Respiratory Pathogens Panel Kit v6ngms.co.za/wp-content/uploads/2020/01/Respiratory...Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2 Dec.2019 5 cut-off value. This

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

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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 )


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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


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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.


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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


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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.

http://www.qcmd.org/

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


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


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




Challe nge :S


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LaboratoryTR088



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




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LaboratoryTR088



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




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LaboratoryTR088



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




Challe nge :S


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LaboratoryTR088



SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts


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




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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts


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



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


87

60

5

14

12

10

9

11

27

26

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)

RESPIII17S-03 Bordetellapertussis

Saline Bordetellaspecies

81.6 40 2 1 16.3 8



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)

RESPIII17S-04 Mycoplasmapneumoniae

TransportMedium

Mycoplasmaspecies

93.9 46 N/A 0 6.1 3



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)


TransportMedium

DS1_2 Streptococcuspneumoniae

46.9 23 10.2 5 42.9 21


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%


Num


Score Breakdown


86

60

6

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)

RESPIII17S-06 Legionellapneumophilasg1 (ST47)

TransportMedium

Legionellaspecies

77.6 38 6.1 3 16.3 8



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

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SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)


TransportMedium

DS1_1 Streptococcuspneumoniae

49 24 8.2 4 42.9 21



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

Re port UID:3358/10755/1307

LaboratoryTR088



SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)


TransportMedium

DS2_1 HaemophilusInfluenz ae

40.8 20 6.1 3 53.1 26



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

Re port UID:3358/10755/1307

LaboratoryTR088



SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)


TransportMedium

DS2_2 HaemophilusInfluenz ae

42.9 21 4.1 2 53.1 26



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

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LaboratoryTR088



SampleCode

SampleConte nts

SampleMatrix


Expe cte dtarge ts



NotTe ste d

(%) (n) (%) (n) (%) (n)

RESPIII17S-10 Negative Saline 98 48 2 1 N/A 0



0% 20% 40% 60% 80% 100%


Num


Score Breakdown


86

60

5

14

12

10

9

11

26

25

0% 20% 40% 60% 80% 100%


► Comme rcial

■ Certest

■ Seegene


■ bioMerieux



► In-House


IndividualReport




Challe nge :S


Datase t :192622

Re port UID:3358/10755/1307

LaboratoryTR088



Documents

Respiratory Pathogens Panel Kit v6ngms.co.za/wp-content/uploads/2020/01/Respiratory...Bosphore® Respiratory Pathogens Panel Kit v6 Technical Filev2 Dec.2019 5 cut-off value. This