PRODUCT CATALOG - · PDF fileToday’s healthcare professionals ... Our reagents feature liquid stable technology ... Direct-SL 247-30 3 x 100 mL (R1) Liver Disease DCA assay 1 x 75

c l i n i c a l c h e m i s t r y

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E L I S A / L I N E a s s a y s

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P R O D U C T C A T A L O G

l a b o r a t o r y a n d h e a l t h c a r e p r o f e s s i o n a l s

2 0 1 4 / 2 0 1 5

Please note that some products listed may not be available in all markets.

C H E M I S T R YC L I N I C A LC L I N I C A L C H E M I S T R Y

r e a g e n t s

s y s t e m s

f o r l a b o r a t o r y a n d h e a l t h c a r e p r o f e s s i o n a l s2 0 1 4 / 2 0 1 5 P roduc t Ca ta log

Today’s healthcare professionals have a challenging job. You needto deliver quality, cost-effective test results that support patient careand effective outcomes.

Accurate, reliable diagnostic products and instruments from SekisuiDiagnostics can help you provide the quality results doctors, patientsand researchers expect in a fast, cost-effective, and responsible way.Our broad product line includes:

• Clinical chemistry systems and reagents • Coagulation systems and reagents • Infectious disease rapid tests, LINE immunoassays, ELISA kits and instrumentation

Sekisui Diagnostics works with you to help you improve patient livesby providing:

• Extensive product and instrument knowledge • Exceptional technical support • Training services for systems, infectious disease assays and an online module for our rapid diagnostic products.

CONTACT US TO GET MORE INFORMATION ABOUT OUR PRODUCTS, SUPPORT AND SERVICES.

TABLE OF CONTENTS

Clinical Chemistry Systems: Clinical Chemistry Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Clinical Chemistry Reagents: United StatesClinical Chemistry Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Clinical Chemistry Calibrators and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Clinical Chemistry Linearity/Verifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Clinical Chemistry Reagents: Europe, Middle East, and AfricaClinical Chemistry Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Clinical Chemistry Calibrators and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Clinical Chemistry Linearity/Verifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Sekisui DiagnosticsSekisui Diagnostics is a recognized leader in the development,manufacture, and supply of innovative clinical chemistry reagentsand systems to the IVD industry, with over one billion tests performedeach year using our products.

With a broad line of >65 reagents consisting of cardiovascular,diabetes, renal, liver and specialty assays among many otherswe can meet your individual needs.

Our reagents feature liquid stable technology, exceptionalperformance, accommodating packaging and field provenreliability, along with supporting products and services.

In addition, our replacement chemistries are economical and anumber of applications are available for many automated analyzers.

CCH 1

LABORATORIES AND HEALTHCARE PROFESSIONALSCLINICAL CHEMISTRY PRODUCT CATALOG

Onboard test items 36 + 3 ISE

Throughput (Maximum) 480 tests/hour; 580 tests/hour with ISE

Number of samples on board 72 patient samples, 30 QC or STAT samples

Sample bar code reader Yes

STAT Yes

Auto Rerun Yes

Optics 12 wavelengths (340 - 800 nm)

User Interface Touch screen

QC Management Realtime QC; within a day; day-to-day variation

Dimension (Metric) 105 (W) x 75 (D) x 115 (H) cm

Dimension (English) 41.5 (W) x 29.5 (D) x 45 (H) inches

Weight Approx. 300 kg (660 lbs.)

Minimum Reaction Volume 120 �L

Water Consumption 13 L/hour

SYSTEMS / SK500™ CHEMISTRY SYSTEM

PROPOSED TEST MENU UNDER DEVELOPMENT

SPECIFICATIONS

CCH 3Please note that some products listed may not be available in all markets.

LABORATORIES AND HEALTHCARE PROFESSIONALS

2 CCH

CLINICAL CHEMISTRY PRODUCT CATALOG

The SK500™ Chemistry System and chemistryreagents offer an ideal system for low-to-moderatevolume laboratories seeking exceptional throughput with minimal use of space and water.

LIPIDS

Cholesterol, Total

HDL-Cholesterol

LDL-Cholesterol

Triglyceride

Apolipoprotein A-1

Apolipoprotein B

ROUTINE CHEMISTRY

Albumin

Direct Bilirubin

Total Bilirubin

Urea Nitrogen

ROUTINE CHEMISTRY

Calcium

CO2/Bicarbonate

Creatinine

Iron

Magnesium

Phosphorus

Uric Acid

Total Protein

DIABETES

HbA1c

Glucose

Microalbumin

ELECTROLYTES

Sodium

Potassium

Chloride

ENZYMES

ALT

Alkaline Phosphatase

Amylase

AST

Creatine Kinase

GGT

LDH

Lipase

ANEMIA

Ferritin

Iron

UIBC

Transferrin

SPECIAL

Acetaminophen

Salicylate

Ammonia

Cholinesterase

Lactate

Micro-Total Protein

Wide Range CRP

REAGENTS

PRODUCT PART NO. CONFIGURATION DIAGNOSTIC USE ATTRIBUTES

REAGENTS

CCH 5Please note that some products listed may not be available in all markets.


4 CCH



Acetaminophen-SL 505-10 1 x 10 mL (R1) Toxicology Enzymatic (Acyl-Aminohydrolase) assay2 x10 mL (R2)1 x 5 mL Calibrator

505-30 3 x 10 mL (R1)6 x 10 mL (R2)1 x 5 mL Calibrator

Alanine Aminotransferase 318-30 3 x 100 mL (R1) Liver Disease Enzymatic (Modified IFCC) assay(ALT/SGPT)-SL 1 x 75 mL (R2) Stable liquid

Albumin 200-45 4 x 125 mL Liver/Kidney Bromcresol Green (BCG) assay200-05 1 x 1000 mL Disease Stable liquid

Alkaline Phosphatase 328-30 3 x 100 mL (R1) Liver Disease Enzymatic (p-Nitrophenylphosphate) assay (ALP)-SL 1 x 75 mL (R2) Stable liquid

Ammonia 200-02 12 x 20 mL (R1) Liver Disease Enzymatic (Glutamate Dehydrogenase) assay1 x 2.5 mL (R2) Stable liquid2 x 15 mL Calibrator

(2 levels)

Ammonia Infinity TR-60101 2 x 28 mL Liver Disease Enzymatic (Glutamate Dehydrogenase) assayStable liquidEDTA and heparinized plasma acceptable

Ammonia L3K® 293-10 2 x 20 mL Liver Disease Enzymatic (Glutamate Dehydrogenase) assay1 x 15 mL Calibrator Stable liquid

Amylase Direct 80-5383-00 10 x 5 mL Pancreatitis Enzymatic (CNPG3) assay80-5451-00 1 X 1 L Stable liquid

Serum or plasma acceptable

Angiotensin Converting TR-85056 2 x 28 mL Cardiovascular Kinetic/Rate assayEnzyme Stable liquid


Apolipoprotein A1 KAI-002 3 x 20 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 20 mL (R2) Stable liquid

Apolipoprotein B KAI-004 3 x 20 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 20 mL (R2) Stable liquid

Aspartate 319-30 3 x 100 mL (R1) Liver Disease Enzymatic (Modified IFCC) assayAminotransferase 1 x 75 mL (R2) Stable liquid(AST/SGOT) -SL

ASO KAI-078 4 x 20 mL (R1) Immunology Immunoturbidimetric assay4 x 20 mL (R2) Stable liquid

Beta-Hydroxybutyrate 2440-058 1 x 50 mL (R1) Diabetes Enzymatic (D-3-Hydroxybutyrate1 x 8.5 mL (R2) Dehydrogenase) assay1 x 3 mL Calibrator Stable liquid�


Bile Acids DZ042A-K01 2 x 30 mL (R1) Liver Disease Enzymatic (3-α-Hydroxysteroid2 x 10 mL (R2) Dehydrogenase) assay1 x 5 mL Calibrator Stable liquid

DZ042A-K 2 x 60 mL (R1) Serum or plasma acceptable2 x 20 mL (R2)1 x 5 mL Calibrator

60-018 R1 1 x 250 mL60-019 R2 1 x 100 mL

Bilirubin, Direct-SL 247-30 3 x 100 mL (R1) Liver Disease DCA assay1 x 75 mL (R2) Stable liquid

Bilirubin, Total L3K® 295-10 1 x 100 mL (R1) Liver Disease DCA assay1 x 25 mL (R2) Stable liquid

295-30 3 x 100 mL (R1) Serum or plasma acceptable1 x 75 mL (R2) Neonatal serum samples acceptable


Reagents Available in the United States Only


285-30 3 x 100 mL (R1) Significantly reduced hemolytic and 1 x 75 mL (R2) lipemic interferences

285-50A 1 x 1000 mL (R1 Only)285-50B 1 x 300 mL (R2 Only)

Bilirubin, Total-SL 243-10 1 x 100 mL (R1) Liver Disease DCA assay1 x 25 mL (R2) Stable liquid

Bilirubin, Total-SL-X 284-10 1 x 100 mL (R1) Liver Disease DCA assay1 x 25 mL (R2) Stable liquid

284-30 3 x 100 mL (R1)1 x 75 mL (R2)

284-50A 1 x 1000 mL (R1 Only)284-50B 1 x 300 mL (R2 Only)

Calcium 140-20 4 x 125 mL Metabolic Arsenazo III assay1 x 15 mL Calibrator Disorder Stable liquid

140-24 1 x 1000 mL

Carbon Dioxide 299-17 5 x 100 mL Metabolic Enzymatic (Phosphoenolpyruvate (CO2) L3K® 299-30 6 x 30 mL Disorder Carboxylase) assay

299-50 4 x 500 mL Stable liquid299-55 1 x 500 mL Good correlation to ISE methods299-80 1 x 1000 mL

Carbon Dioxide (CO2) 288-36 3 x 60 mL Metabolic Enzymatic (PhosphoenolpyruvateL3K® Concentrate 288-80 1 x 1000 mL Disorder Carboxylase) assay

Stable liquidConcentrated (5x)

CH50 Autokit 995-40801 Liposome 2 x 20 mL Immunology Lyposome immunoassaySubstrate 1 x 20 mL Serum requiredDiluent 1 x 20 mL

Cholesterol, Total-SL 234-60 2 x 100 mL Cardiovascular Enzymatic (Cholesterol Esterase/Oxidase) assayStable liquid

Cholinesterase 17019H 2 x 50 mL (R1) Liver Disease Kinetic colorimetric assay1 x 20 mL (R2) Stable liquid


Complement C3 KAI-009 4 x 20 mL (R1) Immunology Immunoturbidimetric assay2 x 10 mL (R2) Stable liquid

Serum required

Complement C4 KAI-010 4 x 20 mL (R1) Immunology Immunoturbidimetric assay2 x 10 mL (R2) Stable liquid

Serum required

CRP (C-Reactive Protein) KAI-026 4 x 20 mL (R1) Immunology Immunoturbidimetric assayKit 2 x 10 mL (R2) Stable liquid

Linearity 0.1-25 mg/dLSerum required

CRP Ultra Sensitive Kit KAI-160 1 x 30 mL (R1) Immunology Immunoturbidimetric assay1 x 20 mL (R2) Stable liquid

Serum requiredLinearity: 0.005-1.000 mg/dL

CRP Ultra WR Kit 082 1 x 30 mL (R1) Immunology Immunoturbidimetric assay1 x 20 mL (R2) Stable liquid

Serum or plasma acceptableLinearity: 0.05 – 160 mg/L

Creatine Kinase (CK)-SL 326-10 1 x 100 mL (R1) Cardiovascular Enzymatic (NAC Activated) assay1 x 25 mL (R2) Stable liquid

Extended linear range (2-1500 U/L)

REAGENTS


CLINICAL CHEMISTRY REAGENTS


REAGENTS

CCH 76 CCH


Please note that some products listed may not be available in all markets.Please note that some products listed may not be available in all markets.


Creatinine, Enzymatic 265-30 3 x 100 mL (R1) Kidney Disease Enzymatic (Creatinine Amidohydrolase) assay1 x 100 mL (R2) Stable liquid

Non hazardous reagentIncreased linearitySerum, plasma, and urine acceptable

Creatinine-S 221-30 2 x 250 mL (R1) Kidney Disease Modified Jaffé assay1 x 125 mL (R2) Stable liquid1 x 15 mL Calibrator

221-50 1 x 1000 mL (R1)1 x 250 mL (R2)

Cystatin C DZ133C-K 1 x 100 mL (R1) Kidney Disease Immunoturbidimetric assay,1x 20 mL (R2) Stable Liquid

D-Dimer KAI-090 1 x 16 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 8.5 mL (R2) Stable liquid


Ethanol L3K® 273-30 6 x 30 mL Toxicology Enzymatic (Alcohol Dehydrogenase) assay1 x 5 mL Calibrator Stable liquid

Serum, plasma, and urine acceptable

Ferritin KAI-095 1 x 18 mL (R1) Anemia Immunoturbidimetric assay1 x 9 mL (R2) Stable liquid


Fibrinogen KAI-035 2 x 20 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 8 mL (R2) Stable liquid1 x 1 mL Calibrator Calibrator included

Fructosamine F7546-110 10 x 11 mL Substrate Diabetes Nitroblue Tetrazolium (Modified NBT) assay1 x 120 mL Buffer Reconstituted reagent stable 30 days1 x 2 mL Calibrator Serum required

Fructosamine DZ112B-K 2 x 23 mL (R1) Diabetes Enzymatic assay2 x 7.5 mL (R2) Stable liquid

Gamma Glutamyl- 334-10 1 x 100 mL (R1) Liver Disease Enzymatic (Carboxy Substrate/ModifiedTransferase (GGT) 1 x 20 mL (R2) IFCC) Kinetic assay

Stable liquidSerum or plasma acceptable

Glucose 220-32 4 x 100 mL Diabetes Enzymatic (Glucose Oxidase) assay1 x 15 mL Calibrator Reconstituted reagent stable 30 days

Glucose-SL 235-60 2 x 100 mL Diabetes Enzymatic (Hexokinase) assay235-99 1 x 1000 mL Stable liquid

Haptoglobin KAI-022 3 x 18 mL (R1) Immunology Immunoturbidimetric assay2 x 7 mL (R2) Stable liquid

Serum required

Hemoglobin A1c 00.H7541-40 1 x 30 mL (R1) Diabetes Immunoturbidimetric assay(HbA1c) 1 x 9.5 mL (R2a) EDTA plasma required

1 x 0.5 mL (R2b) On board lyse applications available1 x 125 mL (Lyse)

00.H7541-120 1 x 90 mL (R1)1 x 28.5 mL (R2a)1 x 1.5 mL (R2b)

HDL, Ultra N-geneous® 80-6283-00 1 x 750 mL (R1) Cardiovascular Accelerator Selective Detergent assayCholesterol 80-6277-00 1 x 250 mL (R2) Stable liquid

On board stability 4 weeksSerum or plasma acceptable


HDL Ultra Test Kit 6121 1 x 60 mL (R1) Cardiovascular Accelerator Selective Detergent assay1 x 20 mL (R2) Stable liquid

6122 1 x 250 mL (R1) On board stability 4 weeks1 x 80 mL (R2) Serum or plasma acceptable

Homocysteine (2 Part) FHRWR100 1 x 30 mL (R1) Cardiovascular Homogenous Enzymatic assay1 x 5 mL (R2) Stable liquid2 x 3 mL Calibrator Calibrator included

FHRWR200 1 x 60 mL (R1) Serum or plasma acceptable 1 x 10 mL (R2)2 x 3 mL Calibrator

Homocysteine Synchron® DZ568A-K04 2 x 18 mL (R1) Cardiovascular Enzymatic assayCartridge 2 x 2.8 mL (R2) Stable liquid

2 x 2.5 mL (R3) Packaged in Synchron® cartridgesDZ568A-K05 2 x 45 mL (R1) Serum or plasma acceptable

2 x 9 mL (R2)2 x 5.7 mL (R3)

Homocysteine AU™ DZ568B-BY1 1 x 52 mL (R1) Cardiovascular Enzymatic assayCartridge 1 x 15 mL (R2) Stable liquid

DZ568B-BY2 2 x 52 mL (R1) Packaged in AU™ cartridges2 x 15 mL (R2) Serum or plasma acceptable

Homocysteine DZ568B-K 2 x 25 mL (R1) Cardiovascular Enzymatic assay1 x 14 mL (R2) Stable liquid

Homocysteine DZ568A-KD1 4 x 4 mL (R1) Cardiovascular Enzymatic assayDimension® Flex 1 x 4 mL (R2) Stable liquid

1 x 3.5 mL (R3) Packaged in Dimension® Flex DZ568A-KD2 8 x 4 mL (R1) Serum or plasma acceptable

2 x 4 mL (R2)2 x 3.5 mL (R3)

Homocysteine (DZ Series) DZ568A-K 1 x 54 mL (R1) Cardiovascular Enzymatic Assay 1 x 11 mL (R2) Stable liquid1 x 8 mL (R3) Serum or plasma acceptable

Homocysteine-Roche DZ568A-K07 1 x 90 mL (R1) Cardiovascular Enzymatic Assay PMod 1 x 20 mL (R2) Stable liquid

1 x 13 mL (R3) Packaged in a Roche/Hitachi Wedge Serum or plasma acceptable

Ig A KAI-013 4 x 20 mL (R1) Immunology I2 x 3 mL Calibrator 2 x 10 mL (R2) Stable liquid

Ig E KAI-092 2 x 20 mL (R1) Immunology Immunoturbidimetric assay1 x 6.6 mL (R2) Stable liquid

Ig G KAI-014 4 x 20 mL (R1) Immunology Immunoturbidimetric assay4 x 20 mL (R2) Stable liquid

Ig M KAI-015 4 x 20 mL (R1) Immunology Immunoturbidimetric assay2 x 10 mL (R2) Stable liquid

Insulin KAI-071 2 x 13.5 mL (R1) Diabetes Immunoturbidimetric assay2 x 5 mL (R2) Stable liquid

KAI-040 1 x 13.5 mL (R1)1 x 5 mL (R2)


REAGENTS REAGENTS


CCH 98 CCH




Iron, Total-PC 102-15 1 x 250 mL Acid Anemia Ferrozine® assay(Protein Clearing) Dissociating Reduced paraprotein interference

Reagent (R1)1 x 250 mL AcidDissociating Diluent (R1a)

1 x 0.75 g AscorbicAcid (R1b)

1 x 125 mL Color Reagent (R2)

102-25 1 x 500 mL Acid DissociatingReagent (R1)

1 x 500 mL AcidDissociating Diluent (R1a)

1 x 1.5 g AscorbicAcid (R1b)

1 x 250 mL Color Reagent (R2)

Iron, Total-SL 157-30 3 x 100 mL (R1) Anemia Ferene® assay1 x 75 mL (R2) Stable liquid1 x 10 mL Calibrator

Lactate L7596-50 1 x 30 mL (R1) Acidosis Enzymatic (Lactate Oxidase) assay1 x 20 mL (R2) Stable liquid

Lactate Dehydrogenase 327-30 3 x 100 mL (R1) Liver/ Enzymatic (Lactate�Pyruvate) assay(LDH)-SL 1 x 75 mL (R2) Cardiovascular Stable liquid

Disease

LDL, N-geneous® 80-4598-00 1 x 250 mL (R1) Cardiovascular Selective Detergent assayCholesterol 80-4601-00 1 x 80 mL (R2) Stable liquid

Open vial stability 4 weeksSerum or plasma acceptableNo fasting required

LDL Reagent Kit 7120 1 x 30 mL (R1) Cardiovascular Selective Detergent assay(Liquid Select) 1 x 10 mL (R2) Stable liquid


LDL ST Reagent 80-5727-02 1 x 30 mL (R1) Cardiovascular Accelerator Selective Detergent assayN-geneous® 80-5729-02 1 x 10 mL (R2) Stable liquid

80-5665-01 1 x 250 mL (R1) Open vial stability 4 weeks80-5714-00 1 x 80 mL (R2) Serum or plasma acceptable

No fasting required

Lipase (LCK) Reagent Kit 905-B 5 x 30 mL Reagent Pancreatitis Enzymatic Methodology(Includes calibrator) 1 x 200 mL Solvent

1 x 60 mL Activator2 x 3 mL Calibrator

Lipase Liquid Reagent Kit 17.401B 4 x 10 mL (R1) Pancreatitis Kinetic Colorimetric assay1 x 8 mL (R2) Stable liquid1 x 1 mL Calibrator Open vial stability 90 days

Lithium Beckman DZ116B-KB1 1 x 20 mL (R1) Toxicology Enzymatic AssayCartridge 1 x 10 mL (R2) Stable liquid

5 x 3 mL Calibrator Packaged in a Synchron® cartridgeDZ116B-KB2 2 x 20 mL (R1)

2 x 10 mL (R2)5 x 3 mL Calibrator


Lithium Roche/Hitachi DZ116B-KH1 2 x 10 mL (R1) Toxicology Enzymatic Assay2 x 5 mL (R2) Stable liquid3 x 3 mL Calibrator Packaged in a Roche/Hitachi Wedge

Lithium Liquid TR-66056 2 x 28 mL (R1) Toxicology Spectrophotometric assayStable liquid

LP(a) KAI-017 3 x 21 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 9 mL (R2) Stable liquid

KAI-044 1 x 21 mL (R1) Serum required1 x 3 mL (R2)

LP(a) Cholesterol L7597-40 1 x 30 mL (R1) Cardiovascular Immunoturbidimetric assay1 x 10 mL (R2) Stable liquid

Magnesium 175-12 4 x 125 mL Diabetes/Kidney Xylidyl Blue assayDisease Stable liquid

Extended linear range: 0.3-8.0 mg/dL

Microalbumin 252-20 4 x 20 mL (R1) Kidney Disease Immunoturbidimetric assay2 x 10 mL (R2) Stable liquid

Micro-Total Protein 450-50 2 x 250 mL (R1) Kidney Disease Pyrogallol Red assay1 x 15 mL Calibrator Stable liquid

Urine or cerebrospinal fluid acceptable

Non-esterified 999-34691 4 x 50 mL Color A Diabetes ACS-ACOD assayFatty Acid (NEFA-HR) 995-34791 4 x 50 mL Solvent A

991-34891 4 x 25 mL Color B993-35191 4 x 25 mL Solvent B

Phospholipid C 433-36201 8 x 50 mL Buffer Liver Disease Choline oxidase assay(For research only) 8 x 50 mL Color For research only

2 x 10 mL Calibrator Not for use in diagnostic procedures

Phosphorus, Inorganic-SL 117-30 3 x 100 mL (R1) Kidney Disease Ammonium Molybdate assay1 x 75 mL (R2) Stable liquid

Wide Linear Range: 0.1-20.0 mg/dL

Prealbumin KAI-053 4 x 20 mL (R1) Liver Disease Immunoturbidimetric assay2 x 8 mL (R2) Stable liquid

Serum required

Rheumatoid Factor KAI-031 4 x 20 mL (R1) Immunology Immunoturbidimetric assay2 x 8 mL (R2) Stable liquid

Serum required

Salicylate-SL 511-40 4 x 10 mL Toxicology Enzymatic (Salicylate Hydroxylase) assay(Enzyme Reagent) Stable liquid

4 x 10 mL (NADH Reagent)

1 x 5 mL Calibrator

Sorbitol Dehydrogenase 740-25 20 x 0.2 mg (R1) Liver Disease Enzymatic; Kinetic assay�(SDH) 1 x 50 mL (R1a) For veterinary use only

1 x 10 mL (R2)740-10 10 x 1.18 mg (R1)

1 x 125 mL (R1a)1 x 20 mL (R2)

TIBC Direct 00.I7517-150 1 x 90 mL (R1) Anemia Chromazurol B assay1 x 60 mL (R2) Stable liquid�

00.H1717-120 1 x 90 mL (R1)1 x 30 mL (R2)

REAGENTS


CALIBRATORS AND CONTROLS

PRODUCT PART NO. CONFIGURATION



CCH 1110 CCH




Total Protein 200-55 4 x 125 mL Liver/Kidney Biuret assayDisease Stable liquid

Transferrin KAI-023 3 x 20 mL (R1) Anemia Immunoturbidimetric assay 2 x 10 mL (R2) Stable liquid

Serum required

Triglyceride-SL 236-60 2 x 100 mL Cardiovascular Enzymatic (Glycerol Phosphate Oxidase) assay236-99 1 x 1000 mL Stable liquid

Wide Linear Range: 3.0 mg/dL to 1000.0 mg/dL

Unsaturated Iron 153-10 1 x 100 mL (R1) Anemia Ferene®; Endpoint assayBinding Capacity (UIBC) 1 x 25 mL (R2) Stable liquid

153-30 3 x 100 mL (R1) Exceptional high end linearity (600 µg/dL)1 x 75 mL (R2)

153-50 1 x 500 mL (R1)1 x 300 mL (R2)

153-90 1 x 1000 mL (R1)1 x 240 mL (R2)

Urea (BUN) L3K® 283-30 6 x 30 mL Kidney Disease Enzymatic (Urease) assayStable liquid

Uric Acid-SL 237-60 2 x 100 mL Kidney Disease Enzymatic (Uricase) assayStable liquid�Wide Linear Range: 0.3 mg/dL to 20.0 mg/dL


Alcohol/Ammonia Controls Level 1 and Level 2 95505 6 x 3 mL

Alcohol/Ammonia Controls Level 1 95501 6 x 3 mL

Alcohol/Ammonia Controls Level 2 95502 6 x 3 mL

Ammonia Standard Infinity TR-60901 2 x 5 mL (A), 2 x 5 mL (B), 2 x 5 mL (C)

Angiotensin Converting Enzyme Calibrator TR-85201 6 x 1 mL

Angiotensin Converting Enzyme Control TR-85101 L1 3 x 1 mL, L2 3 x 1 mL

Apolipoprotein A1/B Calibrator KAI-008C 1 x 1 mL Lyophilized, 2 x 2 mL diluent

ASO Calibrator KAI-079C 5 x 1 mL

Beta-Hydroxybuterate Control (Tri-Level) 2460-605 6 x 5 mL

Beta-Hydroxybuterate Control (Bi-Level) 2465-605 6 x 5 mL

Bile Acid Calibrator 60-036 1 x 5 mL

Carbon Dioxide Standard (CO2) 9217 1 x 15 mL

CH50 Autokit Calibrator 997-43801 5 x 0.5 mL

CH50 Autokit Control Low and High 991-43701 Low 10 x 0.5 mL, High 10 x 0.5 mL

CRP Ultra Sensitive Calibrator Set KAI-161C 4 x 1 mL

CRP Serum Protein Control Level 1 91201 6 x 1 mL




CRP Ultra Sensitive Calibrator Kit KAI-062C 5 x 2 mL

CRP Ultra WR Calibrator kit 082B 5 x 2 mL

Cystatin C Calibrator DZ113C-CAL 5 X 1 mL

Cystatin C Control DZ133C-CON 2 x 1 mL

Wide Range CRP Multi-Calibrator Set SE-250 5 x 2 mL

N-geneous® wrCRP Calibrator 80-6655-00 5 x 2 mL

DC-Cal Multi-Analyte Calibrator SE-035 5 x 3 mL

DC-Trol Multi-Analyte Control Material Level 1 SM-052 10 x 5 mL


D-Dimer Calibrator KAI-091C 6 x 1 mL

D-Dimer Control K81C-6M L1 3 x 0.5 mL, L2 3 x 0.5 mL

Ferritin Calibrator KAI-094C 4 x 1 mL

Ferriti, IgE, Insulin Controls K59C-3M L1 1 x 5 mL, L2 1 x 5 mL, L3 1 x 5 mL

Fructosamine Control DZ112B-CON 2 x1 mL

Fructosamine Control F7546-CTL L1 3 x 2 mL, L2 3 x 2 mL

HDL Ultra Calibrator Kit 6272-3 3 x 1 mL

Ultra N-geneous® HDL Cholesterol Calibrator 80-6449-00 6 x 1 mL

Hemoglobin A1c Calibrator (HbA1c) 00.H7541-CAL 4 x 0.5 mL

Hemoglobin A1c Control (HbA1c) 00.H7541-CTL 4 x 0.5 mL

Hemoglobin A1c Control Bi-level (HbA1c) 91815 3 x 2 x 0.5 mL

Homocysteine Calibrator DZ568B-CAL 3 x 3 mL

Homocysteine Calibrator DZ568A-CA5 5 x 3 mL

Homocysteine Integra® Calibrator DZ568CAL 2 x 3 mL

Homocysteine Integra® Controls DZ568CON 4 x 3 mL

Homocysteine Controls DZ568A-CON 4 X 3 mL

Homocysteine Controls DZ568CL2 2 x 3mL

Homocysteine Controls FHCY200 3 x 1.5 mL

ImmuTROL Serum Protein Control 91105 L1 2 x 3 mL, L3 2 x 3 mL

ITA Controls K49C-4M L1 2 x 2 mL, L2 2 x 2 mL

N-geneous® LDL ST Calibrator 80-5666-02 3 x 1 mL

N-geneous® LDL Cholesterol Calibrator 80-4610-02 3 x 1 mL

Lactate Calibrator L7956-STD 1 x 15 mL

Lipid Control Tri-level 41001-33 6 x 3 mL

Lithium Standard TR-66901 1 x 10 mL



LINEARITY/VERIFIERS


LINEARITY/VERIFIERS


CCH 1312 CCH




Lp(a) Calibrator KAI-018C 1 x 1 mL Lyophilized, 2 x 2 mL diluent

Lp(a) Calibrator L7597-Cal 5 x 1 mL

Lp(a) Control L7580-18 L1 3 x 3 mL, L2 3 x 3 mL

Lp(a) Control K114C-4M L1 2 x 1 mL, L2 2 x 1 mL

Microalbumin Calibrator SE-252 6 x 1 mL

Microalbumin Controls SM-252 L1 2 x 8 mL, L2 2 x 8 mL

Multi-Analyte Calibrator KAI-016C 6 x 1 mL

Non-esterified Fatty Acid (NEFA-HR) Standard 276-76491 4 X 10 mL

Prealbumin Calibrator KAI-054C 6 x 1 mL

Rheumatoid Factor Calibrator KAI-032C 3 x 2 mL

Rheumatoid Factor Control K47C-4M L1 2 x 2 mL, L2 2 x 2 mL

Sorbitol Dehydrogenase (SDH) Control Material Level 1 SM-740 6 x 2 mL


TIBC Direct Calibrator I7517-CAL 2 x 1 mL

UIBC Calibrator SE-090 6 x 10 mL



Ammonia/Iron Standard Kit 9040 5 x 15 mL

Ammonia/Iron Standard Kit, Level F 9046 1 x 15 mL

Beta-Hydroxybuterate Linearity 2450-604 6 X 4 mL

Bilirubin Standard 9456 2 x 5 mL

Bilirubin Standard Kit 9450 10 x 5 mL

Bilirubin Standard Kit, Level F 9436 2 x 5 mL

Chemistry Reference Set 9500 5 x 15 mL

Chemistry Reference Set, Level F 9506 1 x 15 mL

Cholesterol Reference Kit 9550 5 x 15 mL

Cholesterol, Level F 9556 1 x 15 mL

CO2 Standard Kit 9210 5 x 15 mL

CO2 Standard Kit, Level F 9216 1 x 15 mL

Electrolyte Standard Kit 9200 5 x 15 mL

Enzyme Verifier Kit 9410 6 x 5 mL

Ethanol Standard Kit 9670 6 x 5 mL

HDL/LDL Cholesterol Verifier Kit 9560 6 x 5 mL

LDL Cholesterol ExR (Extended Range) Kit Configuration 9580 2 X 5 mL

LiniCAL Calibration Verifier/Linearity Sets for Beckman Coulter Synchron®/ Bilirubin 98224 5 x 1 mL

LiniCAL Calibration Verifier/Linearity Sets for Beckman Coulter Synchron®/ ImmunoProteins 98227 5 x 1 mL

LiniCAL Calibration Verifier/Linearity Sets for Beckman Coulter Synchron®/ RF and CRP 98228 5 x 1 mL

LiniCAL Calibration Verifier/Linearity Sets for Beckman Coulter Synchron®/Esoterics 98226 5 x 1 mL

LiniCAL Calibration Verifier/Linearity Sets for Olympus AU Systems/Protein 2 98302 5 x 1.5 mL

LiniCAL Calibration Verifier/Linearity Sets for Olympus AU Systems/TDM 98308 5 x 3 mL

LiniCAL Specific Protein Calibration Verifier/Linearity Sets (Levels A-E)/hsCRP 98210 5 x 1.5 mLfor Beckman Coulter Immage®

LiniCAL Specific Protein Calibration Verifier/Linearity Sets (Levels A-E)/Protein 1 98211 5 x 1 mLfor Beckman Coulter Immage®/Array®

LiniCAL Specific Protein Calibration Verifier/Linearity Sets (Levels A-E)/Protein 1 98501 5 x 1 mLfor Roche Integra®/Hitachi





LiniCAL Specific Protein Calibration Verifier/Linearity Sets (Levels A-E)/Protein 4 98214 5 x 1.5 mLfor Beckman Coulter Immage®


LiniCAL Specific Protein Calibration Verifier/Linearity Sets (Levels A-E)/Protein 5 98205 5 x 1 mLfor Beckman Coulter Array®

Microprotein Standard Kit 9480 5 x 15 mL

Mulit-Enzyme Verifier Kit (Low Range) 9440 12 x 5 mL

Non-esterified Fatty Acid (NEFA-HR) Linearity 997-76491 1 x 10 mL

Total Protein/Albumin Standard Kit 9460 5 x 15 mL

Total Protein/Albumin Standard Kit, Level F 9466 1 x 15 mL

UIBC Lineate SE-091 3 (2 x 5 mL)

Urine Chemistry Standard Kit 9000 5 x 15 mL

REAGENTS REAGENTS


CCH 1514 CCH




Reagents Available in Europe, Middle East, Africa and Asia

Acetaminophen L3K® 506-10 1 x 10 mL (R1) Toxicology Enzymatic (Acyl-Aminohydrolase) assay2 x 10 mL (R2) Stable liquid1 x 5 mL Calibrator Reduced NAC interference


Acetaminophen-SL 505-10 1 x 10 mL (R1) Toxicology Enzymatic (Acyl-Aminohydrolase) assay2 x10 mL (R2)1 x 5 mL Calibrator


Alanine Aminotransferase 318-30 3 x 100 mL (R1) Liver Disease Enzymatic (Modified IFCC) assay(ALT/SGPT)-SL 1 x 75 mL (R2) Stable liquid

Significant linear range of 5-800 U/L

Albumin 200-45 4 x 125 mL Liver/Kidney Bromcresol Green (BCG) assay200-05 1 x 1000 mL Disease Stable liquid

Alkaline Phosphatase 328-30 3 x 100 mL (R1) Liver Disease Enzymatic (p-Nitrophenylphosphate) assay (ALP)-SL 1 x 75 mL (R2) Stable liquid

Ammonia L3K® 293-10 2 x 20 mL (R1) Liver Disease Enzymatic (Glutamate Dehydrogenase) assay1 x 15 mL Calibrator Stable liquid

No significant interferences from ascorbic acid or bilirubin

Amylase Direct 80-5383-00 10 x 5 mL Pancreatitis Enzymatic (CNPG3) assay 80-5451-00 1 x 1000 mL Serum or plasma acceptable

Stable liquid

Aspartate 319-30 3 x 100 mL (R1) Liver Disease Enzymatic (Modified IFCC) assayAminotransferase 1 x 75 mL (R2) Stable liquid(AST/SGOT) -SL

Bilirubin, Direct-SL 247-30 3 x 100 mL (R1) Liver Disease DCA assay1 x 75 mL (R2) Stable liquid


295-30 3 x 100 mL (R1) Serum or plasma acceptable1 x 75 mL (R2) Neonatal serum samples acceptable

Significantly reduced hemolytic and lipemic interferences

Calcium 140-20 4 x 125 mL Metabolic Arsenazo III assay1 x 15 mL Calibrator Disorder Stable liquid

140-24 1 x 1000 mL Excellent precision

Carbon Dioxide 299-17 5 x 100 mL Metabolic Enzymatic (Phosphoenolpyruvate (CO2) L3K® 299-30 6 x 30 mL Disorder Carboxylase) assay

299-50 4 x 500 mL Stable liquid 299-55 1 x 500mL Good correlation to ISE methods299-80 1 x 1000 mL

Carbon Dioxide (CO2) 288-36 3 x 60 mL Metabolic Enzymatic (Phosphoenolpyruvate L3K® Concentrate 288-80 1 x 1000 mL Disorder Carboxylase) assay

Stable liquid Concentrated (5x)

Cholesterol, Total-SL 234-60 2 x 100 mL Cardiovascular Enzymatic (Cholesterol Esterase/Oxidase) assayStable liquid

Creatine Kinase (CK)-SL 326-10 1 x 100 mL (R1) Cardiovascular Enzymatic (NAC Activated) assay1 x 25 mL (R2) Stable liquid

Extended linear range (2-1500 U/L)


Creatinine, Enzymatic 265-30 3 x 100 mL (R1) Kidney Disease Enzymatic (Creatinine Amidohydrolase) assay1 x 100 mL (R2) Stable liquid

Non hazardous reagentIncreased linearitySerum, plasma, and urine acceptable

Creatinine-S 221-30 2 x 250 mL (R1) Kidney Disease Modified Jaffé assay1 x 125 mL (R2) Stable liquid1 x 15 mL Calibrator

221-50 1 x 1000 mL (R1)1 x 250 mL (R2)

Ethanol L3K® 273-30 6 x 30 mL (R1) Toxicology Enzymatic (Alcohol Dehydrogenase) assay1 x 5 mL Calibrator Stable liquid

Serum, plasma, and urine acceptable

Gamma Glutamyl- 334-10 1 x 100 mL (R1) Liver Disease Enzymatic (Carboxy Substrate/ModifiedTransferase (GGT) 1 x 20 mL (R2) IFCC) Kinetic assay

Stable liquidSerum or plasma acceptable

Glucose 220-32 4 x 100 mL (R1) Diabetes Enzymatic (Glucose Oxidase) assay1 x 15 mL Calibrator Reconstituted reagent is stable for 30 days at 2-8°C

Glucose-SL 235-60 2 x 100 mL Diabetes Enzymatic (Hexokinase) assay235-99 1 x 1000 mL Stable liquid

HDL, N-geneous® HDCE-70- 4 x 60 mL (R1) Cardiovascular Accelerator Selective Detergent assayCholesterol 5955-03 4 X 20 mL (R2) Stable liquid

On board stability 4 weeksSerum or plasma acceptable

Iron, Total-PC 102-15 1 x 250 mL (R1) Anemia Ferrozine® assay(Protein Clearing) 1 x 250 mL (R1a) Reduced paraprotein interference

1 x 0.75 g (R1b) Suitable for protein containing serum 1 x 125 mL (R2) and lithium heparin plasma

102-25 1 x 500 mL (R1)1 x 500 mL (R1a) 1 x 1.5 g (R1b) 1 x 250 mL (R2)

Iron, Total-SL 157-30 3 x 100 mL (R1) Anemia Ferene® assay1 x 75 mL (R2) Stable liquid1 x 10 mL Calibrator

KL-6, Nanopia Reagents ES336904 2 x 24 mL (R1) Interstitial Lung Latex agglutination assayDisease

ES336911 2 X 8 mL (R2) Useful for assessing disease activityFully automated methodology

Lactate Dehydrogenase 327-30 3 x 100 mL (R1) Liver/ Enzymatic (Lactate�Pyruvate) assay(LDH)-SL 1 x 75 mL (R2) Cardiovascular Stable liquid

Disease

LDL, N-geneous® LDCE-70- 4 x 30 mL (R1) Cardiovascular Selective Detergent assayCholesterol 5170-04 4 x 10 mL (R2) Stable liquid


Lipase (LCK) Reagent Kit 905-B 5x 30 mL Reagent Pancreatitis Enzymatic Methodology(Includes calibrator) 1 x 200 mL Solvent

1 x 60 mL Activator2 x 3 mL Calibrator

Magnesium 175-12 4 x 125 mL Diabetes/ Kidney Xylidyl Blue assayDisease Stable liquid

Extended linear range: 0.3-8.0 mg/dL (0.12 mmol/L-3.29 mmol/L)


REAGENTS


LINEARITY/VERIFIERS



Carbon Dioxide Standard (CO2) 9217 1 x 15 mL

DC-Cal Multi-Analyte Calibrator SE-035 5 x 3 mL



HDL, Ultra N-geneous® Cholesterol Calibrator HCCE-70-5954 2 x 1 mL

KL-6, Nanopia Calibrator ES336928 4 Levels x 0.5 mL

Nanopia E Control SC305573 2 Levels (3 x 1 mL)

LDL N-geneous® Cholesterol Calibrator LCCE-70-5174 2 x 1 mL

Microalbumin Calibrator SE-252 6 x 1 mL

Microalbumin Controls SM-252 2 Levels (2 x 8 mL)

RPR Calibrator Set 486623 5 x 1 mL

RPR Control Set 486630 2 Levels (2 x 1 mL)



TPLA Calibrator Set 486654 5 x 1 mL

TPLA Control Set 486661 2 Levels (2 x 1 mL)

UIBC Calibrator SE-090 6 x 10 mL

HDL/LDL Cholesterol Verifier Kit 9560 6 x 5 mL

HDL/LDL Cholesterol ExR (Extended Range) Kit 9580 2 x 5 mL

UIBC Lineate SE-091 3 Levels (2 x 5 mL)


CCH 1716 CCH

CLINICAL CHEMISTRY PRODUCT CATALOG LABORATORIES AND HEALTHCARE PROFESSIONALS


Microalbumin 252-20 4 x 20 mL (R1) Kidney Disease Immunoturbidimetric assay2 x 10 mL (R2) Stable liquid

Micro-Total Protein 450-50 2 x 250 mL (R1) Kidney Disease Pyrogallol Red assay1 x 15 mL Calibrator Stable liquid

Urine or cerebrospinal fluid acceptable

Phosphorus, Inorganic-SL 117-30 3 x 100 mL (R1) Kidney Disease Ammonium Molybdate assay1 x 75 mL (R2) Stable liquid

Wide linear range: 0.1-20 mg/dL (0.03-6.46 mmol/L)

RPR 486616 1 x 52 mL (R1) Syphilis Latex- Immunoturbidimetric assay1 x 20 mL (R2) Fully automated methodology for use on multiple

clinical chemistry platforms

Salicylate-SL 511-40 4 x 10mL(Enzyme Reagent) Toxicology Enzymatic (Salicylate Hydroxylase) assay4 x 10 mL (NADH Reagent) Stable liquid 1 x 5 mL Calibrator

Sorbitol Dehydrogenase 740-25 20 x 0.2 mg (R1) Liver Disease Enzymatic; Kinetic assay�(SDH) 1 x 50 mL (R1a) For veterinary use only

1 x 10 mL (R2)740-10 10 x 1.18 mg (R1)

1 x 125 mL (R1a)1 x 20 mL (R2)

Total Protein 200-55 4 x 125 mL Liver/Kidney Biuret assayDisease Stable liquid

TPLA 486647 1 x 45 mL (R1) Syphilis Latex- Immunoturbidimetric assay1 x 10 mL (R2) Fully automated methodology for use on multiple

clinical chemistry platforms

Triglyceride-SL 236-60 2 x 100 mL Cardiovascular Enzymatic (Glycerol Phosphate Oxidase) assay236-99 1 x 1000 mL Stable liquid

Wide linear range: 3.0-1000.0 mg/dL (0.03-11.3 mmol/L)

Unsaturated Iron 153-10 1 x 100 mL (R1) Anemia Ferene®; Endpoint assayBinding Capacity (UIBC) 1 x 25 mL (R2) Stable liquid

153-30 3 x 100 mL (R1) Exceptional high end linearity: 600 µg/dL 1 x 75 mL (R2) (107.4 µmol/L)

153-50 1 x 500 mL (R1)1 x 300 mL (R2)

153-90 1 x 1000 mL (R1)1 x 240 mL (R2)

Urea (BUN) L3K® 283-30 6 x 30 mL Kidney Disease Enzymatic (Urease) assay Stable liquid

Uric Acid-SL 237-60 2 x 100 mL Kidney Disease Enzymatic (Uricase) assayStable liquid�Wide linear range: 0.3-20.0 mg/dL (18-1190 µmol/L)



Please note that some products listed may not be available in all markets. Please note that some products listed may not be available in all markets.

18 CCH

NOTES

CCH 19

20 CCH

NOTES

80-8229-00-00 10/14

SKTM is a trademark of Sekisui Diagnostics, LLC.N-geneous® and L3K® are registered trademarks of Sekisui Diagnostics, LLC.Other trademarks used herein are owned by their respective companies.

© 2014 Sekisui Diagnostics, LLC. All rights reserved.

r e a g e n t s

s y s t e m s

C O A G U L A T I O N

2 0 1 4 / 2 0 1 5 P roduc t Ca ta log

Sekisui Diagnostics is a leader in the development, manufacture, andsupply of coagulation systems and reagents for IVD use.

Our compact, high-throughput instrument system has had marketleading success in Japan, and is now being introducedinternationally.

Sekisui Diagnostics also offers a broad range of innovative, specialtycoagulation products including assays for Thrombosis, vWD, LupusAnticoagulant, Fibrinolysis and Heparin testing.

Coagulation Systems and Specialty Coagulation Reagents

COA 1

COAGULATION PRODUCT CATALOG


PRODUCT DETAIL

COAGULATION SYSTEMS


ASSAY PRODUCT NAME PACKAGE PART NO.

REAGENTS / CP2000

BUFFERS, CALIBRATORS, CONTROLS PRODUCT NAME PACKAGE PART NO.

CONSUMABLES PRODUCT NAME PACKAGE PART NO.

COA 3Please note that some products listed may not be available in all markets.


SIMULTANEOUS MEASUREMENT ITEMS Up to 20 items

TEST THROUGHPUT Up to 400 tests/hour (clotting assays); Up to 200 tests/hour (including chromogenic and turbidimetry assays)

MEASUREMENT PRINCIPLE Light scattering photometry method for clotting time assay, absorbance photometrymethod for chromogenic and latex turbidimetry assay

LIGHT SOURCE LED (660nm), halogen lamp (405/570/730nm)

SAMPLE COMPARTMENT Rack-turntable system holds up to 60 samples• STAT SAMPLE 3 dedicated STAT ports. Racks can be prioritized.

REAGENT COMPARTMENT 25 refrigerated positions

CALIBRATION Automatic dilution setting, INR calibration curve, automaticswitching of calibration curves

QUALITY CONTROL X-chart, twin plot

OPERATING SYSTEM Windows® 7 or Windows® XP

BARCODE • REAGENT BARCODE READER Hand-held• SAMPLE BARCODE READER Internal reader. Reads 16 digit, 2 of 5, CODE 39, CODE 128,

NW 7 barcode types

PHYSICAL DIMENSIONS (main unit only) W 26.4 in. (including STAT) x D 27.6 in. x H 46.9 in.W 670 mm (including STAT) x D 700 mm x H 1190 mm

WEIGHT (main unit only) 374.8 lbs, 170 kg

2 COA Please note that not all products listed are available in all markets

Windows® 7 and Windows® XP are registered trademarks of Microsoft Corporation in the United States. Specifications may change without notice due to developments. Coagpia®and Nanopia®are registered trademarks of Sekisui Medical Co., Ltd. Coapresta® is a registered trademark of Sekisui Medical Co., Ltd.

Coagulation buffer Coagpia® Buffer 10 x 10 mL 491528

Coagulation calibrator Coagpia® Calibrator 10 x 1mL 491542

Coagulation control Coagpia® Control Set 2 levels x 5 x 1 mL 491559

D-dimer calibrator Nanopia® D-dimer Calibrator Set 6 levels x 1 x 0.5 mL 491603

D-dimer control Nanopia® D-dimer Control Set 2 levels x 3 x 1 mL 491610

FDP calibrator Nanopia® FDP Calibrator Set 5 levels x 1 x 0.5 mL 491573

FDP control Nanopia® FDP Control Set 2 levels x 3 x 1 mL 491580

Thrombin time normal control Coagpia® TT Normal Control 5 x 1 mL CP701.00

Thrombin time abnormal control Coagpia® TT Abnormal Control 5 x 1 mL CP702.00

Cuvettes Cuvettes 1 x 5000 423796

Wash solution New Alkali Wash Solution 1 x 250 mL 494147

PT Coagpia® PT-N Reagent 10 x 10 mL 491498

APTT Coagpia® APTT-N Reagent 10 x 10 mL 491504

Coagpia® CaCl2 Reagent 10 x 10 mL 491511

Fibrinogen Coagpia® Fbg Reagent 10 x 3 mL 491535

AT Coagpia® AT Reagent 2 x 10 mL493096

1 x 10 mL

D-dimer Nanopia® D-dimer Reagent 1x 10.5 mL491597

1 x 10 mL

FDP Nanopia® FDP Reagent 1 x 10.5 mL491566

1 x 10 mL

Thrombin time Coagpia® Thrombin Time Reagent 5 x 6 mL CP703.00

COMPACTCAPABLE

Coapresta®2000Offering the benefits of a small footprint withhigh-throughput, combined with excellentreagent performance and stability, theCoapresta®2000 (CP2000) system is a flexiblechoice for laboratories of all sizes.

A range of routine coagulation reagents with long on-board stability, predominately in liquid, ready-to-useformat with multiparametric calibrators and controls optimized for the Sekisui coagulation analyzers.A range of specialty coagulation assays are currently in development.


PRODUCT PART NO. DESCRIPTION

SPECIALTY COAGULATION REAGENTSCLINICAL CHEMISTRY REAGENTS


SPECIALTY COAGULATION REAGENTS

VWF AND ADAMTS13

IMUBIND® vWF Activity ELISA 885 An ELISA assay that measures vWF activity in human plasma by making

use of a monoclonal antibody that recognizes a functional epitope of

the vWF molecule. vWF functions as a carrier protein for Factor VIII.

Measurement of both vWF antigen and activity aids in the differential

diagnosis of the classes of vWF disease.

ACTIFLUOR ADAMTS13 Activity 812 A Fluorescence Resonance Energy Transfer (FRET)-based assay for the

measurement of ADAMTS13 activity in human plasma. Citrated plasma is

assayed for ADAMTS13 protease activity using recombinant

VWF86-ALEXA FRET substrate.

IMUBIND ADAMTS13 Antigen ELISA 813 An enzyme-linked immunosorbent assay to measure ADAMTS13 protein

in human plasma.

IMUBIND ADAMTS13 Autoantibody ELISA 814 An enzyme-linked immunosorbent assay to measure ADAMTS13 IgG

autoantibodies in human plasma. The acquired form of TTP is an

autoimmune-like disorder caused by the development of

autoantibodies to ADAMTS13 that inhibit its activity.

LUPUS ANTICOAGULANT

ACTICLOT® dPT™ 824 A dilute Prothrombin Time (dPT) test for screening and confirming the

presence of phospholipid-dependent LA autoantibodies in plasma.

Clinical studies show that dPT is an effective LA coagulation assay that

identifies LA not detected by other tests, such as Lupus-sensitive aPTT

and dRVVT test.

DVVtest® 810, 825 A simplified single-vial dilute Russell’s Viper Venom Time (dRVVT) test

reagent for the determination of Lupus Anticoagulant (LA) in plasma.

The reagent contains Russell’s Viper Venom that directly activates Factor

X to Factor Xa in the presence of phospholipids and calcium. Factor Xa

cleaves prothrombin to thrombin, which converts fibrinogen to fibrin

leading to detectable clot formation in plasma.

DVVconfirm® 815, 815L A high phospholipid reagent used in conjunction with DVVtest®

(Part No. 810 & 825) to confirm the presence of LA in plasma.

DVVconfirm® is formulated with Russell’s Viper Venom and a high

concentration of phospholipids. The clotting time of a plasma containing

LA should be significantly shorter with DVVconfirm® compared to that

with DVVtest®.

LAtrol® Abnormal Control Plasma 816A Abnormal control plasma to be used with DVVtest® (Part No. 810 & 825),

DVVconfirm® (Part No. 815 & 815L), and ACTICLOT® dPT™ (Part No. 824).

LAtrol® Normal Control Plasma 816N Normal control plasma to be used with DVVtest® (Part No. 810 & 825),

DVVconfirm® (Part No. 815 & 815L), and ACTICLOT® dPT™ (Part No. 824).

COA 5Please note that some products listed may not be available in all markets.


THROMBOSIS

ACTICHROME® Antithrombin III (ATIII) 838 A chromogenic assay for the quantitative measurement of

antithrombin III in human plasma. Antithrombin III is an inhibitor of plasma

serine proteases, including thrombin, which converts soluble fibrinogen

into soluble strands of fibrin. The residual thrombin activity is inversely

proportional to the Antithrombin III concentration.

ACTICLOT® Protein C ACC-45 An end-point clotting assay to measure Protein C activity in human

plasma. The assay uses Protac®, a direct Protein C activator, and an

APTT reagent to activate both Protein C and the contact factors of the

intrinsic pathway.

ACTICLOT® Protein S 843L A functional clotting assay for the quantitative determination of Protein S

activity in human plasma. The prolongation of the clotting time is directly

proportional to the concentration of Protein S in the patient’s plasma.

ACTICLOT® Protein C Resistance ADG840 A plasma based functional assay for determination of resistance to

activated Protein C (aPC) caused by the Factor V Leiden mutation

(FV:Q506). Activated protein C (APC) resistance is the most frequent

hereditary defect associated with deep vein thrombosis. The assay

clearly distinguishes between homozygous and heterozygous Factor V

Leiden (FV:Q506) and normal patients.

ACTICLOT® Protein C Resistance Control Plasma ADG840C Control plasmas for confirmation of factor V Leiden mutation (FV:Q506)

in assays for determination of the functional phenotype for activated

protein C resistance caused by the factor V Leiden mutation.

IMUBIND® TAT ELISA ADG833 The IMUBIND® TAT ELISA measures Thrombin-Antithrombin III (TAT)

complexes. Elevated plasma levels of TAT have been associated with a

wide variety of active thrombotic events including disseminated

intravascular coagulation (DIC), sepsis, multiple trauma, pregnancy

complications (pre-eclampsia), deep vein thrombosis (DVT), and

malignancies. TAT levels have also been found to be elevated in many

patients with disturbances in global coagulation when routine

coagulation parameters are in the sub-normal or normal range.

4 COA Note: Not all products are available in all regions. Please contact your local distributor for details.



SPECIALTY COAGULATION REAGENTS

COA 7


FIBRINOLYSIS

IMUBIND® tPA ELISA 860 An ELISA assay which measures human tissue-type Plasminogen

Activator (tPA) antigen in plasma including single- and two-chain tPA as

well as tPA/PAI-1 complexes. The role of tPA is to activate plasminogen to

plasmin, which in turn degrades fibrin, resulting in thrombolysis.

IMUBIND® Plasma PAI-1 ELISA 822 An ELISA assay which measures human Plasminogen Activator Inhibitor

Type-1 (PAI-1) antigen in plasma. The ELISA measures active and latent

forms of PAI-1 as well as tPA/PAI-1 complexes.

SPECTROLYSE® PAI-1 Activity 101201 The assay is a two-stage colorimetric assay which measures Plasminogen

Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The first stage

involves incubating samples with a known amount of tPA, allowing PAI-1

in the sample to react with tPA. In the second stage, the residual tPA

activity converts plasminogen to plasmin, which in turn hydrolyzes a

plasmin chromogenic substrate, SPECTROZYME® PL.

DIMERTEST DLHK7 A rapid immunoagglutination assay using latex beads coupled with a

highly specific monoclonal antibody (DD3B6/22) to D-dimer, cross linked

fibrin degradation product (XL-FDP). XL-FDP is a specific marker for

fibrinolysis, and when present in the test plasma sample, binds to the

coated latex beads causing agglutination.

HEPARIN

ACTICHROME® Heparin (anti-fIIa) 820 A chromogenic assay for the quantitative determination of therapeutic

heparin in human plasma by measurement of Factor IIa (thrombin)

activity. The inhibitory effect of antithrombin III (ATIII) on Factor IIa

(thrombin), Factor Xa and other coagulation serine proteases in plasma

is increased several-thousand fold by heparin. In the second stage, the

heparin–ATIII complex formed inhibits the added thrombin. The residual

thrombin hydrolyzes the thrombin-specific chromogenic substrate

SPECTROZYME® TH.

ACTICHROME® Heparin (anti-fXa) 832 A three-stage chromogenic assay for the quantitative determination of

unfractionated and low molecular weight heparins in human plasma by

measurement of Factor Xa inhibition.

6 COA Please note that some products listed may not be available in all markets.

NOTES

NOTES

8 COA

80-8230-00-00 10/14

CoaprestaTM is a trademark of Sekisui Medical Co., Ltd.ACTICLOT®, ACTICHROME®, ActiScreen®, DVVtest® , DVVconfirm®, IMUBIND®, LAtrol®,SPECTROLYSE® are registered trademarks of Sekisui Diagnostics, LLC.


r a p i d d i a g n o s t i c s

E L I S A / L I N E a s s a y s

D I S E A S EI N F E C T I O U SI N F E C T I O U S D I S E A S E

2 0 1 4 / 2 0 1 5 P roduc t Ca ta log

TABLE OF CONTENTS

OSOM® Rapid DiagnosticsOSOM Point-of-Care Rapid Tests Woman’s Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

OSOM Point-of-Care Rapid Tests Family Health. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Infectious DiseaseThe Virotech ELISA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

The Virotech LINE System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Seramun Stool ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Sekisui DiagnosticsSekisui Diagnostics is a recognized leader in the development,manufacture, and supply of infectious disease assays to the IVDindustry.

The Virotech product line consists of over 120infectious disease assays and automated solutions to simplify your laboratory experience.

The OSOM® family of rapid diagnostics offers you avariety of family and women's health products andour services deliver unparalleled value. Fast, point-of-care results may help reduce follow-upvisits, promote education/prevention and allow formore precise treatment.

®

rapid diagnostics

INFECTIOUS DISEASE

INF 1

OSOM® Ultra Strep A Test 25 Tests 147 50 Tests 149

OSOM® Strep A Test 50 Tests 141 or 141E (CE marked)OSOM® Atrep A Test 25 Tests 141E-20 (CE marked)

OSOM® Mono Test 25 Tests 145 (CE marked)

OSOM® Influenza A&B Test 25 Tests 190 or 190E (CE marked)Influenza A&B Control Kit 191 (CE marked)

OSOM® H. Pylori Test 25 Tests 175 (CE marked)

ORDERING INFORMATION CONFIGURATION CATALOG NUMBER

OSOM® POINT-OF-CARE RAPID TESTS / WOMEN’S HEALTH OSOM® POINT-OF-CARE RAPID TESTS / FAMILY HEALTH

OSOM® hCG Urine Test� One-step simple; dip and read� 25 mlU/mL sensitivity� Two-color results

OSOM® BVBLUE® Test� To aid in the diagnosis of Bacterial Vaginosis� Detects elevated vaginal fluid sialidase activity

� Sensitivity 92.8% vs Grams stain� Fast, objective results

OSOM® Card Pregnancy and hCG Combo Test� Increased sensitivity: 10 mlU/mL serum; 20 mlU/mL urine

� Easy to read black lines� Results in 3 minutes� No drop counting pipette

OSOM® Trichomonas Rapid Test� The only CLIA-waived rapid test available� More sensitive than wet mount� Two-color results in 10 minutes� Detects antigen; does not require live organisms

OSOM® Mono Test� Aids in the diagnosis of infectious mononucleosis

� >99% sensitivity; 96% specificity� Two-color results in 5 minutes� Includes 2 extra tests for QC

OSOM® Influenza A&B Test� Differentiates between Flu A&B� Results in 10 minutes� Nasal swab specimens� Includes 2 extra tests for QC

OSOM® Ultra Strep A Test� Sensitivity not statistically different thansingle swab culture*

� Two-color results in 5 minutes� Includes 2 extra tests for QC

OSOM® Strep A Test� 96% sensitivity; 98% specificity� Fits easily into a busy practice� Two-color results in 5 minutes� Includes 2 extra tests for QC

OSOM® H. pylori Test� 95.9% sensitivity; 89% specificity� Results in 10 minutes� Sample types: serum, plasma orwhole blood

OSOM® BVBlue®Test 25 Tests 183

BVBlue®Control Kit 184

OSOM® hCG URINE Test 50 Tests 101hCG Urine Control Set 134

OSOM® Trichomonas Rapid Test 25 Tests 181 or 181E (CE marked)Trichomonas Positive Control Kit 182 (CE marked)

OSOM® Card Pregnancy Test 25 Tests 102hCG URINE Control Set 134

OSOM® hCG Combo Test 25 Tests 124hCG Serum Control Set 138

ORDERING INFORMATION CONFIGURATION CATALOG NUMBER

INF 32 INF

OSOM® RAPID DIAGNOSTICS

* Refer to package insert for details


THE VIROTECH ELISA SYSTEM

INFECTIOUS DISEASE SEROLOGY / ELISA

PRODUCT FORMAT ORDER NUMBER FEATURES

INF 54 INF

ELISA ASSAYS

The Virotech ELISA assays deliver qualitative, semi-quantitative and quantitative results for all important parameters of InfectiousDisease Serology. They are intended for the detection of specific IgG-, IgM- and IgA antibodies in human serum.

They are suitable for use on automated Immunoassay Analyzers and have been successfully evaluated on devices such as BEP III, DSX, Freedom EVOlyzer, ETI MAX 3000, Triturus and Thunderbolt (in evaluation). The ELISAs are thus released on thesedevices referring to the IVD guidelines 98/79/EG. In addition to serology the Virotech ELISAs can also be used for the detectionof pathogen-specific antibodies in Cerebrospinal Fluid (CSF).

For determining the accuracy and precision of the antibody index (AI), specific Antibody-Index-Controls (AI-Controls) areoffered. These AI-Control pairs for the normal range and the pathological range allow comprehensive quality control in dailylaboratory routine for the diagnosis of Cerebrospinal Fluid parameter.

Infectious Disease

ELISA ADVANTAGES• Uniform serum dilution• General IgG-, IgM-, IgA-conjugate• Uniform incubation times• Uniform interpretation with ready to use cut-off controls• Ready to use controls, conjugates, substrates• Automatable

CSF DIAGNOSTIC ADVANTAGES• User friendly Serum- & CSF-Dilution• Identical Serum-/CSF-Dilution for all available Serum-/CSF ELISAs• Antibody-Index (AI)-determination referring to

the Reiber-diagraphs• Excellent precision and reliability shown in the German proficiency testing• Software-based calculation of the CSF data possible• Paralell CSF/ Serum procedure on one plate (including serology)• Ideal elimination of the Matrix-effect• Ready-to-use CSF-standards

ANTIBODY-INDEX-CONTROL (AI-CONTROL) ADVANTAGES• Verification of the accuracy and precision of the determined AI• Qualitiy Control in the daily CSF-routine-diagnostic• CSF/Serum-Control Pair for the normal range (AI <1,5) ready to use• CSF/Serum-Control Pair for the pathologic range (AI >1,5) ready to use

Adenovirus ELISAIgG / IgM Testkit 96 wells EC121.00 Can be processed in one run with all other kits IgA-Set Set EC121.08 of the respiratory panel

Bordetella pertussis ELISAIgG / IgA Testkit 96 wells EC115.00 Sensitive Screening due to use of combined

antigens PT and FHA

Pertussis Toxin ELISAIgA Testkit 96 wells EC215A00 Highly specific and sensitive diagnostics due to use IgG Testkit 96 wells EC215G00 of pure Pertussis Toxin. Quantitative IgG detection IgG-Quantification-Set 3x 2 mL EN215Q60 in IU/mL (WHO-Std) via 4PL-method byIgM Testkit 96 wells EC215M00 using the IgG quantification set

Borrelia afzelii + VIsE IgG ELISAIgG Testkit 96 wells EC022G00 Maximum diagnostic sensitivity and good IgG CSF Standards Standards EC022L60 specificity due to an antigen mix of B. afzelii strain IgG AI-Control 4 x 1 mL EN022L65 PKo, B. garinii strain PBr and B. burgdorferi

strain ZS7

Borrelia afzelii +VIsE Europe ELISAIgG Testkit 96 wells EC024G00 Increased specificity due to a special IgG CSF Standards Standards EC022L60 cut-off adjustment IgG AI-Control 4 x 1 mL EN022L65

Borrelia afzelii IgM ELISAIgM Testkit 96 wells EC022M00 High sensitivity due a strong expressing IgM CSF Standards Standards EC022L80 OspC-Borrelia afzelii-strain PkoIgM AI-Control 4 x 1 mL EN022L85

Borrelia VIsE IgG ELISAIgG Testkit 96 wells EC023G00 High-specific Screening Assay, coated solely with

the in vivo expressed antigen VlsE

Borrelia burgdorferi Veterinary ELISAIgG Testkit dog/horse 96 wells DC122.00 Sensitive IgG antibody screening of dog or IgM Set dog Set DC122K80 horse serum

Brucella ELISAIgG / IgM Testkit 96 wells EC101.00 Detects Brucella abortus, Brucella IgA-Set Set EC101.08 melitensis and Brucella suis

Candida albicans ELISAIgG / IgM Testkit 96 wells EC111.00 Adjusted to primarily detect acute IgA-Set Set EC111.08 infections in IgG

Cytomegalo Virus ELISAIgG / IgM Testkit 96 wells EC113.00 Very sensitive mix of native andIgG CSF-Standards Standards EC113L60 recombinant antigens

Diphtheria ELISAIgG Testkit 96 wells EC129.00 Usable for survey of vaccination status and

vaccination success. Aligned with WHO standards for quantitative detection in IU/mL via 4PL-methodor 6 standards

EBV ELISAIgG / IgM Testkit 96 wells EC102.00 EBV screening ELISAIgG CSF-Standards Standards EC102L60 A diagnostic statement with regard to IgG AI-Control 4 x 1 mL EN102L65 seronegativity, suspicion to an EBV primary

infection or past EBV infection can be made when combining the two antibody classes

EBV EA-D ELISAIgG Testkit 96 wells EC202.00 “Early Antigen-Diffuse” belongs to the early

antigens, which are synthesised in the viralreplication cycle (acute phase of infection)





INFECTIOUS DISEASE SEROLOGY / ELISA — PREABSORPTION OF RHEUMATOID FACTORS


INF 76 INF

ELISA ASSAYS

EBV EBNA 1 ELISAIgG Testkit 96 wells EC204.00 Diagnostic factor for a clear differentiation

between primary infection and past infectionat a positive result of EBNA1-IgG and VCA-IgM

EBV VCA IgG ELISAIgG Testkit 96 wells EC205G00 Includes the important high specific marker

for EBV: gp125 and p18

EBV VCA IgM ELISAIgM Testkit 96 wells EC203M00 Diagnostic factor for a clear differentiation

between primary infection and past infection at a positive result of EBNA1-IgG and VCA-IgM

Enterovirus ELISA (Coxsackie- and Echovirus)IgA Testkit 96 wells EC116A00 Coxsackievirus B5 and Echovirus 24: ScreeningIgG Testkit 96 wells EC116G00 Assay for the detection of heterotypicIgM Testkit 96 wells EC116M00 IgG-, IgA-, IgM-antibodies

Helicobacter pylori ELISAIgA Testkit 96 wells EC143A00 Sensitive detection of specific IgG- and IgG Testkit 96 wells EC143G00 IgA-antibodies

HSV 1 (gG1) ELISAIgG / IgM Testkit 96 wells EC130.00 High-specific recombinant glycoprotein gG1 IgG CSF-Standards Standards EC130L60

HSV 2 (gG2) ELISAIgG / IgM Testkit 96 wells EC131.00 High-specific affinity-purified glycoprotein gG2 IgG CSF-Standards Standards EC131L60

HSV Screen ELISAIgG / IgM Testkit 96 wells EC108.00 Screening of IgG and IgM of HSV 1and HSV 2 IgG CSF-Standards Standards EC108L60 in one assayIgA CSF-Standards Standards EC108L40IgG AI-Control 4 x 1 mL EN108L65IgG AI-Control 4 x 1 mL EN108L45

Influenza A ELISAIgG / IgM Testkit 96 wells EC118.00 Up to date antigens as per seasonal IgA Testkit 96 wells EC118A00 recommendation of the WHO

Influenza B ELISAIgG / IgM Testkit 96 wells EC119.00 Up to date antigens as per seasonal IgA Testkit 96 wells EC119A00 recommendation of the WHO

Measles ELISAIgG Testkit 96 wells EC105G00 Complete package of serum and IgM Testkit 96 wells EC105M00 CSF diagnosticIgG CSF-Standards Standards EC105L60IgM CSF-Standards Standards EC105L80IgG AI-Controls 1 x 4 mL EN105L65

Mumps ELISAIgG / IgM Testkit 96 wells EC106.00 Complete package of serum and IgG CSF-Standards Standards EC106L60 CSF diagnostic

Mycoplasma pneumoniae ELISAIgG / IgM Testkit 96 wells EC114.00 Cut-off adjustment to detect acute infections IgA-Set Set EC114.08 in IgG. Specific infants cut-off adjustment.

Mycoplasma pn. polyvalent ELISAIgG/IgA+M Testkit 96 wells EC214.00 Efficient diagnostic due to simultaneous detection

of IgA & IgM antibodies with one polyvalentconjugate. Cut-off adjustment to detect acute infections in IgG. Specific infants cut-off adjustment.

ParaScreen ELISAIgG / IgM Testkit 96 wells EC148.00 Detects Parainfluenza 1-3 in one test runIgA-Set Set EC148.08

RSV ELISAIgG / IgM Testkit 96 wells EC107.00 Can be processed in one run with all other kits IgA-Set Set EC107.08 of the respiratory panel

Rubella ELISAIgG CSF-Kit 96 wells EC109L00 CSF Diagnostic for IgG, AI-Controls for IgG IgG CSF-Standards Standards EC109L60IgG AI-Control 4 x 1 mL EN109L65

TBE ELISAIgG / IgM Testkit 96 wells EC117.00L00 Sensitive detection of an acute or recent infection IgG CSF-Standards Standards EC117L60 with Tick-Borne-Encephalitis-Virus (TBE) or for the IgM CSF-Standards Standards EC117L80 detection of vaccination antibodiesIgG AI-Control 4 x 1 mL EN117L65

Tetanus ELISAIgG Testkit 96 wells EC124.00 Survey of vaccination status and vaccination

success, routinely aligned with WHO standardsfor quantitative detection in IU/ml via4PL-method or 6 standards

VZV ELISAIgG / IgM Testkit 96 wells EC110.00 IgG adjusted as recommended by the IgA-Set Set EC110.08 Robert-Koch-Institute (aligned to the WHO IgG CSF-Standards Standards EC110L60 standard: > 100IU/l = seropositive titer)IgM CSF-Standards Standards EC110L80IgA CSF-Standards Standards EC110L40IgG AI-Control 4 x 1 mL EN110L65

Yersinia enterocolitica ELISAIgG / IgA Testkit 96 wells EC142.00 Mix of purified native antigens and recombinant

antigens YopD, YopB & YopE

RF-SorboTech vial – 2 mL 161101 Rheumatoid factor absorbent for all IgM andIgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech vial – 10 mL 161102 Rheumatoid factor absorbent for all IgM andIgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech-80x 2 vials RF – 2 mL, B/300.00 Rheumatoid factor absorbent for all IgM anddilution buffer IgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech Kit 1 vial RF – 2 mL, B/300.11 Rheumatoid factor absorbent for all IgM and 40 tubes with IgA+M ELISA tests and Pertussis Toxin IgA ELISA 450 μl dilutionbuffer each

INFECTIOUS DISEASE SEROLOGY / ELISA — SINGLE COMPONENTS FOR HUMAN SEROLOGY EIA

PRODUCT FORMAT ORDER NUMBER

VALIDATION OF ELISA PROCESSORS


VIROTECH ELISA ASSAYS - PACKAGE CONTENTS

INF 9

ELISA ASSAYS

8 INF

Tetramethylbenzidine – Substrate Solution 11 mL 151101

PBS-Washing Solution (20x concentrated) 50 mL 141201

Citrate-Stopping Solution 6 mL 141101

PBS-Dilutionbuffer (blue, ready to use) 50 mL 141301

VZV-IgM-Dilutionbuffer (green, ready to use) 50 mL 141401

IgA-Conjugate (anti-human) 11 mL 131301

IgA-Conjugate 2 (anti-human) 11 mL 131601

IgA+M Conjugate 11mL 131401

IgG-Conjugate (anti-human) 11 mL 131101

IgM-Conjugate (anti-human) 11 mL 131201

12 breakable microtiter strips (antigen-coated) 1 Plate ECXXX.01

IgA-Set (IgA-Controls and IgA-Conjugate) Set ECXXX.08

IgA-Controls Set ENXXXK40

IgG-Controls Set ENXXXK60

IgM-Controls Set ENXXXK80

Diphtheria ELISA Set EN129K60IgG Standards

Tetanus ELISA Set EN124K60IgG Standards

XXX = order number of the parameter (refer to the product list). Please note that the control sets are kit-specific.Please always indicate the batch-number of the kit they are intended to be used with.

Validation Kit, ELISA 96 wells EC250.00 Kit to verify ELISA devices (semi- or fully automated)

Pipetting Control-Set 2.5 mL EN250K60 Set to verify the pipetting process of ELISA devices (semi- or fully automated). For use with EC250.00

Semiquantitative ELISA-Testkits, ECXXX.00

• 12 separable microtiter strips• Anti-human conjugates: IgA, IgG, IgM, depending

on test format• Controls: negative, cut-off, positive, IgA, IgG, IgM,

depending on test format• dilution buffer, washing buffer

Tetanus (EC124.00) and Diphtheria (EC129.00) ELISA, quantitative Assays

• additional 6 standard sera to create a standard curve

CSF-Standards, ECXXXL40/ECXXXL60/ECXXXL80

• 4 IgA-CSF standards, IgM-CSF standards or IgG-CSF standards to prepare a standard curve. For the parallel detection of specific IgA-, IgM- or IgG-antibodies in Cerebrospinal Fluid.

ENXXXL65, ENXXXL45 AI-Control

• CSF / Serum Control pair for the normal range• CSF / Serum Control pair for the pathological range

ECXXX.08, IgA-Set

• IgA- negative, cut-off and positive-control• Anti-human IgA-conjugate

ECXXXK40, IgA-controls

• IgA-negative-, cut-off- and positive-controlonly for Bordetella pertussis, Enterovirus,Helicobacter pylori, Influenza A, Influenza B,Pertussis Toxin and Yersinia enterocolitica

ENXXXK60, IgG-controls

• IgG-negative-, cut off-, positive-controls

ENXXXK80, IgM-controls

• IgM-negative-, cut off-, positive-controls


THE VIROTECH LINE SYSTEM

INFECTIOUS DISEASE SEROLOGY LINE


INF 1110 INF

LINE ASSAYS

The Virotech Line Immuno Assays (LINE) are intended for the qualitative detection of pathogen-specific antibodies in humanserum. Our continuously extended product range serves for the detection of IgG-, IgM- and IgA-specific antibodies in humanserum and can be used in the uniform LINE system. The Borrelia LINEs assays can be used for the detection of specific antibodiesin Cerebrospinal Fluid. In this system, the proteins are transferred to a nitrocellulose membrane using a special micro-dispensingmethod.

The Virotech LINEs are suitable for the use on Automated Immunoassay Analyzers and have been successfully evaluated on theTecan Profiblot.

Infectious Disease

ADVANTAGES OF THE VIROTECH LINE SYSTEM:• Solid strips stabilised on a plastic foil• Sorted strips in a booklet• Clear strip numbering• Quality control on each strip• Identical incubation times (30´/30´/10´)• Automatable• Test result after 100 minutes available• Identical serum and conjugate dilution• General components• Cut off control included in the Kit• Positive-/negative controls available

Bordetella pertussis + CatACT LINEIgG Line Immunoblot 32 strips WE116G32 New marker CatACT allows differentiation between IgG Line Immunoblot 96 strips WE116G96 vaccination and infection. Note towardsIgG cut off control 0,5 mL WE116C60 parapertussis possible.IgG positive control 0,5 mL WE116P60IgA Line Immunoblot 32 strips WE116A32IgA Line Immunoblot 96 strips WE116A96IgA cut off control 0,5 mL WE116C40IgA positive control 0,5 mL WE116P40IgG/IgA negative control 0,5 mL WE116N20

Borrelia LINEIgG Line Immunoblot 32 strips WE222G32 Excellent specificity and sensitivity due to the IgG Line Immunoblot 96 strips WE222G96 optimised combination of the most important IgG cut off control 0,5 mL WE222C60 common antigens (OspC, p39, p83/100)IgG positive control 0,5 mL WE222P60 with well-known „in-vivo“ antigens.IgM Line Immunoblot IgM Line Immunoblot WE222M32 EBV-band as exclusion marker in IgM diagnostics.IgM Line Immunoblot IgM Line Immunoblot WE222M96 Validated for CSF testing.IgM cut off control 0,5 mL WE222C80IgM positive control 0,5 mL WE222P80IgG/IgM negative control 0,5 mL WE222N10

Borrelia in vivo LINE plusIgG Line Immunoblot 32 strips WE223G32 Treponema-band (TpN17) as exclusion marker IgG Line Immunoblot 96 strips WE223G96 in IgG diagnostics. Validated for CSF testing.IgG cut off control 0,5 mL WE223C60IgG positive control 0,5 mL WE223P60IgG negative control 0,5 mL WE223N60

Borrelia Europe LINEIgG Line Immunoblot 32 strips WE224G32 Optimised combination of high purified lysate IgG Line Immunoblot 96 strips WE224G96 antigens (OspC, DbpA-PKo) and recombinantIgG cut off control 0,5 mL WE224C60 antigens (VlsE, p83, p58, p39, DbpA-Mix).IgG positive control 0,5 mL WE224P60 EBV-band as exclusion marker in IgM diagnostics. IgM Line Immunoblot 32 strips WE224M32 Validated for CSF testing.IgM Line Immunoblot 96 strips WE224M96IgM cut off control 0,5 mL WE224C80IgM positive control 0,5 mL WE224P80IgG/IgM negative control 0,5 mL WE224N10

Borrelia Europe plus TpN17 LINEIgG Line Immunoblot 32 strips WE225G32 Treponema-band (TpN17) as exclusion IgG Line Immunoblot 96 strips WE225G96 marker in IgG diagnostics. Validated for CSF testing.IgG cut off control 0,5 mL WE225C60IgG positive control 0,5 mL WE225P60IgG negative control 0,5 mL WE225P60

EBV LINEIgG Line Immunoblot 32 strips WE102G32 Double-cut-off strategy for EBNA1-interpretation. IgG Line immunablot 96 strips WE102G96 Tool for a clear differentiation between primary IgG cut off control 0,5 mL WE102C60 and past infection.IgG positive control 0,5 mL WE102P60IgM Line Immunoblot 32 strips WE102M32IgM Line Immunoblot 96 strips WE102M96IgM cut off control 0,5 mL WE102C80IgM positive control 0,5 mL WE102P80IgG/IgM negative control 0,5 mL WE102N10

INFECTIOUS DISEASE SEROLOGY LINE


INFECTIOUS DISEASE SEROLOGY LINE — SINGLE COMPONENTS FOR LINE TEST KITS

PRODUCT FORMAT ORDER NUMBER

INFECTIOUS DISEASE SEROLOGY LINE — DOG KIT (BASIS KIT) WITH ADDITIONAL HORSE SET


INF 1312 INF

LINE ASSAYS

Helicobacter pylori LINEIgG Line Immunoblot 32 strips WE243G32 Therapy-relevant differentiation of virulent and IgG Line Immunoblot 96 strips WE243G96 non-virulent strains via CagA and VacAIgG cut off control 0,5 mL WE243C60IgG positive control 0,5 mL WE243P60IgA Line Immunoblot 32 strips WE243A32IgA Line Immunoblot 96 strips WE243A96IgA cut off control 0,5 mL WE243C40IgA positive control 0,5 mL WE243P40IgG/IgA negative control 0,5 mL WE243N20

HSV LINEIgG Line Immunoblot 16 strips WE130G16 High specific bands for HSV1 (gG1-recombinant) IgG Line Immunoblot 32 strips WE130G32 and HSV2 (gG2-purified) as well as a native IgG cut off control 0,5 mL WE130C60 total antigen band (1+2)IgG positive control 0,5 mL WE130P60IgG negative control 0,5 mL WE130N60

Mycoplasma pneumoniae LINE (recomb.)IgG Line Immunoblot 16 strips WE214G16 The only commercially available LINE, with IgG cut off control 0,5 mL WE214C60 an ideal combination of establishedIgG positive control 0,5 mL WE214P60 (P1) & new antigens (P200, P400)IgA Line Immunoblot 16 strips WE214A16IgA cut off control 0,5 mL WE214C40IgA positive control 0,5 mL WE214P40IgM Line Immunoblot 16 strips WE214M16IgM cut off control 0,5 mL WE214C80IgM positive control 0,5 mL WE214P80IgG/IgA/IgM negative control 0,5 mL WE214N50

Treponema pallidum LINE (recomb.)IgG Line Immunoblot 16 strips WE150G16 Very good sensitivity and specificity IgG Line Immunoblot 32 strips WE150G32 using recombinant proteinsIgG cut off control 0,5 mL WE150C60IgG positive control 0,5 mL WE150P60IgM Line Immunoblot 16 strips WE150M16IgM Line Immunoblot 32 strips WE150M32IgM cut off control 0,5 mL WE150C80IgM positive control 0,5 mL WE150P80IgG/IgM negative control 0,5 mL WE150N10

Yersinia enterocolitica LINE(recomb.)IgG Line Immunoblot 32 strips WE242G32 Prevalence band YopDD in IgG shows IgG Line Immunoblot 96 strips WE242G96 contact with the pathogenIgG cut off control 0,5 mL WE242C60IgG positive control 0,5 mL WE242P60IgA Line Immunoblot 32 strips WE242A32IgA Line Immunoblot 96 strips WE242A96IgA cut off control 0,5 mL WE242C40IgA positive control 0,5 mL WE242P40IgM Line Immunoblot 32 strips WE242M32IgM cut off control 0,5 mL WE242C80IgM positive control 0,5 mL WE242P80IgG/IgA/IgM negative control 0,5 mL WE242N50

IgG-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.62

IgM-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.82

IgA-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.42

Dilution- / Washbuffer (10x concentrated) 50 mL WE200.08

Substrate Solution (BCIP/NBT, ready to use) 57 mL WE200.02

Incubationtray with 42 cavities, to be used with the Apollo automates 1 pcs WE300.42

Incubationtray with 30 cavities, black, to be used with the ProfiBlot automates 1 pcs WE300.30S

Incubationtray with 48 cavities, black, to be used with the ProfiBlot automates 1 pcs WE300.48S

Incubationtray with 8 cavities 1 pcs WE300.08

Blotrix Record Sheet 1 booklet WE301APB

Borrelia Europe plus TpN17 LINEIgG LINE Immunoblot dog 32 strips DE226G32 Specific LINE assay to detect the most importantIgG LINE Immunoblot dog 96 strips DE226G96 Borrelia genospecies in dog and horse serum.IgG Horse Set Set DE226K62


INFECTIOUS DISEASE — ANTIGEN DETECTION ELISA WITH A SYSTEM

SERAMUN ANTIGEN DETECTION TESTS — ELISA (TEST MATERIAL: HUMAN STOOL SAMPLES / CULTURE MATERIAL)

BACTERIA FORMAT ORDER NUMBER FEATURES

VIRUSES FORMAT ORDER NUMBER FEATURES

PARASITES FORMAT ORDER NUMBER FEATURES

INF 1514 INF

ELISA ASSAYS

The Seramun Stool ELISA system is used for the qualitative detection of pathogen specific antigens/toxins in stool samples andculture material.

Special Kit packages have been developed for the use on Automated Immunoassay Analyzers (see order numbers ending –A2). The Kits intended for manual procedure are available in a drop-bottle-format. Seramun offers the Serazym StoolSystem - meaning all reagents in the kit (except conjugate, controls and microtiter plate) can be used independent from lotnumber or pathogen. This offers significant advantages!

Seramun Stool ELISA

SERAMUN STOOL ELISA DIAGNOSTIC FEATURES• ONE SYSTEM in pre-analytics• Optimal results / excellent performance data• 1 sample diluent & 1 dilution • General lot-independent reagents (overall reagents)• Separate controls available• Two kit versions; one for Automated Immunoassay Analyzers and one for

manual procedure (drop-bottle-format)• Color coded vial caps and plates for ease of use• Removable label for wash buffer

Serazym® Campylobacter 96 wells HW/E-093 Specific detection of C. jejuni and C. coli in stool Serazym® Campylobacter 2 x 96 wells HW/E-093-A2 and culture samples

Serazym® Clostridium difficile GDH 96 wells HW/E-107 Sensitive screening for the detection ofSerazym® Clostridium difficile GDH 2 x 96 wells HW/E-107-A2 Glutamatdehydrogenase of Clostridium difficile

Serazym® Clostridium difficile Toxin A + B 96 wells HW/E-040 Sensitive detection with a biotin/streptavidin Serazym® Clostridium difficile Toxin A + B 2 x 96 wells HW/E-040-A2 conjugate system of Toxin A & B in stool

and culture samples

Serazym® Verotoxin 1 + 2 96 wells HW/E-030 Sensitive detection with a biotin/streptavidin Serazym® Verotoxin 1 + 2 2 x 96 wells HW/E-030-A2 conjugate system of Verotoxin 1 & 2

(Shiga Toxin 1 & 2) in stool and culture samples

Serazym® Adenovirus 96 wells HW/E-017 Detection of the capsid protein hexon, commonSerazym® Adenovirus 2 x 96 wells HW/E-017-A2 to all human pathogenic Adenovirus serotypes

Serazym® Astrovirus 96 wells HW/E-045 Detection of Astrovirus specific antigens in aSerazym® Astrovirus 2 x 96 wells HW/E-045-A2 short incubation time of 60-10 min

Serazym® Norovirus 96 wells HW/E-061 Detection of Norovirus capsid proteins Serazym® Norovirus 2 x 96 wellst HW/E-061-A2 of the genogroups GGI and GGII

Serazym® Rotavirus 96 wells HW/E-020 Detection of the major protein VP-6 Serazym® Rotavirus 2 x 96 wells HW/E-020-A2 of group A Rotaviruses

Serazym® Cryptosporidium parvum 96 wells HW/E-039-A Sensitive detection with monoclonal antibodies

Serazym® Entamoeba histolytica 96 wells HW/E-018-A Sensitive detection of E. histolytica while detection of E. dispar is onlypossible with high organism counts ( >105 mL)

Serazym® Giardia lamblia 96 wells HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1) despite intermittent excretion

16 INF

NOTES

80-8231-00-00 10/14

Other trademarks used here in are owned by their respective companies.


SEKISUI DIAGNOSTICSYOUR GLOBAL PARTNER FOR OVER 30 YEARS

Sekisui Diagnostics was created in 2011 when Sekisui Medicalacquired Genzyme Diagnostics. The new company brings togetherextensive product development capabilities and a broad globalsales/distribution network for our comprehensive product lines:

• Clinical chemistry systems and reagents • Coagulation systems and reagents • Infectious disease rapid tests, line immunoassays, and ELISA Kits • Enzymes and specialty biochemical

Sekisui Diagnostics is a diverse company with extensive productdevelopment capabilities, state of the art manufacturing facilities,and deep diagnostics expertise.

We are Sekisui Diagnostics and we are dedicated to improving thelives of patients all around the world.

Locations

Sekisui Diagnostics (UK) Ltd.Kings Hill, West Malling Kent, UK+44-1732-220022

Sekisui Virotech GmbHRüsselsheim, Germany+49-6142-6909-0

American Diagnostica GmbHPfungstadt, Germany+49-6157-990899

Sekisui Medical Co., Ltd.Tokyo, Japan+81-3-3272-0671

Sekisui Medical Technology (China) Ltd.Shunyi District, Beijing, China+86-10-8048-6325

Sekisui Medical Technology (China) Ltd.Chaoyang District, Beijing, China+86-10-6269-2662

www.sekisuidiagnostics.com

Worldwide HQSekisui Diagnostics, LLCLexington, MA, USA+1-781-652-7800

Sekisui Diagnostics, LLCSan Diego, CA, USA+1-858-777-2600

Sekisui Diagnostics, LLCExton, PA, USA+1-610-594-8590

Sekisui Diagnostics, LLCStamford, CT, USA+1-203-602-7777

Sekisui Diagnostics P.E.I. Inc.Charlottetown, PEI, Canada+1-902-566-1396


Documents

PRODUCT CATALOG - · PDF fileToday’s healthcare professionals ... Our reagents feature liquid stable technology ... Direct-SL 247-30 3 x 100 mL (R1) Liver Disease DCA assay 1 x 75