hiv serology laboratory : distribution : 4235 page 1 of 10 ... · plasma (serum) donations....

Dispatch Date : 26-Feb-2018

HIV serology

Distribution : 4235

Laboratory :

Operated by Public Health England NIS - Specialist Microbiology Services 133-155 Waterloo Road Wellington House London SE1 8UG

© Copyright. The data in UK NEQAS reports are confidential. Participants must consult the scheme organiser before quoting data from the scheme. UK NEQAS for Microbiology PO Box 63003 London NW9 1GH Published at 8:20 on Thursday 12 July 2018

Your Score Intended Result Your Report

Specimen 4240 HIV1 Ag/Ab positive HIV1 Ag/Ab positive 2


Specimen 4242 HIV Ag/Ab negative HIV Ag/Ab negative 2

Specimen 4243 HIV Ag/Ab negative HIV Ag/Ab negative 2



Cumulative score information Total number of specimens sent to you for UK NEQAS for HIV serology over the last 3 distributions is 18 For these distributions specimen numbers 3884 3885 3886 3887 3888 3889 4101 4102 4103 4104 4105 4106 4240 4241 4242 4243 4244 4245 have been analysed and scored. Number of reports analysed 18 Number of specimens reported as not examined (not scored) 0 Number of specimens received too late for analysis (not scored) 0 Number of specimens for which no report was received (not scored) 0 Your cumulative score for these specimens was 36 out of a possible total of 36 The mean score calculated from the reports returned by UK laboratories was 35.22 with a standard error of 1.73. Performance rating Your performance rating for UK NEQAS for HIV serology (i.e. the number of standard errors by which your cumulative score lies above or below the mean for UK laboratories) is 0.45. A performance rating of more than 1.96 standard errors below the mean indicates possible poor performance. Your performance rating may change if other participants' results are amended. No score penalty is incurred for non return of reports. However non return of results may be used as a measure of poor performance.

Comments: A total of 365 sets of specimens were distributed for testing with 355 participants returning results within the specified period. The overall performance was excellent with 98.9% of participants obtaining the correct results. Specimens 4240, 4241 and 4244 were HIV-1 antigen/antibody positive with 99.2% of participants reporting a correct result. Specimens 4242 and 4243 were HIV antigen/antibody negative with 98.7% of the participants reporting a correct result. Please find comments on specimen 4245 on pages 8-11. Prior to dispatch all samples in this distribution were tested using 5 different EIAs. In addition, the presence of antibodies to specific proteins was determined using the BioRad New LAV Blot 1 and the Fujirebio INNO-LIA HIV 1/2 assays. Results were interpreted based on a 2 hour sample incubation time for the LAV Blot 1 assay and a 3 hour sample incubation time with the INNO-LIA assay. Images of the Fujirebio INNO-LIA profiles of the positive specimens can be viewed on the website: www.ukneqasmicro.org.uk by logging onto the Results and Reports section and selecting the 'Dist' button for the scheme. In the histograms on page 2 and subsequent pages a maximum of 12 kits results are displayed: these include the most commonly used methods and the method(s) used in your laboratory indicated by an arrow. The figures in the histograms and those in the overall results tables may differ (1) due to exclusion of kits displayed in the histograms resulting in apparently lower numbers of data sets in the histograms or (2) due to participants using more than one kit resulting in higher numbers of data sets in the histograms. Turn around time: The time taken to report your results was 0-days. This information is provided for your own use and does not form part of your performance assessment. Enquiries: Any queries about this distribution can be addressed to Dr Beatrix Kele at the e-mail address below. For repeat specimens please request using the web form or e-mail [email protected] stating your laboratory identification number, the distribution name, distribution number and specimen numbers and reason for request. Acknowledgements: We thank colleagues at the PHE-NIS-Public Health Laboratories, Colindale and Manchester and the Department of Microbiology, Gloucestershire Royal Hospital for assistance with pre-distribution testing. Report authorised by:Dr Sanjiv Rughooputh, Scheme Organiser.

Per

form

ance

Rat

ing

Distribution

Your performance rating over the past 12 distributions Your current performance rating is 0.45

MICPERF

3496 3562 3603 3707 3776 3819 3932 4001 4044 4119 4190 4235-4-3-2-101234

All

UK

Tot

al s

core

Distribution

Total score you achieved for each of the last 12 distributionsYour current total score is 12

MICPERFX

3496 3562 3603 3707 3776 3819 3932 4001 4044 4119 4190 4235-6-30369

1215

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HIV serology

Distribution : 4235

Laboratory :



Six specimens were dispatched with requests for the determination of HIV 1/2 antigen/antibody status. The specimens were derived from thrombinised human plasma (serum) donations. Specimens 4240, 4241, 4244 and 4245 consisted of HIV 1/2 Ag/Ab positive donations, diluted 1:16, 1:20, 1:14 and 1:20 respectively in HIV 1/2 Ag/Ab negative donations. Specimens 4242 and 4243 consisted of HIV 1/2 Ag/Ab negative human thrombinised plasma (serum).

Specimen : 4240 HIV1 Ag/Ab positive

UK (%) All (%)

17 (7.0) 30 (5.5)BioRad : HIV Ag/Ab45 (18.5) 82 (15.0)Roche73 (30.0) 109 (20.0)bioMerieux : Vidas

2 (0.8) 6 (1.1)Unspecified3 (1.2) 7 (1.3)BioRad : Genscreen6 (2.5) 7 (1.3)Beckman : Access6 (2.5) 9 (1.6)Determine HIV1/2 Ag/Ab 0 (0.0) 9 (1.6)OCD : VITROS3 (1.2) 14 (2.6)Murex : HIV Ag/Ab

13 (5.3) 30 (5.5)Siemens:ADVIA HIV Ag/Ab15 (6.2) 33 (6.0)DiaSorin : Liaison46 (18.9) 171 (31.3)Architect HIV Ag/Ab

Number of Reports0 40 80 120 160 200

Positive Equivocal Negative HIV1 HIV2 Positive

Your Report : HIV1 Ag/Ab positive

Positive (HIV1)

133

Positive

3

Overall Results

355

-10109

------------------------------------------------------------UK

24343

Total

2Positive (HIV2)

90

All

------------------------------------------------------------

2

Score

Your Score : 2


UK (%) All (%)

1 (2.2) 10 (5.8)BioRad : LAV blot I5 (11.1) 72 (41.9)Fujirebio : INNO-LIA0 (0.0) 1 (0.6)Arnika 0 (0.0) 1 (0.6)Standard Diagnostic HIV0 (0.0) 1 (0.6)OCD : Chiron RIBA0 (0.0) 3 (1.7)BioRad : LAV blot II0 (0.0) 7 (4.1)Mikrogen recomLine1 (2.2) 9 (5.2)MP diagnostics HIV Blot1 (2.2) 10 (5.8)Unspecified

37 (82.2) 58 (33.7)BioRad: Geenius





ENV gp36ENV gp41/45

ENV gp120/110ENV gp160

GAG p17/18GAG p24/25

GAG p26GAG p53/55

POL p31/32/34POL p51/52/66

POL p68


Unspecified BioRad : LAV blot I BioRad : LAV blot II BioRad: Geenius Fujirebio : INNO-LIA OCD : Chiron RIBA MP diagnostics HIV Blot Mikrogen recomLine Arnika



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HIV serology

Distribution : 4235

Laboratory :



UK (%) All (%)


3 (1.2) 7 (1.3)BioRad : Genscreen6 (2.5) 7 (1.3)Beckman : Access2 (0.8) 7 (1.3)Unspecified6 (2.5) 9 (1.6)Determine HIV1/2 Ag/Ab 0 (0.0) 9 (1.6)OCD : VITROS3 (1.2) 14 (2.6)Murex : HIV Ag/Ab





Negative

1

Positive

355

108

Overall Results

-12

------------------------------------------------------------

431

133

------------------------------------------------------------UK

2450

0Positive (HIV1)

-190

All

Total

Positive (HIV2)

2

Score

Your Score : 2


UK (%) All (%)


37 (82.2) 58 (33.5)BioRad: Geenius





ENV gp36ENV gp41/45

ENV gp120/110ENV gp160


GAG p26GAG p53/55

POL p31/32/34POL p51/52/66

POL p68ENV gp140





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HIV serology

Distribution : 4235

Laboratory :


Specimen : 4242 HIV Ag/Ab negative

UK (%) All (%)

17 (8.5) 29 (6.0)BioRad : HIV Ag/Ab45 (22.6) 70 (14.5)bioMerieux : Vidas44 (22.1) 81 (16.8)Roche

4 (2.0) 6 (1.2)Determine HIV1/2 Ag/Ab 2 (1.0) 6 (1.2)BioRad : Genscreen2 (1.0) 6 (1.2)Unspecified6 (3.0) 7 (1.4)Beckman : Access0 (0.0) 9 (1.9)OCD : VITROS3 (1.5) 13 (2.7)Murex : HIV Ag/Ab

10 (5.0) 26 (5.4)DiaSorin : Liaison13 (6.5) 30 (6.2)Siemens:ADVIA HIV Ag/Ab46 (23.1) 168 (34.8)Architect HIV Ag/Ab



Your Report : HIV Ag/Ab negative

NegativePositive

133

Overall Results

355Total

354

------------------------------------------------------------UK

1132

------------------------------------------------------------2

1

All

-1

Score

Your Score : 2


UK (%) All (%)

1 (6.7) 2 (3.8)BioRad : LAV blot I3 (20.0) 30 (57.7)Fujirebio : INNO-LIA0 (0.0) 1 (1.9)MP diagnostics HIV Blot0 (0.0) 4 (7.7)Unspecified

11 (73.3) 15 (28.8)BioRad: Geenius






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HIV serology

Distribution : 4235

Laboratory :



UK (%) All (%)

17 (8.6) 29 (6.0)BioRad : HIV Ag/Ab44 (22.2) 69 (14.3)bioMerieux : Vidas44 (22.2) 81 (16.7)Roche

4 (2.0) 6 (1.2)Determine HIV1/2 Ag/Ab 2 (1.0) 6 (1.2)BioRad : Genscreen6 (3.0) 7 (1.4)Beckman : Access2 (1.0) 7 (1.4)Unspecified0 (0.0) 9 (1.9)OCD : VITROS3 (1.5) 13 (2.7)Murex : HIV Ag/Ab

10 (5.1) 26 (5.4)DiaSorin : Liaison13 (6.6) 30 (6.2)Siemens:ADVIA HIV Ag/Ab46 (23.2) 169 (34.9)Architect HIV Ag/Ab




NegativeEquivocal

133

Overall Results

355Total

347

------------------------------------------------------------UK

8131

------------------------------------------------------------2

2

All

1

Score

Your Score : 2


UK (%) All (%)

1 (7.7) 3 (5.9)BioRad : LAV blot I3 (23.1) 30 (58.8)Fujirebio : INNO-LIA0 (0.0) 1 (2.0)MP diagnostics HIV Blot0 (0.0) 5 (9.8)Unspecified9 (69.2) 12 (23.5)BioRad: Geenius






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HIV serology

Distribution : 4235

Laboratory :



UK (%) All (%)


3 (1.2) 7 (1.3)BioRad : Genscreen6 (2.5) 7 (1.3)Beckman : Access3 (1.2) 8 (1.5)Unspecified6 (2.5) 9 (1.6)Determine HIV1/2 Ag/Ab 0 (0.0) 9 (1.6)OCD : VITROS3 (1.2) 14 (2.6)Murex : HIV Ag/Ab





Negative

3

Positive

355

104

Overall Results

-12

------------------------------------------------------------

421

133

------------------------------------------------------------UK

2470

0Positive (HIV1)

-191

All

Total

Positive (HIV2)

2

Score

Your Score : 2


UK (%) All (%)


35 (79.5) 54 (31.0)BioRad: Geenius





ENV gp36ENV gp41/45

ENV gp105ENV gp120/110

ENV gp160GAG p17/18GAG p24/25

GAG p26GAG p53/55

POL p31/32/34POL p51/52/66

POL p68ENV gp140





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HIV serology

Distribution : 4235

Laboratory :



UK (%) All (%)


6 (2.5) 7 (1.3)Beckman : Access2 (0.8) 7 (1.3)Unspecified3 (1.2) 8 (1.4)BioRad : Genscreen0 (0.0) 9 (1.6)OCD : VITROS6 (2.5) 11 (2.0)Determine HIV1/2 Ag/Ab 3 (1.2) 14 (2.5)Murex : HIV Ag/Ab





Equivocal

5

Positive

2

1

Overall Results

-1-1

355

Positive (HIV2)

028

133------------------------------------------------------------

57

------------------------------------------------------------

Total

UK

2643

3Negative

298

All

29Positive (HIV1)

2

Score

Your Score : 2


UK (%) All (%)

1 (2.2) 10 (5.4)BioRad : LAV blot I7 (15.2) 74 (40.0)Fujirebio : INNO-LIA0 (0.0) 1 (0.5)Arnika 0 (0.0) 1 (0.5)Standard Diagnostic HIV0 (0.0) 1 (0.5)OCD : Chiron RIBA0 (0.0) 7 (3.8)Mikrogen recomLine0 (0.0) 10 (5.4)BioRad : LAV blot II2 (4.3) 11 (5.9)MP diagnostics HIV Blot1 (2.2) 15 (8.1)Unspecified

35 (76.1) 55 (29.7)BioRad: Geenius





ENV gp36ENV gp41/45

ENV gp105ENV gp120/110


GAG p26POL p31/32/34POL p51/52/66

POL p68ENV gp140





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Comments on distribution 4235

Specimen 4245

This HIV-2 positive sample was dispatched for HIV screening and confirmation in the HIV

serology scheme in distribution 4235. The original donation was positive for HIV-2 antibodies

with the following line blot profile (Innogenetics: INNO-LIA, table 1):

gp120 gp41 gp31 p24 p17 gp105 gp36 Overall

interpretation

Result - - +/- - - 2+ 3+ HIV-2 positive

Table 1

The original donation was diluted 20 times in HIV-negative sera. Pre-distribution test results

were concordant for this sample (table 2): the sample was positive with all fourth generation

assays (BioRad Genscreen Ultra, Roche Cobas, Siemen Enzygnost Integral, DiaSorin

Murex and bioMerieux Vidas HIV Duo Quick assays).

Specimen

BioRad

Genscreen Ultra

Siemens

Enzygnost Integral II

Roche

Cobas

DiaSorin

Murex

bioMerieux

Vidas HIV Duo Quick

OD Index Index Index Index TV

4245 2.048 7.3 13.45 1912 16.19 23.70

Grey zone

with cut-off 0.252-0.280 0.9-1.0 1

1 1 0.25

Table 2

Western-blot assay results were indeterminate for this sample (BioRad New LAV BLOT I

and Fujirebio INNO-LIA HIVI/II).

321 (90.4%) out of 355 participants reported a positive result, 28 (7.9%) equivocal, one

(0.3%) negative and five participants (1.4%) reported a HIV-1 positive result for this sample.

Out of the 321 positive results 264 (82.2%) participants reported the sample as HIV

½ positive and 57 (17.8%) as HIV-2 positive.

Those participants who reported a HIV-2 positive result for this sample performed at

least one fourth generation ELISA assay and a line assay. According to the line

assay result the specimen was interpreted as HIV-2 positive.

Equivocal result was reported by participants who initially performed at least one

fourth generation ELISA assay on the sample however the initial positive screening

result was not confirmed with a HIV-1/HIV-2 antibody differentiation assay (line blot

assay).

One participant reported a negative result for this sample. This participant has used

two fourth generations ELISA assays for HIV screening followed by a HIV-1/HIV-2

differentiation assay. Due to the indeterminate confirmatory test result the sample

was interpreted as negative.

HIV serology

Distribution : 4235

Laboratory :



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Five participants reported HIV-1 positive results for this sample. All of these

participants have used at least one fourth generations ELISA assay for screening

followed by a HIV-1/HIV-2 differentiation assay. Incorrect interpretation was due to

the lack of attention to details.

The four most commonly used line blot assays for confirmation were Fujirebio:INNOLIA,

BioRad: Geenius, BioRad: LAV blot I and MP diagnostics HIV blot. Table 3 below shows the

band profile of these four line assays.

Fujirebio: INNO-

LIA BioRad: Geenius BioRad: LAV blot I

MP Diagnostics HIV blot

gp120 √ √

gp41 √ √ √ √

p31 √ √ √

p24 √ √ √

p17 √ √

sgp105 √

gp36 √ √ √

gp160 √ √ √

gp110/120 √

p68/66 √

p55 √ √

p51/52 √

p40 √

p31/34 √

p24/25 √

p17/18 √

gp140 √

p39 √

p51 √

p66 √

Table 3

Many participants commented that an indeterminate result was submitted for this sample as

there was only one band present on the blot (either gp105 or gp36). According to the kit

inserts, for a positive test results at least two bands have to be present.

The original donation contained gp105 and gp36 antibodies. The only assay that was able to

detect both of these two antibodies was the Fujirebio:INNO-LIA assay. The other line blot

assays were able to detect gp36 only.

According to the Standard Microbiology Investigation (SMI) document on HIV screening and

confirmation this specimen can be interpreted as positive or indeterminate depending on the

assays used in the laboratory and depending on the interpretation of test results. Please

note, that according to current guidelines (BHIVA, BASHH, BIS, SMI)

Fourth generation tests are the first line choice test for initial testing (1).

If fourth generation test is positive and HIV-1/HIV-2 antibody differentiation

immunoassay typing assay is indeterminate then follow up testing for HIV p24

antigen or HIV-1 RNA. If these tests are negative, consider HIV-2 and send it for

reference laboratory testing. (1)

HIV serology

Distribution : 4235

Laboratory :



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The scoring and interpretation of this sample was also discussed with the Virology Steering

Advisory Group members.

References (1) UK Standards for Microbiology Investigations: HIV screening and confirmation.

Published online in November, 2016.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/57350

5/V_11i4.pdf

HIV serology

Distribution : 4235

Laboratory :



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