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Respiratory Pathogens Panel Kit v6
Performance Evaluation File v2
December 2019
CONTENTS
1. Name and Address of the Manufacturer
2. Name and Address of the Facilities
3. Conformity Assessment Procedure
4. Description of the Device
5. Relevant Regulations
6. Compliance with Technical Standards
7. Bench Testing
8. Performance Analysis and Clinical Data
8.1. Sensitivity
8.2. Cross Reactivity
8.3. Clinical Data
Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2
Dec.2019
3
1. NAME AND ADDRESS OF THE MANUFACTURER
Name of the manufacturer is Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. A.Ş.’
and the address of the manufacturer is Eğitim Mah. Kasap İsmail Sk. Istanbul Plaza No10/23
34722 Kadıköy, İstanbul TURKEY.
2. NAME AND ADDRESS OF THE FACILITIES
The address of the manufacturer is Eğitim Mah. Kasap İsmail Sk. Istanbul Plaza No10/23
34722 Kadıköy, İstanbul TURKEY, with the second facility at İstanbul Endüstri ve Ticaret Serbest
Bölge Şubesi, Aydınlı Sb Mahallesi Matraş Caddesi No: 18/Z02 Tuzla-Istanbul TURKEY.
3. CONFORMITY ASSESSMENT PROCEDURE
Conformity assessment procedure followed is Annex III (EC Declaration of Conformity) of the
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In
Vitro Diagnostic Medical Devices.
4. DESCRIPTION OF THE DEVICE
Bosphore Respiratory Pathogens Panel Kit v6 is a Real-Time PCR-based in vitro diagnostic
medical device, that can be used both for screening and monitoring purposes. It is composed of
Real-Time PCR reagents and the positive controls. Positive controls are provided in the separate
smaller boxes inside the main box, to avoid contamination risk during opening by the end user,
and to enable easy separate storage of PCR reagents and DNA containing components.
5. RELEVANT REGULATIONS
This technical documentation has been prepared in accordance with the following;
• Directive 98/79/EC of the European Parliament And of The Council of 27 October 1998
on In Vitro Diagnostic Medical Devices
• Harmonized Directive (T.C. Sağlık Bakanlığı Vücut Dışında Kullanılan Tıbbi Tanı Cihazları
Yönetmeliği - Turkish Republic Ministry of Health In Vitro Diagnostic Medical Devices
Directive )
Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2
Dec.2019
4
6. COMPLIANCE WITH TECHNICAL STANDARDS
• Quality management system which has been established according to ISO 9001:2015was
adapted to the harmonized standard “EN ISO 13485:2016 Medical devices–Quality
management systems–Requirements for regulatory purposes”
• Risk analysis was carried out with reference to the harmonized standard “EN ISO 14971 –
2012 Application of the risk management to medical devices”.
• For the integration of in vitro diagnostic symbols into the labels and user manual, the
applicable sections of the harmonized standard EN ISO 15223-1:2012 and TS EN ISO
18113-1 were referred to.
• For the stability evaluation, EN ISO 23640:2013 was referred to.
7. BENCH TESTING
Performance evaluation was performed in accordance with the Commission Decision of 3
Feb. 2009 on Common Technical Specifications for In Vitro Diagnostic Medical Devices. The
specifications; sensitivity, cross reactivity, cross contamination was tested in Anatolia Inc.
laboratory.
Clinical data has been obtained via experimental feedback from end user institutions and
EQA panels.
8. PERFORMANCE ANALYSIS AND CLINICAL DATA
Performances of Bosphore Respiratory Pathogens Panel Kit v6 was evaluated in accordance
with the Commission Decision of 3 Feb. 2009 on Common Technical Specifications for In Vitro
Diagnostic Medical Devices.
8.1. SENSITIVITY/ANALYTICAL DETECTION LIMIT
In the context of the Common Technical Specifications (published by The Commission of
the European Communities, see “Relevant Regulations” section), analytical sensitivity may be
expressed as the limit of detection: i.e. the smallest amount of the target marker that can be
precisely detected. The detection limit of an individual analytical procedure is the lowest amount
of nucleic acid in a sample which can be detected but not necessarily quantitated as an exact
value. Analytical sensitivity or detection limit for NAT assays is expressed by the 95 % positive
Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2
Dec.2019
5
cut-off value. This is the analyte concentration where 95 %of test runs give positive results
following serial dilutions of an international reference material.
A preliminary test was done in order to obtain a preliminary value for the positive cut-off
point (i.e. the highest dilution giving a positive signal). Concentrations, at which the sensitivity
would be tested, were then chosen around the pre-determined value. These dilution series (were
prepared and tested with replicates for each dilution on different days in replicates. Results of
the experiments are given below.
Sensitivity data was obtained using the Montania 4896 Real Time PCR Instrument,
Magnesia16 DNA/RNA Extraction System and Magnesia Viral DNA/RNA Nucleic Acid Extraction
Kit with a starting volume of 400 µl and an elution volume of 60 µl. Analytical detection limits for
Bosphore® Respiratory Pathogens Panel Kit v6 were calculated as shown below. Dilutions were
tested in different runs in replicates and results were analyzed by probit method.
Parameter Sensitivity Parameter Sensitivity
Adenovirus 193 copies/reaction Parainfluenza 1 508 copies/ reaction
Bocavirus 40 copies/ reaction Parainfluenza 2 18 copies/ reaction
Coronavirus HKU1 100 copies/ reaction Parainfluenza 3 87 copies/ reaction
Coronavirus NL63 11 copies/ reaction Parainfluenza 4 782 copies/ reaction
Coronavirus OC43 15 copies/ reaction Rhinovirus 24 copies/ reaction
Coronavirus 229E 112 copies/ reaction RSV A 14 copies/ reaction
Enterovirus 123 copies/ reaction RSV B 98 copies/ reaction
H. influenza type B 104 copies/ reaction M. pneumoniae 4 copies/ reaction
Influenza A 888 copies/ reaction Pandemic H1N1 590 copies/ reaction
Influenza B 21 copies/ reaction Parechovirus 53 copies/ reaction
Metapneumovirus 229 copies/ reaction
To ensure the sensitivity in different systems, dilutions of pre-quantitated sample extracted
by Magrev Viral Extraction Kit on Magrev 24 system dilutions at 2X LOD and LOD levels in 24
replicates were run on Roche Light Cycler 480, Biorad CFX 96, ABI 7500 Real-Time PCR System-
ABI, LineGene 9600-Bioer and Rotorgene Q-Qiagen instruments, and all the samples were found
positive.
Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2
Dec.2019
6
8.2. CROSS REACTIVITY
Potential cross-reactive markers were eliminated by assay design evidence. Sequence
alignment results were obtained by NCBI Blast analysis (National Center for Biotechnology
Information Basic Local Alignment Search Tool). In order to eliminate the possibility of
nonspecific amplifications (complementarity to other viral genomic sequences, a sequence
search for the primers and probe sequences was executed by “Nucleotide-Nucleotide Blast”
analysis, by excluding the present pathogens, and including all the viral and genomic databases.
Experimental studies were also employed to eliminate potential cross-reactivity. In order to
eliminate potential cross-reactivity, both assay design evidence and experimental studies were
employed. Primer and probe sequences were checked for possible homology to other known
pathogen sequences by sequence comparison analysis using database alignment. To eliminate
the risk of cross-reactivity; Chlamydia pneumoniae, CMV, Neisseria meningitidis, VZV, HSV-1
and HSV-2 samples with known high positivity were tested and found negative. Moreover, each
component of the kit has been tested for cross reactivity using high positive samples of
Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Enterovirus, Metapneumovirus,
Mycoplasma pneumoniae, Pandemic H1N1 Influenza A, Influenza A, H. influenza type B,
Influenza B, RSV A/B, Bocavirus, Rhinovirus, Coronavirus 229E, Coronavirus OC43, Coronavirus
NL63, Coronavirus HKU1, Adenovirus and Parechovirus. Appropriate experimental results
indicated that every PCR Master mix detects specifically and only the respiratory tract infection
pathogens that it only intends to detect, but not the others.
*Enterovirus positive samples also give positive signal for Rhinovirus assay. The positive samples
on both Rhinovirus and Enterovirus assays should be regarded as Enterovirus positive only.
8.3. CLINICAL DATA AND PERFORMANCE
Clinical data has been obtained via QCMD EQA panels and as experimental feedback from
end user institutions. Bosphore Respiratory Pathogens Panel Kits have been used by the end
users since 2017.
Quality Control for Molecular Diagnostics (QCMD) is an independent International External
Quality Assessment (EQA)/Proficiency Testing (PT) organisation. QCMD provides a wide-ranging
Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2
Dec.2019
7
quality assessment service primarily focused on molecular infectious diseases to over 2000
participants in over 100 countries. QCMD is dedicated to advancing the quality of molecular
diagnostics through External Quality Assessment (EQA), Proficiency Testing (PT) and other
supporting quality initiatives. http://www.qcmd.org/
Duplicates from each type of sample (biopsy/tissue samples, BAL, sputum, tracheal aspirate,
nasopharyngeal aspirate, throat swab, nose swab, nasopharyngeal swab: Flocking swabs and
Liquid Amies, Universal Transport Medium) concentrations at LOD and LODx2 were tested with
both Magnesia16 Viral DNA/RNA Extraction system, run on Montania 4896 Real-Time PCR
Instrument and were found positive.
The following DNA extraction systems that are not manufactured by Anatolia,
Qiasymphony, Qiacube and EZ1 Instrument (Qiagen), MagNA Pure Instruments (Roche) ,
Nuclisens EasyMAG (Biomerieux), ExiPrep Dx (Bioneer) have been tested with this kit, in end user
sites using previously tested samples, and the end users provided positive feedback about the
internal control amplifications and respiratory pathogen detection results in concordance with
other system results.
Using Respiratory Pathogens Panel Kits, QCMD 2017 Respiratory III Programme has already
been participated successfully; the resulting reports can also be seen enclosed.
Intended Results / Panel Composition
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
De te cte d /De te rmine d
Not De te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-01 Negative TransportMedium
100 49 N/A 0 N/A 0
RESPIII17S-02 Legionellapneumophila sg1(ST62)
TransportMedium
73.5 36 14.3 7 12.2 6
RESPIII17S-03 Bordetellapertussis
Saline 81.6 40 2 1 16.3 8
RESPIII17S-04 Mycoplasmapneumoniae
TransportMedium
93.9 46 N/A 0 6.1 3
RESPIII17S-05 Streptococcuspneumoniae
TransportMedium
DS1_2 46.9 23 10.2 5 42.9 21
RESPIII17S-06 Legionellapneumophila sg1(ST47)
TransportMedium
77.6 38 6.1 3 16.3 8
RESPIII17S-07 Streptococcuspneumoniae
TransportMedium
DS1_1 49 24 8.2 4 42.9 21
RESPIII17S-08 Haemophilusinfluenz ae
TransportMedium
DS2_1 40.8 20 6.1 3 53.1 26
RESPIII17S-09 Haemophilusinfluenz ae
TransportMedium
DS2_2 42.9 21 4.1 2 53.1 26
RESPIII17S-10 Negative Saline 98 48 2 1 N/A 0
[1] Sample Re lat ionship: Ind icate s the re latio nship s o f the samp le s within this challe ng e . Dilutio n se rie s are ind icte d b y 'DS1' withe ach p ane l me mb e r in the d ilutio n se rie s re p re se nte d b y a numb e r in o rd e r o f titre , whe re DS1_1 re p re se nts the hig he st titre withinthat d ilutio n se rie s. Furthe r d ilutio n se rie s are ind icate d b y 'DS2' 'DS3' e tc. If o ne d up licate p air is p re se nt this is ind icate d b y 'D1' .Furthe r d up licate p airs are ind icate d b y 'D2' , 'D3' e tc.[2] De t e ct e d / De t e rmine d; Not De t e ct e d / Not De t e rmine d; Not T e st e d: The p e rce ntag e (%) o f d atase ts re p o rte d b y allp artic ip ants in re latio n to the assig ne d status o f the p ane l me mb e r i.e . ‘p o sitive ’ o r ‘ne g ative ’ and the e xp e cte d p atho g e n typ e asd e fine d thro ug h p re -te sting and the to tal numb e r o f d atase ts (n) fo r e ach p ane l me mb e r. For further details please refer to the current participant manual.
EQA Asse ssme nt Group N/A (Refer to My Workf low de tails section below)
Your Summary Results
[1] [2]
[2]
[2]
[1]
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 1 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
Expe cte d Re sult Your Final Laboratory Re porte d Re sult
Qualitat ive Pathoge n ID Pathoge n include d inworkf low(s) Ye s/No
Qualitat ive Re porte dPathoge n ID
RESPIII17S-01 Negative N/A Negative
RESPIII17S-02 Positive Legionella species Yes Positive Legionellaspecies
RESPIII17S-03 Positive Bordetella species Yes Positive Bordetellapertussis
RESPIII17S-04 Positive Mycoplasmaspecies
Yes Positive Mycoplasmapneumoniae
RESPIII17S-05 Positive Streptococcuspneumoniae
Yes Positive Streptococcuspneumoniae
RESPIII17S-06 Positive Legionella species Yes Positive Legionellaspecies
RESPIII17S-07 Positive Streptococcuspneumoniae
Yes Positive Streptococcuspneumoniae
RESPIII17S-08 Positive HaemophilusInfluenz ae
Yes Positive HaemophilusInfluenz ae
RESPIII17S-09 Positive HaemophilusInfluenz ae
Yes Positive HaemophilusInfluenz ae
RESPIII17S-10 Negative N/A Negative
[1] EQA Asse ssme nt Group: To aid analys is p artic ip ant re sults are g ro up e d acco rd ing to the mo le cular amp lificatio n/ d e te ctio nme tho d sp e cifie d within the ir mo le cular wo rkflo w fo r this challe ng e / d is trib utio n. Fo r furthe r d e tails re fe r to the Ad d itio nalInfo rmatio n: Ind ivid ual Pane l Me mb e r Analys is se ctio n o f this re p o rt. [2] Expe ct e d re sult : p o sitive / ne g ative re sult and the sp e cific p atho g e n p re se nt within e ach p ane l me mb e r. [3] Your Final Laborat ory Re port e d Re sult : the final re p o rte d re sult which may b e b ase d o n o ne o r mo re wo rkflo ws use d to te ste ach p ane l me mb e r. [4] Pat hoge n include d in workf low(s): Ye s / No answe r to whe the r the e xp e cte d p atho g e n was te ste d fo r. [5] Qualit at ive : The final q ualitative re sult yo u re p o rte d fo r e ach samp le within this EQA challe ng e / d is trib utio n. [6 ] Re port e d Pat hoge n ID: The final p atho g e n(s) id e ntificatio n yo u re p o rte d fo r e ach samp le within this EQA challe ng e /d is trib utio n. For further details please refer to the current participant manual.
[2] [3]
[4]
[5]
[6 ]
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 2 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
Multiple Pathogen Programme - Qualitative
Assessment of ResultsResults are categorised based on the workflow used and the pathogen(s) targeted as shown in the table below.
Part icipant Repo rt ed Result s
Result Cat ego ry
Expect edQualit at iveResult Po sit ive Negat ive
No tDet ermined
Expect ed pat ho gen(s)included in wo rkf lo w(s)
Expect edpat ho gen(s) no tincluded inwo rkf lo w(s)
Expect edpat ho gen(s)det ect ed
Expect edpat ho gen(s)no t det ect ed
Unexpect edpat ho gen(s)det ect ed
Pos i tive ExpectedPathogenRepor ted
Det ect ed /Det ermined
Negative No pathogenrepor ted
Negative Fals e pos i tive No tDet ect ed /
No tDet ermined
Pos i tive Repor tedPathogen(s )
not as expected
Pos i tive No pathogenrepor ted
Pos i tive Repor tedPathogen(s )
not as expected
Pos i tive orNegative
Res u l t repor tedas not
determ ined
Pos i tive Expectedpathogen not
tes ted for
No t T est ed
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 3 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
My workflow details:
Name Respiratory (v3)
Descript io n Respiratory Panel
T arget s B Legionella species B Salmonella species B Mycoplasma pneumoniae B Streptococcus pneumoniae B Bordetella pertussis B Haemophilus Influenzae B Klebsiella pneumoniae
Assays Extraction - Anato lia Geneworks - Magnesia 16 Commercial
Kit Manufacturer: Anatolia GeneworksKit Type: Magnesia Bacterial DNA Extraction Kit
Amplification - Anato lia Geneworks - Montania 4896 MultiplexCommercial
Kit Manufacturer: Anatolia GeneworksKit Type: Bosphore Respiratory Pathogens Panel KitKit Version:
Used to test samples: RESPIII17S-01, RESPIII17S-02, RESPIII17S-03, RESPIII17S-04, RESPIII17S-05, RESPIII17S-06,RESPIII17S-07, RESPIII17S-08, RESPIII17S-09, RESPIII17S-10
Further Programme Details
Number of Participants 55
Number of Countries 22
Number of Respondents 44
Number of Datasets Submitted 49
EQA Programme AimsThe Respiratory III EQA pilo t study focuses on the molecular detection and determination o f various Bordetella pertussis,Legionella pneumoniae, Mycoplasma pneumoniae, Streptococcus pneumoniae o r Haemophilus influenzae strains.
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 4 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
Feedback and EnquiriesParticipants are encouraged to read the QCMD Participants' Manual, which can be downloaded from the QCMD website.
Any queries about this report should be addressed to the QCMD Neutral Office (neutralo [email protected]).
Additional Information: Individual Panel Member AnalysisQualitative analysis fo r each panel member is provided in relation to your EQA assessment group. EQA assessmentgroups are established using the molecular workflow information reported by all participants within this EQA challenge /distribution.
To allow meaningful assessment at the individual method level the EQA assessment group must consist o f 5 or moredatasets. If there are not sufficient datasets at the individual method level then your results will be included within a higherEQA assessment group based on whether it is a commercial o r in house techno logy/method. The highest levelassessment grouping is “All” participant reported qualitative results.
A breakdown of qualitative results reported for all workflows used by participants on each o f the panel members within thisEQA challenge / distribution is provided below. Note: participants may use multiple workflows for each sample.
The final laboratory result indicates the final reported result which may be based on one or more workflows used to testeach panel member.
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 5 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
Not De te cte d /Not De te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-01 Negative TransportMedium
100 49 N/A 0 N/A 0
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 6 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-02 Legionellapneumophilasg1 (ST62)
TransportMedium
Legionellaspecies
73.5 36 14.3 7 12.2 6
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
87
60
5
14
12
10
9
11
27
26
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 7 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
Not De te cte d /Not De te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-03 Bordetellapertussis
Saline Bordetellaspecies
81.6 40 2 1 16.3 8
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 8 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-04 Mycoplasmapneumoniae
TransportMedium
Mycoplasmaspecies
93.9 46 N/A 0 6.1 3
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 9 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-05 Streptococcuspneumoniae
TransportMedium
DS1_2 Streptococcuspneumoniae
46.9 23 10.2 5 42.9 21
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=3), Vitassay - Vitassay Re al-Time PCR (n=3),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=6 ), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
6
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 10 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-06 Legionellapneumophilasg1 (ST47)
TransportMedium
Legionellaspecies
77.6 38 6.1 3 16.3 8
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 11 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-07 Streptococcuspneumoniae
TransportMedium
DS1_1 Streptococcuspneumoniae
49 24 8.2 4 42.9 21
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 12 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-08 Haemophilusinfluenz ae
TransportMedium
DS2_1 HaemophilusInfluenz ae
40.8 20 6.1 3 53.1 26
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 13 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
NotDe te cte d /NotDe te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-09 Haemophilusinfluenz ae
TransportMedium
DS2_2 HaemophilusInfluenz ae
42.9 21 4.1 2 53.1 26
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 14 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)
SampleCode
SampleConte nts
SampleMatrix
SampleRe lat ionship
Expe cte dtarge ts
De te cte d /De te rmine d
Not De te cte d /Not De te rmine d
NotTe ste d
(%) (n) (%) (n) (%) (n)
RESPIII17S-10 Negative Saline 98 48 2 1 N/A 0
Groups be low n=5: Anato lia Ge ne wo rks (n=1), Anato lia Ge ne wo rks - Anato lia Ge ne wo rks Bo sp ho re (n=1), AusDiag no stics (n=1),AusDiag no stics - AusDiag no stics Easy-Ple x (n=1), Bio le g io (n=2), Bio le g io - Bio le g io Re ad yMax (n=2), Ge nMark Dx (n=3), Ge nMarkDx - Ge nMark DX e Ple x (n=3), Ge no mica (n=1), Ge no mica - Ge no mica CLART (n=1), Ing e ne tix (n=1), Ing e ne tix - ing e ne tix Bacto Re al(n=1), Lumine x (n=1), Lumine x - Lumine x xTAG (n=1), Patho Find e r (n=1), Patho Find e r - Patho Find e r Re al Time PCR (n=1), R-Bio p harm(n=2), R-Bio p harm - R-Bio p harm RIDA Ge ne (n=2), Ro che (n=1), Ro che - Ro che Lig htCycle r (n=1), Se e g e ne - Se e g e ne Se e p le x(n=2), TIB MOLBIOL (n=2), TIB MOLBIOL - TIB-Mo lBio l Lig htMix (n=2), Vitassay (n=4), Vitassay - Vitassay Re al-Time PCR (n=4),b io Me rie ux - b io Me rie ux R-g e ne Kit (n=1), In-Ho use - In-Ho use Co nve ntio nal and Re al-time PCR (n=1)
Groups Rolle d Up: Ce rte st - Ce rte st Re al Time PCR (n=5), fast-track DIAGNOSTICS - FTD re al time PCR (n=11)
0% 20% 40% 60% 80% 100%
◉ Final laboratory re sult (All) 49
Num
ber of Values in Groups
Score Breakdown
Det ect ed / Det ermined No t Det ect ed / No t Det ermined No t T est ed
86
60
5
14
12
10
9
11
26
25
0% 20% 40% 60% 80% 100%
◉ Workf low Spe cif ic Re sults (All)
► Comme rcial
■ Certest
■ Seegene
● Seegene Real Time PCR
■ bioMerieux
● BioFire FilmArray
■ fast- track DIAGNOSTICS
► In-House
● Real- time In-House PCR
IndividualReport
QCMD 2017 Respiratory III EQA PilotStudy
Catalogue Code :QAM174193
Re f Code :RESPIII17
Challe nge :S
Analysis Type :Multiple Pathogen Qualitative
Datase t :192622
Re port UID:3358/10755/1307
LaboratoryTR088
Q C M D , Te ch n o l o g y Te rrace , To d d C amp u s , We s t o fSco t l an d Sc i e n ce Park , Gl asg o w, G20 0 XA Te l : +44 (0 ) 1419 45 6 474, Fax: +44 (0 ) 141 9 45 579 5 We b : www.q cmd .o rg
Pag e 15 o f 15 Issu e D ate : 26 Jan 20 18 R e p o rt au th o ri se d b y th e Q C M D Exe cu t i ve (1)