.After rehydration the reagents must be stored below -18 °C

EP 2.6.7 Compliance Yes, after appropriate sample preparation and process validation. Validation report available on request

Fig. Amplified PCR products are visualized by standard gel electrophoresis.

191

bp

265

bp

M NTC

NTC

PC 104

103

102

10 copi

es

Venor®GeM Classic

12 13




Food & Water Assays



191

bp

265

bpM NTC

PC

104

103

102

10 copi

esFig. Amplified PCR products are visualized by standard gel electrophoresis.Fig. Amplified PCR products are visualized by standard gel electrophoresis. 19

1 bp

265

bp

M NTC

PC

105

104

103

102

10 copi

es

Features


Description Venor®GeM Advance contains PCR reaction tubes pre-casted with all PCR reagents to reduce the total assay time without need to prepare aliquots of a master mix. For additional convenience the gel loading buffer and dye are already included in the reaction buffer. After thermal cycling the PCR can be loaded directly on the agarose gel.

Recommended Use / Scope Applicable in research for direct testing of cell cultures and cell culture-derived biologicals. Intended for research use only. Not recommended for clinical diagnostics or testing of human samples.

Kit Components Primer sets, nucleotides, polymerase and internal amplification control DNA, freeze-dried, filled in 0.2 ml PCR reaction tubesRehydration buffer including gel loading buffer and running dyePositive controls, freeze-dried, filled in 0.2 ml PCR reaction tubes

Package Sizes Cat. No. 11-7024 24 TestsCat. No. 11-7048 48 TestsCat. No. 11-7096 96 TestsCat. No. 11-7240 240 Tests


Required Consumables Agarose gels and DNA stains

Required Lab Devices Regular PCR cyclerAgarose gel electrophoresis and DNA staining systemPipetting equipmentTube centrifuge

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After rehydration of the individual PCR tubes the reagents must be used within 1 hour.

EP 2.6.7 Compliance No

Features


Description Venor®GeM OneStep is a complete kit which includes all reagents required for PCR. Primer, nucleotides, polymerase and the internal amplification control are provided ready-to-use in a freeze-dried reaction mix. The included rehydration buffer is added to the mix, aliquots made according to the sample number, sample or Positive Control DNA added and the setup is ready for PCR.

Recommended Use / Scope Applicable in research for direct testing of cell cultures and biologicals. Intended for research use only. Not recommended for clinical diagnostics or testing of human samples.

Kit Components Primer sets, nucleotides, internal amplification control DNA and polymerase at optimized concentrations freeze-dried in one tubeRehydration bufferFreeze-dried positive control DNAPCR grade water

Package Sizes Primer and nucleotides in aliquots of 25 tests.Cat. No. 11-8025 25 TestsCat. No. 11-8050 50 TestsCat. No. 11-8100 100 TestsCat. No. 11-8250 250 Tests


Required Consumables Agarose gels and DNA stainsPCR reaction tubes


Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C

EP 2.6.7 Compliance No

Venor®GeM Advance Venor®GeM OneStep

14 15




Food & Water Assays



Features

Type of PCR Probe assay for qPCR

Description Venor®GeM qEP utilizes quantitative, real-time PCR for high quality and reliable detection of mycoplasma contamination with a maximized sensitivity for Mycoplasma species, A. laidlawii and S. citri. The kit was validated according to EP 2.6.7 "Mycoplasmas" in combination with EP 2.6.21 "Nucleic Acid Amplification Techniques" with respect to detection limit for all listed mycoplasma species, specificity and robustness for cell cultures and autologous cell transplants (e.g. chondrocytes).

Recommended Use / Scope Venor®GeM qEP is used for direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) in cell cultures and cell culture derived biologicals, like autologous transplants (ATMPs), sera, cell culture media and therapeutic antibody formulations, according to European Pharmacopoeia (EP) 2.6.7 Mycoplasmas. Not applicable for clinical diagnostics.

Kit Components Freeze-dried primer/nucleotides/probes/polymerase mix, aliquoted for 25 tests internal amplification control DNA usable as DNA extraction control rehydration buffer, PCR grade water freeze-dried positive control DNA

Package Sizes Cat. No. 11-9025 25 TestsCat. No. 11-9100 100 TestsCat. No. 11-9250 250 Tests

Result Evaluation Cycler based, real-time PCR

Required Consumables PCR reaction tubes.Optional for process validation and EP 2.6.7 compliant testing:Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-1905)For validation and performance control:Quantification Standards for all EP listed mycoplasma species provide titrated DNA for the quantification of the mycoplasma DNA load in the sample (SEE PAGE 74).10CFU™ Sensitivity Standards for validation and performance control (SEE PAGE 18)

Required Lab Devices qPCR cycler with filters for FAM™ and HEXPipetting equipment Centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage Kit components must be stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C.

EP 2.6.7 Compliance Yes, after appropriate sample preparation and process validation.Validation report available on request

Features

Description 37% of all cell culture supernatants, and almost all of confluent cell culture supernatants, inhibit PCR. Proficiency studies have demonstrated the importance of further DNA extraction for a sensitive PCR results even for unremarkable sample materials.

The Venor®GeM Sample Preparation Kit provides samples highly compatible with Minerva Biolabs Venor®GeM Mycoplasma PCR kits. A special protocol allows the purification of the samples in order to meet the high demands of the EP 2.6.7. The sample DNA is eluted in a volume of 60 µl in a high concentration and purity for maximum sensitivity of the PCR. The kit works with DNA extraction columns which are directly suitable for the treatment of up to 200 µl of your sample.

Recommended Use / Scope For DNA extraction from:Cell culture supernatants including cells and cell debrisATMPsSamples with polymers and glycerine (e.g. cryo conservation media)Cell culture mediaProtein solutions, incl. antibodies and enzymes

Kit Components Spin columnsCollection tubesConditionerBinding bufferWash and elution buffers

Package Sizes Cat. No. 56-1010 10 extractionsCat. No. 56-1050 50 extractionsCat. No. 56-1200 200 extractions

Required Consumables Ethanol is required for the reconstitution of the wash buffer but not included in the kit. Microcentrifuge vials (1.5 ml) are needed for DNA elution.

At protein concentrations above 10 mg/ml in the sample pretreatment with Proteinase K is strongly recommended (Cat. No. 11-9905).

Shelf Life and Storage Stored at room temperature.

Compliance The protocol allows purification of the samples to meet the EP 2.6.7 criteria.

Venor®GeM qEP Venor®GeM Sample Preparation Kit

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Food & Water Assays



Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the Venor®GeM Sample Preparation Kit and mycoplasmal DNA amplified with Venor®GeM qEP. PCR was performed on a MxPro – Mx3005P®.

1 x positive control

2 x negative control

6 x 10 CFU

Features

Description European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml sample volume for NAT-based methods like PCR to replace the traditional culture method. This feature of the test method must be shown by the performing lab as part of the robustness testing in presence of the sample matrix. As most cell culture labs and production facilities cannot accept vital mycoplasma in their facility or do not have access to a microbiology lab able to cultivate mycoplasma, 10CFU™ Mycoplasma Sensitivity Standards allow safe and reliable validation of the procedure.

The mycoplasma have been cultivated in culture broth as described in EP 2.6.7, titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by different operators for highest precision. The mycoplasma broth was harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU:CFU ratio. All strains have been obtained from official culture collections and cultivated in low passages.

Recommended Use / Scope For validating the robustness and sensitivity of NAT-based mycoplasma test methods in presence of the sample matrix.Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample matrix of interest, a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.

Kit Components 3 vials with 10 CFU of the corresponding mycoplasma species2 negative control vials

For the mycoplasma set:2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 2 negative controls

Features

Selection Cat. No. 102-1003 Mycoplasma argininiCat. No. 102-2003 Mycoplasma orale Cat. No. 102-3003 Mycoplasma gallisepticumCat. No. 102-4003 Mycoplasma pneumoniaeCat. No. 102-5003 Mycoplasma synoviaeCat. No. 102-6003 Mycoplasma fermentansCat. No. 102-7003 Mycoplasma hyorhinisCat. No. 102-8003 Acholeplasma laidlawiiCat. No. 102-9003 Spiroplasma citriCat. No. 102-0002 Mycoplasma Set, all EP 2.6.7 listed species

Result Evaluation Use of a suitable Mycoplasma PCR kit, e.g. Venor®GeM Classic (SEE PAGE 13) or Venor®GeM qEP (SEE PAGE 16)

Required Consumables None

Required Lab Devices Regular lab equipment (centrifuge, pipettes, etc.)

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months

10CFU™ Mycoplasma Sensitivity Standards

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Food & Water Assays



Benefits

Universal and highly effective for mycoplasmaMynox® is the first biological reagent that eliminates mycoplasma by killing and not just inhibiting their growth. Mynox® is effective against any type of microorganisms belonging to the group of Mollicutes, including Mycoplasma, Spiroplasma, Acholeplasma, and Ureaplasma.

Even for virus stocksMynox® is the only anti-mycoplasma reagent that can be used to clean stocks of non-enveloped viru-ses directly.

FastMynox® has been shown to be effective with only one treatment.

Universal for cell linesMynox® can be used for any cell type without restriction (permanent cell lines like Vero, BHK21, GBK, ML, Hep2, 293, CRFK, H9, Molt4, MT-4, Jurkat, or even stem cells) as well as virus stocks (e.g. SHV-1, BHV-1, HSV-1, VSV, SFV, FCV, MEV etc.).

Save to cellsTo date, Mynox® has not been shown to cause any changes in normal cell characteristics. The cytoto-xicity of Mynox® is low. In the rare case of cytotoxic effects, Mynox® is easily removed after treatment by replacing the culture medium.

InteroperableMynox® can be used with antibiotic selection agents, for example G418, blastocyclin, and hygromycin. It also does not interfere with killer genes turned on by tetracyclin or doxycyclin.

Mycoplasma Elimination Reagents

Mycoplasma are parasitic bacteria which are either present in the supernatant of a cell culture or attached to the surface of the host cell. The lack of a cell wall makes myco-plasma resistant to many antibiotics. Active penetration and intracellular existence of mycoplasma is scientifically discussed and not generally accepted for cell lines routinely used in the cell culture lab.Mynox® is a biological agent that integrates selectively into the mycoplasma membrane and compromises its integrity. The result is an osmotic influx that leads to the complete disintegration of the mycoplasma membrane. (SEE FIGuRE BELOW) With mycoplasma eradicated, cells can immediately return to their native morphology and normal proliferation rates.

Fig. Electron micrograph showing the effects of Mynox® when applied

to contaminated cell cultures.

(A) Mycoplasma contaminated cell culture before treatment.

(B) With one application of Mynox® membranes of all mycoplasma are

destroyed while the membrane of the mammalian cell is unaffected.

Black arrows indicate mycoplasmas, white arrows indicate parts of a

mammalian cell.

A

B

Fig. Cytotoxicity of Mynox® Gold on contaminated cells. Adherent cell lines (Vero, ML/S MDBK and RK13) were treated with Mynox® Gold according to the protocol for 4 days. The cultures were inactivated and stained as described by Flick & Gifford. Untreated cultures had been used as reference (100 %).

30

20

10

0Vero ML/S MDBK RK13

0 %5 % 6.5 %

10.3 %

Cyt

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y (%

)

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Food & Water Assays



Features

Description The classic Mynox® is an antibiotic-free formulation; its effect is based on a biophysical mechanism, thus there is no development of resistant strains. Mycoplasma are permanently destroyed within 2-3 hours.

Benefits Free of antibiotics.

Recommended Use / Scope Mynox® is intended for research use only. Not applicable for clinical treatment. The direct treatment of enveloped viruses is not possible.

Kit Components Mynox® is a sterile, ready-to-use solution, aliquoted per tube for single use, 200 µl per vial.

Package Sizes Cat. No. 10-0200 2 applicationsCat. No. 10-0500 5 applicationsCat. No. 10-1000 10 applications1 application can be used to cure one cell culture permanently from mycoplasma contamination.

Result Evaluation Elimination success should be verified with a suitable mycoplasma detection system, e.g. Minerva Biolabs’s Venor®GeM Mycoplasma PCR Detection Kits (PAGE 13-16).

Required Consumables 6-well tissue culture plate or small tissue culture petri dish (6 mm Ø)Regular cell culture plastics.

Required Lab Devices Regular cell culture equipment (incubator, centrifuge, pipettes, etc.).

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months.

Features

Description Mynox® Gold represents the further development of the classical Mynox®. Mynox® Gold is a combination of a standard antibiotic and the biological Mynox® reagent. One application comprises of a starter and a main treatment. The starter treatment eliminates most of the mycoplasma particles without harming the cells. The main treatment kills all remaining mycoplasma.

Benefits No cytotoxicity - cytotoxicity is basically not detectable for most cell types. Most cell lines do not show any changes in morphology during treatment.

Low resistance risk - due to the combination of an antibiotic and a reagent showing a biophysical mode of action directly eliminating the mycoplasma, formation of resistances against Mynox® Gold is most unlikely.

Highly effective - the ratio for a permanent eradication is close to 100 %.

Recommended Use / Scope Mynox® Gold is intended for research use only. Not applicable for clinical treatment. Not applicable for the direct treatment of cells used as host systems for enveloped viruses or harboring Chlamydia or other bacteria. The antibiotic portion of the product might affect the intracellular microorganisms.

Kit Components 1 application of Mynox® Gold contains 1 vial for the starter treatment and 3 vials for the main treatment. Each vial contains 500 µl of a sterile, ready-to-use solution.

Package Sizes Cat. No. 10-0201 2 applicationsCat. No. 10-0501 5 applicationsCat. No. 10-1001 10 applications1 application can be used to cure one cell culture permanently from mycoplasma contamination.

Result Evaluation Elimination success should be verified with a suitable mycoplasma detection system, e.g. Minerva Biolabs’s Venor®GeM Mycoplasma PCR Detection Kits. (SEE

PAGE 13-16)

Required Consumables 6-well tissue culture plate or small tissue culture petri dish (6 mm Ø)Regular cell culture plastics.

Required Lab Devices Regular cell culture equipment (incubator, centrifuge, pipettes, etc.).


Mynox® GoldMynox®

22 23




Food & Water Assays



Onar® Bacteria – Bacteria Detection Kit

Bacteria are frequently found as contaminants in cell cultures. Studies have identified an overall 6 % incidence of bacterial contamination of cell cultures examined. Many cell cultures lack visual signs of bacterial contamination, by microscopy as well as culture medium indicator. Moreover, it has been demonstrated that standard antibiotics are ineffective against resistant bacterial infection and also have a strong impact on cell growth and differentiation. Onar® Bacteria utilizes the polymerase chain reaction (PCR) for highly sensitive detection of bacterial contamination in various in situ biologicals including cell cultures and virus stocks. The primer set is specific to a highly conserved region within the 16S ribosomal RNA gene in the bacteria genome. This allows for detection of all bacteria species tested thus far and usu-ally encountered as airborne contaminants in cell cultures. Eukaryotic DNA is not amplified by Onar® Bacteria. The Primer/Nucleotide Reaction Mix already provides an Internal Control DNA as an essential tool for successfully executed reactions.

Benefits

SensitiveDetection of 10 copies per sample volume, corresponding to ~40 fg bacterial DNA (e.g. Bacillus subtilis).

Broad Range Detection of more than 45 bacteria genera: Actinomyces, Bacillus, Enterococcus, Escherichia coli, Fuso-bacterium, Klebsiella, Lactobacillus, Micrococcus, Mycobacterium, Peptostreptococcus, Pseudomonas, Por-phyromonas, Prevotella, Salmonella, Serratia, Staphylococcus, Streptococcus, etc.

Reliable and RapidThe kit contains positive control DNA, and an internal control to eliminate the possibility of false-nega-tive results. Hands-on time less than 40 min.

ConvenientThe Primer/Nucleotide Reaction Mixes are always aliquoted for long time stability and easy handling. The protocol only requires a few pipetting steps which reduces time, risks for mistakes and contamination.The kit works with samples prepared by boiling the supernatant of cell cultures or other sample material. Only complex matrices need to be prepared by DNA isolation using common methods.

ClearA clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious detection or cost-intensive devices are required.

StableThe relevant kit components are freeze-dried and need to be rehydrated with a supplied buffer to redu-ce shipping costs and increase product stability

Contamination preventionThe kit can also be used with UNG for carry-over prevention. UNG is not included.

Fig. The amplified PCR products are visualized by standard gel electrophoresis.

1 kb DNA Ladder

positive control DNA

negative sample/internal control

1000 copies (positive sample)



1 copy

210 bp468 bp

Onar® Bacteria

Features

Description PCR kit for conventional, endpoint PCR of bacteria in various in situ biologicals including cell cultures and virus stocks.

Recommended Use / Scope Applicable in research and industry for direct testing of cell cultures and biologicals. For QA application specific validation might be required. Intended for research use only. Not recommended for clinical diagnostics or testing of human samples.

Kit Components Freeze-dried Primer/Nucleotide Mix including the internal amplification control DNAand polymeraseRehydration bufferFreeze-dried positive control DNAPCR grade Water

Package Sizes Cat. No. 12-1025 25 TestsCat. No. 12-1050 50 TestsCat. No. 12-1100 100 TestsCat. No. 12-1250 250 TestsPrimer/Nucleotides/Polymerase sets are prepared in aliquots for 25 tests.


Required Consumables PCR reaction tubes


Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C.

24 25




Food & Water Assays



Decontamination, Disinfection, and Prevention

There are manifold ways how contaminations either through cell culture setup, the media components or the equipment can impact your results: It is speculated that more than 60-70 % of the cell cultures worldwide are contaminated with myco-plasma. Mycoplasma are the smallest self-replicating organisms (0.1 to 0.8 μm) known thus far. Myco-plasma lack a cell wall which makes them resistant to cell wall specific antibiotics, such as penicillin. Also other microorganisms like bacteria, fungi and viruses are common contaminations of cell cultures, cell culture equipment and water reservoirs. Water required for water and heating baths, reservoirs and in CO

2 incubators is preset to microbial contamination due to ideal environmental conditions.

For these reasons it is of special interest and need to take any preventive action to avoid contami-nations with unwanted microorganisms impacting your results or risking to lose your valuable cell cul-tures: • ZellShield® protects cell cultures from a broad range of common contaminants. ZellShield® is active against most intracellular and extracellular growing gram negative and gram

positive bacteria, mycoplasma, protozoon, fungi and yeast.

• WaterShield™ protects the water in the reservoir from microbial growth. WaterShield™ can be used in any kind of laboratory water reservoirs and is compatible with common work surfaces.

• Mycoplasma-Off™ is a highly effective solution for cleansing and disinfection of all suitable labora-tory surfaces and apparatus. Mycoplasma-Off™ is outstandingly safe in use possessing not only a strong mycoplasmacidal effect, but also being effective against bacteria, yeasts and viruses: My-coplasma-Off™ has been proven to be effective against bacteria such as Staphylococcus aureus, Enterococcus hirae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans, BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus.

Features

Description ZellShield® protects cell cultures from a broad range of common contaminants. The extremely powerful combination of innovative antibiotics is blocking the bacterial DNA synthesis, the protein biosynthesis or shows macrolidic properties. These bactericidal features allow the permanent removal of contaminants from the culture. The use of old fashioned antibiotics like penicillin/streptomycin, nystatin or amphotericin B is no longer required!

Benefits Broad applicabilityZellShield® can be used for permanent cell cultures as well as for the protection of freshly prepared primary cells.

No cell toxicityUp to date, no cytotoxic effect on various cell lines treated nor interference with endotoxin tests have been reported if used as described.

SpecificityZellShield® is active against most intracellular and extracellular growing gram negative and gram positive bacteria, mycoplasma, protozoa, fungi, and yeast.

Easy to useSimply add ZellShield® directly to a freshly prepared cell culture or premix with the cell culture medium. The mix is stable for up to 4 weeks at 2-8 °C.

StabilityThe reagent is stable and active during typical incubation periods and conditions.

Low Resistance RiskThe well selected antimicrobials show an extremely low resistance bias. Their combined activity reduces the probability for the survival of resistant mutants.

Recommended Use / Scope Applicable in research and industry for cell cultures only. Not recommended for clinical applications.

Kit Components The easy applicable 100x aqueous solution is sterile filtrated and ready-to-use.

Package Sizes Cat. No. 13-0050 50 mlCat. No. 13-0150 3x 50 ml

Result Evaluation None

Required Consumables Cell culture equipment

Required Lab Devices Pipetting equipment

Shelf Life and Storage Shipped on cool packs and should be stored in the dark below -18 °C. Stable for at least 12 months.

ZellShield® The Cell Culture Contamination Preventive

26 27




Food & Water Assays



Features

Description Mycoplasma-Off™ Wipes are the simple solution for cleaning and disinfecting a variety of laboratory surfaces at the same time. There’s no need for multiple products when you have the convenience of a simple-to-use wipe. When you use a sponge or even paper towel, you can spread bacteria from one surface to another. Instead of killing germs, you are pushing them around and potentially increasing the contaminated surface area.

Benefits Broad ApplicabilityMycoplasma-Off™ Wipes can be used on hard, nonporous surfaces in every room of the lab including safety cabinets, pipettes, cell storage boxes, lab equipment exterior (like liquid nitrogen containers), incubator interior, and many more.

Non-corrosive and non-carcinogenicMycoplasma-Off™ Wipes are made with a bleach-free formula leaving a light, clean scent every time you wipe off a surface. Mycoplasma-Off™ Wipes are soaked with an alcohol-based, non-corrosive and non-carcinogenic solution. They can be used as a routine contamination control program or for known or suspected mycoplasma challenges.

Broad inactivation rangeMycoplasma-Off ™ Wipes kill mycoplasma within seconds. Wipes are also effective against common bacteria such as Staphylococcus aureus, Enterococcus hirae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans, BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus.

Easy to useIt’s simple. Wipe surface clean with Mycoplasma-Off™ Wipes. Let it air-dry. Convenient where spraying is not applicable (e.g. covers of electronic devices, electronic pipettes).

Recommended Use / Scope Applicable in research and industry, only. Not recommended for clinical applications. Use as directed. Always test a small area first for stability and coloration. Mycoplasma-Off™ Wipes should not be used on alcohol sensitive surfaces like acrylic and fiberglass.

Kit Components Single use wipes in a product safety sachet.

Package Sizes Cat. No. 15-1001 120 wipes in a dispenser boxCat. No. 15-5001 5x 120 refill sachets


Required Lab Devices None

Shelf Life and Storage Stable at room temperature for at least 12 months.

Features

Description Mycoplasma-Off™ is used for cleaning and disinfection of all laboratory surfaces and apparatus, including clean benches, incubators, work benches, cell storage boxes and liquid nitrogen containers from mycoplasma contamination.

Benefits RapidMycoplasma-Off™ affects mycoplasma immediately. Within seconds mycoplasma are completely eradicated.

Non-corrosive and non-carcinogenicMycoplasma-Off™ is an alcohol-based, non-corrosive and non-carcinogenic.

Broad spectrum of antimicrobial activityBactericidal, fungicidal, and virucidal! Mycoplasma-Off™ is outstandingly safe in use. It possesses not only a strong mycoplasmacidal activity but was also found to be effective against as Staphylococcus aureus, Enterococcus hirae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans, BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus.

Convenient and ready-to-useMycoplasma-Off™ is a ready-to-use solution supplied in a refillable spray bottle use of Mycoplasma-Off™ is fast, easy and ideal to maintain a clean work area.

Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications. Use as directed. Always test a small area first for stability and coloration. Mycoplasma-Off™ should not be used on alcohol sensitive surfaces like acrylic and fiberglass.

Kit Components Ready-to-use formulation in a spray bottle or refill bottles.

Package Sizes Cat. No. 15-1000 1000 ml spray bottleCat. No. 15-5000 5x 1000 ml refill bottle

Result Evaluation None

Required Consumables Paper towels



Mycoplasma-Off™Disinfection Spray for the Removal of Mycoplasma

Mycoplasma-Off™ WipesQuick and Easy Cleaning & Disinfection

28 29




Food & Water Assays



Features

Description Water required for CO2 incubators is preset to microbial contamination due to

ideal environmental conditions. WaterShield™ protects the water in the reservoir from microbial growth.

Benefits Broad ApplicabilityWaterShield™ can also be used in regular water/heating baths and is compatible with common work surfaces (e.g. tin plated iron, chrome, nickel steel, high grade steel and copper).

No cell toxicityThe water additive contains quaternary ammonium compounds and surfactants as disinfecting and cleaning ingredients, but no aldehydes, phenols, alcohols or azides. These reagents are not vaporizing and are therefore safe to the cells. All ingredients are safe to humans and do not cause any irritating effects to the skin when used in the recommended concentration. No odor annoyance is noticeable.

Broad inactivation rangeWaterShield™ is active against most bacteria, mycoplasma, protozoa, algae, fungi and yeast.

Easy to useSimply add one bottle (5 ml) of WaterShield™ directly to one liter of deionized water.

StabilityThe reagent is usually active for 4 weeks. A blue stain indicated the status of the additive. In case of increasing bioburden a renewal of the water and the additive is required.

Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications. Do not use with acrylic glass or aluminum surfaces.

Kit Components The easy applicable 200x aqueous solution is provided in aliquots of 5 ml ready-to-use for 1 liter of water.

Package Sizes Cat. No. 15-3015 30x 5 mlCat. No. 15-3020 3x 50 mlCat. No. 15-3050 500 ml

Result Evaluation Color change



Shelf Life and Storage Shipped and storage at room temperature. Stable for at least 12 months.

WaterShield™Water Disinfection Additive

MB Taq DNA Polymerasehot start

Features

Description MB Taq DNA Polymerase is a highly processive 5´→3´ polymerase with no 3´→5´ exonuclease (proofreading) activity. At 72 °C and around pH 9 conditions, MB Taq DNA Polymerase reaches its highest level of activity, capable of amplifying a standard 1 kb strand of DNA in approximately 30 seconds. The Taq‘s activity is blocked at ambient temperature, e.g. while preparing your sample. The inhibition of the Taq polymerase is completely reversed when the temperature is above 70 °C. Complete activation of the polymerase is achieved at 94 °C for 2 min. MB Taq DNA Polymerase is supplied with a 10x buffer for maximal yield and sensitivity which should fit most standard applications.

Recommended Use / Scope Routine and multiplex PCR; real-time PCR; T/A cloning; DNA labeling with biotin, digoxygenin or radioactive nucleotids; sequencing of double or single stranded DNA

Kit Components MB Taq DNA Polymerase, supplied in 10 mM Tris-HCl (pH 7.0), 50 mM KCl, 0.1 mM EDTA, and 50 % (v/v) glycerol. 10x reaction buffer.100 mM MgCl

2 solution.

If the polymerase is used in combination with Venor®GeM Classic the buffer provided with the polymerase is not required.

Package Sizes MB Taq DNA Polymerase available in concentrations of 1 u/μl and 5 u/μl.

1 Unit/μlCat. No. 53-1050 50 UnitsCat. No. 53-1100 100 UnitsCat. No. 53-1200 200 UnitsCat. No. 53-1250 250 Units

5 Unit/μlCat. No. 53-0050 50 UnitsCat. No. 53-0100 100 UnitsCat. No. 53-0200 200 UnitsCat. No. 53-0250 250 Units

Shelf Life and Storage Components must be stored below -18 °C. Shipment on cool packs. The product is stable for at least 12 months.

30 31




Food & Water Assays




32 33

34 35

Introduction

False negative PCR results or unspecific amplifications might be caused by a defect PCR cycler. Both events are highly critical for Good Laboratory Practise. Verification of the correct temperature control of the used equipment is usually a stressful but essential issue. To comply with quality management systems is not easy to fulfil for PCR cyclers. Electronic temperature sensors offered for purchase or as service usually measure the temperature homogeneity in a cycler block, only, which does not neces-sarily reflect all parameters which need to be controlled by the cycler and can fail to provide reliable PCR results. Only a reference setup can investigate all relevant parameters of the process reliably. The PCR Cycler Check™ kits allow a realistic verification of block and air heated PCR cyclers for ins-tallation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) according to legal requirements, like ISO 17025, EN 45001, ISO 13485, ISO/TS 20836:2007, GLP, GMP and others.The PCR Cycler Check™ series provides temperature sensitive PCR reactions to monitor an upper and lower temperature range in one PCR reaction. The primer sequences and the PCR protocol were desig-ned to react extremely sensitive on fluctuations of more than 2 °C within the cycler protocol with a drop out of amplification. This way the temperature homogeneity, the precision of the temperature control and the timing can be verified. In addition, the pre-adjusted target concentrations are only amplified at high PCR efficiencies as an additional indicator for accurate temperature control of the thermal cycler.

Features

Type of Thermal Cycler Traditional, block heating, thermal cyclers

Description PCR Cycler Check™ is available as OneStep and Advance version. PCR Cyc-ler Check™ OneStep is a ready-to-use lyophilized master mix in a tube while the Advance version is pre-aliquoted and lyophilized in high profile stripes ready upon rehydration with buffer.

Recommended Use / Scope Applicable with any block PCR cycler in research or industrial quality assurance lab in order to fulfil legal requirements for the reliability testing of instruments used for analysis (ISO 17025, EN 45001, ISO 13485, GLP, GMP).

Kit Components AdvancePrimer sets, template, nucleotides, and polymerase, lyophilized, filled in 0.2 ml PCR reaction tubes (stripes). Rehydration buffer, gel size marker for result interpretation.

OneStepPrimer sets, template, nucleotides, and polymerase lyophilized in one tube. Rehydration buffer, gel size marker for result interpretation.

Package Sizes Cat. No. 57-2102 6 strips, 8 vials each

Cat. No. 57-2103 100 reactions


Required Consumables Reagents for agarose gel electrophoresis

PCR reaction tubesReagents for agarose gel electrophoresis

Required Lab Devices Tube centrifuge, Pipetting equipment, PCR cycler. Agarose gel electrophoresis and documentation system


After rehydration of the individual PCR tubes the reagents must be used within 1 hour.

After rehydration the reagents must be stored below -18 °C

PCR Cycler Check™




Food & Water Assays



36 37

qPCR Cycler Check™ Color Compensation Kit

Features

Type of Thermal Cycler Real-time PCR (qPCR) thermal cyclers with optical unit

Description The qPCR Cycler Check™ kit is based on the well-established PCR Cycler Check™ temperature sensitive PCR but additional temperature sensitive probes allow you to monitor quantitative realtime PCR cycler precision in one PCR reaction. Probes of each amplification system are labeled with different fluorescent dyes to allow individual evaluation.

Recommended Use / Scope Applicable for any real-time qPCR cycler in research or industrial quality assurance lab in order to fulfil legal requirements for the reliability testing of instruments used for analysis (ISO 17025, EN 45001, ISO 13485, GLP, GMP). The kit can be used with block as well as with air heating systems.

Kit Components Freeze-dried primer/probe sets, polymerase and nucleotidesRehydration Buffer

Package Sizes Cat. No. 57-2202 100 reactions

Result Evaluation Measuring fluorescence signal with qPCR cycler.

Required Consumables qPCR reaction tubes and caps

Required Lab Devices Tube centrifugePipetting equipmentqPCR cycler with filters for the detection of FAM™, VIC™ and ROX™ dyes

Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C

Features

Type of Thermal Cycler Real-time PCR (qPCR) thermal cyclers with optical unit

Description The Color Compensation Kit is designed for generating color compensation files on qPCR cyclers to allow proper interpretation of multiplex experiments. To generate a color compensation object, the labeled calibration dyes are used in an initial color compensation run. The calibration dyes contain labeled oligonucleotides for the determination of crosstalk corresponding to each individual dye being used in a multiplex assay, and a blank reaction buffer without dye for the determination of background fluorescence of the buffer.

Recommended Use / Scope As real-time qPCR cyclers may vary in their fluorescence detection sensitivity, color compensation experiments must be performed on each specific multiplex PCR instrument. In the case of overcompensation or remaining crosstalk it is recommended to adjust the calibration dye concentration used for performing the color compensation experiment to result in an equal level of (absolute) fluorescence signal.

Kit Components Calibration dyes for different wavelengths, freeze-driedRehydration buffer

Package Sizes 10 calibrations, 25 µl eachCat. No. 57-0110 FAM™, ROX™ and VIC®Cat. No. 57-0210 FAM™Cat. No. 57-0310 TAMRA™Cat. No. 57-0410 ROX™Cat. No. 57-0510 VIC®Cat. No. 57-0610 SYBR® GreenCat. No. 57-0710 JOE™Cat. No. 57-0810 CY-3™Cat. No. 57-0910 CY-5™Cat. No. 57-1010 Texas Red®

Result Evaluation Generation of color compensation files

Required Consumables qPCR reaction tubes and caps

Required Lab Devices Tube centrifuge, pipetting equipment, qPCR cycler

Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C




Food & Water Assays



Food and Water Testing

38 3938 39

40 41

AquaScreen®

AquaScreen® is a test system for quantitative detection of water pathogens. AquaScreen® combines water filtration, lysis of the collected microorganisms, DNA extraction and elution of the DNA in mini-mal volumes ready for subsequent PCR analysis.

Step 1: Preparation of the Sample MaterialDrinking water, condensed water from cooling systems, bathing or pool water, and waste water released from suspended particles can be used as sample materials. The sample conditioning affects the re-liability of the test findings and must be in accordance with the guidelines ISO Norm 11731/11731-2. Preservation with chemical or physical means is not possible as intact microorganisms are needed for the filtration procedure. With suspended particles or fixed volatile contents, contaminated water samples can be purified by prior filtration with a paper folded filter. The samples may not be centrifuged for purification. The testing procedure requires 100-1000 ml.

Step 2: PCR ApplicationThe AquaScreen® qPCR kits are assays for quantitative detection of Legionella pneumophila, Legionella species, Pseudomonas aeruginosa and Escherichia coli in water samples. The test is based on quanti-tative real-time PCR (qPCR) which allows for highest specificity and sensitivity. The corresponding PCR mix contains a primer/probe set specific for the microorganism to be detected and emits a fluorescent light at ~520 nm. The kit includes an internal control that is detected by another probe emitting light at ~610 nm. The internal control is constructed as a homologous control containing primer binding sites identical to the target but with a unique internal sequence. In addition, a surrogate spike can be used to monitor the pre-analytical process. By using the supplied internal control or alternatively the surrogate spike, false negative results (e.g. due to inhibition of the reaction by the sample matrix) can be excluded individually for each sample.

Benefits

Very sensitiveDetection accomplished with less than 500 microorganisms per sample volume of 1000 ml.

Ease of useSample preparation includes simple water filtration and DNA extraction prior to direct PCR analysis.

Instrument compatibilityOur assays work with most available qPCR cyclers with the standard filters for FAM™ and ROX™/Texas Red® if not specified otherwise. All kits are tested on the following qPCR devices: ABI Prism®7500, Ro-torGene®6000, Mx3005P®, LightCycler® 1.2.

One extract – multiple parametersThe AquaScreen® FastExtract procedure is very simple and represents an inexpensive method to obtain suitable template DNA for routine PCR tests. In addition one extract can be used for PCR reactions with different specificities, so that multiple microorganisms can be analyzed in parallel and on users’ choice.

FastThe fast extraction procedure in combination with the rapid PCR method allows detection of patho-genic organisms (including those that may be non-culturable) in industrial and environmental water samples within a few hours.

Recognizes VBNC (Viable But Not Culturable)Free DNA of dead and already lysed microorganisms in the sample pass through the membrane filter and are not detectable in the test system. The test detects both “viable and cultura-ble” and “viable but not culturable” (VBNC) legionella. The effect of hygiene measures like heat treat-ment can be monitored instantly.

ReliableThe extraction kit contains only high quality products, including amongst others membrane filters, spin columns and buffers. All components have been pre-tested for DNA contamination.


StableAll PCR kits are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.

Contamination preventionAll PCR kits can also be used with UNG for carry-over prevention (UNG is not included).




Food & Water Assays



42 43

Features

Description Rapid DNA Extraction from water samples

Recommended Use / Scope AquaScreen® FastExtract can be used with your established suction device (47 mm frit) for the extraction of legionella and other microbial contaminations. AquaScreen® FastExtract is optimized for high flow and throughput and provides high quality DNA for subsequent PCR analysis.

Kit Components Membrane filtersIncubation dishesIncubation, collection and sample storage tubesLysis, binding buffer, wash, and elution buffers

Package Sizes Cat. No. 32-1010 10 extractionsCat. No. 32-1050 50 extractions

Required Consumables Ethanol (96-100 %)

Required Lab Devices Vacuum pumpMicro centrifugeFiltration system, 47 mm fritPipetting equipment and filtered tipsIncubator (37 °C for petri dishes, 70 °C for reaction tubes)

Shelf Life and Storage Kit components are maintainable at room temperature for at least 12 months.

Compliance AFNOR XP T90-471 and ISO/TS 12869:2012

Features

Type of PCR Quantitative real-time PCR (qPCR)

Description The AquaScreen® Legionella species qPCR Detection Kit is used for DNA sam-ples prepared with the AquaScreen® Fast Extract for quantification of Legionella in waters samples. The supplied primer set is specific for a braod range of legio-nella species, but does not detect other water born bacteria as required by ISO/TS 12869:2012.

Recommended Use / Scope Applicable for water testing as described in ISO/TS 12869:2012, in research and industry for QA testing of process water. Not recommended for clinical diagnos-tics, testing of human samples or pharmaceutical products.

Kit Components Freeze-dried primer, probes, nucleotides and polymeraseRehydration BufferFreeze-dried Positive Control DNAFreeze-dried Internal Amplification Control

Package Sizes Cat. No. 33-2025 25 reactionsCat. No. 33-2100 100 reactionsCat. No. 33-2250 250 reactionsPrimer sets and nucleotides are prepared in aliquots for 25 tests.

Required Consumables qPCR reaction tubes and capsOptional: For calibration we recommend our Legionella pneumophila PCR Quan-tification Standard (Cat. No. 52-0101).

Required Lab Devices Pipetting equipmentqPCR cycler with filter sets for FAM™ and ROX™

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re-hydration the reagents must be stored below -18 °C


AquaScreen® FastExtract AquaScreen®

Legionella species




Food & Water Assays



44 45

AquaScreen®

Features


Description The AquaScreen® Pseudomonas aeruginosa qPCR Detection Kit is used for DNA samples prepared with the AquaScreen® FastExtract for quantification of Pseu-domonas aeruginosa in water samples.

Recommended Use / Scope Applicable in research and industry for QA testing of household and process wa-ter. Not recommended for clinical diagnostics, testing of human samples or phar-maceutical products.



Required Consumables qPCR reaction tubes and capsOptional: For calibration we recommend our Pseudomonas aeruginosa PCR Quan-tification Standard (Cat. No. 52-0071).

Required lab devices Pipetting equipmentqPCR cycler with filter sets for FAM™ and ROX™

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re-hydration the reagents must be stored below -18 °C

Compliance No guidelines are available for molecular testing of Pseudomonas aeruginosa in water samples.

Features


Description The AquaScreen® Legionelle pneumophila qPCR Detection Kit is used for DNA samples prepared with the AquaScreen® FastExtract for quantification of Legio-nelle pneumophila in water samples.




Required Consumables qPCR reaction tubes and capsOptional: For calibration we recommend our Legionella pneumophila PCR Quan-tification Standard (Cat. No. 52-0101).


Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re-hydration the reagents must be stored below -18 °C.


AquaScreen® Legionella pneumophila Pseudomonas aeruginosa




Food & Water Assays



46 47

Features


Description The AquaScreen® Escherichia coli qPCR Detection Kit is used for DNA samples prepared with the AquaScreen® FastExtract for quantification of Escherichia coli in waters samples.




Required Consumables qPCR reaction tubes and capsOptional: For calibration we recommend our Escherichia coli PCR Quantification Standard (Cat. No. 52-0083).


Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re-hydration the reagents must be stored below -18 °C.

Compliance No guidelines are available for molecular testing of Escherichia coli in water sam-ples.

AquaScreen® Escherichia coli




Food & Water Assays



48 49

Food Control™

Detecting bacterial contamination is a key aspect in food microbiology. Consequently, microbiological quality control programs are intensified throughout food chain production in order to minimize the risk of intoxicating consumers. Reliability, speed and robustness of a test system to detect the presence or absence, or even the degree of contamination with pathogens, becomes increasingly important.

Food Control™ kit series includes Food Control™ qPCR, Food Control™ LFA and Food Control™ LFA+ PCR kits for fast and reliable detection of foodborne pathogens via real-time PCR or via our proprietary Lateral Flow Assay (LFA) technology, respectively. Food Control™ qPCR is a diagnostic system for easy determination of contamination degree in agricultural or food industry via real-time PCR. LFA techno-logy provides stripes as an easy read-out making DNA gels obsolete and in combination with our LFA+ cartridges and pre-cast chambers provide maximum contamination prevention. Food Control™ kits can be combined with our optimized DNA extraction system ExtractNow™ Food Control.

Benefits

Very sensitiveDetection accomplished down to 10 DNA copies/assay.

Ease of useIsolated total DNA from potentially contaminated food serves as starting material, typically after pre-cultivation in a suited sample growth medium. Detection is done via qPCR or via conventional PCR plus Lateral Flow Assay (LFA) technology, making gels unnecessary and if combined with pre-cast hybridiza-tion cartridges and chamber significantly reduces carry-over.

Instrument CompatibilityFood Control™ qPCR works on cyclers with FAM™ and HEX™ filters.Food Control™ LFA requires any conventional PCR cycler.

One extract – multiple parametersOne extract can be used for PCR reactions with different specificities, so that multiple microorganisms can be analyzed in parallel and on users’ choice.


StableAll master mixes are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.





Food & Water Assays



50 51

Features


Description Taqman® Assay based on FAM and HEX labeled probes. Food Control™ qPCR is a PCR-kit for fast and reliable detection of foodborne pathogens via real-time PCR.

Recommended Use / Scope Can be used in research and industry for detection of pathogenic contamina-tion in food or agricultural products. Do not use for clinical diagnostic or testing of patient samples.

Kit Components qPCR mix, species mix, rehydration buffer, PCR grade water, internal control, positive control

Package Sizes 25 reactions each:Cat. No. Species11-02-01-025 Salmonella enterica 11-02-02-025 Yersinia enterocolitica 11-02-03-025 Shigella spp. 11-02-04-025 Campylobacter spp. 11-02-05-025 Clostridium perfringens 11-02-06-025 Shiga Toxin 1 11-02-07-025 Shiga Toxin 2 11-02-08-025 Escherichia coli O15711-02-09-025 Escherichia coli O104 11-02-10-025 Listeria spp.11-02-11-025 Listeria monocytogenes 11-02-12-025 Salmonella spp.

Required Consumables PCR reaction tubes, 1.5 ml reaction tubes Optional: DNA can be extracted from enrichment broth using the DNA extraction kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method.

Required Lab Devices qPCR cycler with FAM™ and HEX™ filter, variable microliter pipettes, benchtop centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage Components can be stored at +2 to +8 °C for at least 12 months. After rehydra-tion the reagents must be stored below -18 °C.

Compliance No, certification in progress

Food Control™ qPCR

Features

Description Spin column based DNA extraction method for a broad range of different enrich-ment broths as starting material. Using a cutting-edge chemistry, the duration of the DNA purification is reduced to a minimum.

Recommended Use / Scope The ExtractNow™ Food Control kit is for research and industrial use only. Not rec-ommended for clinical applications. The kit is used for the extraction of bacte-rial DNA only. The kit is not suitable for the extraction of eukaryotic DNA or RNA.

Kit Components Spin filter columns, collection tubes, lysis, wash and elution buffers.

Package Sizes Cat. No. 609-1010 10 extractions Cat. No. 609-1050 50 extractions

Required Lab Devices Micro centrifuge, rack for 1.5 ml tubesVariable microliter pipettes and filter tips

Shelf Life and Storage Components can be stored room temperature for at least 12 months.


ExtractNow™ Food Control




Food & Water Assays



52 53

Features

Type of PCR Conventional PCR, LFA Stripe, Hybridization Cartridge

Description Food Control™ PCR-LFA+ is based on the regular Food Control™ PCR-LFA design, but provides additionally a convenient pre-casted hybridization cartridge. This system allows the single-use, cross-contamination safe reading of the PCR re-sult for each sample individually.


Kit Components PCR Mix, rehydration buffer, PCR grade water, positive control, species specific primer, species specific probe, LFA stripe, LFA running buffer, LFA+ cartridge, LFA cartridge chamber.

Package Sizes 25 reactions each:Cat. No. Species11-04-01-025 Salmonella enterica 11-04-02-025 Yersinia enterocolitica 11-04-03-025 Shigella spp. 11-04-04-025 Campylobacter spp. 11-04-05-025 Clostridium perfringens 11-04-06-025 Shiga Toxin 1 11-04-07-025 Shiga Toxin 2 11-04-08-025 Escherichia coli O15711-04-09-025 Escherichia coli O104 11-04-10-025 Listeria spp.11-04-11-025 Listeria monocytogenes 11-04-12-025 Salmonella spp.

Required Consumables 0.2 ml PCR reaction tubesOptional: DNA can be extracted from enrichment broth using the DNA extraction kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method.

Required Lab Devices Racks for reaction tubes, benchtop centrifuge for reaction tubes or PCR plates, vortex, variable microliter pipettes (1 µl - 1000 µl), sterile filter tips, any conven-tional PCR cycler.

Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After rehy-dration the reagents must be stored below -18 °C.


Food Control™ LFA+

Features

Type of PCR Conventional PCR, LFA StripeFood Control™ LFA is a PCR-kit for fast and reliable detection of foodborne patho-gens via conventional PCR in combination with our reliable Lateral Flow Assay (LFA) evaluation technology.

Description The assay is based on a one tube amplification with a conventional PCR cycler and a subsequent probe specific hybridization technique. The resulting interpre-tation is a simple readout of colored bars on a lateral flow stripe.


Kit Components PCR Mix, rehydration buffer, PCR grade water, positive control, species specific primer, species specific probe, LFA stripe, LFA running buffer

Package Sizes 25 reactions each:Cat. No. Species11-03- …01-025 Salmonella enterica …02-025 Yersinia enterocolitica …03-025 Shigella spp. …04-025 Campylobacter spp. …05-025 Clostridium perfringens …06-025 Shiga Toxin 1

Cat. No. Species11-03- …07-025 Shiga Toxin 2 …08-025 Escherichia coli O157…09-025 Escherichia coli O104 …10-025 Listeria spp.…11-025 Listeria monocytogenes …12-025 Salmonella spp.

Required Consumables PCR reaction tubes, 2.0 ml reaction tubes Optional: DNA can be extracted from enrichment broth using the DNA extraction kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method.

Required Lab Devices Racks for reaction tubes, benchtop centrifuge for reaction tubes or PCR plates, vortex, variable microliter pipettes (1 µl - 1000 µl), sterile filter tips, any conven-tional PCR cycler.



Food Control™ LFA




Food & Water Assays



54 55

Meat ID™ Kits

Meat ID™ kit series includes Meat ID™ Screen and Meat ID™ Halal, which can be combined with our optimized DNA extraction system ExtractNow™ Meat. The identification of different meats, especially in minced meat products is a serious task in food safety and from an ethical perspective, especially for Muslims. Authentication of forbidden or none declared ingredients such as pork or substandard meat is essential to ensure confidence in the supply chain and regulatory compliance.

Meat ID™ Screen introduces our qPCR based screening system for simultaneous detection of the most common meat species, i.e. Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, Zebra in meat and other foods by qPCR. Meat ID™ Screen is provided as lyophilized mix in PCR stripes, which after rehydration is ready to go for your samples and subsequent qPCR. Meat ID™ Halal is a PCR kit for the detection of pork and donkey contamination in meat products and is provided as lyophilized ready to use master-mix. Both kits are available for rapid and reliable analysis from various matrices including raw, or even highly processed and cooked meat products where the DNA may be significantly degraded.

Benefits

Very sensitiveIt is possible to identify relevant species down to a threshold level of 0.5 % with a semi-quantitative result.

Ease of useSample preparation includes simple DNA extraction (ExtractNow™ Meat ID) prior to direct PCR analysis.

Instrument CompatibilityMeat ID™ qPCR works on cyclers with FAM™ and HEX™ filters.




Features

Description Spin column based DNA extraction method for a broad range of meat starting materials. Using a cutting-edge chemistry, the duration of the DNA purification is reduced to a minimum.

Recommended Use / Scope The ExtractNow™ Meat ID kit is for research and industrial use only. Not recom-mended for clinical applications. The kit is used for the extraction of eukaryotic DNA only. The kit is not suitable for the extraction of bacterial DNA or RNA.

Kit Components Spin filter columns, collection tubes, lysis, wash and elution buffers.


Required Lab Devices Micro centrifuge, rack for 1.5 ml tubesVariable microliter pipettes and filter tips


Compliance None

ExtractNow™ Meat ID




Food & Water Assays



56 57

Features


Description Meat ID™ Screen is a kit for the fast and reliable identification of several animal species (Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, Zebra) in meat and other foods by qPCR in a single parallel run.

Meat ID™ Screen is available for rapid and reliable analysis from various matri-ces including raw, or even highly processed and cooked meat products where the DNA may be significantly degraded. It is possible to identify relevant species down to a threshold level of 0.5 % with a semi-quantitative result.

Recommended Use / Scope Can be used in research and industry for detection (screening) of animal species (Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, Zebra) in meat and other foods by qPCR. For research use only! Do not use for clinical di-agnostic or testing of patient samples.

Kit Components Primer sets, nucleotides, polymerase and internal control DNA, lyophilized, filled in 0.2 ml PCR reaction tubes (Stripes). Rehydration buffer, Positive control, PCR grade water.

Package Sizes Cat. No. 12-01-005 5 tests Cat. No. 12-01-020 20 testsCat. No. 12-01-040 40 tests

Required Consumables Pipette tips

Optional: DNA can be extracted from sample material using DNA extraction kits e.g. ExtractNow™ Meat (Cat. No. 608-1050) or user method.

Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop centrifuge for 1.5 and 0.2 ml reaction tubes

Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After re-hydration of the individual PCR tubes the reagents must be used within 1 hour.

Compliance No guidelines are available for molecular testing of meat contamination in meat samples.

Features


Description Meat ID™ Halal is a kit for the fast and reliable identification of pork and donkey contamination in meat and other foods by qPCR.

Meat ID™ Halal is available for rapid and reliable analysis from various matrices including raw, or even highly processed and cooked meat products where the DNA may be significantly degraded. It is possible to identify pork and donkey down to a threshold level of 0.5% with a semi-quantitative result.

Recommended Use / Scope Can be used in research and industry for detection of pork and donkey in meat and other foods by qPCR. For research use only! Do not use for clinical diagnos-tic or testing of patient samples.

Kit Components Primer sets, nucleotides, internal amplification control and polymerase at op-timized concentrations lyophilized in one tube. Rehydration buffer, Lyophilized positive control, PCR grade water.

Package Sizes Cat. No. 12-02-025 25 tests Cat. No. 12-02-100 100 tests

Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, pipette tips Optional: DNA can be extracted from sample material using DNA extraction kits e.g. ExtractNow™ Meat (Cat. No. 608-1050) or user method.



Compliance Halal ethical guidelines

Meat ID™ Screen Meat ID™ Halal




Food & Water Assays



58 59

Features

Description Manual magnetic bead based DNA extraction method for a broad range of food starting materials. Using a cutting-edge chemistry, the duration of the DNA puri-fication is reduced to a minimum.

Recommended Use / Scope The ExtractNow™ Food kit is for research use only. Not recommended for clini-cal applications

Kit Components Magnetic beads, tubes, lysis, wash and elution buffers.


Required Lab Devices Magnetic rack for 1.5 ml tubes (E.G. CAT. NO. 607-0001), variable microliter pipet-tes and filter tips


Compliance None

ExtractNow™ Vegan Control

Vegan Control™ Kits

Vegan Control™ kit series includes Vegan Control™ OneStep and Vegan Control™ Advance, and can be combined with our optimized DNA extraction system ExtractNow™ Vegan Control. Vegan Control™ One-Step is a ready-to-use lyophilized master mix in a tube while Vegan Control™ Advance is pre-aliquoted and lyophilized in high profile stripes ready for your samples upon rehydration with buffer.

The population number of vegetarians and people following the vegan lifestyle increase from year to year. This may be due to ethical, religious, cultural or health reasons. How do you ensure that your ve-gan sausage has really been processed without meat and animal derived products? We offer a quick and inexpensive solution. The solution is Vegan Control™, a qPCR based System for the detection of animal traces in food.

Benefits

Very sensitiveIt is possible to identify relevant species down to a threshold level of 0.05 % with a semi-quantitative result.

Ease of useSample preparation includes simple DNA extraction (ExtractNow™ Vegan Control kit) prior to direct PCR analysis.

Instrument CompatibilityVegan Control™ qPCR works on cyclers with FAM™ and HEX™ filters.







Food & Water Assays



60 61

Features


Description Vegan Control™ Advance contains PCR reaction tubes pre-coated with all PCR reagents to reduce the total assay time without need to prepare aliquots of a master mix.

Recommended Use / Scope Can be used in research and industry for detection of meat/animal based con-tamination of vegan foods. For research use only! Do not use for clinical diagnos-tic or testing of patient samples.

Kit Components Primer sets, nucleotides, polymerase and internal control DNA, lyophilized, filled in 0.2 ml PCR reaction tubes, rehydration buffer, lyophilized positive control, PCR grade water.

Package Sizes Cat. No. 12-06-024 24 tests Cat. No. 12-06-096 96 tests Cat. No. 12-06-240 240 tests

Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, Pipette Tips Optional: DNA can be extracted from sample material using DNA extraction kits e.g. ExtractNow™ Vegan (CAT. NO. 607-1050) or user method.


Shelf Life and Storage Components can be stored at +2 to +8 °C for at least 12 months. After rehydra-tion the reagents must be stored below -18 °C.

Compliance No guidelines are available for molecular testing of animal traces in vegan food.

Vegan Control™ Advance

Features


Description Vegan Control™ OneStep is a qPCR based system for the detection of animal traces in food provided as a lyophilized one tube master mix.

Recommended Use / Scope Can be used in research and industry for detection of meat/animal based con-tamination of vegan foods. For research use only! Do not use for clinical diagnos-tic or testing of patient samples.

Kit Components Primer sets, nucleotides, internal amplification control and polymerase at opti-mized concentrations lyophilized in one tube, rehydration buffer, lyophilized po-sitive control, PCR grade water.

Package Sizes Cat. No. 12-05-025 25 tests Cat. No. 12-05-100 100 tests

Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, Pipette TipsOptional: DNA can be extracted from sample material using DNA extraction kits e.g. ExtractNow™ Vegan (ART.-NR. 607-1050) or user method.

Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop centrifuge for 1.5 and 0.2 ml reaction tubes.


Compliance No guidelines are available for molecular testing of animal traces in vegan food.

Vegan Control™ OneStep




Food & Water Assays




62 63

6564

ExtractNow™ DNA Mini Kit

Features

Description Universally applicable DNA extraction method for a broad range of starting ma-terials.Using a cutting-edge chemistry, the duration of the DNA purification is reduced to a minimum.

Type of Sample Tissue samples of up to 50 mgRodent tail specimens 0.5 – 1 cm in lengthParaffin samples (tissue)Eucaryotic cells (max. 5 × 106)Buccal swabs

Separation principle Spin filter columns

Recommended Use / Scope The ExtractNow™ DNA Mini kit is for research use only. Not recommended for clinical applications


Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months.Store the lyophilized Proteinase K at +2 to +8 °C

Specifications Time for extraction: Approx. 8 minutes after lysisBinding capacity: > 100 μg gDNAAverage yield: Up to 65 μg (depends on the type and quantity of the sample material)Average purity: 1.7 – 2.0

ExtractNow™ Plasmid Mini Kit

Features

Description Easy and quick plasmid isolation from bacterial lysis.

Type of Sample Bacterial suspensionsIsolation of high-copy plasmids: 0.5 – 5 mlIsolation of low-copy plasmid DNA, P1 constructions, etc.: > 5 - 10 ml


Recommended Use / Scope The ExtractNow™ Plasmid Mini Kit is for research use only. Not recommended for clinical applications.


Shelf Life and Storage Components are maintainable at room temperature for at least 6 months.

Specifications Time of Extraction: Approx. 16 minutesBinding capacity: Column binding capacity: approx. 40 μg pDNAAverage yield: Typical yield from 2 ml starting material (highcopy plasmid) 6 - 20 μgAverage purity: 1.8 - 2.0




Food & Water Assays



6766

ExtractNow™ RNA Mini KitExtractNow™ Blood DNA Mini Kit

Features

Description Purification of total RNA from eukaryotic and microbial materials. Prefiltration to selectively remove genomic DNA with no DNase digestion.

Type of Sample Eucaryotic cells (max. 5 × 106)Tissue samples (max. 20 mg)Gram+ and gram– bacteria (max. 1 × 109)Biopsies


Recommended Use / Scope The ExtractNow™ RNA Mini Kit is for research use only.Not recommended for clinical applications.



Specifications Time for Extraction: Approx. 15 – 40 minutesBinding capacity: approx. 100 μg RNAAverage yield: Depends on the type and quantity of the starting material up to 100 μg RNAAverage purity: 1.8 – 2.1

Features

Description Direct and rapid isolation of genomic DNA from whole blood up to 400 μl. High yields of up to 30 mg and extremely high-quality gDNA, depending on the sample and the amount used.There are two protocols available: < 200 µl and up to 400 µl blood samples. Tested for EDTA and citrate stabilized and for fresh or frozen blood sample (including long time storage).

Type of Sample Whole blood samples (up to 400 μl)Fresh or frozen bloodStabilizers: EDTA or citrate


Recommended Use / Scope The ExtractNow™ Blood DNA Mini kit is for research use only. Not recommended for clinical applications


Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months.Store the lyophilized Proteinase K at +2 to +8 °C

Specifications Time for Extraction: Approx. 24 minutes, including lysisBinding capacity: > 50 μg gDNAAverage yield: Up to 30 μg gDNA (depends on the type and quantity of the sample material)Average purity: 1.7 – 2.0




Food & Water Assays



6968

ExtractNow™ Virus DNA/RNA KitExtractNow™ CleanUp Kit

Features

Description Simultaneous isolation of viral DNA and RNA from a variety of starting materials. Extraction method based on the use of Spin Filters. Optimum removal of inhibitors ensures trouble-free use of nucleic acids in subsequent applications. Recommended for samples with unknown viruses. Includes Carrier Mix.

Type of Sample Serum, plasma, cell-free bodily fluids, supernatants from cell cultures (400 μl each)Tissues and biopsies of up to 20 mgSwab samples


Recommended Use / Scope ExtractNow™ Virus DNA/RNA Kit is for research use only.Not recommended for clinical applications.


Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months.Store the lyophilized Proteinase K at +2 to +8 °CStore the lyophilized Carrier Reagent below -18 °C

Specifications Time of Extraction Approx: 25 minutesQuality: Positive PCR and real-time PCR testing results

Features

Description Combination kit for fast extraction of DNA fragments from agarose gels or amplification products from PCR reaction mixtures. Flexible elution volumes between 30 and 50 μl and 10 to 20 μl. High recovery rates of up to 95 %. Capable of processing fragment lengths of up to 30 kb.

Type of Sample PCR reaction mixes (up to 50 μl)TAE agarose gels (up to 300 mg)TBE agarose gels (up to 300 mg)


Recommended Use / Scope The ExtractNow™ CleanUp Kit is for research use only.Not recommended for clinical applications.



Specifications Time for Extraction: PCR purification: approx. 3 minutes (2-step process) Gel extraction: approx. 20 minutesBinding capacity: > 20 μg DNAFragment lengths: PCR purification: > 60 bp – 30 kb Gel extraction: 100 bp – 30 kbAverage rate of recovery depending on fragment length: PCR purification: approx. 60 % to 95 % Gel extraction: approx. 60 % to 90 %




Food & Water Assays



DNA Standards and Cleaning

70 71

7372

Specifity Standards

Features

Description These preparations contain genomic DNA extracted from low passage and defined microorganisms, prepared by phenol/chloroform extraction and subsequent column absorption methods. The DNA extract was partially sequenced to confirm identity. Titration was done by optical density measurement against a weight calf thymus DNA standard.

Recommended Use / Scope Genomic DNA extracts are required for specificity testing of new assays. Genomic DNA extracts are intended for research use only. Not recommended for clinical diagnostics or testing of human samples.

Kit Components 1 vial of genomic DNA extract, containing 10 ng +/- 2 ng DNA, freeze-dried1 vial 10 mM Tris pH 8.5

Shelf Life and Storage Stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C.

Available Strains

Cat. No.

51-0116 Acholeplasma laidlawii2127-30007 Acinetobacter bamanii2128-30187 Aeromonas hydrophila2101-00819 Aspergillus fumigatus51-0031 Bacillus cereus51-0010 Bacillus subtilis2129-02046 Bacillus thueringiensis51-3415 Bordetella parapertussis51-5571 Bordetella pertussis2130-07288 Burkholderia capacia2102-04688 Campylobacter jejuni51-1386 Candida albicans2103-11226 Candida glabrata2104-11947 Candida guiliermondii2105-70624 Candida haemulonii2106-30039 Citrobacter freundii2125-90874 Candida tropicalis2107-04595 Citrobacter koseri51-0792 Clostridium acetobutylicum2108-00756 Clostridium perfringens51-0053 Enterobacter aerogenes2110-30054 Enterobacter cloacae2111-20680 Enterococcus casseliflavus2112-30633 Enterococcus durans51-0478 Enterococcus faecalis2113-20477 Enterococcus faecium2114-20160 Enterococcus hirse51-0083 Escherichia coli2115-08579 Escherichia coli 0157:H751-1368 Fluoribacter bozemanae (syn. Legionella bozemanae)2131-05934 Geobacillus stearothermophilus2132-30104 Klebsiella pneumoniae2133-70603 Klebsiella pneumoniae, ESBL+51-1723 Lactobacillus acidophilus51-1370 Legionella dumofii51-1533 Legionella jordanis51-0101 Legionella pneumophila51-1514 Legionella pneumophila subsp. fraseri

Cat. No.

51-1515 Legionella pneumophila subsp. pascullei51-3361 Methicilin-resistant Staphylococcus aureus (MRSA)2134-30164 Morganella morganii51-0030 Micrococcus luteus51-0129 Mycoplasma arginini51-0162 Mycoplasma arthritidis51-0117 Mycoplasma fermentans51-0115 Mycoplasma gallisepticum51-0195 Mycoplasma genitalium51-0111 Mycoplasma hominis51-0130 Mycoplasma hyorhinis51-0112 Mycoplasma orale51-1746 Mycoplasma penetrans51-0119 Mycoplasma pneumoniae51-0113 Mycoplasma salivarium51-0124 Mycoplasma synoviae2135-10036 Neisseria meningitidis2136-13387 Proteus vulgaris51-4479 Proteus mirabilis51-0071 Pseudomonas aeruginosa51-7058 Salmonella enterica2117-30121 Serratia marcescens2137-04782 Shigella flexneri2138-05570 Shigella sonnei51-0164 Spiroplasma citri51-0231 Staphylococcus aureus51-0044 Staphylococcus epidermidis2118-20328 Staphylococcus hominis2119-20263 Staphylococcus haemolyticus2122-20480 Streptococcus bovis2123-06176 Streptococcus dysgalactiae2126-20523 Streptococcus mutans51-0566 Streptococcus pneumoniae2139-20068 Streptococcus sanguinis2120-20229 Staphylococcus saprophyticus2121-50170 Stenotrophomonas maltophilia51-0177 Ureaplasma urealyticum2140-04780 Yersinia enterocolitica2141-08992 Yersinia pseudotuberculosis

Genomic DNA Extracts




Food & Water Assays



7574

PCR Quantification Standards

Features

Available Strains Cat. No. 52-0116 Acholeplasma laidlawiiCat. No. 52-5571 Bordetella pertussisCat. No. 52-0101 Legionella pneumophilaCat. No. 52-0129 Mycoplasma argininiCat. No. 52-0117 Mycoplasma fermentansCat. No. 52-0115 Mycoplasma gallisepticumCat. No. 52-0130 Mycoplasma hyorhinisCat. No. 52-0112 Mycoplasma oraleCat. No. 52-0119 Mycoplasma pneumoniaeCat. No. 52-0124 Mycoplasma synoviaeCat. No. 52-0164 Spiroplasma citriCat. No. 52-0071 Pseudomonas aeruginosaCat. No. 52-0083 Escherichia coli

Shelf Life and Storage Stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C.

Features

Description Standardization and quantification of nucleic acid detection is a difficult task as there are no reliable standards for low nucleic acid copy numbers. Detection methods such as PCR and NASBA are prone to inhibition caused by many substances commonly found in plant and animal tissues, food matrices and extraction solutions. When co-purified with DNA or RNA, inhibitors reduce amplification efficiency, causing an underestimation of the quantity of target nucleic acid or even false-negative results.

Minerva Biolabs calibration reagents contain genomic DNA extracted from low passage and defined microorganisms. The DNA is manufactured by means of phenol/chloroform extraction with ethanol precipitation and subsequent column absorption methods. The DNA extract was partially sequenced and the sequence aligned to confirm identity. Titration was done after photometric quantification of the preparation standard and dsDNA fluorometric quantification against a synthetic standard.

For the first time, qPCR user are able to include a precise low count of DNA copies in their assays, providing them with a true value for the estimation of detection limits and the comparison of different detection methods.

Recommended Use / Scope These PCR Calibration reagents with a defined concentration of genome copies are used as calibrators to generate standard curves for quantification of target loads with the qPCR technology. In addition, the standards are suitable for specificity testing of assays and sensitivity testing of procedures during quality assurance (QA) validation, especially in correspondence with EP 2.6.7.

Kit Components 1 vial (green cap) of PCR Quantification Standard contains 108 genomes, freeze-dried3 vials (white cap) with 2 ml of Tris buffer, 10 mM, pH 8.5




Food & Water Assays



7776

Features

Description European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml sample volume for NAT-based methods like PCR to replace the traditional culture method. This feature of the test method must be shown by the performing lab as part of the robustness testing in presence of the sample matrix. As most cell culture labs and production facilities cannot accept vital mycoplasma in their facility or do not have access to a microbiology lab able to cultivate mycoplasma, 10CFU™ Mycoplasma Sensitivity Standards allow safe and reliable validation of the procedure.

The mycoplasma have been cultivated in culture broth as described in EP 2.6.7, titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by different operators for highest precision. The mycoplasma broth was harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU:CFU ratio. All strains have been obtained from official culture collections and cultivated in low passages.

Recommended Use / Scope For validating the robustness and sensitivity of NAT-based mycoplasma test methods in presence of the sample matrix.Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample matrix of interest, a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.

Kit Components 3 vials with 10 CFU of the corresponding mycoplasma species2 negative control vials

For the mycoplasma set:2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 2 negative controls

Features

Selection Cat. No. 102-1003 Mycoplasma argininiCat. No. 102-2003 Mycoplasma orale Cat. No. 102-3003 Mycoplasma gallisepticumCat. No. 102-4003 Mycoplasma pneumoniaeCat. No. 102-5003 Mycoplasma synoviaeCat. No. 102-6003 Mycoplasma fermentansCat. No. 102-7003 Mycoplasma hyorhinisCat. No. 102-8003 Acholeplasma laidlawiiCat. No. 102-9003 Spiroplasma citriCat. No. 102-0002 Mycoplasma Set, all EP 2.6.7 listed species

Result Evaluation Use of a suitable Mycoplasma PCR kit, e.g. Venor®GeM Classic (SEE PAGE 13) or Venor®GeM qEP (SEE PAGE 16)


Required Lab Devices Regular lab equipment (centrifuge, pipettes, etc.)

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months

10CFU™Mycoplasma Sensitivity Standards

Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the Venor®GeM Sample Preparation Kit and mycoplasmal DNA amplified with Venor®GeM qEP. PCR was performed on a MxPro – Mx3005P®.

1 x positive control

2 x negative control

6 x 10 CFU




Food & Water Assays



7978

Cleaning

Contaminations affect various levels of your laboratory routine e.g. by introduction of microbial conta-mination on laboratory surfaces, water baths or incubators or can be acquired at the analytical level through carry over or by trace amounts of target molecules. This poses a significant problem especially in the area of highly sensitive PCR or analytical procedures where trace amounts of contaminating mo-lecules can result in inaccurate data or experimental artifacts.

We offer our highly effective decontamination products WaterShield™, Lab Clean™, PCR Clean™ and PCR Clean™ Wipes in order to help you to protect your research. Watershield™ is a disinfection additive for incubators and water baths and is active against a broad range of typical water contaminations from bacteria, mycoplasma, protozoan, algae, fungi and yeast. Water exchange is conveniently indicated by a diminishing blue stain. Lab Clean™ is a large area decontamination solution useful for floors preven-ting room-to-room spreading of e.g. DNA carry over or trace amounts of DNA, keeping your lab “DNA-load” low if regularly applied. Finally, protect your PCR experiments from e.g. carry over or DNases and RNases using PCR Clean™ or PCR Clean™ Wipes highly effective surface decontamination reagents.

Features

Description Contaminant DNA is especially problematic in the highly sensitive PCR technique, as its removal has proven to be no trivial matter. Originating from aerosolized fragments, contaminant DNA can lead to cross contamination between samples thus resulting in inaccurate data or PCR artefacts. Even a single DNA molecule can be detected in the amplification process leading to widespread problems throughout the testing procedure.

PCR Clean™ is a ready-to-use solution for eliminating DNA, RNA, DNases and RNases from any surface. They are completely destroyed and removed within seconds. The solution contains a surfactant and a non-alkaline and non-carcinogenic nucleic acid and protein destroying agent. PCR Clean™ is intended for use at PCR workstations, lab devices, pipettors, etc.

Benefits Highly effectivePCR Clean™ is effective against amplicon, plasmid, or genomic DNA and RNA as well as proteins on most surfaces with the exception of light or non-ferrous metals.

Convenient and ready-to-usePCR Clean™ is ready-to-use, provided in a spray bottle for the efficient treatment of work spaces.

Fast and easy decontaminationThe use of PCR Clean™ both before and after PCR analysis is fast, easy and ideal to maintain a clean work area and thereby saves time and expenses.

StablePCR Clean™ is heat resistant and stable for several years

Recommended Use / Scope None

Kit Components Ready-to-use formulation in a spray bottle or refill bottles.

Package Sizes Cat. No. 15-2025 250 mlCat. No. 15-2200 4 x 500 mlCat. No. 15-2500 5 l

Required Consumables Paper towels



PCR Clean™Decontamination Spray

for the Removal of DNA, RNA, DNases, RNases




Food & Water Assays



8180

PCR Clean™ WipesDecontamination Wipes for the Removal of DNA, RNA, DNases, RNases

Features

Description PCR Clean™ Wipes are the simple solution for cleaning and removal of DNA, RNA, DNases and RNases from a variety of laboratory surfaces at the same time. There’s no need for multiple products when you have the convenience of a simple-to-use wipe. When you use a sponge or even paper towel, you can spread nucleic acids and proteins from one surface to another. Instead of degrading these contaminants, you are pushing them around and potentially increasing the contaminated surface area.

Benefits Broad ApplicabilityPCR Clean™ Wipes can be used on hard, nonporous surfaces in every room of the lab including PCR cabinets, pipettes, lab equipment exterior (like PCR cycler, vortexer, centrifuges, pipetting robots) and many more.

Non-corrosive and non-carcinogenicPCR Clean™ Wipes are made with a bleach- and odor-free formula, composed of the powerful combination of a surfactant and a DNA-destroying agent. PCR Clean™ Wipes are ready-to-use for degrading DNA, RNA, DNases and RNases from surfaces like glass, ceramic, plastic, rubber, steel and precious metal. They can be used as a routine contamination control program in your PCR laboratory.

Broad inactivation rangePCR Clean™ Wipes degrade DNA, RNA, DNases and RNases within seconds.

Easy to useIt’s simple. Wipe surface clean with PCR Clean™ Wipes. Let it air-dry. Convenient where spraying is not applicable (e.g. covers of electronic devices, electronic pipettes).

Recommended Use / Scope Applicable in research and industry, only. Not recommended for clinical applications. Use as directed. Always test a small area first for stability and coloration. PCR Clean™ Wipes should not be used for the cleaning of light or non-ferrous metals.

Kit Components Single use wipes in a product safety sachet.

Package Sizes Cat. No. 15-2001 120 wipes in a dispenser boxCat. No. 15-2002 5x120 refill sachets




Lab Clean™Molecular Microbiology Lab Cleaner

Features

Description DNA contaminations are notoriously difficult to remove and can be easily spread via spills especially in connected laboratory areas via the room floor and/or dispersed dust. Keeping room “DNA-load” low is helping to prevent cross contamination or PCR artefacts in DNA sensitive environments where even a single DNA molecule can be detected in the amplification process leading to widespread problems throughout the testing procedure (e.g. PCR, qPCR, sequencing).

Lab Clean™ is a DNA decontamination solution available as a concentrate for routine laboratory cleaning to eliminate DNA from large areas like room floors and is based on a non-carcinogenic DNA destroying chemistry.

Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications.

Kit Components Easy applicable 200x aqueous solution.

Package Sizes Cat. No. 15-4100 1 l bottle



Shelf Life and Storage Stored at room temperature. Stable for at least 12 months.




Food & Water Assays



8382

Features

Description Water required for CO2 incubators is preset to microbial contamination due to

ideal environmental conditions. WaterShield™ protects the water in the reservoir from microbial growth.

Benefits Broad ApplicabilityWaterShield™ can also be used in regular water/heating baths and is compatible with common work surfaces (e.g. tin plated iron, chrome, nickel steel, high grade steel and copper).

No cell toxicityThe water additive contains quaternary ammonium compounds and surfactants as disinfecting and cleaning ingredients, but no aldehydes, phenols, alcohols or azides. These reagents are not vaporizing and are therefore safe to the cells. All ingredients are safe to humans and do not cause any irritating effects to the skin when used in the recommended concentration. No odor annoyance is noticeable.

Broad inactivation rangeWaterShield™ is active against most bacteria, mycoplasma, protozoa, algae, fungi and yeast.

Easy to useSimply add one bottle (5 ml) of WaterShield™ directly to one liter of deionized water.

StabilityThe reagent is usually active for 4 weeks. A blue stain indicated the status of the additive. In case of increasing bioburden a renewal of the water and the additive is required.

Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications. Do not use with acrylic glass or aluminum surfaces.

Kit Components Easy applicable 200x aqueous solution.

Package Sizes Cat. No. 15-3015 30x 5 mlCat. No. 15-3020 3x 50 mlCat. No. 15-3050 500 ml

Result Evaluation Color change




WaterShield™Water Disinfection Additive




Food & Water Assays



Contract Manufacturing

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Introduction

Minerva Biolabs is a contract manufacturer specialised in the design and production of molecular bio-logical reagents, PCR assays and sample preparation kits.

With our flexibility and experience as contract manufacturer of complex assays and kits for various notable customers, we are an ideal partner for you and your product. We will reliably handle small to large batch sizes according to your needs.

As a contract manufacturer, we offer our service and experience of more than 15 years in producing various molecular biological reagents and kits. Our special asset is to manufacture lyophilized molecu-lar biological components and PCR kits, including in vitro diagnostics. In addition, we will help you to make your product successfully marketable.

We are certified according to iSO 13485 with a proven record as contract manufacturer serving cus-tomers around the world. In our production facilities, we handle chemicals as well as biotechnologi-cally produced substances, e.g. enzymes, peptides, proteins, polysaccharides, hormones, vaccines and homeopathic drugs.

Product Design

The design is the key to success for any product. Various aspects need to be considered when an idea, an assay or even an existing product is transformed into a marketable and successful product.

We offer our service for the entire design process from assay optimization and composition to kit development and final product appearance. Our team of product development specialists, graphic designers, manufacturing professionals as well as market and logistics experts is looking forward to assist you.

As an established contract manufacturer with a proven record of success, we will tailor your product to meet your expectations as well as your customers’ including regulatory requirements.

Lyophilization

Minerva Biolabs operates state-of-the art freeze-dryers with capacities from 100 to 10,000 vials per day providing highest flexibility for any batch size. Our lyophilization service is compatible with various formats such as PCR tubes, 96-well microtiter plates, microfluidic disks and microtubes.

We will establish the lyophilization process for your product components including process engineering.

As an innovative manufacturer, we perform research projects facilitated by public funding to further develop our expertise in the lyophilisation of molecular biological reagents and mixes for PCR, qPCR, and RT-PCR.

Liquid Handling

Our service portfolio also includes any kind of liquid handling from litre to microlitre. We use auto-mated and semi-automated devices to guarantee highest and consistent accuracy. Our liquid han-dling service includes aqueous (low to moderate viscosity) and alcoholic solutions from small to large batch sizes.

Quality Control

Minerva Biolabs’ analytical services include incoming goods inspection, in-process controls as well as product release testing.

We perform HPLC analysis, UV and iR-Spectroscopy, microbiological batch monitoring and qPCR anal-ysis. With our GMP-certified partner Minerva Analytix GmbH, we are able to perform further methods and analyses to meet your requirements.

Packaging

Our packaging team offers various options ranging from bulk to final packaging to meet your individual expectations and requirements. We even organise the purchasing, storage and logistics of your pack-ing materials if desired.

Logistics

We offer traceable raw material supply for product shipment including purchasing, storage, and in-coming goods inspection.

As part of our clinical trial service we provide small batches of APi’s or diagnostic products but also randomized packaging according to individual requirements and shipping toclinical trial sites.

We will store your product at defined conditions, constantly monitored, and ship your products to destinations around the world, even anonymously under your company ID. We organise any shipment including dry ice shipments to your customers or distributors.

Licenses & Trademark Information

Limited Product WarrantyThis warranty limits our liability for replacement of this product. No warranties of any kind, express or implied, including, without limitation, implied warranties of merchantability or fitness for a particular purpose, are provided. Minerva Biolabs shall have no liability for any direct, indirect, consequential, or incidential damages arising out of the use, the results of use, or the inability to use this product.

TrademarksVenor, Onar, AquaScreen, Mynox, and ZellShield are registered trademarks of Minerva Biolabs GmbH. 10CFU, Mycoplasma Off, Watershield, PCR Clean, Lab Clean, Vegan Control, Meat ID, and ExtractNow are trademarks of Minerva Biolabs GmbH. VIC, Texas Red, and SYBR are registered trademarks and HEX, JOE, ROX, and TAMRA are trademarks of Applera Corp. or its subsidiaries in the US and/or certain other countries. SYBR and Texas Red are registered trademarks of Molecular Probes, Inc. Cy 3 and Cy 5 are trademarks of GE Healthcare.LightCycler is a registered trademark of a member of the Roche Group. ABI Prism is a registered trade-mark of Applera Corporation or its subsidiaries in the US and certain other countries. Mx3005P is a reg-istered trademark of Agilent Technologies. RotorGene is a registered trademark of Corbett Life Science.

Limited License - Mynox® / Mynox®GoldThe purchase price of this product includes a limited, non-transferable license under German Patent 195 21 938 or its foreign counterpart, owned by Minerva Biolabs GmbH, to use only this amount of the prod-uct to practice the Mynox® technique. No right to perform or offer commercial services of any kind using Mynox® is hereby granted by implication or estoppel. Further information on purchasing licenses may be obtained by contacting Minerva Biolabs GmbH, Koepenicker Strasse 325, 12555 Berlin, Germany.

Terms and Conditions

By ordering a product hereunder, the customer accepts these terms and conditions. The terms and conditions may be subject to change at any time and it is the customer’s responsibility to check the terms and conditions prior to ordering such products for any amendments and/or alterations. Unless otherwise specifically agreed in writing by the Minerva Biolabs GmbH these conditions shall govern all contracts between the Minerva Biolabs GmbH and the customer for the sale of any of the products and shall prevail over any conditions or terms stipulated, referred to or incorporated by the customer in its or-der or negotiations.

Placing of OrdersAll orders placed by a customer shall be subject to the product availability and the written acceptance of the Minerva Biolabs GmbH. The Minerva Biolabs GmbH shall confirm acceptance of the order in wri-ting, sending the product and invoice or by e-mail. The customer shall submit its full company name, address, telephone and fax numbers and custo-mer number (if applicable) to the Minerva Biolabs GmbH.

Payment and DeliveryThe Minerva Biolabs GmbH will use its reasonable endeavours to deliver the products to the customer as soon as practicable and in general within 1-3 days of the date of order acceptance. For the avoi-dance of doubt, the Minerva Biolabs GmbH will not be in breach of these conditions or have any liability whatsoever for failing to deliver the products to the customer by this date. Partial deliveries are permit-ted, any delivery is an autonomous business. Unless otherwise agreed in writing by the Minerva Biolabs GmbH, payment of the full price (including any VAT) and any additional costs (including but not limited to postage /packaging/carraige costs) will be made by the customer in full before delivery shall be effected. The Customer hereby agrees to effect payment to Minerva Biolabs GmbH by way of bank draft or cheque or credit card.

PriceThe prices of the products shall be as set out in the Price List and are correct at the time of entering the information. However, the Minerva Biolabs GmbH reserves the right to change the price without prior noti-ce. All Prices quoted are in Euro or US$ as indicated in the Prise List / Invoice. All Prices quoted are exclu-sive of VAT and all other duties, taxes or charges which the customer shall pay in addition to the price.

CancellationWhilst every effort will be made to meet the customer’s individual requirements, the Minerva Biolabs GmbH shall be under no obligation to accept amendments or cancellation of any order or any part thereof. If cancellation is accepted by the Minerva Biolabs GmbH, any costs or expenses incurred by the Minerva Biolabs GmbH up to the date of cancellation and all loss or damage resulting from the cancellation will be paid by the customer. The Minerva Biolabs GmbH shall be entitled to cancel any contract(s) with the customer (subject to refunding the price previously paid by the customer) without penalty at any time by giving written notice to the customer.

Use of ProductThe product information sheet (“Product Information Sheet”) delivered with the products sets out the Company’s recommended use and storage of the products. The information contained in the Product

Appendix

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Information Sheet is for informational purposes only and should not be relied upon. The Minerva Biolabs GmbH accepts no responsibility for and excludes all liability for damage and loss in connection with the use of the product and/or the information contained in the Product Information Sheet. Whilst the Minerva Biolabs GmbH believes the information to be true and accurate at the date of writing the Minerva Biolabs GmbH can give no assurances or warranty regarding the accuracy, currency or applicability of any of the information in relation to specific situations or particular circumstances. Although every care is taken by the Company in responding to requests for information and advice by telephone, facsimile, and e-mail no liability is accepted by the Minerva Biolabs GmbH where information relating to the customer’s order is distorted in transmission. Any claim by the customer which is based on any non-performance of the products shall be notified to the Minerva Biolabs GmbH in writing within 30 days from the date of deli-very of the Products. If the customer omits to notify the Minerva Biolabs GmbH in accordance with this Condition the Minerva Biolabs GmbH shall have no liability for such non-performance.

LiabilityNot with standing anything in these Conditions to the contrary and save for the liability of the Minerva Biolabs GmbH for death and personal injury caused by its negligence, the liability of the Minerva Bio-labs GmbH under these Conditions (whether by reason of breach of contract, tort, delict or otherwise) shall be limited to the price paid by the Customer for the relevant products. In no event shall the Minerva Biolabs GmbH be liable for any indirect damages including but not limited to, damages for loss of business or revenue, loss of profits or loss of goodwill or other damages consequential upon the same regardless of whether or not the Minerva Biolabs GmbH has been infor-med of the possibility of such damages or is negligent. The Minerva Biolabs’ liability for selling and delivering the products is as expressly stated and limited by these Conditions. All other warranties, rights, obligations, representations, undertakings liabilities, terms and or conditions (whether they are express or implied, or arise in contract, tort delict or otherwise, irrespective of the negligence of the Minerva Biolabs GmbH) in connection with the products and all such warranties, rights, obligations, representations, liabilities, terms or conditions are hereby expressly excluded.

Quality ControlThe Minerva Biolabs GmbH will endeavour to comply with all applicable regulations and other legal requirements concerning sale and delivery of the products.

TerminationThe Company may defer or suspend the performance of the contract and or treat these Conditions as determined if the customer: breaches any of these Conditions; undergoes insolvency proceedings of any nature or enters into any arrangement with its creditors. Termination for whatever reason shall not affect the rights and remedies accrued by the parties as at the date of such termination or any rights or obligations which due to the nature thereof are intended to survive termination.

MiscellaneousIf the Minerva Biolabs GmbH is delayed or prevented from delivering the products due to circumstances beyond its control, the Minerva Biolabs GmbH may cancel or suspend the contract without any liabil-ity (subject to providing the customer with the appropriate refund in the event that such delay or pre-vention is not due to an act or omission of the customer). These Conditions shall be governed by and construed in accordance with German Law. The customer hereby submits itself to the non-exclusive jurisdiction of the German Courts.

The Minerva Biolabs GmbH shall be responsible for adherence to German laws and regulations insofar as products manufactured in Germany are exported. The observance and implementation of laws and regulations applying outside Germany shall be the exclusive responsibility of the customer. If any provi-sion of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the remaining conditions shall not be affected. Failure or omission by the Minerva Biolabs GmbH to enforce strict compliance with these Conditions by the customer shall not constitute a waiver of any of these Conditions. Notices must be in writing to the Minerva Biolabs’ or the customer’s address and shall be deemed delivered on the first working day after sending by hand or (subject to confirmation of the transmission) by telex or facsimile or, on the third working day after being placed prepaid in the first class post to the Minerva Biolabs’ or the customer’s address.

Minerva Biolabs GmbH, Berlin 01.2016

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Food & Water Assays



110CFU Standards 18, 19, 76

AAcinetobacter bamanii 73Acholeplasma laidlawii 10, 19, 73, 75, 77Aeromonas hydrophila 73Advance 12, 14, 35, 54, 59AFNOR 42, 44Antibiotics 10, 20, 24, 26, 27AquaScreen® 40, 41AquaScreen® Escherichia coli 46AquaScreen® FastExtract 42AquaScreen® Legionella pneumophila 44AquaScreen® Legionella species 43AquaScreen® Pseudomonas 45AquaScreen® Escherichia coliAspergillus fumigatus 73ATMPs 11, 16, 17

BBacteria Detection 24Bacillus cereus 73Bacillus thueringiensis 73Bacillus subtilis 24, 73Bacterial Contamination 24, 48Beef 54, 56Blood 66Bordetella parapertussis 73Bordetella pertussis 73, 75Burkholderia capacia73

CCamel 54, 56Campylobacter jejuni 73Campylobacter spp. 51, 52, 53Candida albicans 26, 28, 29, 73Candida glabrata 73Candida guiliermondii 73Candida haemulonii 73Candida tropicalis 73Cancelation 89Cell Culture Contamination 27Chicken 54, 56Citrobacter freundii 73Citrobacter koseri 73Cleaner 81Clostridium perfringens 73 Clostridium acetobutylicum 73Clostridium perfringens 51, 52, 53, 73Colony Forming Units 18, 76

Color Compensation 37Color Compensation Kit 37Conditions 89Contamination 3, 10, 13, 16, 22, 23, 24, 26, 27, 29, 30, 41, 42, 48, 49, 51, 52, 53, 54, 56, 57, 58, 60, 61, 78, 79, 80, 81, 82Contaminated Food 49Contract manufacturing 3, 84Culture Method 11, 18, 76Cycler Check 35, 36Cycler Validation 32

DDecontamination 26, 78, 79, 80, 81Disinfection 3, 26, 28, 29, 30, 87, 82DNA 3, 10-19, 24, 25, 31, 40 -61DNA Extraction 16, 17, 18, 40, 41, 42, 50-61, 65, 76Donkey 54, 56, 57

EElimination 3, 20, 22, 23Endpoint PCR 13, 14, 15, 25Enterobacter aerogenes 73Enterococcus casseliflavus 73Enterobacter cloacae 73Enterococcus durans 73Enterococcus faecalis 73Enterococcus faecium 73Enterococcus hirse 73Escherichia coli 24, 26, 28, 40, 46, 51, 52, 53, 73, 75Escherichia coli 0157:H7 73European Pharmacopoeia 11, 16, 18 ,76ExtractNow™ 50-69ExtractNow™ Food Control 48-53ExtractNow™ Meat ID 54-57ExtractNow™ Vegan 58-61Extraction 12, 16-18, 40, 42, 51-61, 64-69, 72, 74, 76

FFastExtract 41, 42, 44, 46Fish 54, 56Fluoribacter bozemanae 73Foodborne Pathogens 48, 51, 52Food Chain Production 48Food Control™ 48-53Food Safety 54Food 3, 48-61

GGel electrophoresis 13, 14, 15, 25, 35Genomic DNA Extracts 72, 73Geobacillus stearothermophilus 73Goat 54, 56GU:CFU Ratio 18, 76

HHalal 54, 57Horse 54, 56

IIncubators 26, 28, 30, 78, 82ISO 13485 3, 34-36, 86ISO 9001 3

KKlebsiella pneumoniae 73Klebsiella pneumoniae, ESBL+ 73

LLab Clean 81Lactobacillus acidophilus 73Legionella 40, 41, 42, 43, 44, 73, 75Legionella dumofii 73Legionella jordanis 73Legionella pneumophila 40, 43, 44, 73, 75Legionella pneumophila subsp. fraseri 73Legionella pneumophila subsp. pascullei 73Licenses 88LightCycler 88Listeria monocytogenes 51-53Listeria spp. 51-53

MMB Taq DNA Polymerase 13, 31Meat 3, 54-61Meat ID™ Halal 54, 57Meat ID™ Screen 54, 56Meat identification 3Mera Scientific 3Methicilin-resistant Staphylococcus aureus (MRSA) 73Micrococcus luteus 73Minerva Analytix 3, 87Morganella morganii 73Mycoplasma 10, 11, 12, 13, 16, 17, 18, 19, 20, 21, 22, 23, 26, 27, 28, 29, 73, 75Mycoplasma arginini 19, 73, 75, 77Mycoplasma arthritidis 73Mycoplasma Detection 12, 18, 22, 23, 27, 76

Mycoplasma Elimination 20Mycoplasma fermentans 19, 73, 75, 77Mycoplasma gallisepticum 19, 73, 75, 77Mycoplasma genitalium 73Mycoplasma hominis 73Mycoplasma hyorhinis 11, 73, 75, 77Mycoplasma-Off™ 26, 28, 29Mycoplasma orale 19, 73, 75, 77Mycoplasma penetrans 73Mycoplasma pneumoniae 19, 73, 75, 77Mycoplasma salivarium 73Mycoplasma Set 18, 19, 76, 77Mycoplasma species 13, 16, 18, 76,Mycoplasma synoviae 19Mynox® 20, 21, 22, 88Mynox® Gold 21, 23

NNeisseria meningitidis 73

OOnar® Bacteria 24, 25OneStep 12, 15, 35, 58, 60

PPayment 89PCR Calibration 74PCR Clean 79, 80PCR Cycler Check 34,35PCR Cycler qualification 3PCR Quantification 43-46, 74PCR Quantification Standard 43-46, 74Pharma 12Plasmid 34, 79Polymerases 5Pork 54, 56, 57Prevention 10, 24, 26, 41, 48, 49, 55, 90Prime 24Proteinase K 17, 65, 66, 69Proteus mirabilis 26, 28, 29, 73, Proteus vulgaris 73Pseudomonas aeruginosa 26, 28, 29, 40, 45, 73, 75

QqPCR 12, 16, 36, 37, 40, 41, 43, 44, 45, 46, 48, 49, 51, 54, 56-58, 60, 61, 74, 81, 86-88qPCR Cycler Check 36Quality Management System 3, 34Quantification 16, 18, 43-46Quantification Standards 16, 74

Index

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Food & Water Assays



RReal-time qPCR 36, 37Removal 3, 27, 28, 69, 79, 80Removal of DNA 79, 80RNA 3, 24, 74, 79, 80, 82

SSalmonella enterica 51-53, 73Salmonella spp. 51-53Sensitivity 11, 13, 16, 18, 31, 37, 40, 74, 77Sensitivity Standards 13, 16, 18, 76Serratia marcescens 73Service 3, 34, 86, 87, 88Sheep 54, 56Shiga Toxin 1 51-53Shiga Toxin 2 51-53Shigella flexneri 73Shigella sonnei 73Shigella spp. 51-53Standards 70, 72, 74, 76Staphylococcus aureus 26, 28, 29, 73Staphylococcus epidermidis 73Staphylococcus hominis 73Staphylococcus haemolyticus 73Streptococcus bovis 73Streptococcus dysgalactiae 73Streptococcus mutans 73Streptococcus sanguinis 73Staphylococcus saprophyticus 73Stenotrophomonas maltophilia 73Specifity Standards 72, 73Spiroplasma citri 19, 73, 75, 77Supernatants 17, 69

TTaq DNA Polymerase 31Temperature control 34Terms 89Trademarks 88Turkey 54, 56

UUreaplasma urealyticum 73

VVegan 3, 54, 55, 58-61, 88Vegan Control™ Advance 58, 61Vegan Control™ OneStep 58, 60Validation 3, 11, 13, 16, 18, 25, 32, 76Venor®GeM 12, 13, 14, 15, 16, 17, 26, 27

Venor®GeM Advance 14Venor®GeM Classic 13Venor®GeM OneStep 15Venor®GeM Sample Preparation Kit 17Verification 34Virus 10, 12, 21, 22, 23, 24, 25, 26, 28, 29, 69Virus DNA 69

WWater 15, 16, 25, 26, 30, 38, 40, 41, 42 , 43, 44, 45, 46, 50, 51, 52, 56, 57, 58, 59, 78, 82Water pathogen 40WaterShield 30, 82Wipes 29, 78, 80

YYersinia enterocolitica 51-53, 73Yersinia pseudotuberculosis 73

ZZebra 54, 56ZellShield 27

94 95

HIGHLY EFFECTIVE AND EASY DECONTAMINATION

PCR Clean™

THE EXCELLENT WAY TO ISOLATE NUCLEIC ACID

ExtractNow™

BEEF OR NO BEEF? THAT’S THE QUESTION!

Meat ID™

IN QUALIFICATION WE TRUST!

Cycler Check™

SURFACE DISINFECTION

Mycoplasma Off™

STILL USING PEN/STREP?IT’S TIME TO CHANGE!

ZellShield®

Minerva Biolabs GmbH Koepenicker Str. 325

12555 Berlin / Germany

Tel. +49 (0)30 2000437-0

[email protected]

www.minerva-biolabs.com

For ordering:Internet: shop.minerva-biolabs.com

E-mail: [email protected]

Fax: +49 (0) 30 2000437-9

Do not hesitate to contact us: Mo - Fr 8.00 - [email protected]

Documents

Catalogue - ELITech Group · PDF file · 2016-09-12Bestellinformationen Ordering Information All customers may order via our online shop, by e-mail, fax, or telephone. For customers