FINAL REPORT HIV Serology External Quality Assessment Scheme Programme codes: HIVC4310, HIVC435 Panel ID: 2008/Oct/28
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The NRL is a: • NATA-accredited proficiency testing provider, complying with ILAC-G13:2000 • World Health Organization (WHO) Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections
Report prepared by Wayne Dimech and Kathy Smeh and distributed in the week beginning 2008/Nov/24
National Serology Reference Laboratory, Australia (NRL) 4th Floor, Healy Building, 41 Victoria Parade, Fitzroy, Victoria 3065 Australia
HIV Serology EQAS Panel ID 2008/Oct/28
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1 INTRODUCTION The National Serology Reference Laboratory, Australia (NRL) distributes three Human Immunodeficiency Virus (HIV) Serology External Quality Assessment Scheme (EQAS) panels each year to participants that conduct HIV serology testing. The NRL manages its EQAS using the DigitalPT informatics system (DigitalPT) developed and operated by HealthMetrx Canada Inc. (HMX). AcroMetrix Corporation and its subsidiaries (AcroMetrix) provide logistical support for participants enrolled through AcroMetrix. All participants in the NRL’s EQAS are provided with a unique and confidential identifier. identifier is known only by the participant, NRL, HMX and AcroMetrix.
This
This report presents and discusses the results reported for HIV Serology EQAS Panel ID 2008/Oct/28. The aims of this panel were to: • examine the integrity of result reporting • investigate whether sample carryover is occurring.
1.1 Copyright The information and data included in this report are the intellectual property of the NRL, a division of St. Vincent’s Institute. They may not be reproduced, in whole or in part, for any purpose without the written permission of the NRL; nor may they be used in any type of advertising or sales promotion.
2 METHODS 2.1 Panel composition, preparation and distribution The HIV Serology EQAS panel for programme code HIVC4310 consisted of ten plasma samples. The HIV Serology EQAS panel for programme code HIVC435 consisted of five samples which were the same as the first five samples included in the panel for programme code HIVC4310. The HIV reactivity of each sample is detailed in Tables A1 and A2. The samples were obtained from blood donors from Africa and Australia. All 10 panel samples were pooled samples. Each panel sample was prepared by mixing similar volumes of at least two samples that were from the same country of origin or from the same region and that had similar antibody and antigen profiles. The samples were tested by the NRL in a range of assays to confirm their reactivity (Table A2). The samples were aliquotted and their homogeneity was confirmed by testing conducted at the NRL. Representative samples were tested by the NRL following shipment to participants to confirm their stability. HIV Serology EQAS Panel ID 2008/Oct/28was distributed to 234 participants in 43 countries.
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2.2 Evaluation of results 2.2.1 Qualitative evaluation Results reported by participants for assay interpretations and status were compared with the relevant reference results (Tables A1 and A2). In instances where an assay interpretation was not provided for a sample tested in a rapid or agglutination assay, the reactivity for the sample that was reported by the participant was taken to also be the assay interpretation. An aberrant assay interpretation is one that did not agree with the relevant reference result. An aberrant status is one that did not agree with the relevant reference result or consensus status (if applicable). 2.2.2 Statistical analyses Tukey’s Outlier Filter was used to identify outlying results. An outlying test result is a numerical test result that is found to be statistically different from other test results reported by participants that tested the same sample in the same assay. Occasionally the EQAS coordinator may manually flag a result as outlying, which will cause it to be removed from the statistical analysis. This will only occur when inclusion of the result will erroneously bias the statistical analysis e.g. when the result is from the testing of an incorrect sample.
3 RESULTS Results from 219 participants were received for HIV Serology EQAS Panel ID 2008/Oct/28. Results were not received by the closing date for the acceptance of results from Participants NRL0084, NRL0108, NRL0118, NRL0146, NRL0183, NRL0259, NRL0354, NRL0355, NRL0424, NRL0485, NRL0501, NRL0558, NRL0561 and NRL0591. Results in an appropriate format were not received by the closing date for the acceptance of results from Participant NRL0580. Participant NRL0108 submitted results after the closing date for the acceptance of results. These results have not been evaluated. Participants NRL0076, NRL0079, NRL0085, NRL0092, NRL0117, NRL0358, NRL0439, NRL0598, NRL0565 and NRL0568 used kits that had expired. The NRL does not recommend the use of kits once the expiry date has passed and urges participants to check expiry dates prior to testing. Participants NRL0198 and NRL0545 reported an incorrect test date for one or more of the test runs. All participants that reported outlying test results, aberrant assay interpretations or results that warranted comment are listed in Table 1. Each participant is advised to check Table 1 and to review Section 4 (DISCUSSION), which comments on other results that may need review.
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Table 1. Participants that reported outlying test results, aberrant assay interpretations or status, or results that warranted comment Participant ID*
Sample ID
Reference Result
Assay
Type of Result Identified Outlying Test Results**
NRL0002
F
Negative
I
Negative
J
Reactive
F
Negative
B, D, E, G, J
Positive
NRL0027
F, H
Negative
Abbott AxSYM HIV Ag/Ab Combo MEIA
NRL0047
A, F
Negative
Bayer ADVIA Centaur HIV1/O/2 Enhanced (EHIV) Assay
NRL0049
B, D, E, G, J
Positive
E
Positive
F
Negative
I
Negative
Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA
F
Negative
Abbott ARCHITECT HIV Ag/Ab Combo CMIA
C, F, H
Negative
Ortho Vitros Anti-HIV 1+2 Assay
G
Positive
A, C, F, I
Negative
B, D, E
Positive
G
Reactive
I
Negative
NRL0119
B, D, E, G, J
Positive
NRL0121
I
Negative
NRL0014 NRL0018
NRL0062 NRL0078 NRL0092 NRL0106 NRL0109 NRL0117
Aberrant Assay interpretations***
An Aberrant Status****
Miscellaneous Comments
Abbott ARCHITECT HIV Ag/Ab Combo CMIA Abbott AxSYM HIV 1/2 gO MEIA Abbott AxSYM HIV Ag/Ab Combo MEIA
Abbott Determine HIV-1/2 Immunoassay
Bio-Rad Genscreen HIV-1/2 Version 2 EIA
Ortho Vitros Anti-HIV 1+2 Assay bioMerieux Vironostika HIV-1 Ag ELISA (Qualitative)
NRL0128
B, E
Negative
bioMerieux Vironostika HIV-1 Ag Neutral / bioMerieux Vironostika HIV-1 Ag ELISA
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Table 1. Participants that reported outlying test results, aberrant assay interpretations or status, or results that warranted comment (continued) Participant ID*
Sample ID
Reference Result
Assay
Type of Result Identified Outlying Test Results**
NRL0136
B, D, E, G, J
Positive
NRL0191
F
Negative
NRL0195
C
Negative
Bayer ADVIA Centaur HIV1/O/2 Enhanced (EHIV) Assay
C
Negative
Ortho Vitros Anti-HIV 1+2 Assay
B, D, E, G, J
Positive
NRL0275
H
Negative
Abbott PRISM HIV O Plus ChLIA
NRL0299
B, D, G
Reactive
Abbott ARCHITECT HIV Ag/Ab Combo CMIA
NRL0317
B, D, E, G, J
Reactive
Bio-Rad Genscreen HIV-1/2 Version 2 EIA
NRL0325
C
Negative
Abbott PRISM HIV O Plus ChLIA
F
Negative
Innovacon Foresight HIV 1/2/O Antibody EIA Test Kit
C, F, H
Negative
Atlas Link HIV 1+2 Antibody ELISA
A
Negative
Bayer ADVIA Centaur HIV1/O/2 Enhanced (EHIV) Assay
F
Negative
H
Negative
NRL0460
B, D, E
Reactive
Abbott ARCHITECT HIV Ag/Ab Combo CMIA
NRL0477
I
Negative
bioMerieux Vironostika HIV Uni-Form II Ag/Ab ELISA
NRL0488
F
Negative
Abbott AxSYM HIV Ag/Ab Combo MEIA
NRL0532
C
Negative
A, C
Negative
B, D, E
Reactive
NRL0559
A
Negative
Abbott ARCHITECT HIV Ag/Ab Combo CMIA
NRL0565
A
Negative
Abbott ARCHITECT HIV Ag/Ab Combo CMIA
NRL0240
NRL0399 NRL0421 NRL0442
NRL0533
An Aberrant Status****
Miscellaneous Comments
Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA
Abbott ARCHITECT HIV Ag/Ab Combo CMIA Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA
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Table 1. Participants that reported outlying test results, aberrant assay interpretations or status, or results that warranted comment (continued) Participant ID*
Sample ID
Reference Result
Assay
Type of Result Identified Outlying Test Results**
Aberrant Assay Interpretations***
An Aberrant Status****
Miscellaneous Comments
NRL0580 NRL0584 NRL0598 Note:
J
Reactive
B
Reactive
C
Negative
Roche Elecsys HIV Combi ECLIA Roche Elecsys HIV Combi ECLIA
* **
Identification. An outlying test result is a numerical test result that is found to be statistically different from the other test results reported by participants that tested the same sample in the same assay. *** An aberrant assay interpretation is one that did not agree with the relevant reference result. **** An aberrant status is one that did not agree with the relevant reference result or consensus status (if applicable).
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4 DISCUSSION Eleven participants each reported at least one assay interpretation that was considered to be aberrant. Fourteen participants each reported at least one status that was considered to be aberrant. Participants NRL0014, NRL0062, NRL0195 and NRL0598 reported aberrant results that may be due to sample mix-up. Participant NRL0014 tested all of the panel samples once in the Abbott AxSYM HIV 1/2 gO MEIA. The participant reported a reactive test result (S/Co 20.22) for the HIV negative sample I which was interpreted as reactive. The participant did not perform supplemental or confirmatory testing. The participant assigned a positive status to the sample and indicated that it would refer the sample for further testing. Participant NRL0014 reported a negative test result (S/Co 0.37) for the HIV positive sample J which was interpreted as negative. The participant assigned a negative status to the sample and indicated that it would not refer the sample for further testing. No other participant that tested the same samples in the same assay reported similar test results and assay interpretations for samples I and J. Participant NRL0062 tested all of the panel samples once in the Abbott Determine HIV-1/2 Immunoassay. The participant did not perform any further testing. The participant reported negative reactivity for the HIV positive sample E which was interpreted as negative. The participant assigned a negative status to the sample and indicated that it would not refer the sample for further testing. Participant NRL0062 reported the HIV negative sample F to be reactive. The participant assigned a positive status to the sample and indicated that it would refer the sample for further testing. No other participant that tested the same samples in the same assay reported similar test results and assay interpretations for samples E and F. Participant NRL0195 tested all of the panel samples in duplicate in the Bayer ADVIA Centaur HIV1/O/2 Enhanced (EHIV) Assay. The participant reported that it obtained test results for the HIV negative sample C that were above the linear/detection limit for the assay and interpreted the sample as reactive in the assay. The participant did not perform any further testing. The participant assigned a positive status to the sample and indicated that it would refer the sample for further testing. Eight other participants tested the sample in the same assay and reported assay interpretations that agreed with the reference results. Participant NRL0598 tested all of the panel samples in duplicate the Roche Elecsys HIV Combi ECLIA. The participant reported negative test results (COI 0.32 and 0.30) that were interpreted as negative for the HIV positive sample B. The participant reported reactive test results (COI 272.40 and 272.90) that were interpreted as reactive for the HIV negative sample C). The participant did not perform any further testing. No other participant that tested the same samples in the same assay reported the same assay interpretations for samples B and C. The participant did not complete the ‘Final Interpretation’ section in DigitalPT. It is thus not known whether or not the participant would assign a status to the sample or whether the participant would refer the sample for further testing. The above participants should review their sample processing procedures. These errors highlight the importance of: • • •
having a means by which to trace samples through the testing process adequately training staff periodically checking the competency of staff.
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Participants NRL0106, NRL0109, NRL0191, NRL0275 and NRL0584 reported aberrant results that appear to be due to data entry or transcription error. Participant NRL0106 tested all of the panel samples once in six assays: Oncoprobe Onco HIV 1/2 Ab, Standard Diagnostics SD HIV-1/2 3.0 Rapid Assay, Abbott Murex HIV Ag/Ab Combination EIA, Dade Behring Enzygnost HIV Integral EIA, InTec One Step anti-HIV Tri-line Test and bioMerieux Vironostika HIV Uni-Form II Ag/Ab ELISA. The participant reported assay interpretations for all ten panel samples in each of the assays that agreed with the reference results. The participant reported a negative status for the HIV positive sample G. Using multiple tests to screen samples is not an effective testing strategy, particularly for determining those samples that are anti-HIV negative. Participant NRL0109 tested all of the panel samples in the bioMerieux VIDAS HIV DUO Ultra ELFA and the Standard Diagnostics SD HIV-1/2 3.0 Rapid Assay. The participant reported assay interpretations for all ten panel samples in each of the assays that agreed with the reference results. The participant assigned an aberrant status to seven of the panel samples. Participant NRL0191 tested all of the panel samples once in the Abbott AxSYM HIV Ag/Ab Combo MEIA. The participant reported a negative test result (S/Co 0.45) that was interpreted as negative for the HIV negative sample F. The participant did not perform any further testing. The participant assigned a positive status to the sample and indicated that it would refer the sample for further testing. Participant NRL0275 tested all of the panel samples once in each of three test runs in the Abbott PRISM HIV O Plus ChLIA. The participant reported an initial reactive result (S/Co 1.21) for the HIV negative sample H. The participant reported that it obtained negative test results for the sample in each of the two subsequent test runs (S/Co 0.28 and 0.33). The participant interpreted the sample to be reactive in the assay rather than negative. The participant did not perform any further testing. The participant assigned an inconclusive/indeterminate status to the sample and indicated that it would refer the sample for further testing. Participant NRL0584 tested all of the panel samples in the Roche Elecsys HIV Combi ECLIA. The participant reported a negative test result (COI 0.51) that was interpreted as negative for the HIV positive sample J. The participant did not perform any further testing. The participant assigned a positive status to the sample and indicated that the sample would not be referred for further testing. These errors highlight the importance of: • • • •
laboratories having a second individual check any manually entered or transcribed results before they are released having a means by which to trace samples through the testing process adequately training staff periodically checking the competency of staff.
Participants NRL0027, NRL0317, NRL0325, NRL0442 and NRL0533 reported results that were outlying. Participant NRL0027 tested the panel samples once in the Abbott AxSYM HIV Ag/Ab Combo MEIA and then retested samples that were initially reactive singly in the same assay. The participant reported test results for the HIV negative samples F (S/Co 0.79) and H (S/Co 0.78) that were flagged as outlying. The mean of the results reported by other participants that tested samples F and H in the same assay were 0.372 and 0.359 respectively. Participant NRL0317 tested all of the panel samples in the Bio-Rad Genscreen HIV-1/2 Version 2 EIA. The participant reported assay interpretations for all of the panel samples that agreed with the HIV Serology EQAS Panel ID 2008/Oct/28
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reference results. The test results reported by the participant for all of the HIV positive panel samples were flagged as outlying. The test results reported by the participant for these samples were approximately twice the mean of the S/Co values reported by the other 13 participants that tested the samples in the same assay. It is recommended that participant NRL0317 review its testing process, the reactivity of the particular reagent batch used to test the EQAS samples and the calibration status of its equipment. Participant NRL0325 tested all of the panel samples once in the Abbott PRISM HIV O Plus ChLIA. The participant reported a test result of S/Co 0.99 for the HIV negative sample C that was interpreted as reactive. For this assay, test results that are greater than or equal to S/Co 1.00 are considered to be reactive. The test result was flagged as outlying. The mean of the test results reported by the other participants that tested the sample in the same assay was 0.308. Participant NRL0325 then proceeded to test the sample once in the Orgenics ImmunoComb II HIV 1 & 2 CombFirm and interpreted the sample to be negative in this assay. Participant NRL0325 was the only one to test the sample in this assay. The participant assigned an inconclusive/ indeterminate status to the sample. Participant NRL0442 tested all of the panel samples in duplicate in the Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA. The participant reported reactive test results for the HIV negative sample H (S/Co 3.08 and 3.31), which were interpreted as reactive and were flagged as outlying. The mean of the results reported by other participants that tested the same sample in the same assay was 0.421. Participant NRL0442 did not perform further testing. The participant did not complete the ‘Final Interpretation’ section in DigitalPT. It is thus not known whether or not the participant would assign a status to the sample or whether the participant would refer the sample for further testing. Sample H was preceded in the panel by the HIV positive sample G and followed by the HIV negative sample I. It is recommended that Participant NRL0442 investigates whether sample carryover could have caused the low reactive results obtained for sample H. Participant NRL0533 tested all of the panel samples in duplicate in the Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA. All of the test results reported by the participant were identified as outlying. For the assay used, a test result is considered reactive if the S/Co is greater than or equal to 1.00. All of the results reported by the participant were reactive. The test results for the HIV negative samples ranged from S/Co 6.00 to 44.00 while the test results for the HIV positive panel samples ranged from S/Co 149.00 to 174.00. Participant NRL0533 however reported interpretations for all of the panel samples that agreed with the reference results. The reason(s) for the aberrant results reported by Participant NRL0533 is/are not clear. It is recommended that participant NRL0533 review its testing process, the reactivity of the particular reagent batch used and the calibration status if its equipment. Participant NRL0128 tested the HIV p24 negative panel samples B and E in the bioMerieux Vironostika HIV-1 Ag ELISA (Qualitative). The participant reported reactive test results that were interpreted as reactive for the samples: B (S/Co 1.50) and E (S/Co 1.80). Two other participants tested these samples in the same assay. These participants reported assay interpretations that agreed with the reference results. Participant NRL0128 further tested samples B and E in the bioMerieux Vironostika HIV-1 Ag Neutralisation / bioMerieux Vironostika HIV-1 Ag ELISA. The participant was able to neutralise reactivity in both samples and interpreted the samples as reactive. No other participant tested the samples in this assay. Participant NRL0399 tested all of the panel samples once in the Innovacon Foresight HIV 1/2/O Antibody EIA Test Kit. The participant reported a reactive test result (S/Co 1.80) for the HIV negative sample F, which was interpreted to be reactive. Participant NRL0399 also tested all of the panel samples once in the Atlas Link HIV 1+2 Antibody ELISA. The participant reported reactive test results for the HIV negative samples C (S/Co 1.90), F (S/Co 4.80) and H (S/Co 1.00). Participant NRL0399 was the only participant to test the panel samples in the two assays in question. HIV Serology EQAS Panel ID 2008/Oct/28
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Participant NRL0532 tested all of its panel samples singly in the Abbott ARCHITECT HIV Ag/Ab Combo CMIA. This assay detects both anti-HIV and HIV p24 antigen but does not distinguish between the two. The participant reported a reactive test result (S/Co 1.20) for the HIV negative sample C, which was interpreted as reactive. No other participant that tested the same sample in the same assay reported this sample as reactive. The mean of the 49 test results reported by the other participants that tested the same sample in the same assay was 0.156. Participant NRL0532 further tested sample C singly in the Bio-Rad Genscreen ULTRA HIV Ag-Ab EIA. This assay detects both anti-HIV and HIV p24 antigen but does not distinguish between the two. The participant reported a reactive test result (S/Co 3.54) for the sample that was interpreted as reactive. No other participant that tested the same sample in the same assay reported this sample as reactive. The mean of the 19 test result reported by the other participants that tested the same sample in the same assay was 0.515. The participant assigned a positive status to sample C and indicated that the sample would be referred for further testing. It is recommended that Participant NRL0532 review its sample processing procedures and investigate whether sample C may have been contaminated at some point during the process. With the testing strategy used by Participant NRL0532, it would not be possible to distinguish whether reactivity, when true, is due to the presence of anti-HIV or of HIV p24 antigen. Many participants tested the panel samples in a single assay and assigned a status to samples that were reactive. Some of these participants reported at least one status that did not agree with the relevant reference status (e.g. Participants NRL0014, NRL0018, NRL0049, NRL0062, NRL0119, NRL0136, NRL0195 and NRL0240) [Table 1]. Some of the participants that assigned a status to a panel sample after only testing in one assay indicated that they would refer the sample in question for further testing. Participant NRL0584 tested the panel samples in only one assay, assigned a positive status to samples that were reactive and indicated that it would not refer these samples for further testing. A final serology status (final interpretation) of positive, negative or indeterminate should only be assigned to a sample after consideration of all test results (screening, supplemental and confirmatory). Participants that test samples using only one assay should refer any reactive samples for further testing in order to distinguish true from false reactivity. When reporting a final interpretation in DigitalPT, a participant that would not report a status/final interpretation but would refer a sample for further testing should submit their results as: Serology Status Refer for Further Testing Select problem code
Do not select any option Do not select any option Would not report a status based on these results.
Otherwise, participants that would report a status/final interpretation should assign an appropriate status and select “No” for “Refer for Further Testing”. Other Comments Results reported by Participant NRL0580 were not received in the specified format. Participants are reminded that results should be submitted via DigitalPT or on the approved result forms. Results not reported in the specified format will not be accepted.
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Follow Up to HIV Serology EQAS Panel ID 2008/Jun/24 Participant NRL0335 notified the NRL that it had omitted to submit the ‘Final Interpretation’ for the HIV negative sample H. The participant indicated that it would have assigned a negative status to the sample and would not refer the sample for further testing.
Acknowledgements The NRL thanks our colleagues who supply samples for the EQAS. We thank all our participants for their cooperation. Comments or queries about this report, or about any problems you might experience with HIV serology testing, will be welcomed by Kathy Smeh on +61 3 9418 1110 or via email on
[email protected].
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5 APPENDIX Table A1. Composition of HIV Serology EQAS Panel ID 2008/Oct/28 Sample Identification by Programme
Sample Origin
Sample Type
HIV Status
HIVC4310
HIVC435
A
A
Australian blood donors
Pooled plasma
Negative
B
B
African blood donors
Pooled plasma
Positive
C
C
Australian blood donors
Pooled plasma
Negative
D
D
African blood donors
Pooled plasma
Positive
E
E
African blood donors
Pooled plasma
Positive
F
Not applicable
Australian blood donors
Pooled plasma
Negative
G
African blood donors
Pooled plasma
Positive
H
Australian blood donors
Pooled plasma
Negative
I
Australian blood donors
Pooled plasma
Negative
J
African blood donors
Pooled plasma
Positive
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Table A2. Characterisation of the samples that comprised HIV Serology EQAS Panel ID 2008/Oct/28 Sample Identification by Programme
Abbott Murex HIV-1.2.O
Bio-Rad Genetic Systems HIV-1 Ag EIA
HIVC4310
Test Result (S/Co*)
Assay Interpretation
Test Result (S/Co)
Assay Interpretation
HIVC435
Bio-Rad Genetic Systems HIV-1 Ag Confirmatory Test Result
Assay Interpretation
A
A
0.51
Negative
0.45
Negative
Not tested
Not applicable
B
B
15.59
Reactive
0.32
Negative
Not tested
Not applicable
C
C
0.45
Negative
0.19
Negative
Not tested
Not applicable
D
D
16.11
Reactive
0.27
Negative
Not tested
E
E
12.22
Reactive
0.59
Negative
F
Not applicable
0.58
Negative
0.28
Negative
16.08
Reactive
0.43
Negative
Not tested
Not applicable
0.51
Negative
0.17
Negative
Not tested
Not applicable
I
0.57
Negative
0.22
Negative
Not tested
Not applicable
J
14.03
Reactive
0.21
Negative
Not tested
Not applicable
G H
NRL In-house HIV-1 WB p18
p24
p31
p34
HIV Status
gp41
p53
p68
++++
+++
++++
Not tested ++
+++
+
+++
Not applicable
++++
++++
Atypical
+
+++
++
++++
Not tested
Not applicable
++++
++++
+++
+
+++
++
++
Not tested
Not applicable
Not tested
Not tested ++++
++++
++
+
+++
+
++
Not tested Not tested ++++
++++
++
+
+++
++
++++
Assay Interpretation Not applicable
Negative
Positive
Positive
Not applicable
Negative
Positive
Positive
Positive
Positive
Not applicable
Negative
Positive
Positive
Not applicable
Negative
Not applicable
Negative
Positive
Positive
Note: * Sample divided by cut-off, where ≥ 1 is reactive.
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