Post on 02-Jun-2020
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NATA Accredited Proficiency Testing Scheme ProviderNumber: 14863 Accredited for compliance with ISO/IEC 17043
Molecular Infectious Diseases Hepatitis C RNA Program
Generic Report
Report prepared by
RCPAQAP Serology
Copyright
This material is copyright and may not be used in any form for advertising, sales promotion or publicity. The material may not be reproduced in whole or in part for any purpose whatsoever (including presentations at meetings and conferences), without the prior written permission of the RCPA Quality Assurance Programs Pty Limited. Permission must be sought in writing from the Program but will not be unreasonably refused.
Confidentiality
RCPA Quality Assurance Programs Pty Limited keeps all participant details confidential. No information related to any of the participants will be divulged to a third party, unless required by legislation, without the express written consent of the participant. General information may be discussed at meetings or presented as papers to journals.
RCPA Quality Phone +61 2 9045 6000Assurance Programs Fax +61 2 9356 2003
ABN 32 003 520 072Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au
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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.
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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
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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
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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
1017 NE pos pos pos neg neg
20001 pos pos pos pos neg neg
20002 pos pos pos pos neg neg
20004 pos pos pos pos neg neg
20006 pos pos pos pos neg neg
30002 pos pos pos pos neg neg
43000 pos pos pos pos neg neg
50001 NE pos pos pos neg neg
70001 pos pos pos pos neg neg
80009 pos neg NR pos neg pos
80011 pos pos pos pos neg neg
80040 pos pos pos pos neg neg
83021 NE pos NE pos neg neg
NR – Not Returned NE – Not Enrolled
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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.
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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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐ 0.25 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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐ 0.25 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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐ 0.25 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
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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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 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
Inter‐run Comparisons ‐HCV RNA Quantitation
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
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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
80006 Target Not Detected Target Not Detected 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
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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
90004 Target Not Detected Target 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
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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
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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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐ 0.25 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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 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
Inter‐run Comparisons ‐HCV RNA Quantitation
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
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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
Inter‐run Comparisons ‐HCV RNA Quantitation
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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 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
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
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
Inter‐run Comparisons ‐HCV RNA Quantitation
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
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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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 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
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 Range log10 +0.25
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
Table 17 Review of Genotype at 104 IU/mL
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 Range log10 +0.25
Specimen 1A (genotype 1a)
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
Table 18 Review of Genotype at 105 IU/mL
Units: IU/mL log 10 No. of Results Median Minimum Maximum Range log10 ‐0.25 Range log10 +0.25
Specimen 2A (genotype 6a)
28 5.27 3.42 5.53 5.02 5.52
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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).
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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.
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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.
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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
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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
20001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
20002 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 650 65
20004 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
20006 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
43000 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
50001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 650 65
70001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15
80011 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
80040 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153958 Apr 15 500 65
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Hepatitis C Qualitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
20002 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
20006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
43000 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
50001 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
80011 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
80040 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 50 50 Single round
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Hepatitis C Qualitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
20002 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 Single round
20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round
20006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round
43000 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 Single round
50001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round
70001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round
80011 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153958 Apr 15 Single round
80040 Roche Diagnostics Cobas TaqMan HCVQL v2.0 Cobas TaqMan 153958 Apr 15 Single round
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Hepatitis C Qualitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
43000 Roche 153958 Apr 15 Roche 153958 Apr 15 Roche 153958 Apr 15
50001 Roche 153958 Apr 15 Roche 153958 Apr 15 Roche 153958 Apr 15
70001 Roche 153958 Apr 15 Roche 153958 Apr 15 Roche 153958 Apr 15
80011 Roche Diagnostics 153958 Apr 15 Roche Diagnostics 153958 Apr 15 Roche Diagnostics 153958 Apr 15
80040 ROCHE HCVQL v2 153958 Apr 15 ROCHE HCVQL v2 153958 Apr 15 ROCHE HCVQLv2 153958 Apr 15
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NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
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
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NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
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
1017 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153957 Jul 15 500 65
20001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 156339 May 15 500 65
20002 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 650 65
20004 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep S17740 Oct 15 500 65
20005 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 65
20006 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 156339 May 15 500 65
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NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
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
43000 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153957 Jul 15 500 65
50001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 156339 May 15 650 65
70001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15
80006 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 65
80011 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 65
80014 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 140519 Jan 15 500 65
80040 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 153957 Jul 15 500 65
80052 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 65
83001 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 131002 Nov 14 500 65
90003 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 65
90004 Roche Diagnostics Cobas AmpliPrep Cobas AmpliPrep 146205 Apr 15 500 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
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Issued Wednesday, 18 February 2015 Page Page 32 of 35
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
1017 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
20002 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan S17740 Oct 15 50 50 Single round
20005 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
20006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 50 50 Single round
43000 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 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
80006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
80011 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
80014 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 140519 Jan 15 50 50 Single round
80040 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 50 50 Single round
80052 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
83001 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 131002 Nov 14 50 50 Single round
90003 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 50 50 Single round
90004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 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
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Issued Wednesday, 18 February 2015 Page Page 33 of 35
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
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
1017 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 Single round
20001 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 Single round
20002 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
20004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan S17740 Oct 15 Single round
20005 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
20006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 156339 May 15 Single round
43000 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 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
80006 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
80011 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
80014 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 140519 Jan 15 Single round
80040 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 153957 Jul 15 Single round
80052 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
83001 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 131002 Nov 14 Single round
90003 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
90004 Roche Diagnostics Cobas TaqMan HCV v2.0 Cobas TaqMan 146205 Apr 15 Single round
© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reservedReport Issued Wednesday, 18 February 2015 Page Page 34 of 35
NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C (continued)
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
89185 Roche Diagnostics Cobas TaqMan HCV Cobas TaqMan 134194 Apr 15 Single round
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C
Part
Inhib Control Neg Control Pos Control
Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry
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
1017 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
20005 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15
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NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043
Hepatitis C Quantitative Kit Information for Survey MHC4:2014:4A, 4B & 4C (continued)
Part
Inhib Control Neg Control Pos Control
Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry Manufacturer Lot No. Expiry
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
70001 Roche 146205 Apr 15 Roche 146205 Apr 15 Roche 146205 Apr 15
80006 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15
80011 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15
80014 Roche Diagnostics S09204 Jan 15 Roche Diagnostics S09204 Jan 15 Roche Diagnostics S90075 Jan 15
80040 HCVQT v 2.0 153957 Jul 15 HCVQT v 2.0 153957 Jul 15 HCVQT v 2.0 153957 Jul 15
80052 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15 Roche Diagnostics 146205 Apr 15
83001 Roche S05556 May 15 Roche S90073 Jan 15
90003 ROCHE 146205 Apr 15 ROCHE S13905 Oct 15 ROCHE S90078 & S90079 Jul 15
90004 Roche 146205 Apr 15 Roche 146205 Apr 15 Roche 146205 Apr 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