molecular infectious diseases hepatitis c rna...

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Re‐issued Wednesday, 18 February 2015 Page of 35

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Molecular Infectious Diseases Hepatitis C RNA Program

Generic Report

Report prepared by

RCPAQAP Serology

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Generic Report MHC4:2014 Participant Results

The Molecular HCV RNA Program was distributed to 36 participants. 31 participants returned results for this survey.

Clerical Error

There was a clerical error included in this survey for Specimen 4B.

Specimen 4B labelled: Rene BRYAN; U/N 503284 Instructions to Participant labelled: Rena Brian; U/N 503284

23/31 (74%) participants detected the clerical error for Specimen 4B.

21/23 (91%) participants identified the clerical error in both the first and last names. 2/23 (9%) participants (30002 and 70001) identified the clerical error in the last name only.

1/31 (3%) participants (83001) identified a clerical error, however incorrectly identified Specimen 4A and did not further identify the error.

7/31 (23%) participants (1004, 1015, 1017, 1136, 80006, 80040 and 83023) did not identify the clerical error.

Specimen Details

Samples are of human origin and tested negative for HIV antibody and Hepatitis B surface antigen. (Ref. 2014 RCPAQAP Serology MDM Program Plan section MHC4:2014)

4A Hepatitis C RNA positive fresh frozen plasma, genotype 1a, diluted 1/1000 in Hepatitis C RNA negative fresh frozen plasma.

4B Hepatitis C RNA positive fresh frozen plasma, genotype 3a, diluted 1/100 in Hepatitis C RNA negative fresh frozen plasma.

4C Hepatitis C antibody and RNA negative fresh frozen plasma. Source: Australian Red Cross Blood Service, NSW and RCPAQAP Serology MDM Serum Bank. Preliminary testing: Australian Red Cross Blood Service, NSW; Sydney South West Pathology Service, Liverpool, NSW; South Eastern Area Laboratory Services, Randwick, NSW and VIDRL, VIC. Pre‐issue results: Douglass Hanly Moir Pathology, Macquarie Park, NSW; Sydney South West Pathology Service, Liverpool, NSW and Pathology Queensland, RBWH Campus, QLD.

Survey Aims

Specimen 4A (genotype 1a), is a positive for Hepatitis C, with a mid‐range viral load to assess quantitation of Hepatitis C RNA at this level. This specimen is the same dilution as a specimen surveyed in 2012 (MHC4:2012:4B), to assess inter‐run variability.

Specimen 4B (genotype 3a), is a positive for Hepatitis C, with a mid‐range viral load to assess quantitation of Hepatitis C RNA at this level. This specimen is the same dilution as a specimen surveyed in 2013 (MHC4:2013:4B), to assess inter‐run variability.

Specimen 4C is negative for Hepatitis C, to assess contamination placed after a specimen containing mid‐range RNA level to assess carryover. This specimen is a duplicate of a specimen in the first survey (Specimen 1B), to assess inter‐run variability.



Pre-issue Results

These results were obtained in pre‐issue testing of the survey specimens using the below mentioned assays. These results are to be used as a guideline only and are not target values or reference values.

Specimen HCV

Antibody

HCV RNA

QUALITATIVE QUANTITATIVE HCV

Genotype [Sequence Analysis

(core region)]

[Roche Cobas AmpliPrep/ Cobas

TaqMan HCVQL v2.0]

[Abbott RealTime HCV] [Roche COBAS AmpliPrep/

COBAS TaqMan v2.0]

IU/mL Log10 IU/mL IU/mL Log10 IU/mL

4A positive positive (4,615)4.6 x 103

3.66 (6,090)6.1 x 103

3.78 1a

4B positive positive (84,258)8.4 x 104

4.93 (90,300)9.0 x 104

4.96 3a

4C negative negative Target Not Detected Target Not Detected NA

NA ‐ Not Applicable

Method Performance

It is up to all users to form their own opinion or conclusions on each kit's performance based on the accumulation of data and information that is supplied by this survey, and other information available to the participant.

Result Review

Molecular Hepatitis C RNA ‐ Qualitative 14 participants returned results.

Table 1 Qualitative Results

Molecular HCV Qualitative RNA

Part 4A 4B 4C

1004 pos pos neg

1017 pos pos neg

20001 pos pos neg

20002 pos pos neg

20004 pos pos neg

20006 pos pos neg

30002 pos pos neg

43000 pos pos neg

50001 pos pos neg

70001 pos pos neg

80009 neg pos pos

80011 pos pos neg

80040 pos pos neg

83021 pos pos neg

13/14 participants (93%) returned the correct result for Specimens 4A and 4C. Participant 80009 returned a negative (incorrect) result for Specimen 4A and a positive (incorrect) result for Specimen 4C. This participant may have made a transcription error or reversed the specimens.

All participants (100%) returned the correct results for Specimen 4B.

Figure 1

0

2

4

6

8

10

12

14

4A 4B 4C

No. of Participants

Specimen

HCV RNA Qualitative Results ‐ MHC4:2014 negative

positive



Participant 70001 has not provided complete extraction/elution or master/sample volume details for the assay in use and Participants 20002 and 50001 have provided an incorrect extraction volume for the assay in use. [Roche Diagnostics CobasAmpliprep/Cobas TaqMan HCV Qualitative test, v2.0: Input volume =650uL; Extraction volume =500uL; Elution volume =65uL; Master volume =50uL; Sample volume =50uL].

Participant 20001 appears to have selected the incorrect assay for the detection assay.

Participant 1004 has not provided the inhibition control information.

Participant 1004 appears to have used an expired extraction assay and made transcription errors with the amplification, detection and control expiry dates. Please enter expiry dates as month and year, that is, Mmm YY, for example Oct 14.

Figure 2 Returned Values for Roche Cobas TaqMan HCVQL v2.0 This graph shows the nine participants performing the Roche Cobas TaqMan HCVQL v2.0 returned Ct values consistent with other users and the HCV viral load for each specimen. There was approximately 1 log10 difference between the viral load of these specimens. Participant 20001 also using this assay did not return result values in this survey.

0

5

10

15

20

25

30

35

40

Ct/Cp Value

Participant

MHC4‐2014 Cobas TaqMan HCVQL v2.0 (n=9)Specimen 4A

Specimen 4B

1017 8004080011700015000143000200062000420002



Comparison of Hepatitis C RNA Qualitative Results Most participants that returned results for the duplicate specimens for 2014 and the specimens of the same dilution from 2013 and 2014 showed consistent results. Participant 80009 was the only exception returning incorrect results in this survey for Specimens 4A and 4C having returned the correct results in previous surveys. Table 2 Comparison of Hepatitis C RNA Qualitative Results

Specimen

HCV Qualitative

RNA

Positives Negative

Same Dilution Specimens Same Dilution Specimens Duplicate Specimens

Part MHC4:2012:4B 4A MHC4:2013:4B 4B 1B 4C

1004 NE pos pos pos neg neg


20001 pos pos pos pos neg neg








80009 pos neg NR pos neg pos



83021 NE pos NE pos neg neg

NR – Not Returned NE – Not Enrolled



Molecular Diagnostics Module ‐ Hepatitis C RNA Quantitative 30 participants returned results.

Specimen 4A 29/30 (97%) participants returned results within the dynamic range. 1 participant responded ‘HCV RNA Not Detected’

Specimen 4B All (30/30) participants returned results within the dynamic range.

Specimen 4C 23 participants responded ‘Not Detected’, ‘Target not detected’ or ‘HCV RNA Not Detected’. 5 participants responded ‘0’ or ‘negative’. 2 participants returned results within the dynamic range.

Participant 80009 has provided incorrect results for Specimens 4A and 4C. Specimen 4A was reported as ‘HCV RNA Not Detected’ however contained approximately 5000 IU/mL. Specimen 4C reported as 9400 IU/mL (3.97 log10) however was the negative specimen. This participant also returned a result for Specimen 4B that was approximately 1 log10 lower than the median result obtained by all other participants. Investigation is recommended. Participant 80014 has provided an incorrect result for Specimen 4C, reporting 2104 IU/mL (3.32 log10) for the negative specimen. Investigation is recommended. Participants 70001, 83001 and 93002 have been moved to the Roche Diagnostics Cobas TaqMan HCV v2.0 kit group based on the lot numbers provided.

Participant 1004 is using an expired kit for extraction; however appears to have made transcription errors with expiry dates for all reagents used. Please enter expiry dates as month and year, that is, Mmm YY, for example Jan 14.

Participant 1136 appears to be using a different extraction volume compared to others in the same user group.

Participants 20002, 50001, 70001 and 93002 have provided incorrect or incomplete extraction/elution and/or master/sample volume details for the assay in use. [Roche Diagnostics CobasAmpliprep/Cobas TaqMan v2: Input volume =1000uL; Extraction volume =500uL; Elution volume =65uL; Master volume=50uL; Sample volume =50uL].

Participants 1004 and 83001 appear not to have used an inhibition control.

Please note when primer sequence information is returned by participants it is not published to protect confidentiality.



Table 3 Summary of Hepatitis C RNA Quantitative Results MHC4:2014

Range log10 ± 0.25

Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐ 0.25 Range log10 + 0.25

Specimen 4A 29 3.96 3.63 4.13 3.71 4.21

Specimen 4B 30 5.02 3.95 5.30 4.77 5.27

Figures 3 & 4 Quantitative Result Values as IU/mL log10 Participant 83023 submitted a log10 value which was outside the log10 + 0.25 range for Specimen 4A.

Participants 1004 and 83021 submitted log10 values which were outside the log10 + 0.25 range for Specimen 4B.

Participants 80009 and 80013 submitted log10 values which were outside the log10 + 0.25 range for Specimens 4A & 4B.

Figure 5 Comparison of Hepatitis C RNA Quantitative Results for MHC4:2014 – Specimens 4A & 4B

Most participants were able to detect the approximate 1 log10 difference in HCV RNA viral load between these specimens.

Participant 80009, as mentioned previously, appears to have returned incorrect results for all three specimens in this survey.

0.00.51.01.52.02.53.03.54.04.55.05.56.0

Values (IU/m

L Log10)

Participant Results

HCV RNA Quantitation (n=29) ‐ Specimen 4A

Median

Range ‐ 0.25

Range + 0.25

Specimen 4A0.00.51.01.52.02.53.03.54.04.55.05.56.0

Values (IU/m

L Log10)

Participant Results

HCV RNA Quantitation (n=30) ‐ Specimen 4B

Median

Range ‐ 0.25

Range + 0.25

Specimen 4B

0.00.51.01.52.02.53.03.54.04.55.05.56.06.57.07.58.0

Values (IU/m

L Log10)

Participants

HCV RNA Quantitation Results MHC4:2014

4A

4B

2000520001

1136 83021

80014

Roche Cobas

AmpliPrep

/TaqMan

v2

8004020002 430001015

8001383023

Abbott/

RealTime

Qiagen/Artus

/Rotorgene

Roche HPS/TaqMan

83027 70001

50001

Pre‐issue

Pre‐issue

90003200062000483001

8000611561004

90006 9300280052

80011 114980009 89185

1017 90004

Roche Cobas

AmpliPrep /TaqMan



Comparison of Hepatitis C RNA Quantitative Results using Abbott RealTime HCV This following table and graph shows participants using the Abbott RealTime HCV comparing the assay user group.

Table 4 Summary of Hepatitis C RNA Quantitative Results using Abbott RealTime HCV

Range log10 ± 0.25


Specimen 4A 5 3.68 3.63 3.83 3.43 3.93

Specimen 4B 5 4.92 4.74 5.01 4.67 5.17

Figure 6 Inter‐run Comparison of Hepatitis C RNA Quantitative Results using Abbott RealTime HCV

Comparison of Hepatitis C RNA Quantitative Results using Cobas AmpliPrep/Taqman v2 This following table and graph shows participants using the Cobas Roche AmpliPrep/Taqman v2 comparing the assay user group.

Table 5 Summary of Hepatitis C RNA Quantitative Results using Cobas AmpliPrep/Taqman v2

Range log10 ± 0.25


Specimen 4A 19 3.97 3.84 4.10 3.72 4.22

Specimen 4B 19 5.02 4.82 5.16 4.77 5.27

Figure 7 Inter‐run Comparison of Hepatitis C RNA Quantitative Results using Cobas AmpliPrep/Taqman v2

All values submitted were within the log10 + 0.25 ranges for both specimens.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

Values (IU/m

L Log10)

Participant

MHC4‐2014 Roche Cobas AmpliPrep/TaqMan v2 (n=19)

Specimen 4A

Specimen 4B

1015 80014800067000120005

200041017 830018004043000

2000690004

8005280011

5000120002

9300220001 90003

All values submitted were within the log10 + 0.25 ranges for both specimens.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

Values (IU/m

L Log10)

Participant

MHC4‐2014 Abbott RealTime HCV (n=5)

Specimen 4A

Specimen 4B

8302783023 90006pre‐issue 80013



Comparison of Hepatitis C RNA Quantitative Results using Qiagen/artus/Rotorgene This following table and graph shows participants using the Qiagen/artus/Rotorgene comparing the assay user group.

Table 6 Summary of Hepatitis C RNA Quantitative Results using Qiagen/artus/Rotorgene

Range log10 ± 0.25


Specimen 4A 5 4.09 0.00 4.13 3.84 4.34

Specimen 4B 5 4.94 3.95 5.30 4.69 5.19

Figure 8 Inter‐run Comparison of Hepatitis C RNA Quantitative Results using Qiagen/artus/Rotorgene

Participant 80009 submitted a negative result for Specimen 4A and a result for Specimen 4B approximately 1 log10 lower than expected.

Participant 1004 submitted a log10 value which was outside the log10 + 0.25 range for Specimen 4B.

All other values submitted were within the log10 + 0.25 ranges for both specimens.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

Values (IU/m

L Log10)

Participant

MHC4‐2014 Qiagen/artus/Rotogene HCV (n=5)

Specimen 4A

Specimen 4B

800091136 830211004 1056



Inter‐run Comparison of Hepatitis C RNA Quantitative Specimens 2012 & 2014 In this survey, Specimen 4A is the same dilution as a specimen surveyed in 2012 (MHC4:2012:4B). The following table and graph shows a comparison between results for the specimens. Table 7 Inter‐run Comparison of Quantitative Results for 2012 & 2014

Range log10 + 0.25

Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 Range log10 +0.25

MHC4:2012:4B 19 3.82 3.59 4.00 3.57 4.07

Specimen 4A 29 3.96 3.63 4.13 3.71 4.21

Figure 9 Inter‐run Comparison of Hepatitis C RNA Quantitative Results 2012 & 2014 This graph shows good inter‐run reproducibility for specimens at the same dilution issued in 2012 and 2014.

In 2012, Participant 80009 returned results that did not appear to be IU/mL or log10 IU/mL values, therefore the results for MHC4:2012:4B do not appear on this graph. In this survey Participant 80009 reported the result for Specimen 4A as ‘HCV RNA Not Detected’.

Participants 83023 and 83027 changed kits from Roche HPS/TaqMan and Qiagen/Artus/Rotorgene respectively, to Abbott/ RealTime HCV.

Participants submitting log10 values which were outside the log10 + 0.25 range.

Specimen MHC4:2012:4B ‐ All within range. Participant 80009 removed.

Specimen 4A ‐ Participants 80009, 80013 and 83023.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

IU/m

L Log10

Participant

Inter‐run Comparisons ‐HCV RNA Quantitation

MHC4:2012:4B

Specimen 4A

Roche

Cobas

Ampli Prep

/TaqMan

Pre‐issue

test

Pre‐issue

test

80011

Qiagen/artus

/ Rotorgene

80013

Roche

HPS/TaqMan

Abbott/

RealTim

e

8302320002 20006

8000670001

80014200052000180009 80040

9000383027

9000690004

930024300089185



Inter‐run Comparison of Hepatitis C RNA Quantitative Specimens 2013 & 2014 In this survey, Specimen 4B is the same dilution as a specimen surveyed in 2013 (MHC4:2013:4B). The following table and graph shows a comparison between results for the specimens. Table 8 Inter‐run Comparison of Quantitative Results for 2013 & 2014

Range log10 + 0.25


MHC4:2013:4B 24 4.88 4.67 5.16 4.63 5.13

Specimen 4B 30 5.02 3.95 5.30 4.77 5.27

Figure 10 Inter‐run Comparison of Hepatitis C RNA Quantitative Results 2013 & 2014 This graph shows good inter‐run reproducibility for the specimens at the same dilution issued in 2013 and 2014.

Participant 80009 showed the greatest variation between testing of the same dilution. As discussed previously, this participant reported a result for Specimen 4B approximately 1 log10 lower than expected.

Participant 80014 changed kits from Roche HPS/TaqMan to Roche Cobas AmpliPrep/TaqMan v2. Participant 83023 changed kits from Roche HPS/TaqMan to Abbott/ RealTime HCV.

Participants submitting log10 values which were outside the log10 + 0.25 range.

Specimen MHC4:2013:4B ‐ Participant 30007 (not enrolled in 2014).

Specimen 4B ‐ Participants 1004, 80009, 80013 and 83021.

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

6.5

7.0

IU/m

L Log10

Participant


MHC4:2013:4B

Specimen 4B

Roche

Cobas

Ampli Prep

/TaqMan

Pre‐issue

test

Pre‐issue

test

80006

Qiagen/artus

/ Rotorgene

80013

Roche

HPS/TaqMan

Abbott/

RealTim

e

8302320001 20006

7000150001

8001120002101780009 80014

8004090006

1004 90003 891854300083001

20005200041015 90004



Negative Specimen Result Review

In this survey, Specimen 4C was the same negative specimen as Specimen 1B from survey 1. The specimen was negative for Hepatitis C antibody and HCV RNA to assess contamination and was correctly identified as negative by most participants. Participants 80009 and 80014 incorrectly reported a level of 9400 IU/mL (3.97 log10) and 2104 IU/mL (3.32 log10) respectively for this specimen. Participant 83021 appeared not to return a result for this specimen, leaving the results blank, this should be reviewed.

The participants using the Abbott/RealTime HCV system reported ‘Target not detected’, ‘Not detected’ and ‘HCV RNA not detected’. A ‘negative’ specimen should be resulted as ‘target not detected’ and reported as ‘HCV RNA not detected’.

The participants using the Qiagen/Artus/Rotorgene system reported ‘HCV RNA not detected’, ‘target not detected’ and ‘0 IU/mL’. A ‘negative’ specimen should be resulted as ‘target not detected’ and reported as ‘HCV RNA not detected’. Participant 80009 returned a positive result and Participant 83021 appeared not to return a result, previously discussed.

Participants using the Roche/AmpliPrep/TaqMan and v2.0 system reported; ‘Target Not Detected’, ‘not detected’, ‘HCV RNA not detected’, ‘negative’ and ‘0 IU/mL’. Participant 80014 returned a positive result, previously discussed. Participants using the Roche/HPS/TaqMan system reported ‘HCV RNA Not Detected’ and ‘undetected’. According to the assay inserts a ‘negative’ specimen should be resulted as ‘target not detected’ and reported as ‘HCV RNA not detected’. If a ‘< figure’ is used the inserts state this is reported as ‘HCV RNA detected, <figure HCV RNA IU/mL’.

Table 9 Review of Negative Results

Part Specimen 1B Specimen 4C Testing System

80013 Not detected, Target not detected Not detected, Target not detected Abbott RealTime HCV

83023 Target not detected, HCV RNA not

detected Target not detected, HCV RNA NOT

DETECTED Abbott RealTime HCV changed from Roche HPS/TaqMan for this survey

83027 0 Target Not Detected Abbott RealTime HCV

90006 Not Detected Not Detected Abbott RealTime HCV

1004 0 0 Qiagen/Artus/Rotorgene

1056 1286 IU/mL (3.11 log10) HCV RNA not detected Qiagen/Artus/Rotorgene

1136 Not Enrolled Target not detected Qiagen/Artus/Rotorgene

80009 ‐, HBV DNA Not Detected 9400 IU/mL (3.97 log10) Qiagen/Artus/Rotorgene

83021 not detected ‐ Qiagen/Artus/Rotorgene

1015 Target not detected Target not detected Roche Cobas AmpliPrep/TaqMan v2.0

1017 Target not detected target not detected Roche Cobas AmpliPrep/TaqMan v2.0

20001 Target Not Detected Target Not Detected Roche Cobas AmpliPrep/TaqMan v2.0

20002 TARGET NOT DETECTED Target Not Detected Roche Cobas AmpliPrep/TaqMan v2.0

20004 Not detected, HCV RNA not detected Not detected, HCV RNA not detected Roche Cobas AmpliPrep/TaqMan v2.0

20005 Target Not detected TARGET NOT DETECTED Roche Cobas AmpliPrep/TaqMan v2.0

20006 Not Detected Not Detected Roche Cobas AmpliPrep/TaqMan v2.0

43000 Negative Negative Roche Cobas AmpliPrep/TaqMan v2.0

50001 0 0 Roche Cobas AmpliPrep/TaqMan v2.0

70001 0 0 Roche Cobas AmpliPrep/TaqMan v2.0


80011 Target Not Detected, HCV RNA Not

Detected Target Not Detected, HCV RNA Not

Detected Roche Cobas AmpliPrep/TaqMan v2.0

80014 Target Not Detected, HCV RNA Not

Detected 2104 IU/mL (3.32 log10) Roche Cobas AmpliPrep/TaqMan v2.0

80040 Target not detected target not detected Roche Cobas AmpliPrep/TaqMan v2.0

80052 Not Returned Target Not Detected Roche Cobas AmpliPrep/TaqMan v2.0



Table 9 Review of Negative Results (continued)

Part Specimen 1B Specimen 4C Testing System

83001 Target not detected, HBV DNA not

detected Target not detected Roche Cobas AmpliPrep/TaqMan v2.0

90003 Target not detected, HCV RNA not

detected Target not detected, HCV RNA not

detected Roche Cobas AmpliPrep/TaqMan v2.0


93002 Not Returned Target not detected Roche Cobas AmpliPrep/TaqMan v2.0

1149 Not Enrolled Target Not Detected Roche Cobas AmpliPrep/TaqMan

89185 ‐, HCV RNA NOT DETECTED HCV RNA NOT DETECTED Roche HPS/TaqMan 90002 undetected Not Returned Roche HPS/TaqMan



SUMMARY OF THE HEPATITIS C RNA MODULE 2014

Overall Aims for the module

To include; A range of RNA levels and genotypes including; 103 (GT1a & GT6a), 104 (GT1a, GT1b, GT3a & GT6a) and 105

(GT6a).

The same negative specimen in two surveys to assess contamination. [Both placed after a specimen containing a mid range RNA level to assess carry‐over].

One specimen (GT6a) at three different dilutions (103, 104, 105 IU/mL), to assess the performance of a dilution series.

One specimen (104 IU/mL GT1b) in duplicate in one survey, to assess detection and intra‐run reproducibility, (~20,000 IU/mL).

Two duplicate specimens (103 IU/mL GT6a & 104 IU/mL GT1a) in different surveys to assess stability and inter‐run reproducibility, (~9,000 & 20,000 IU/mL).

One high level specimen (105 IU/mL GT6a) to assess assay level of detection.

Four specimens (103 IU/mL GT1a & 104 IU/mL GT1a, 1b & 3a) have been included at the same level in previous surveys, to assess stability and inter‐run reproducibility.

Log level differences will also be assessed for significant differences.

All of these aims will be compared throughout the year and at year’s end to assess performance throughout 2014. Summary of Results

Qualitative Results

Most participants performed the HCV RNA qualitative analysis well, returning the correct results for the positive and negative specimens including the duplicate specimens, when tested (refer Figure 11).

Participant 80009 returned a negative (incorrect) result for Specimen 4A (103 IU/mL). The same dilution of this specimen was included in 2012 and this participant returned the correct positive result.

Participant 80009 returned a positive (incorrect) result for one of the duplicate negative specimens. Figure 11 Hepatitis C RNA Qualitative Results for 2014

0

2

4

6

8

10

12

14

16

1A ̂ 1B # 1C * 2A 2B 2C * 3A ~ 3B ̂ 3C ~ 4A 4B 4C #

No. of Participants

Specimen

Hepatitis C RNA Qualitative Results ‐ 2014 negative

positive

*, ^, ~ Same positive specimen# Same negative specimen



Quantitative Results

Range of RNA levels The majority of participants were able to detect the range of HCV RNA levels tested in the program including 103, 104 and 105 IU/mL. The variety of genotypes (1a, 1b, 3a, 6a) appeared to be satisfactorily detected by participants (refer Figure 12).

Figure 12 Hepatitis C RNA Quantitative Results for 2014

Range of RNA levels The lowest RNA level specimens, 103 IU/mL (Specimen 1C/2C), were included in duplicate to assess detection and reporting at this level. Most participants correctly reported a value within the dynamic range of the assay in use. Participant 1056 reported ‘HCV RNA NOT DETECTED’ for Specimen 1C and Participant 90004 reported 316657 IU/mL (5.5 log10) for Specimen 2C. Both of these participants appear to have made a transcription error or reversed specimens within the survey. Participant 83021 showed the greatest variability in returned results (refer to Figure 12). Eight participants (1056, 80009, 80013, 83021, 83027, 90002, 90004 and 90006) submitted one or both log10 values for this specimen, which were outside the 0.5 log10 range.

The highest DNA level specimen, 105 IU/mL (Specimen 2A), was included to assess detection and reporting at this level. All participants correctly reported a value within the dynamic range of the assay in use. Three participants (89185, 90004 and 90006) submitted log10 values for this specimen which were outside the 0.5 log10 range.

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

IU/m

L Log 1

0

Participants

Hepatitis C RNA Quantitative Results ‐ 2014

1A ^

1C *

2A

2B

2C *

3A ~

3B ^

3C ~

4A

4B

2000480013 2000283027 83001

* , ^, ~ Same specimen

Roche HPS

/TaqMan

Roche Cobas

AmpliPrep

/TaqMan

v2

Abbott/

RealTim

e HCV

Qiagen/Artus

/Rotorgen

e

2000520006

43000101720001 5000183023

Pre‐issue

Pre‐issue

101583021

8001480011

8000670001

9000390004

900061004 1136

1056 891851149

93002

Roche Cobas

AmpliPrep/TaqMan

8000980040

8005290002



Range of RNA levels & Dilution Series Specimens 2A, 2B & 2C (2014) One specimen was diluted to simulate a dilution series including the RNA levels, 103, 104, 105 IU/mL, included in the same survey and a graph illustrating these results showed good detection, sensitivity and consistency for the same specimen at different levels (refer MHC2:2014 report, also refer Figure 13 below). All participants were able to detect the approximate 1 log10 difference in HCV RNA viral load between these specimens. A table has been included to show median IU/mL log10 values and ranges for comparison.

Participant 90004 appears to have made a transcription error or reversed Specimens 2A and 2C, which meant that the pattern of results in the graph appeared reversed. Table 10 Review of Inter‐run Reproducibility Results for Dilution Series

Range log10 ± 0.25


Specimen 2A 28 5.27 3.42 5.53 5.02 5.52

Specimen 2B 28 4.35 3.81 4.54 4.10 4.60

Specimen 2C 28 3.40 2.62 5.50 3.15 3.65

Figure 13 Review of Inter‐run Reproducibility Results for Dilution Series

0.00.51.01.52.02.53.03.54.04.55.05.56.06.57.07.58.0

Values (IU/m

L Log10)

Participants

HCV RNA Quantitation Results ‐ Dilution Series

2A

2B

2C

20005

2000180009 1015 80014

Roche Cobas

AmpliPrep

/TaqMan

8004020002 430001017

80013

83027

Abbott/

RealTime

Qiagen/Artus

/Rotorgene

Roche HPS

/TaqMan

90006

70001

50001

Pre‐issue

Pre‐issue

900042000620004

90003

80006

1136

1056

1004 83023

83001

80011

8918583021 90002



Range of RNA levels, Intra‐run & Inter‐run Reproducibility – 2013 & 2014 (replicate samples & same dilution) Specimens MHC1:2013:1B & MHC2:2013:2C and 3A & 3C (2014) One of the specimens at the RNA level, 104 IU/mL, to simulate ~ 20,000 IU/mL, was included twice in the same survey (Specimens 3A & 3C), a graph illustrating these results showed good intra‐ and inter‐run reproducibility of the same specimen (refer MHC3:2014 report, also refer Figure 14 below). A table has been included to show median IU/mL log10 values and ranges for comparison. Table 11 Review of Intra and Inter‐run Reproducibility Results 2013 & 2014

Range log10 ± 0.25


MHC1:2013:1B 23 4.23 4.14 4.77 3.98 4.48

MHC2:2013:2C 25 4.34 4.10 4.59 4.09 4.59

Specimen 3A 30 4.27 3.99 4.76 4.02 4.52

Specimen 3C 30 4.29 4.05 4.76 4.04 4.54

Figure 14 Review of Intra and Inter‐run Reproducibility Results 2013 & 2014

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

6.5

IU/m

L Log 1

0

Participant


MHC1:2013:1B

MHC2:2013:2C

Specimen 3A

Specimen 3C

1017 20001

Roche Cobas

Ampli Prep

/TaqMan

Pre‐issue test

Pre‐issue

test

7000143000 80040

Qiagen/ Artus/

Rotorgene

80013

Roche HPS/

TaqMan

Abbott/

RealTime

90006

2000620004 83001500019000380011

8000683027 900042000520002101580009

8001489185

8302310041056

1136 830211149 93002

90002



0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

IU/m

L Log 1

0

Participant


Specimen 1C

Specimen 2C

10151017

Roche

Cobas

Ampli Prep

/TaqMan

Pre‐issue test

Pre‐issue

test

500012000680011

Qiagen/ artus/

Rotorgene

80013

Roche

HPS/TaqMan

Abbott/

RealTim

e

830272000520002

8001443000 80040

800067000190006

83001200042000183021

100490003 90002

900041056

8000983023

89185

Range of RNA levels & Inter‐run Reproducibility – 2014 (duplicate samples) Specimens 1C & 2C (2014) One of the specimens at the RNA level, 103 IU/mL, to simulate ~ 2,000 IU/mL, was included twice in different surveys (Specimens 1C & 2C), a graph illustrating these results showed good inter‐run reproducibility of the same specimen (refer MHC2:2014 report, also refer Figure 15 below). A table has been included to show median IU/mL log10 values and ranges for comparison.

Participant 1056 appears to have made a transcription error or reversed Specimens 1B and 1C, therefore no value was returned for Specimen 1C, which was reported as ‘HCV RNA NOT DETECTED’.

Participant 90004 appears to have made a transcription error or reversed Specimens 2A and 2C, therefore the log10 value returned for Specimen 2C was 5.5 which is beyond the scale of this graph and does not appear.

Other than the two participants mentioned above, the greatest variation between the results for the duplicate specimens was seen for Participant 83021. Table 12 Review of Inter‐run Reproducibility Results for 2014

Range log10 ± 0.25


Specimen 1C 26 3.43 3.01 3.64 3.18 3.68

Specimen 2C 28 3.40 2.62 5.50 3.15 3.65

Figure 15 Review of Inter‐run Reproducibility Results for 2014



Range of RNA levels & Inter‐run Reproducibility – 2014 (duplicate samples) Specimens 1A & 3B (2014) One of the specimens at the RNA level, 104 IU/mL, to simulate ~ 20,000 IU/mL, was included twice in different surveys (Specimens 1A & 3B), a graph illustrating these results showed good inter‐run reproducibility of the same specimen (refer MHC3:2014 report, also refer Figure 16 below). A table has been included to show median IU/mL log10 values and ranges for comparison. Table 13 Review of Inter‐run Reproducibility Results for 2014

Range log10 ± 0.25


Specimen 1A 27 4.14 4.01 4.68 3.89 4.39

Specimen 3B 30 4.21 4.05 4.73 3.96 4.46

Figure 16 Review of Inter‐run Reproducibility Results for 2014

Range of RNA levels & Inter‐run Reproducibility – 2012 & 2014 (same dilution) Specimens MHC4:2012:4B & Specimen 4A (2014) One of the specimens at the RNA level, 103 IU/mL (Specimen 4A), was a specimen at the same dilution included in 2012. Graphical representation of these results (refer page 10 of this report) showed good inter‐run reproducibility of the same specimen dilution. A table has been included to show median IU/mL log10 values and ranges for comparison. Table 14 Inter‐run Comparison of Quantitative Results for 2012 & 2014

Range log10 + 0.25


MHC4:2012:4B 19 3.82 3.59 4.00 3.57 4.07

Specimen 4A 29 3.96 3.63 4.13 3.71 4.21

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

5.5

6.0

6.5

IU/m

L Log 1

0

Participant


Specimen 1A

Specimen 3B

10151017

Roche

Cobas

Ampli Prep

/TaqMan

Pre‐issue

test

Pre‐issue

test

500012000680011

Qiagen/ artus/

Rotorgene

80013

Roche

HPS/TaqMan

Abbott/

RealTim

e

830272000520002

8001443000 80040

800067000190006

83001200042000183021

100490003 90002

900041056

8000983023

89185



Range of RNA levels & Inter‐run Reproducibility – 2013 & 2014 (same dilution) Specimens MHC4:2013:4B & Specimen 4B (2014) One of the specimens at the RNA level, 104 IU/mL (Specimen 4B), was a specimen at the same dilution included in 2013. Graphical representation of these results (refer page 11 of this report) showed good inter‐run reproducibility of the same specimen dilution. A table has been included to show median IU/mL log10 values and ranges for comparison. Table 15 Inter‐run Comparison of Quantitative Results for 2013 & 2014

Range log10 + 0.25


MHC4:2013:4B 24 4.88 4.67 5.16 4.63 5.13

Specimen 4B 30 5.02 3.95 5.30 4.77 5.27

Similar HCV RNA Levels & Different Genotypes HCV genotype 1a was represented at a RNA level of 103 and 104 IU/mL, Specimens 4A and 1A/3B respectively, included to assess detection and reporting at this level, refer Tables 16 and 17.

HCV genotype 1b was represented at a RNA level of 104 IU/mL, Specimens 3A/3C, and was included to assess detection and reporting at this level, refer Table 17.

HCV genotype 3a was represented at a RNA level of 104 IU/mL, Specimen 4B, and was included to assess detection and reporting at this level, refer Table 17.

HCV genotype 6a was represented in a series of RNA levels, 103, 104 and 105 IU/mL, Specimens 1C/2C, 2B and 2A, were included to assess detection and reporting at these levels, refer Tables 16, 17 and 18.

Table 16 Review of Genotype at 103 IU/mL


Specimen 1C (genotype 6a)

26 3.43 3.01 3.64 3.18 3.68

Specimen 2C (genotype 6a)

28 3.40 2.62 5.50 3.15 3.65

Specimen 4A (genotype 1a)

29 3.96 3.63 4.13 3.71 4.21




27 4.14 4.01 4.68 3.89 4.39

Specimen 3B (genotype 1a) 30 4.21 4.05 4.73 3.96 4.46

Specimen 2B (genotype 6a)

28 4.35 3.81 4.54 4.10 4.60

Specimen 3A (genotype 1b)

30 4.27 3.99 4.76 4.02 4.52

Specimen 3C (genotype 1b)

30 4.29 4.05 4.76 4.04 4.54

Specimen 4B (genotype 3a)

30 5.02 3.95 5.30 4.77 5.27




28 5.27 3.42 5.53 5.02 5.52



Intra‐run, Inter‐run Reproducibility & Stability The majority of participants showed good inter‐run reproducibility throughout the year. Comparisons with other specimens included in 2012 and 2013 also showed comparable results. The median values for these specimens can be seen in the tables above. Regression analysis of the specimens throughout 2014 has shown that the specimens included in this module were stable and homogenous. Log10 differences The majority of participants showed results consistent with the RNA levels included in the surveys. Negative Specimens (Specimens 1B & 4C) Two surveys (first and fourth) contained the same negative specimen; most participants correctly identified the negative specimens indicating that most had no contamination issues. The exceptions were the three participants mentioned below. All three reported the correct result for the duplicate specimen.

Participant 1056 reported a level of 1286 IU/mL (3.11 log10) for Specimen 1B, however reported not detected for Specimen 1C, appearing to make a transcription error or reversed the specimens.

Participants 80009 and 80014 reported a level of 9400 IU/mL (3.97 log10) and 2104 IU/mL (3.32 log10) respectively for Specimen 4C.

Both of the negative specimens were placed after a specimen containing an RNA level of ~104 IU/mL, this may account for the values reported by Participants 80009 and 80014, indicating there may have been some carry over contamination. There were some inconsistencies with the reporting of the ‘negative’ specimens and these were discussed throughout the reports. It is important that validation data be retained when differing from the manufacturer’s instructions. Module Inconsistencies 2014

MHC1‐2014 Most participants reported similar quantitative values to the pre‐issue tests, detecting approximately the 1.0 log10 IU/mL difference in viral load and that the other specimen was HCV RNA negative. Participant 1056 appeared to have made a transcription error or reversed Specimens 1B and 1C, reporting a level of 1286 IU/mL (3.11 log10) for Specimen 1B and not detected for Specimen 1C. Seven participants (1004, 1056, 80009, 80013, 83027, 89185 and 90006) submitted log10 values outside the log10 + 0.25 range.

14/28 (50%) of participants did not identify the clerical error in this survey; Participants 1004, 1015, 1017, 20001, 80006, 80011, 80014, 80040, 83021, 83023, 83027, 89185, 90004 and 90006 did not identify the clerical error. Review is recommended. MHC2‐2014 Most participants reported similar quantitative values to the pre‐issue tests, detecting the approximate 1 log10 IU/mL difference between the three specimens (dilution series). Participant 90004 appeared to have made a transcription error or reversed Specimens 2A and 2C. Eight participants (1056, 80009, 80013, 83021, 89185, 90002, 90004 and 90006) submitted log10 values outside the log10 + 0.25 range. (Participants 1056, 90002 and 90004 for two specimens; Participant 90006 for three specimens). MHC3‐2014 Most participants reported similar quantitative values to the pre‐issue tests, detecting comparable values for the intra‐run duplicate specimens and the similar quantitative value of the other specimen, with a different genotype. Six participants (1004, 1056, 1136, 80009, 80013 and 89185) submitted log10 values outside the log10 + 0.25 range, (Participants 1004, 80009 and 89185 for two specimens; Participant 1056 for three specimens).



MHC4‐2014 Most participants reported similar quantitative values to the pre‐issue tests, detecting the approximate 1 log10 IU/mL difference in viral load and that the other specimen was HCV RNA negative. Participant 80009 provided incorrect results for Specimens 4A and 4C. Specimen 4A was reported as ‘HCV RNA Not Detected’ however contained approximately 5000 IU/mL. Specimen 4C reported as 9400 IU/mL (3.97 log10), however was the negative specimen. This participant also returned a result for Specimen 4B that was approximately 1 log10 lower than the median result obtained by all other participants. Participant 80014 provided an incorrect result for Specimen 4C, reporting 2104 IU/mL (3.32 log10) for the negative specimen. Five participants (1004, 80009, 80013, 83021 and 83023) submitted log10 values outside the log10 + 0.25 range. (Participants 80009 and 80013 for both specimens).

7/31 (23%) of participants did not identify the clerical error in this survey; Participants 1004, 1015, 1017, 1136, 80006, 80040 and 83023 did not identify the clerical error. Review is recommended.

Overall the Molecular Diagnostics Hepatitis C program for 2014 was performed well by participants.



Review discussion prepared by: Geoff Higgins, Infectious Diseases Laboratories, IMVS, South Australia, on behalf of RCPAQAP Serology. Overview Thirty one participants returned results for this survey with 13 returning both qualitative and quantitative results and one only the qualitative result. All but one of the 14 participants returning qualitative results correctly identified the two positive and one negative specimen. Thirty participants returned quantitative results with 28 correctly identifying the two positives and one negative specimen with five separate participants with one or more results outside of the log10 +/‐ 0.25 range. Qualitative Assay Results Of the 14 participants reporting qualitative results all used single round commercial assays. Thirteen participants reported the correct results. Participant 80009 has incorrectly reported Specimen 4A as not detected and Specimen 4C as positive. This may be a transcription error (see further comments below). In inter run comparisons with MHC4:2012:4B and Specimen 4A; and MHC4:2013:4B and Specimen 4B were concordant for all participants except Participant 80009 who found MHC4:2012:4B positive but Specimen 4A negative. Quantitative Assay Results Thirty participants reported quantitative results. Quantitation was performed using the Cobas Ampliprep Taqman assay by 21 participants (version 1 by one participant), the Cobas Taqman (with the High Pure extraction method by one participant), the Abbott Real Time HCV assay by four participants and the Qiagen/Artus assay by five participants. Twenty eight of the 30 participants returned reactive quantitative results for the two positive and one negative specimen. Participant 80009 which has reported the same results in the qualitative and quantitative sections has incorrectly reported Specimen 4A as negative and Specimen 4C as positive. This may be a transcription error, but Participant 80009 did not report a log difference between the two positive specimens in this survey, suggesting other issues may be involved. Result values outside the log10 +/‐ 0.25 range were reported by two of four participants (80013 and 83023) using the Abbott assay and two of five participants (80009 and 83021) using the Qiagen assay. Participants 80009 (Qiagen) and 80013 (Abbott) reported both results outside the log10 +/‐ 0.25 range. When Abbott users are analysed separately, there were no participants outside of the log10 +/‐ 0.25 range. For Qiagen users, Participant 1004 had one result and Participant 80009 had both results (one negative and the other more than a log) outside of the log10 +/‐ 0.25 range. Inter run quantitative assay comparisons with MHC4:2012:4B and Specimen 4A; and MHC4:2013:4B and Specimen 4B were available for 19 and 23 participants respectively with only three (80009, 80013, 83023) and four (1004, 80009, 80013 and 83021) participants respectively, having a one result outside of the log10 +/‐ 0.25 range. All of these participants used either Abbott or Qiagen assays and most would have been within range if evaluated with like assays. Comments and Review of 2014 This Hepatitis C RNA survey was very well performed with only one participant showing evidence of a transcription and/or technical issue. Overall 2014 has been one of consistently good results aside from small numbers of transcription errors emphasising the need for check of all results including RCPAQAP specimens. As more participants use alternative assays we are able to see that by manufacturer consistency is generally good although there are small differences in quantitative values between manufacturers.

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Issued Wednesday, 18 February 2015 Page of 35

NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043

Hepatitis C Qualitative Results for Survey MHC4:2014:4A, 4B & 4C

Part

4A 4B 4C Cut Off

Value Result Comment Value Result Comment Value Result Units Neg Equ Pos

1004 10002 pos 199023 pos 0 neg IU/ml 64 65

80009 ‐ neg 8864 pos 9400 pos IU/ml n/a n/a n/a

83021 30.08 pos 28.63 pos ‐ neg Ct

30002 4.00 pos Sample re‐extracted and re‐tested in duplicate and confirmed positive. 4.00 pos

Sample re‐extracted and re‐tested in duplicate and confirmed positive 0.003 neg OD 0.199 0.200

1017 29.4 pos 25.1 pos ‐ neg Ct ‐ ‐ 15 UI/ml

20001 pos pos neg Ct N/A N/A N/A

20002 29.6 pos 25.6 pos ‐ neg Ct

20004 29.4 pos 25.4 pos neg Ct

20006 29.5 pos 25.7 pos neg Ct Automated Automated Automated

43000 29.6 pos 25.6 pos neg Ct

50001 29.8 pos 25.6 pos 0 neg Ct

70001 28.9 pos 24.3 pos neg Ct

80011 29.6 pos 25.5 pos ‐ neg Ct

80040 29.5 pos 25 pos ‐ neg Ct ‐ ‐ 15UI/ml



Hepatitis C Qualitative Kit Information for Survey MHC4:2014:4A, 4B & 4C

Part

Extraction

Manufacturer Kit Name Automation Lot No. Expiry Date Extraction Vol Elution Vol

1004 Qiagen QIAamp MinElute QIAcube 148026867 Oct 07 200 60

80009 Qiagen QIAamp Viral RNA Mini Kit ‐ 148012773 Sep 15 150 50

83021 Qiagen QIAamp Viral RNA Mini Kit ‐ 148028782 Apr 16 140 60

30002 Roche Diagnostics AmpliScreen Multiprep Specimen Prep ‐ S10124 Feb 15 200 200

1017 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65







70001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15






Part

Amplification

Manufacturer Kit Name Automation Lot No. Expiry Date Master Vol Sample Vol Single/Nested

1004 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148016195 Oct 31 15 10 Single round

80009 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148022254 Dec 14 30 20 Single round

83021 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148031391 Feb 15 30 20 Single round

30002 Roche Diagnostics Cobas AmpliScreen HCV Test V2.0 ‐ S12154 Apr 15 50 50 Single round

1017 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round

20001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round






70001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round






Part

Detection

Manufacturer Kit Name Automation Lot No. Expiry Date Single/Nested

1004 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148016195 Oct 31 Single round

80009 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148022254 Dec 14 Single round

83021 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148031391 Feb 15 Single round

30002 Roche Diagnostics Cobas Amplicor HCV Detection V2.0 Cobas Amplicor S12154 Apr 15 Single round

1017 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 Single round

20001 Roche Diagnostics Cobas Amplicor HCV Detection V2.0 Cobas Amplicor 153958 Apr 15 Single round












Part

Inhib Control Neg Control Pos Control

Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry

1004 Qiagen 148016195 Oct 31 Qiagen 148016195 Oct 31

80009 Qiagen 148014965 Feb 15 Qiagen 145048129 Oct 18 Qiagen 1456272 Dec 14

83021 Qiagen 148022034 Apr 15 Qiagen 148018053 Feb 19 Qiagen 148614 Feb 15

30002 Roche S10897 Mar 15 Roche S10125 Aug 15 Roche S10902 Feb 15

1017 ROCHE HCVQLv2 153958 Apr 15 ROCHE HCVQLv2 153958 Apr 15 ROCHE HCVQLv2 153958 Apr 15

20001 Roche Diagnostics 153958 Apr 15 Roche Diagnostics S09204 Jul 15 Roche Diagnostics T90087 Aug 15

20002 ROCHE DIAGNOSTICS 153958 Apr 15 ROCHE DIAGNOSTICS 153958 Apr 15 ROCHE DIAGNOSTICS 153958 Apr 15

20004 Roche Diagnostics 153958 Apr 15 Roche Diagnostics 153958 Apr 15 Roche Diagnostics 153958 Apr 15

20006 Roche 153958 Apr 15 Roche 153958 Apr 15 Roche 153958 Apr 15





80040 ROCHE HCVQL v2 153958 Apr 15 ROCHE HCVQL v2 153958 Apr 15 ROCHE HCVQLv2 153958 Apr 15



Hepatitis C Quantitative Results for Survey MHC4:2014:4A, 4B & 4C

Part

4A 4B 4C

Value Log10 Comment Value Log10 Comment Value Log10 Comment Units

80013 4228 3.63 55318 4.74 Not detected ‐ Target not detected IU/mL

83023 4890 3.68 83900 4.92 Target not detected HCV RNA NOT DETECTED IU/mL

83027 6699 3.826 103108 5.013 Target Not Detected Target Not Detected IU/mL

90006 5657 3.75 76618 4.88 Not Detected IU/mL

1004 10002 4.000 199023 5.298 0 0 IU/mL

1056 12429 4.09 87429 4.94 0 0 HCV RNA not detected IU/mL

1136 13500 4.13 142200 5.15 Target not detected IU/mL

80009 ‐ ‐ HCV RNA Not Detected 8864 3.95 9400 3.97 IU/mL

83021 12231.4 4.087 53275.5 4.73 ‐ ‐ IU/mL

1015 12100 4.08 106000 5.03 Target not detected ‐ IU/mL

1017 9340 3.97 123000 5.09 target not detected ‐ IU/mL

20001 8564 3.933 81151 4.91 Target Not Detected Target Not Detected IU/mL

20002 1.14E+4 4.06 9.56E+4 4.98 Target Not Detected ‐ IU/mL

20004 12700 4.1 145000 5.16 Not detected HCV RNA not detected IU/mL

20005 9082 3.96 112339 5.05 TARGET NOT DETECTED 0.00 IU/mL

20006 10500 4.02 83100 4.92 Not Detected IU/mL

43000 11100 4.1 105000 5.0 Negative IU/mL

50001 7720 3.89 65900 4.82 0 IU/mL

70001 6910 3.84 109000 5.04 0 0 IU/mL

80006 7,870 3.90 95,500 4.98 Target Not Detected ‐ IU/mL

80011 9340 3.97 105279 5.02 Target Not Detected ‐ HCV RNA Not Detected IU/mL

80014 9231 3.96 HCV RNA detected 105676 5.02 HCV RNA detected 2104 3.32 HCV RNA detected IU/mL

80040 10700 4.03 117000 5.07 target not detected ‐ IU/mL

80052 12342 4.09 103791 5.02 Target Not Detected IU/mL

83001 8820 3.94 124000 5.09 Target not detected N/A IU/mL

90003 8800 3.94 107000 5.02 Target not detected HCV RNA not detected IU/mL

90004 10132 4.0 109868 5.04 Target Not Detected ND IU/mL



Hepatitis C Quantitative Results for Survey MHC4:2014:4A, 4B & 4C (continued)

Part

4A 4B 4C

Value Log10 Comment Value Log10 Comment Value Log10 Comment Units

93002 7927 3.90 117306 5.07 Target not detected n/a IU/mL

1149 8690 3.94 79600 4.90 Target Not Detected IU/mL

89185 6,797 3.83 155,671 5.19 HCV RNA NOT DETECTED IU/mL

Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C

Part

Extraction

Manufacturer Kit Name Method Automation Lot No. Expiry Date Extraction Vol Elution Vol

80013 Abbott Molecular Sample Preparation System m2000sp 10535021 Feb 15 500 88

83023 Abbott Molecular Sample Preparation System m2000sp 10614191 Aug 15 500 88

83027 Abbott Molecular Sample Preparation System m1000 10543471 May 15 500 88

90006 Abbott Molecular Sample Preparation System m2000sp 10500031 Feb 15 500 88

1004 Qiagen QIAamp MinElute QIAcube 148026867 Oct 07 200 60

1056 Qiagen QIAamp Viral RNA ‐ 148018829 Jan 16 140 60

1136 QIAGEN QIAsymphony DSP Virus/Pathogen Midi Kit artus_HCV_plasma1000_V4 QIAsymphony 148010898 Sep 15 1200 60

80009 Qiagen QIAamp Viral RNA ‐ 148012773 Sep 15 150 50

83021 Qiagen QIAamp Viral RNA ‐ 148028782 Apr 16 140 60

1015 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153957 Jul 15 500 65


20001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 156339 May 15 500 65


20004 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep S17740 Oct 15 500 65





Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C (continued)

Part

Extraction

Manufacturer Kit Name Method Automation Lot No. Expiry Date Extraction Vol Elution Vol



70001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15



80014 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 140519 Jan 15 500 65



83001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 131002 Nov 14 500 65



93002 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153957 Jul 15

1149 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 149899 Aug 15 850 65

89185 Roche Diagnostics High Pure System Viral NA Kit ‐ 17749200 Dec 14 500 75


Part

Amplification

Manufacturer Kit Name Method Automation Lot No. Expiry Date Master Vol Sample Vol Single/Nested

80013 Abbott Molecular RealTime HCV RT‐PCR m2000rt 451324 Apr 15 50 50 Single round

83023 Abbott Molecular RealTime HCV RT‐PCR m2000rt 454007 Jul 15 50 50 Single round

83027 Abbott Molecular RealTime HCV RT‐PCR m2000rt 449608 Feb 15 50 50 Single round

90006 Abbott Molecular RealTime HCV RT‐PCR m2000rt 448923 Jan 15 50 50 Single round

1004 Qiagen artus HCV RG RT‐PCR Rotor‐Gene Q 148016195 Oct 31 15 10 Single round

1056 Qiagen artus HCV RG RT‐PCR Rotor‐Gene Q 148022254 Sep 14 30 20 Single round




Part

Amplification

Manufacturer Kit Name Method Automation Lot No. Expiry Date Master Vol Sample Vol Single/Nested

1136 QIAGEN HCV QS‐RGQ Kit artus HCV Rotor Gene Q 148020226 Dec 14 30 20 Single round

80009 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148022254 Dec 14 30 20 Single round

83021 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148031391 Feb 15 30 20 Single round

1015 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 50 50 Single round


20001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 50 50 Single round


20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan S17740 Oct 15 50 50 Single round


20006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 50 50 Single round


50001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 Single round

70001 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 146205 Apr 15 Single round



80014 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 140519 Jan 15 50 50 Single round



83001 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 131002 Nov 14 50 50 Single round



93002 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 153957 Jul 15 Single round

1149 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 149899 Aug 15 50 50 Single round

89185 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 134194 Apr 15 50 50 Single round




Part

Detection

Manufacturer Kit Name Method Automation Lot No. Expiry Date Single/Nested

80013 Abbott Molecular RealTime HCV RT‐PCR m2000rt 451324 Apr 15 Single round

83023 Abbott Molecular RealTime HCV RT‐PCR m2000rt 454007 Jul 15 Single round

83027 Abbott Molecular RealTime HCV RT‐PCR m2000rt 449608 Feb 15 Single round

90006 Abbott Molecular RealTime HCV RT‐PCR m2000rt 448923 Jan 15 Single round

1004 Qiagen artus HCV RG RT‐PCR Rotor‐Gene Q 148016195 Oct 31 Single round

1056 Qiagen artus HCV RG RT‐PCR Rotor‐Gene Q 148022254 Sep 14 Single round

1136 QIAGEN HCV QS‐RGQ Kit artus HCV Rotor Gene Q 148020226 Dec 14 Single round

80009 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148022254 Dec 14 Single round

83021 Qiagen artus HCV RG RT‐PCR Rotor‐Gene 3000 148031391 Feb 15 Single round

1015 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 Single round




20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan S17740 Oct 15 Single round








80014 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 140519 Jan 15 Single round



83001 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 131002 Nov 14 Single round






Part

Detection

Manufacturer Kit Name Method Automation Lot No. Expiry Date Single/Nested

93002 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 153957 Jul 15 Single round

1149 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 149899 Aug 15 Single round



Part



80013 Abbott 451324 Apr 15 Abbott 450121 Apr 15 Abbott 450121 Apr 15

83023 Abbott 454007 Jul 15 Abbott 450839 May 15 Abbott 450527, 450525 May 15

83027 Abbott 448892 Oct 14 Abbott 446640 Oct 14 Abbott 446726 Oct 14

90006 Abbott 448923 Jan 15 Abbott 450121 Apr 15 Abbott 450121 Apr 15

1004 Qiagen 148016195 Oct 31 Qiagen 148016195 Oct 31

1056 QIAGEN 148014965 Feb 15 QIAGEN 145048129 Oct 18 QIAGEN 1456272 Dec 14

1136 QIAGEN 148014965 Feb 15 QIAGEN 145048129 Oct 18 QIAGEN 1456272 Dec 14

80009 Qiagen 148014965 Feb 15 Qiagen 145048129 Oct 18 Qiagen 1456272 Dec 14

83021 Qiagen 148022034 Apr 15 Qiagen 148018053 Feb 19 Qiagen 148614 Feb 15

1015 HCVQT v 2.0 153957 Jul 15 HCVQT v 2.0 153957 Jul 15 HCVQT v 2.0 153957 Jul 15


20001 Roche Diagnostics 156339 May 15 Roche Diagnostics S07304 May 15 Roche Diagnostics S90084/S90085 Aug 15

20002 ROCHE DIAGNOSTICS 146205 Apr 15 ROCHE DIAGNOSTICS 146205 Apr 15 ROCHE DIAGNOSTICS 146205 Apr 15

20004 Roche Diagnostics S17740 Oct 15 Roche Diagnostics S17740 Oct 15 Roche Diagnostics S17740 Oct 15





Part



20006 Roche 156339 May 15 Roche 156339 May 15 Roche 156339 May 15

43000 Roche 153957 Jul 15 Roche 153957 Jul 15 Roche 153957 Jul 15

50001 Roche 156339 May 15 Roche 156339 May 15 Roche 156339 May 15




80014 Roche Diagnostics S09204 Jan 15 Roche Diagnostics S09204 Jan 15 Roche Diagnostics S90075 Jan 15



83001 Roche S05556 May 15 Roche S90073 Jan 15

90003 ROCHE 146205 Apr 15 ROCHE S13905 Oct 15 ROCHE S90078 & S90079 Jul 15


93002 Roche 153957 Jul 15 Roche 153957 Jul 15 Roche 153957 Jul 15

1149 Roche Diagnostics 149899 Aug 15 Roche Diagnostics 149899 Aug 15 Roche Diagnostics 149899 Aug 15

89185 Roche 134196 Jun 15 Roche S05557 Apr 15 Roche 134199/134198 Jun 15

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