Survey L2:2013: 2A & 2B Final Generic Report ...dataentry.rcpaqap.com.au/serology/admin/document... · Specimens 2A & 2B 21267 Results inconsistent with the consensus; specimens appear

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reservedFile L2‐2013‐cmv Report Issued Thursday, 6 June 2013 Page Page 1 of 30

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Survey L2:2013: 2A & 2B Final Generic Report Lymphadenopathy Program

CMV Serology Report prepared and collated by: RCPAQAP SerologyComments provided by: Jennie Leydon

on behalf of RCPAQAP Serology Victorian Infectious Diseases Reference Laboratory (VIDRL), VIC, Australia

Report prepared by

RCPAQAP Serology Suite 201, 8 Herbert Street St Leonards NSW 2065 AUSTRALIA Phone +61 2 9045 6070Facsimile +61 2 9356 2003Email [email protected] http://www.rcpaqap.com.au/serology

Contact

Susan Badman Group Manager Infectious Diseases & Immunology | Manager ‐ Serology

The completed report has been authorised for issue by

Professor William Rawlinson AM Deputy Program Chair ‐ 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.





Kit 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. A variety of samples are used in this Program (straight, undiluted serum; diluted serum and pooled serum) and this can sometimes impact on results and performance of some kits. With serum specimens, occasional artefactual problems are encountered with some kits due to changes in the matrix caused by rethrombinisation of plasma or dilution.

Request

Please test specimens for CMV and treat in the same manner as routine diagnostic specimens.

Specimen Details

Specimens are of human origin and tested negative for hepatitis B surface antigen, hepatitis C antibody and HIV. (Ref. 2013 SQA Program Plan section L2:2013) 2A is a serum converted from plasma sample that tested positive to Cytomegalovirus IgG and negative to

Cytomegalovirus IgM antibodies. Source: Laverty Pathology, North Ryde, NSW.

2B is a pooled serum sample diluted with another serum sample that tested positive to Cytomegalovirus IgG and

IgM antibodies. Source: Laverty Pathology, North Ryde, NSW and SEALS, Prince of Wales Hospital, NSW.

Pre‐issue testing: SEALS, Prince of Wales Hospital, NSW.

Analysis of Results

For information on “Analysis of Results” please refer to your RCPAQAP Serology Participation Handbook for the current year. The Participant Performance Table is an indicator for participants to review their results and evaluate their own performance as ‘Satisfactory’ or ‘Unsatisfactory’.

Robust Statistics

Analysis of Results using Robust Statistics is performed on user groups of five (5) or more participants using the same units and is now available on your personalised Assessment Report. In order to calculate the statistics as accurately as possible, results that are presented as < or > are entered into the calculations as the next whole number. For example, <10 is entered into the calculation as 9 and >500 is entered as 501. To view robust statistics of user groups other than your own, use the RCPAQAP Serology website http://www.rcpaqap.com.au/serology Log into the ‘Member Services’ section and go to ‘Dynamic Graphs of Results’.





Results

123 participants returned results for CMV.

Clerical Error There was a clerical error included in this survey for Specimen 2B.

78/123 (63.4%) of participants detected the clerical error for Specimen 2B. 45/123 (36.6%) of participants did not identify the clerical error for Specimen 2B.

Specimen 2B labelled: Brooke QIN Clinical notes and Test Instructions labelled: Brook QIN

Survey Results L2:2013 Cytomegalovirus

Cytomegalovirus IgG - Specimen 2A pos: 116 = 100.00% Total Results =116 Consensus: pos

Cytomegalovirus IgG - Specimen 2B pos: 116 = 100.00% Total Results =116 Consensus: pos

Cytomegalovirus Total - Specimen 2A AC: Excluded pos: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Cytomegalovirus Total - Specimen 2B AC: Excluded pos: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Cytomegalovirus IgM Screening Assay - Specimen 2A neg: 118 = 99.16% pos: 1 = 0.84% Total Results =119 Consensus: neg

Cytomegalovirus IgM Screening Assay - Specimen 2B neg: 1 = 0.84% pos: 118 = 99.16% Total Results =119 Consensus: pos

Cytomegalovirus IgM Supplementary Test - Specimen 2A neg: 1 = 100.00% not tested: Excluded Total Results =1 Consensus: Insufficient data (less than 5 results)

Cytomegalovirus IgM Supplementary Test - Specimen 2B pos: 9 = 100.00% Total Results =9 Consensus: pos

Cytomegalovirus Confirmatory Test - Specimen 2A pos: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Cytomegalovirus Confirmatory Test - Specimen 2B pos: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Cytomegalovirus Avidity - Specimen 2A high: 9 = 100.00% insuff: Excluded not tested: Excluded Total Results =9 Consensus: high

Cytomegalovirus Avidity - Specimen 2B equ: 12 = 41.38% high: 17 = 58.62% Total Results =29 Consensus: No





Inconsistencies in this Survey

CMV IgG Participant Comment

Specimens 2A & 2B 89054 Result lower than majority of participants performing this test.

Specimen 2A 21267 Result lower than majority of participants performing this test.

31043 Result lower than majority of participants performing this test.

71246 Result higher than majority of participants performing this test.

89273 Result higher than majority of participants performing this test.

Specimen 2B 29069 Result higher than majority of participants performing this test.

Test Group 1040 The cut‐off is inconsistent with SQAP definition & kit insert for a value above which is positive.

21763 The cut‐off is inconsistent with SQAP definition & kit insert for a value above which is positive.




61033 Lot number provided appears inconsistent with other participants in the same user group.

89058 Units appear inconsistent with manufacturer’s instructions.

89066 A transcription error appears to have been made with the kit expiry date.



89158 Kit past the expiry date.




89227 Reported units inconsistent to other participants within the user group.

89274 Cut‐off in incorrect format. Please see instructions on results sheet.



89277 Other users of the same lot number have a different expiry date.





Inconsistencies in this Survey (continued)

CMV IgG Participant Comment

Test Group 89334 Kit past the expiry date, however a transcription error appears to have been made as other users of the same lot number have an 'in‐date' expiry.

CMV IgM Screening Assay Participant Comment

Specimens 2A & 2B 21267 Results inconsistent with the consensus; specimens appear to be reversed.

Test Group 21189 Kit past the expiry date.



31433 The cut‐off is inconsistent with SQAP definition & kit insert for a value abovewhich is positive.


51044 Units not provided.











89181 Full kit details not provided.


89274 Cut‐off in incorrect format. Please see instructions on results sheet.







Inconsistencies in this Survey (continued)

CMV IgM Screening Assay Participant Comment

Test Group 89334 Other users of the same lot number have a different expiry date.

CMV Avidity Participant Comment

Test Group 31221 Kit past the expiry date, however a transcription error appears to have been made as other users of the same lot number have an 'in‐date' expiry.







91431 A transcription error appears to have been made with the kit expiry date.





Interpretative Comments Combination responses have been split into their appropriate option – for example, if a participant chose 3 & 5, they are counted once in each of those options. % is based on the total number of participants and not the total number of comments. Therefore, the total % adds to more than 100%.

Extra Comments

21347 N.B Refer for avidity testing on pregnancy patients only

41302 2B: An equivocal avidity makes timing of the infection less certain. It is also possible that these results could represent past infection with a nonspecific IgM response and unaccomplished maturity of IgG avidity.

71358 2B: would also send for Avidity testing ‐ but could not highlight.





Comments provided by: Jennie Leydon, Victorian Infectious Diseases Reference Laboratory (VIDRL), VIC, Australia, on behalf of the RCPAQAP Serology

General Overview

CMV IgG

100% (116/116) of participants reported a positive result for Specimen 2A and 100% (116/116) a positive result for Specimen 2B.

CMV IgM – Screening Assay

99.16% (118/119) of participants reported a negative result for Specimen 2A and 99.16% (118/119) of participants reported a positive result for Specimen 2B. One participant appears to have reversed the specimens.

CMV IgM – Supplementary Assay

One participant performed a supplementary assay for Specimen 2A and reported a negative result in agreement with the screening assay consensus for this specimen.

Nine participants performed a supplementary assay for Specimen 2B and all reported a positive result in agreement with the screening assay consensus for this specimen.

CMV Total Antibody

Three participants tested for Total Antibody for Specimen 2A, they all tested by CFT. Two participants reported a positive titre; the other participant reported an anticomplementary result.

Three participants tested for Total Antibody for Specimen 2B, they all tested by CFT. One participant reported a positive titre; the other two participants reported an anticomplementary result.

CMV Confirmatory Test

One participant performed a CMV western blot (IgG) and reported a positive result for Specimens 2A and 2B.

CMV IgG Avidity

Specimen 2A

Nine participants reported avidity results for Specimen 2A, nine methods were used. All participants (100%) reported a high avidity as would be expected with a serology profile IgG positive/IgM negative.

Specimen 2B

Twenty‐nine participants reported avidity results for Specimen 2B, nine methods were used. Seventeen participants (58.62%) reported a high avidity and twelve (41.38%) reported an equivocal result. The two main methods used were the bioMerieux Vidas‐Mini Vidas and the DiaSorin Liaison. Eight Vidas‐Mini Vidas users reported a high avidity and four reported an equivocal result. Three DiaSorin Liaison users reported a high avidity and four reported an equivocal result. Most results were close to the cut‐off value for each manufacturer which accounts for the mixture of high and equivocal results reported.





Review by Methodology

Two main methodologies are in use for CMV IgG testing, 38 participants used Abbott Architect (CMIA) and 21 used the bioMerieux Vidas‐Mini Vidas (ELFA). Eighteen other kits were used among the remaining 57 participants, ranging from 1 to 14 users per kit.





Two main methodologies are in use for CMV IgM testing, 34 participants used Abbott Architect (CMIA) and 26 used the bioMerieux Mini‐Vidas (ELFA). Eighteen other kits were used among the remaining 59 participants, ranging from 1 to 15 users per kit.

Interpretative comments

The majority of comments were appropriate for the results obtained.

The most appropriate comments to use were:

Specimen 2A – IgG positive/ IgM negative

Comment 2. Serological evidence of past infection

Comment 3. No serological evidence of recent infection

Specimen 2B – IgG positive/IgM positive

Comment 4. Serological evidence of recent infection or reactivation

Comment 11. Result excludes primary infection in the last 3 months but doesn’t exclude a reactivation (High avidity)

Comment 14. Refer for avidity testing

Comment 15. Refer for CMV DNA testing





Inconsistencies

Results different to consensus

Four participants reported IgG results lower than the majority of participants

Three participants reported IgG results higher than the majority of participants

Expiry dates

One participant used an expired kit for IgG testing

One participant used an expired kit for IgM testing

Two participants entered inconsistent expiry dates for the IgG testing and another appears to have made a transcription error with the expiry date

One participant entered an inconsistent expiry date for IgM testing.

Two participant entered inconsistent expiry dates for the avidity test

Lot numbers

Three participants entered inconsistent lot numbers for the IgG testing

Three participants entered inconsistent lot numbers for the IgM testing

Units

Units not provided

One participant did not provide units for the IgM testing

Two participants did not provide units for the avidity testing

Units inconsistent with manufacturer’s instructions

Two participants reported units inconsistent with the manufacturer’s instructions for the IgG testing

Three participants entered inconsistent units for the avidity testing

Units inconsistent with other participants

One participant entered inconsistent units for the IgG testing

Two participants entered inconsistent units for the IgM testing

Cut‐off value

Cut‐off inconsistent with SQAP definition & kit insert

Nine participants reported cut‐off values inconsistent with kit insert for the IgG testing

Twelve participants reported cut‐off values inconsistent with kit insert for the IgM testing

One participant reported cut‐off values inconsistent with kit insert for the avidity testing

Cut‐off in incorrect format

One participant entered the cut‐off in an incorrect format for the IgG testing

One participant entered the cut‐off in an incorrect format for the IgM testing

Summary

Consensus of results was very good:

Specimen 3A

IgG consensus 100%

IgM screening assay consensus 99.16% (1 participant appears to have reversed their results)

IgM supplementary assay insufficient data for a consensus

Total Antibody insufficient data for a consensus

Confirmatory test insufficient data for a consensus

Avidity consensus 100%





Specimen 3B

IgG consensus 100%

IgM screening assay consensus 99.16% (1 participant appears to have reversed their results)

IgM supplementary assay consensus 100%

Total Antibody insufficient data for a consensus

Confirmatory test insufficient data for a consensus

Avidity no consensus (most results close to the cut‐off)

There are still many inconsistencies in relation to expiry dates, lot numbers, units and cut‐off values. There are a large number of participants reporting cut‐off values inconsistent with the kit insert, unless the participant has a valid reason for changing the cut‐off the manufacturer’s cut‐off should be adhered to.


NATA Accredited Proficiency Testing Scheme Provider Number: 14863 Accredited for compliance with ISO/IEC 17043:2010 Site Number: 15003


© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File L2‐2013‐cmvReport Issued Thursday, 6 June 2013Page Page 13 of 30

CMV Summary for Survey L2:2013:2A & 2B

Part

Specimen 2A

Specimen 2B

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

1018 neg pos

1040 pos neg 2 pos pos 14



21229 not tested pos neg 2 high pos pos 11

21238 pos neg 2 pos pos 8,14

21267 pos pos 4,15 pos neg 2,3

21292 pos neg not tested 2 pos pos pos 8


21375 high pos neg neg AC 2 high pos pos pos AC 4



21412 not tested pos neg 2 equ pos pos 11





21624 pos neg 2,5 pos pos 4,5,8

21721 pos neg 2,3 pos pos 4,8


29029 not tested pos neg 2 equ pos pos 4,5


29069 pos neg 2 pos pos 2,4,12




31126 not tested pos neg 2 high pos pos 4,11







Part

Specimen 2A

Specimen 2B

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

31234 pos neg not tested 2 pos pos pos 4,14




31369 pos neg not tested 2,3 pos pos pos 4



39009 pos pos neg pos pos pos

39038 pos neg 2 pos pos 8,12,14

41018 not tested pos neg 2,3 equ pos pos 6


41125 pos neg 2 pos pos 4,14,15



41302 high pos neg 2 equ pos pos 4,8,14


51063 not tested pos neg 2,5 high pos pos 4,5,11






61100 pos 5,8,12 pos 5,8,12

61247 pos neg not tested 2 pos pos pos 4



61455 pos neg 2,5 pos pos 4







Part

Specimen 2A

Specimen 2B

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

71246 pos neg 2,3,5 pos pos 4,5,14




81325 pos pos 2 pos pos 2

83618 pos 2 pos 2






89027 neg pos

89035 pos neg not tested pos pos pos




89046 pos neg pos 2 pos pos AC 4


89055 neg 3 pos 4



89061 high pos neg 2 high pos pos 8,11

89063 pos neg pos pos

89065 neg pos


89101 pos neg 2,3,11 pos pos 4

89114 high pos neg not tested 2 high pos pos pos 2,11

89115 high equ






Part

Specimen 2A

Specimen 2B

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

89130 high pos neg equ pos pos

89144 neg pos


89152 high pos neg 2 high pos pos 11,15

89153 not tested pos neg not tested high pos pos pos

89156 pos neg 2,4,8,14 pos pos 2,4,8,14,16

89157 pos neg 2,3 pos pos 2,4,8


89173 high pos neg 2 high pos pos 11

89176 neg pos

89181 pos neg 2,5,8,14 pos pos 2,4,5,8





89272 pos neg 2,7 pos pos 5,8,14





89277 high pos neg 2 equ pos pos 8


89318 insuff pos neg high pos pos











Part

Specimen 2A

Specimen 2B

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP

CMV Avidity

CMV IgG

CMV IgG CT

CMV IgM SA

CMV IgM ST

CMV Total

CMV INTERP




91317 not tested pos neg not tested 2,3 equ pos pos pos 8








CMV IgG Results for Survey L2:2013:2A & 2B

Part Manufacturer Kit Name Method Automation Lot No. Expiry Date Units

Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

1040 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 1 250 pos 145.3 pos

21189 Abbott Diagnostics CMV IgG CMIA Architect 19643LF00 Aug‐13 AU/mL 6 583.5 pos 151 pos

21292 Abbott Diagnostics CMV IgG CMIA Architect 25292LF00 Jan‐14 AU/mL 6 >250.0 pos 154.7 pos

21375 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 >250 pos 153.4 pos

21398 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 >250.0 pos 155.4 pos



21452 Abbott Diagnostics CMV IgG CMIA Architect 22567LF00 Oct‐13 AU/mL 6 250 pos 144 pos



29029 Abbott Diagnostics CMV IgG CMIA Architect 24403LF00 Dec‐13 AU/mL 6 >250.0 pos 146.5 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B


31234 Abbott Diagnostics CMV IgG CMIA Architect 23326LF00 Nov‐13 AU/mL 6.7 >250.0 pos 148.7 pos


31342 Abbott Diagnostics CMV IgG CMIA Architect 21482LF00 Aug‐13 AU/mL 6 250 pos 147.6 pos





61033 Abbott Diagnostics CMV IgG CMIA Architect 1001780960 Oct‐13 AU/mL 6 >250.0 pos 142.65 pos

61100 Abbott Diagnostics CMV IgG CMIA Architect 25467LF00 Jan‐14 AU/mL 6 250 pos 155.2 pos



61455 Abbott Diagnostics CMV IgG CMIA Architect 24403LF00 Dec‐13 AU/mL 6 250 pos 155.7 pos

80930 Abbott Diagnostics CMV IgG CMIA Architect 18092LF00 May‐13 AU/mL 6 250 pos 151.1 pos

81325 Abbott Diagnostics CMV IgG CMIA Architect 18092LF00 May‐13 AU/mL 6 >250.0 pos 136.8 pos

83618 Abbott Diagnostics CMV IgG CMIA Architect 18092LF00 May‐13 AU/mL 6 >250 pos 140.2 pos

83909 Abbott Diagnostics CMV IgG CMIA Architect 19406LF00 Jul‐13 AU/mL 6 250 pos 144.1 pos

89036 Abbott Diagnostics CMV IgG CMIA Architect 17164LF00 May‐13 AU/mL 5.99 587.1 pos 136.5 pos

89046 Abbott Diagnostics CMV IgG CMIA Architect 22309LF00 Oct‐13 AU/mL 6 >250.0 pos 147.8 pos

89196 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 >250.0 pos 141 pos

89318 Abbott Diagnostics CMV IgG CMIA Architect 25761LF00 Feb‐14 AU/mL 6 250 pos 157.8 pos

91180 Abbott Diagnostics CMV IgG CMIA Architect 21439LF00 Sep‐13 AU/mL 6 >250 pos 156.6 pos

91267 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 523 pos 139 pos

91317 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 250 pos 155 pos

91431 Abbott Diagnostics CMV IgG CMIA Architect 17164LF00 May‐13 AU/mL 6 565 pos 145 pos

91458 Abbott Diagnostics CMV IgG CMIA Architect 24068LF00 Nov‐13 AU/mL 6 540.5 pos 146.6 pos

91461 Abbott Diagnostics CMV IgG CMIA Architect 22309LF00 Oct‐13 AU/mL 6 250 pos 171.1 pos

89035 Abbott Diagnostics CMV IgG MEIA AxSYM 16486M500 Jul‐13 AU/mL 15 479.9 pos 143.2 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

89041 Abbott Diagnostics CMV IgG MEIA AxSYM 16486M500 Jul‐13 AU/mL 15 >250 pos 91.7 pos


89056 Abbott Diagnostics CMV IgG MEIA AxSYM 16486M500 Jul‐13 AU/mL 15 >250 pos 165.2 pos

89063 Abbott Diagnostics CMV IgG MEIA AxSYM 16486M500 Jul‐13 AU/mL 15 >250.00 pos 186.8 pos


21721 Beckman Coulter CMV IgG ChLEIA Access 395125 Jan‐14 U/mL 15 416.2 pos 254.8 pos

89019 Biokit bioelisa CMV IgG ELISA ‐ B22320 Dec‐13 OD 0.149 0.664 pos 0.658 pos

21412 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001903560 Sep‐13 AU/mL 6 83 pos 66 pos







51044 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001488690 Jul‐13 AU/mL 6 107 pos 63 pos

71246 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001396210 Jun‐13 AU/mL 6 138 pos 80 pos


89156 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 130912‐0 Sep‐13 AU/mL 3 109 pos 71 pos


89158 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 131018‐0 Jan‐13 AU/mL 6 103 pos 60 pos



89273 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001342230 May‐13 AU/mL 6 166 pos 63 pos

89274 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001488690 Jul‐13 AU/mL 0‐6 115 pos 66 pos

89275 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001629640 Aug‐13 AU/mL 5.9 114 pos 57 pos

89276 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001629640 Aug‐13 AU/mL 6 102 pos 63 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B


91159 bioMerieux CMV IgG ELFA Vidas‐Mini Vidas 1001629640 Aug‐13 AU/mL 6 86 pos 64 pos

92018 BioRad Platelia CMV IgG EIA ‐ 2A0016 Jun‐13 AU/mL 0.5 >10 pos 7.38 pos

92014 BioRad ToRC IgG Multiplex BioPlex 2200 108178 Jul‐13 AI 1 8 pos 8 pos

31126 DiaSorin ETI‐Cytok G Plus ELISA ‐ 0680670A Jul‐13 OD 0.422 2.609 pos 2.268 pos

89061 DiaSorin ETI‐Cytok G Plus ELISA ‐ 0680670A/1 Jul‐13 U/mL 0.5 8.76 pos 5.89 pos

21267 DiaSorin Liaison CMV IgG II ChLIA Liaison/Liaison XL 161010 Oct‐13 U/mL 14 91.7 pos 128 pos

39038 DiaSorin Liaison CMV IgG II ChLIA Liaison/Liaison XL 161010 Oct‐13 U/mL 12 131 pos 101 pos


59000 DiaSorin Liaison CMV IgG II ChLIA Liaison/Liaison XL 161010 Oct‐13 U/mL 14 131 pos 88.9 pos





89153 DiaSorin Liaison CMV IgG II ChLIA Liaison/Liaison XL 161010 Oct‐13 U/mL 14 139 pos 93.8 pos


89277 DiaSorin Liaison CMV IgG II ChLIA Liaison/Liaison XL 161010 Nov‐13 U/mL 12 149 pos 117 pos

91119 Euroimmun Anti‐CMV IgG ELISA Triturus E130122BE Jan‐14 S/CO 1.1 4.06 pos 3.32 pos

89305 GBC CMV IgG EIA ELISA ‐ RN 46534 Feb‐14 S/CO 1.116 1.86 pos 1.87 pos

21229 Medac CMV‐IgG‐ELA Test PKS EIA ‐ CGQ102 Nov‐13 S/CO 1.1 76.35 pos 58.56 pos

21624 MRL BION CMV IFA ‐ CM‐1039 Aug‐14 titre 10 >10 pos >10 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

89326 NovaTec Immunodiagnostica Cytomegalovirus IgG ELISA ‐ CMVG‐058 Jan‐14 AU/mL 1 >250 pos >250 pos

89066 Ortho‐Clinical Diagnostics CMV IgG ECi Vitros 800 Jul‐20 U/mL 8 159 pos 98.9 pos

89181 Roche Diagnostics CMV IgG ECL Cobas e411 170912 Mar‐14 IU/mL 1 758.9 pos 232.9 pos

29033 Roche Diagnostics CMV IgG ECL Cobas e411 169719 Nov‐13 U/mL 1 >500 pos 237 pos

89021 Roche Diagnostics CMV IgG ECL Cobas e411 169719‐01 Nov‐13 U/mL 1 500 pos 277 pos

89058 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 17091201 Mar‐14 AU/mL 1 500 pos 276.2 pos

89227 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 170 912 ‐01 Mar‐14 S/CO 1 500 pos 244.5 pos

21238 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 17091200 Mar‐14 U/mL 1 500 pos 273 pos

29069 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 170912 Mar‐14 U/mL 1 >500 pos 321.7 pos


59006 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 170912 Mar‐14 U/mL 1 >500 pos 279 pos

61360 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 170912 Mar‐14 U/mL 1 500 pos 278.7 pos

89012 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 169719 Nov‐13 U/mL 1 500 pos 266.8 pos


91493 Roche Diagnostics CMV IgG ECL Modular Analytics e601/e602 17091200 Mar‐14 U/mL 1 >500.00 pos 266 pos

51434 Roche Diagnostics CMV IgG ECL Modular Analytics E170 170912 Mar‐14 U/mL 1 >500 pos 277 pos

21164 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 280 Sep‐13 S/CO 1.1 20.4 pos 11.9 pos

31221 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 280 Sep‐13 S/CO 1.1 21 pos 10.8 pos

31293 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 280 Sep‐13 S/CO 1.1 20.5 pos 12 pos


51077 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 281 Nov‐13 S/CO 1.1 20.8 pos 11.7 pos

68646 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 280 Sep‐13 S/CO 1.1 22.4 pos 13 pos

83667 Siemens Healthcare Diagnostics CMV IgG ChLEIA Immulite 280 Sep‐13 S/CO 1.1 20 pos 11.7 pos








Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21347 Siemens Healthcare Diagnostics Enzygnost Anti‐CMV IgG EIA BEP 2000 42186 Jan‐14 OD 0.2 1.517 pos 1.079 pos

39009 Siemens Healthcare Diagnostics Enzygnost Anti‐CMV IgG EIA ‐ 41649 Jun‐13 OD 0.2 1.2034 pos 0.8749 pos

89101 Siemens Healthcare Diagnostics Enzygnost Anti‐CMV IgG EIA BEP III 41863 Jun‐13 OD 0.2 1.742 pos 1.165 pos

89148 Trinity Biotech Captia CMV IgG ELISA ‐ 555 Feb‐14 S/CO 1.1 5.38 pos 5.1 pos

91487 Trinity Biotech Captia CMV IgG ELISA Triturus 552 Aug‐13 S/CO 1.1 4.78 pos 4.46 pos

89260 Vircell CMV IgG ELISA ‐ 13ECMVG101 Nov‐14 S/CO 1.1 3.07 pos 2.31 pos

39009 Supplementary Enzygnost reagents kit lot number:41376. Expiry date:14/07/2013.

61253 Our result for 2A would ordinarily be reported as greater than 250.0 AU/ml.

CMV IgG Confirmatory Test Results for Survey L2:2013:2A & 2B

Cytomegalovirus Confirmatory Test 2A 2A

Result

2B 2B

Result Part Manufacturer Kit Name Method Lot No.

Expiry Date pp28 p38 pp52 p55 pp65 pp130 pp28 p38 pp52 p55 pp65 pp130

39009 Euroimmun Anti‐CMV Western Blot (IgG) WB D120109AC Jul‐13 1+ 1+ 1+ 1+ 1+ 1+ pos 1+ +/‐ ‐ 1+ 1+ 1+ pos

CMV IgM Screening Assay Results for Survey L2:2013:2A & 2B


Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

1018 Abbott Diagnostics CMV IgM CMIA Architect 23036LF00 Oct‐13 S/CO 1 0.22 neg 10.24 pos


21189 Abbott Diagnostics CMV IgM CMIA Architect 17556LF00 Mar‐13 S/CO 0.85 0.16 neg 8.1 pos

21292 Abbott Diagnostics CMV IgM CMIA Architect 20557LF00 Aug‐13 S/CO 1 0.2 neg 10.68 pos









Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21439 Abbott Diagnostics CMV IgM CMIA Architect 22456LF00 Sep‐13 S/CO 1 0.32 neg 12.94 pos




29029 Abbott Diagnostics CMV IgM CMIA Architect 23700LF00 Nov‐13 S/CO 1 0.26 neg 10.26 pos


31234 Abbott Diagnostics CMV IgM CMIA Architect 20562LF00 Aug‐13 S/CO 1.1 0.26 neg 11.74 pos





31433 Abbott Diagnostics CMV IgM CMIA Architect 23032LF00 Oct‐13 S/CO 1.2 0.18 neg 8.72 pos




80930 Abbott Diagnostics CMV IgM CMIA Architect 20561LF00 Jul‐13 S/CO 0.85 0.22 neg 8.83 pos

83909 Abbott Diagnostics CMV IgM CMIA Architect 186375LF00 May‐13 S/CO 1 0.22 neg 10.12 pos

89027 Abbott Diagnostics CMV IgM CMIA Architect 24434LF00 Dec‐13 S/CO 0.5 0.21 neg 7.78 pos

89036 Abbott Diagnostics CMV IgM CMIA Architect 20557LF00 Aug‐13 S/CO 0.99 0.25 neg 11.91 pos

89176 Abbott Diagnostics CMV IgM CMIA Architect 22046LF00 Sep‐13 S/CO 0.5 0.25 neg 11.15 pos


89318 Abbott Diagnostics CMV IgM CMIA Architect 26247LF00 Jan‐14 S/CO 1 0.21 neg 10.06 pos




91431 Abbott Diagnostics CMV IgM CMIA Architect 17347LF00 May‐13 S/CO 1 0.25 neg 11.76 pos









Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

89035 Abbott Diagnostics CMV IgM MEIA AxSYM 15100M500 Apr‐13 S/CO 0.399 0.23 neg 3.984 pos

89041 Abbott Diagnostics CMV IgM MEIA AxSYM 19612M500 Nov‐13 S/CO 0.5 0.125 neg 4.358 pos




89055 Adaltis Italia EIAgen Cytomegalovirus IgM EIA Teknolabo 12262 Oct‐13 S/CO 1.2 0.05 neg 1.107 pos

89144 Adaltis Italia EIAgen Cytomegalovirus IgM EIA ‐ 12262 Oct‐13 S/CO 1.2 0.054 neg 5.885 pos

21721 Beckman Coulter CMV IgM ChLEIA Access 395425 Jan‐14 S/CO 1 0.2 neg 11.26 pos

21401 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001702080 Sep‐13 S/CO 0.9 0.07 neg 2.38 pos



31043 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001820470 Dec‐13 S/CO 0.9 0.06 neg 2.28 pos

39009 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001529710 Aug‐13 S/CO 0.9 0.07 neg 2.45 pos

41018 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001780960 Oct‐13 S/CO 0.9 0.07 neg 2.44 pos




51044 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001702080 Sep‐13 N/A 0.9 0.08 neg 2.34 pos

61033 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 21439LF00 Sep‐13 S/CO 0.9 0.06 neg 2.48 pos




89156 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 130823‐0 Aug‐13 S/CO 0.69 0.07 neg 2.36 pos


89158 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 130823‐0 Aug‐13 S/CO 0.9 0.08 neg 2.33 pos

89267 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001396290 Jun‐13 S/CO 0.9 0.07 neg 2.38 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B



89274 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001629720 Aug‐13 AU/mL 0‐0.9 0.1 neg 2.58 pos




91101 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001488770 Jul‐13 S/CO 0.9 0.07 neg 2.37 pos


92018 BioRad Platelia CMV IgM EIA Evolis 2A0016 Jun‐13 S/CO 1.1 0.386 neg 12.487 pos

92014 BioRad ToRC IgM Multiplex BioPlex 2200 107623 Jun‐13 AI 1 >0.2 neg 4 pos

31126 DiaSorin ETI‐Cytok‐M Reverse Plus ELISA ‐ 2490450A Aug‐13 OD 0.293 0.099 neg 2.654 pos

89061 DiaSorin ETI‐Cytok‐M Reverse Plus ELISA ‐ 2490450A Aug‐13 S/CO 1.2 <0.8 neg 7.3 pos

21267 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167007 May‐13 U/mL 22 81.1 pos <5 neg

39038 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 U/mL 18 <5.0 neg 88.3 pos

41302 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 U/mL 22 <5.00 neg 127 pos

59000 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167008 Jul‐13 U/mL 22 5 neg 61.8 pos

71358 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167008 Jul‐13 U/mL 22 <5.00 neg 103 pos

89114 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 U/mL 22 <5.0 neg 123 pos

89130 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167008 Jul‐13 U/mL 22 5 neg 82 pos

89152 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167008 Jul‐13 U/mL 22 <5.00 neg 103 pos

89153 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 U/mL 22 <5.00 neg 99.9 pos

89173 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 U/mL 18 <5 neg 97 pos

89277 DiaSorin Liaison CMV IgM II ChLIA Liaison/Liaison XL 167009 Nov‐13 AU/mL 18 4 neg 116 pos

89046 Euroimmun Anti‐CMV IgM ELISA ‐ E130110AO Jan‐14 S/CO 1.1 0.188 neg 5.839 pos







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

91119 Euroimmun Anti‐CMV IgM ELISA Triturus E130201AT Jan‐14 S/CO 1.1 0.24 neg 5.46 pos

89305 GBC CMV IgM EIA ELISA ‐ RN 45522 Oct‐13 S/CO 1.045 0.43 neg 1.87 pos

21229 Medac CMV‐IgM‐ELA Test PKS EIA ‐ CMP102 Feb‐14 S/CO 1.1 0.16 neg 7.18 pos

21624 MRL BION CMV IFA ‐ CM‐1039 Aug‐14 titre 10 <10 neg >10 pos

89326 NovaTec Immunodiagnostica Cytomegalovirus IgM ELISA ‐ CMVM‐055 Aug‐13 AU/mL 0.9 0 neg 3.49 pos

89066 Ortho‐Clinical Diagnostics CMV IgM ECi Vitros 710 Jul‐13 S/CO 1.2 0.28 neg 4.25 pos

29033 Roche Diagnostics CMV IgM ECL Cobas e411 170176 Oct‐13 S/CO 1 0.214 neg 3.41 pos

89021 Roche Diagnostics CMV IgM ECL Cobas e411 170176‐01 Oct‐13 S/CO 1 0.229 neg 4.09 pos

89181 170176 Oct‐13 S/CO 1 0.307 neg 3.91 pos

51434 Roche Diagnostics CMV IgM ECL Modular Analytics E170 171428 Jan‐14 S/CO 1 0.2 neg 3.44 pos

83667 Roche Diagnostics CMV IgM ECL Modular Analytics E170 171428 Jan‐14 S/CO 1 0.262 neg 4.16 pos

21238 Roche Diagnostics CMV IgM ECL Modular Analytics e601/e602 17142800 Jan‐14 S/CO 1 0.233 neg 3.93 pos





89012 Roche Diagnostics CMV IgM ECL Modular Analytics e601/e602 170176 Oct‐13 S/CO 1 0.211 neg 3.57 pos

89058 Roche Diagnostics CMV IgM ECL Modular Analytics e601/e602 17017601 Oct‐13 S/CO 1 0.194 neg 3.81 pos

89227 Roche Diagnostics CMV IgM ECL Modular Analytics e601/e602 171428‐01 Jan‐14 S/CO 1 0.24 neg 3.66 pos









Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21164 Siemens Healthcare Diagnostics CMV IgM ChLEIA Immulite 226 Oct‐13 S/CO 1.1 0.244 neg 6.92 pos





68646 Siemens Healthcare Diagnostics CMV IgM ChLEIA Immulite 225 Sep‐13 S/CO 1.1 0.225 neg 8.35 pos


89065 Siemens Healthcare Diagnostics CMV IgM ChLEIA Immulite 316 Oct‐13 S/CO 1 0.22 neg 5.63 pos

21347 Siemens Healthcare Diagnostics Enzygnost Anti‐CMV IgM EIA BEP 2000 41868 Sep‐13 OD 0.2 0.038 neg 1.009 pos

89101 Siemens Healthcare Diagnostics Enzygnost Anti‐CMV IgM EIA BEP III 41868 Sep‐13 OD 0.2 0.018 neg 1.146 pos

89148 Trinity Biotech Captia CMV IgM ELISA ‐ 37 Aug‐13 S/CO 1.1 0.17 neg 3.43 pos

91487 Trinity Biotech Captia CMV IgM ELISA Triturus 163 Jun‐14 S/CO 1.1 0.12 neg 4.13 pos

89019 Vircell CMV IgM Capture ELISA ‐ 12EC104 Jul‐13 OD 0.696 0.459 neg 2.693 pos

89260 Vircell CMV IgM Capture ELISA ‐ 13ECMVC101 Nov‐14 S/CO 1.1 0.38 neg 2.69 pos

61253 Cut off (0.9)is for TV units. No option available.





CMV IgM Supplementary Test Results for Survey L2:2013:2A & 2B


Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21292 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001780960 Oct‐13 S/CO 0.9 not tested 2.25 pos

31234 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001820470 Dec‐13 S/CO 0.9 not tested 2.37 pos

31369 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001702080 Sep‐13 S/CO 0.9 not tested 2.34 pos

61247 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001780960 Oct‐13 S/CO 0.9 not tested 2.37 pos



89153 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1001488770 Jul‐13 S/CO 0.9 not tested 2.42 pos

91317 bioMerieux CMV IgM ELFA Vidas‐Mini Vidas 1000748897A Oct‐13 S/CO 0.9 not tested 2.33 pos

21375 Diesse Diagnostica Chorus Cytomegalovirus IgM EIA Chorus 846 Aug‐13 S/CO 0.7 0.2 neg 6.3 pos

CMV Total Antibody Results for Survey L2:2013:2A & 2B

Part Manufacturer Kit Name Method Lot No. Expiry Date Units

Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21375 Microbe Scope CF Antigen CFT SKA.AT Oct‐20 titre 128 N/A AC N/A AC

81325 Virion CMV CFT Ag CFT SLA.AG Nov‐20 titre 10 80 pos 40 pos

89046 Virion CMV CFT Ag CFT SKA.AT Oct‐20 titre 8 64 pos N/A AC

81325 pos = "Regard as CMV‐antibody positive" in our reports

CMV Avidity Results for Survey L2:2013:2A & 2B


Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

29029 Abbott Diagnostics CMV IgG Avidity Avidity Architect 23712LF00 Nov‐13 % 50 not tested 57 equ

91317 Abbott Diagnostics CMV IgG Avidity Avidity Architect 27291LF00 Feb‐14 % 50 not tested 53.7 equ

91431 Abbott Diagnostics CMV IgG Avidity Avidity Architect 07052LF00 Jul‐13 % 60 not tested 58 equ







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

21229 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001903560 Sep‐13 Ratio RFV 0.8 not tested 0.81 high

21412 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001341460 Apr‐13 Ratio RFV 0.2 not tested 0.78 equ

31043 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001340980 Jun‐13 Ratio RFV 0.8 not tested 0.86 high

31221 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001903560 Sep‐12 Ratio RFV 0.8 not tested 0.71 equ

31252 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001341460 Apr‐13 Ratio RFV 0.8 not tested 0.8 high

31433 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001529620 Aug‐13 N/A 0.8 not tested 0.79 equ

41018 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001341460 Apr‐13 Ratio RFV 0.8 not tested 0.8 equ


51063 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001662030 Sep‐13 Ratio RFV 0.2 not tested 0.83 high

89061 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001160520 Jun‐13 Ratio RFV 0.8 0.94 high 0.81 high


61253 bioMerieux CMV IgG Avidity Avidity Vidas‐Mini Vidas 1001903560 Sep‐13 % 30 not tested 85.5 high

92018 BioRad Platelia CMV IgG Avidity EIA Evolis 2D0015 Nov‐13 S/CO 0.55 not tested 0.812 high

21375 DiaSorin CMV IgG Avidity ‐ 0680670A Jul‐13 % 60 85 high 73 high

31126 DiaSorin CMV IgG Avidity ‐ 0680670A Jul‐13 % 50 not tested 100 high

41302 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 165002 Jun‐13 Ratio RFV 0.25 0.58 high 0.23 equ

89114 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 50056 Jul‐13 AV 0.3 0.689 high 0.343 high

89115 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 165004 Jul‐14 N/A 0.2 0.64 high 0.208 equ

89130 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 50056 Jul‐13 Ratio RFV 0.3 0.62 high 0.23 equ

89153 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 50056 Jul‐13 AV 0.3 not tested 0.312 high

89173 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 165004 Jul‐14 Ratio RFV 0.3 0.69 high 0.35 high

89277 DiaSorin Liaison CMV IgG Avidity Avidity Liaison/Liaison XL 165002 Jun‐13 AV 0.2 0.85 high 0.24 equ

31342 Diesse Diagnostica Chorus Cytomegalovirus IgG Avidity Avidity Chorus 897 Dec‐13 % 40 not tested 51 high







Cut Off

Value 2A

Result 2A

Value 2B

Result 2B

91487 Equipar CMV IgG Avidity Avidity ‐ F2006D Apr‐14 % 25 not tested 40 equ

89152 Euroimmun Anti‐CMV IgG Avidity Avidity ‐ E120613BH Jun‐13 % 60 91 high 73 high

89318 ROCHE COBAS CMV G AVIDITY CLIA ROCHE MODULAR 168122‐01 May‐13 % 45 insuff 68.43 high

Documents

Survey L2:2013: 2A & 2B Final Generic Report ...dataentry.rcpaqap.com.au/serology/admin/document... · Specimens 2A & 2B 21267 Results inconsistent with the consensus; specimens appear