survey an3:2013: 3c & 3d final generic report antenatal...

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reservedFile AN3‐2013‐syp Report Issued Monday, 29 July 2013 Page of 27

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Survey AN3:2013: 3C & 3D Final Generic Report Antenatal Program

Syphilis Serology Report prepared and collated by: RCPAQAP SerologyComments provided by: David Leslie

on behalf of RCPAQAP Serology Microbiology Department, 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 Alison Kesson 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 anyof 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

You are provided with sera from two pregnant women. Each serum requires antenatal screening for syphilis. Test in the same manner as patient 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 AN3:2013) 3C is a plasma converted to serum sample that tested negative to Syphilis CMIA.

Source: RCPAQAP Immunology Serum Bank.

3D is a serum sample that tested negative to Syphilis CMIA. Source: SEALS, Prince of Wales Hospital, NSW.

Pre‐issue testing: IMVS, SA.

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 167 participants returned results for syphilis.

Clerical Error

There was a clerical error included in this survey for Specimen 3D. 128/167 (76.6%) of participants detected the clerical error for Specimen 3D. 39/167 (23.4%) of participants did not identify the clerical error for Specimen 3D. Specimen 3D labelled: Pho BOND Clinical notes and Test Instructions labelled: Phu BOND





Survey Results AN3:2013 Syphilis

Syphilis RPR ‐ Specimen 3C NR: 81 = 98.78% R: 1 = 1.22% Total Results =82 Consensus: NR

Syphilis RPR ‐ Specimen 3D not tested: Excluded NR: 82 = 100.00% Total Results =82 Consensus: NR

Syphilis VDRL ‐ Specimen 3C NR: 6 = 100.00% Total Results =6 Consensus: NR

Syphilis VDRL ‐ Specimen 3D NR: 6 = 100.00% Total Results =6 Consensus: NR

Syphilis Agglut(TPHA,TPPA,PaGIA) ‐ Specimen 3C not tested: Excluded NR: 67 = 98.53% R: 1 = 1.47% Total Results =68 Consensus: NR

Syphilis Agglut(TPHA,TPPA,PaGIA) ‐ Specimen 3D not tested: Excluded NR: 68 = 100.00% Total Results =68 Consensus: NR

Syphilis FTA‐abs ‐ Specimen 3C NR: 8 = 88.89% R: 1 = 11.11% Total Results =9 Consensus: No

Syphilis FTA‐abs ‐ Specimen 3D NR: 9 = 100.00% Total Results =9 Consensus: NR

Syphilis ICT ‐ Specimen 3C NR: 2 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Syphilis ICT ‐ Specimen 3D NR: 2 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Syphilis Total Antibody Screening Assay ‐ Specimen 3C NR: 105 = 100.00% Total Results =105 Consensus: NR

Syphilis Total Antibody Screening Assay ‐ Specimen 3Dequ: 1 = 0.95% NR: 104 = 99.05% Total Results =105 Consensus: NR

Syphilis IgG ‐ Specimen 3C NR: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Syphilis IgG ‐ Specimen 3D NR: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)





Survey Results AN3:2013 Syphilis

Syphilis IgM ‐ Specimen 3C NR: 6 = 100.00% Total Results =6 Consensus: NR

Syphilis IgM ‐ Specimen 3D NR: 6 = 100.00% Total Results =6 Consensus: NR

Syphilis Immunoblot Confirmation ‐ Specimen 3C NR: 5 = 100.00% Total Results =5 Consensus: NR

Syphilis Immunoblot Confirmation ‐ Specimen 3D NR: 5 = 100.00% Total Results =5 Consensus: NR

Inconsistencies in this Survey

Syphilis RPR Participant Comment

Specimen 3C 89066 Result inconsistent with the consensus.

Test Group 29069 Lot number provided appears inconsistent with other participants in the same user group.

81036 A transcription error appears to have been made with the kit expiry date.

89130 Edit ‐ Specimens not tested ‐ entry deleted by SQAP.

89329 Other users of the same lot number have a different expiry date.




Syphilis VDRL Participant Comment

Test Group 89343 Lot number provided appears inconsistent with other participants in the same user group.

Syphilis Agglut (TPHA,TPPA,PaGIA)

Participant Comment

Specimens 3C &3D 89027 Result value appears to be inconsistent with the test method used.

Specimen 3C 71246 Result inconsistent with the consensus.

Test Group 21721 Edit ‐ Entered results in incorrect data entry screen; moved by SQAP to correct section.

89002

Edit ‐ Entered results in incorrect data entry screen; moved by SQAP to correct section.

89027

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.

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.






Inconsistencies in this Survey (continued) .

Syphilis Total Ab EIA Screening Assay

Participant Comment

Specimens 3C & 3D 1000 Omission of result value decimal point has caused this value to be presented as an extreme outlier.

80930 Result value not provided.

91119 Result value not provided.

Specimen 3D 89318 Result assigned is inconsistent with the cut‐off and result value provided.

89318 Result inconsistent with the consensus.

Test Group 1000 The cut‐off is inconsistent with SQAP definition & kit insert for a value above which is positive.

31013 Units appear inconsistent with cut‐off and result values reported.

51434

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

59000


61457


68646


89000


89058 Units appear inconsistent with cut‐off and result values reported.

89114


89145


89212 Kit past the expiry date.

92014


Syphilis IgM EIA Participant Comment

Test Group 21624 The cut‐off is inconsistent with SQAP definition & kit insert for a value above which is positive.

Syphilis ICT Participant Comment

Test Group 1057 Edit ‐ Entered results in incorrect data entry screen; moved by SQAP to correct section.

Clerical Errors Participant Comment

Test Group 61501 Edit ‐ Entered clerical error in incorrect data entry screen ‐ please use dedicated 'Clerical Errors' data entry screen to record clerical errors.

89301

Edit ‐ Entered clerical error in incorrect data entry screen ‐ please use dedicated 'Clerical Errors' data entry screen to record clerical errors.





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%.

Comments provided by: David Leslie, Microbiology Department, Victorian Infectious Diseases Reference Laboratory (VIDRL), VIC, Australia on behalf of RCPAQAP Serology

167 participants took part in this survey. The two sera issued were both consensus negative for both treponemal and non‐treponemal antibodies.

Non-treponemal Tests

Overall, 82 participants reported RPR results in this survey for both Specimens 3C and 3D. There was only one discordant result with Participant 89066 reported Specimen 3C as RPR positive (no titre supplied) and TPPA negative, and used Comment 5 – “if primary syphilis is being investigated serology should be repeated in two weeks”. This is not suggested by the results obtained, and the appropriate comment given the findings would be Comment 6 – Probable BFP (biological false positive). All six participants using VDRL reported both Specimens 3C and 3D as negative. Treponemal Tests Agglutination assays (TPHA, TPPA) Sixty‐eight participants tested Specimens 3C and 3D using agglutination assays and all achieved a non‐reactive result except for one participant (71246) who reported Specimen 3C reactive by TPHA but did not provide a titre. The Comments used by this participant (4 and 9) were appropriate to the result obtained. One participant (89027) reported both Specimens 3C and 3D as non‐reactive, but supplied titre of 2, which is not consistent with the titres obtainable with the Serodia TPPA if performed as per the kit instructions.





FTA Of the nine participants using FTA, all reported a non‐reactive result for Specimens 3C and 3D, except one participant (89072) who reported Specimen 3C as reactive, with no comment. ICT All three users of ICT tests returned consensus negative results for both sera. EIA and variants Of the 105 EIA users, all provided consensus negative results for both sera except for Participant 89318, who reported an equivocal result for Specimen 3D, but negative results for other treponemal tests and appropriately commented that the serum should be forwarded to a reference laboratory. IgM assays Of the six users of IgM EIAs, all returned negative results for both Specimens 3C and 3D. Immunoblots. Of the five participants using immunoblots, all provided consensus negative results for both sera. Test combinations and interpretation. The appropriate comments to use in this setting are Comment 1 – ‘No evidence of treponemal infection’ and Comment 5 – ‘If primary syphilis is being investigated, serology should be repeated in two weeks’ also provides useful advice. As both sera were negative, little information on optimum test combinations can be gleaned from this study. Eleven participants screened with RPR alone during this survey, and four incorrectly used Comment 1 – ‘no evidence of treponemal infection’. This cannot be claimed unless treponemal tests have also been performed.


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 AN3‐2013‐sypReport Issued Monday, 29 July 2013Page of 27

Syphilis Summary for Survey for Survey AN3:2013:3C & 3D

Part

Specimen 3C Specimen 3D

RPR VDRL AGG FTA Total SA IgG IgM ICT INTERP RPR VDRL AGG FTA Total SA IgG IGM ICT INTERP

1000 NR NR NR 1,5 NR NR NR 1,5

1027 NR 1 NR 1

1057 NR NR

1060 NR 1 NR 1

20008 NR NR 1 NR NR 1

20009 NR 1 NR 1

20500 NR NR 1 NR NR 1

21000 NR NR

21147 NR 1,5 NR 1,5

21164 NR 1 NR 1

21189 NR NR 1,5 NR NR 1,5

21229 NR 1 NR 1

21238 NR NR 1,8 NR NR 1,8

21267 NR 1,5 NR 1,5

21292 NR 1,5 NR 1,5

21338 NR NR 1 NR NR 1

21347 NR 1,5 NR 1,5

21375 NR 1 NR 1

21398 NR 1 NR 1

21401 NR 1 NR 1

21412 NR 1 NR 1

21439 NR NR 1 NR NR 1

21452 NR 1 NR 1

21489 NR 1 NR 1

21500 NR 1 NR 1

21550 NR NR 1 NR NR 1

21624 NR NR 1 NR NR 1

21721 NR NR 1 NR NR 1






Part



21763 NR 1 NR 1

29029 NR 1 NR 1

29033 NR 1,5 NR 1,5

29069 NR NR 1,5 NR NR 1,5

29083 NR 1 NR 1

31008 NR 1 NR 1

31010 NR NR 1 NR NR 1

31013 NR 1 NR 1

31043 NR 1 NR 1

31089 NR NR

31126 NR NR 1 NR NR 1

31171 NR NR 1 NR NR 1

31221 NR NR NR NR 1 NR NR NR NR 1

31234 NR 1 NR 1

31252 NR 1 NR 1

31293 NR 1 NR 1

31342 NR 1 NR 1

31369 NR NR NR 1 NR NR NR 1


31433 NR 1 NR 1

39009 NR NR

39038 NR 1 NR 1

40075 NR NR 1 NR NR 1

41002 NR NR NR NR

41018 NR 1 NR 1

41062 NR 1,5 NR 1,5

41125 NR 1,5 NR 1,5

41133 NR 1 NR 1






Part




41183 NR 1,5 NR 1,5

41432 NR 1 NR 1

49000 NR 1 NR 1

49006 NR 1 NR 1

49025 NR 1 NR 1

51044 NR 1 NR 1

51063 NR 1 NR 1

51077 NR 1,8 NR 1,8

51434 NR 1 NR 1

51632 NR 1 NR 1

59000 NR 1 NR 1

59006 NR 1 NR 1

61033 NR NR

61076 NR 1,5 NR 1,5

61100 NR 1,5 NR 1,5

61247 NR 1 NR 1

61253 NR 1,5 NR 1,5

61360 NR NR 1,8 NR NR 1,8

61455 NR 1,5 NR 1,5

61457 NR NR

61501 NR NR 1 NR NR 1

68646 NR NR

71131 NR 1 NR 1

71246 NR R 4,9 NR NR 1

71683 NR 1,5 NR 1,5

80030 NR 1 NR 1

80756 NR NR 1 NR NR 1






Part



80930 NR NR NR 1,5 NR NR NR 1,5

81021 NR NR

81022 NR NR

81023 NR NR NR NR

81024 NR NR NR NR

81025 NR NR NR NR

81028 NR NR

81030 NR NR

81036 NR NR

81325 NR NR NR 1,5 NR NR NR 1,5


83667 NR NR 1 NR NR 1

83909 NR NR 1,5 NR NR 1,5

89000 NR 1 NR 1

89002 NR NR 1 NR NR 1

89019 NR NR 1 NR NR 1

89027 NR NR NR NR

89035 NR NR

89036 NR NR 1 NR NR 1


89054 NR NR 1 NR NR 1

89055 NR NR 1 NR NR 1




89063 NR NR NR NR

89065 NR NR 1 NR NR 1

89066 R NR 5 NR NR 1






Part



89068 NR 1 NR 1

89072 NR NR R NR NR NR

89104 NR NR NR NR

89114 NR NR 1 NR NR 1

89117 NR NR NR NR

89121 NR 1,5 NR 1,5

89123 NR 1 NR 1

89130 not tested NR not tested NR



89144 NR NR


89146 NR NR

89147 NR NR NR NR



89152 NR NR NR NR NR NR 1 NR NR NR NR NR NR 1

89153 NR NR NR NR

89173 NR NR NR NR 1,5 NR NR NR NR 1,5

89174 NR 1 NR 1

89201 NR NR 1 NR NR 1

89212 NR NR

89259 NR NR

89262 NR 1 NR 1

89300 NR NR 1 NR NR 1

89301 NR NR NR NR

89303 NR NR NR NR

89306 NR NR 1 NR NR 1






Part



89318 NR NR NR NR NR 1 NR NR NR equ NR 4

89321 NR NR 1 NR NR 1

89328 NR NR NR NR

89329 NR NR 1 NR NR 1

89334 NR NR NR NR

89340 NR NR NR NR NR NR NR NR

89343 NR NR NR 1,5 NR NR NR 1,5


91119 NR NR NR 1,5 NR NR NR 1,5

91159 NR 1 NR 1

91180 NR 1 NR 1

91267 NR 1 NR 1

91317 NR 1 NR 1

91427 NR 1 NR 1

91431 not tested not tested NR 1,5 not tested not tested NR 1,5

91458 NR 1 NR 1

91461 NR NR NR 1,5 NR NR NR 1,5

91462 NR 1 NR 1

91465 NR NR 1 NR NR 1

91469 NR NR 1 NR NR 1

91482 NR NR NR NR

91487 NR 1 NR 1


92007 NR NR

92009 NR 1 NR 1

92010 NR 1,5 NR 1,5

92014 NR 1 NR 1





Syphilis RPR Results for Survey AN3:2013:3C & 3D

Part Manufacturer Kit Name Lot No. Expiry Date

Value 3C

Result 3C

Value 3D

Result 3D

21238 Alere Wampole Impact RPR 2339123 Dec‐14 N/A NR N/A NR

31369 Alere Wampole Impact RPR 1964 Jun‐14 <1 NR <1 NR

20500 Axis‐Shield SyphScreen RPR 802888473 Jul‐13 N/A NR N/A NR






89153 Axis‐Shield SyphScreen RPR 802894896 Nov‐14 N/A NR N/A NR

89334 Axis‐Shield SyphScreen RPR 802894896 Nov‐28 N/A NR N/A NR

91089 Axis‐Shield SyphScreen RPR 802894896 Nov‐14 NR NR

91465 Axis‐Shield SyphScreen RPR 802894896 Nov‐14 1 NR 1 NR

91493 Axis‐Shield SyphScreen RPR 802894896 Aug‐14 N/A NR N/A NR

20008 Becton Dickinson Macro‐Vue RPR Card 2184186 Jul‐14 N/A NR N/A NR

21189 Becton Dickinson Macro‐Vue RPR Card 2339123 Dec‐14 0 NR 0 NR

31043 Becton Dickinson Macro‐Vue RPR Card 2339123 Dec‐14 N/A NR N/A NR


31171 Becton Dickinson Macro‐Vue RPR Card 2275482 Oct‐14 N/A NR N/A NR

31378 Becton Dickinson Macro‐Vue RPR Card 2123305 May‐14 N/A NR N/A NR

40075 Becton Dickinson Macro‐Vue RPR Card 2310045 Nov‐14 N/A NR N/A NR

71246 Becton Dickinson Macro‐Vue RPR Card 2248251 Sep‐14 N/A NR N/A NR

81023 Becton Dickinson Macro‐Vue RPR Card 1301278 Feb‐14 N/A NR N/A NR

83618 Becton Dickinson Macro‐Vue RPR Card 1214600 Aug‐13 N/A NR N/A NR

89054 Becton Dickinson Macro‐Vue RPR Card 2275482 Oct‐14 0 NR 0 NR










Value 3C

Result 3C

Value 3D

Result 3D

89138 Becton Dickinson Macro‐Vue RPR Card 2052789 Feb‐14 0 NR 0 NR




89306 Becton Dickinson Macro‐Vue RPR Card 1249183 Sep‐13 0 NR 0 NR


89321 Becton Dickinson Macro‐Vue RPR Card 1249183 Sep‐13 N/A NR N/A NR

89329 Becton Dickinson Macro‐Vue RPR Card 2275482 Apr‐14 N/A NR N/A NR



21721 Biokit RPR reditest B22328 May‐14 N/A NR N/A NR

29069 Biokit RPR reditest E‐1012 Nov‐13 0 NR 0 NR

31221 Biokit RPR reditest B22328 May‐14 N/A NR N/A NR

41179 Biokit RPR reditest B22328 May‐14 <1 NR <1 NR

21550 bioMerieux RPR ‐ Nosticon II 802891550 May‐14 0 NR 0 NR

89173 BIORAD RPR Test Kit 101697 Jan‐15 0 NR 0 NR

89152 Cortez Diagnostics Syphilis InstaTest 753005 Oct‐14 <2 NR <2 NR

81021 Human Syphilis RPR 12007 Apr‐14 N/A NR N/A NR

81024 Human Syphilis RPR 12004 Nov‐13 N/A NR N/A NR


81036 Human Syphilis RPR 11006 Aug‐30 N/A NR N/A NR

89058 Human Syphilis RPR 12006 Nov‐13 N/A NR N/A NR








Value 3C

Result 3C

Value 3D

Result 3D

91119 Immunostics Immuno/syphilis RPR 1212212 Aug‐14 N/A NR N/A NR

91469 Immunostics Immuno/syphilis RPR 1212212 Aug‐14 N/A NR N/A NR

91482 Immunostics Immuno/syphilis RPR 912073 Jun‐14 N/A NR N/A NR

1000 Newmarket Laboratories RPR T101351 Aug‐14 0 NR 0 NR

61360 Newmarket Laboratories RPR 101140 Jun‐14 N/A NR N/A NR

89045 Newmarket Laboratories RPR 101697 Jan‐15 N/A NR N/A NR

89061 Newmarket Laboratories RPR 100468 Jul‐14 N/A NR N/A NR

89121 Newmarket Laboratories RPR 101697 Jan‐15 N/A NR N/A NR

89147 Newmarket Laboratories RPR 127604 Oct‐13 N/A NR N/A NR

89201 Newmarket Laboratories RPR 203301 Feb‐14 N/A NR N/A NR

81022 Omega Diagnostics Immutrep RPR 7034924 May‐14 N/A NR N/A NR

83667 Omega Diagnostics Immutrep RPR 99023 Mar‐15 <1 NR <1 NR

83909 Omega Diagnostics Immutrep RPR 7038191 Feb‐15 N/A NR N/A NR

89002 Omega Diagnostics Immutrep RPR 7037315 Dec‐14 N/A NR N/A NR

89019 Omega Diagnostics Immutrep RPR 7039451 Apr‐15 N/A NR N/A NR

89027 Omega Diagnostics Immutrep RPR 7037705 Dec‐14 1 NR 2 NR

89036 Omega Diagnostics Immutrep RPR 7039570 May‐15 0 NR 0 NR

89065 Omega Diagnostics Immutrep RPR 7037705 Dec‐14 N/A NR N/A NR

89066 Omega Diagnostics Immutrep RPR 7039186 Jul‐15 1 R N/A NR

89072 Omega Diagnostics Immutrep RPR 7038190 Mar‐15 N/A NR N/A NR

89104 Omega Diagnostics Immutrep RPR 7039607 May‐15 N/A NR N/A NR

89145 Omega Diagnostics Immutrep RPR 7038617 Apr‐15 N/A NR N/A NR

89343 Omega Diagnostics Immutrep RPR 7039243 Mar‐15 N/A NR N/A NR

80030 Plasmatec RPR Test Kit 184052 Jun‐14 N/A NR N/A NR

81028 Plasmatec RPR Test Kit 70033 Feb‐15 N/A NR N/A NR







Value 3C

Result 3C

Value 3D

Result 3D

80756 Plasmatec VDRL Carbon Antigen Test Kit 350012 Aug‐14 1 NR 1 NR

89068 Plasmatec VDRL Carbon Antigen Test Kit 70033 Feb‐15 0 NR 0 NR

89117 Plasmatec VDRL Carbon Antigen Test Kit 674209 Jan‐14 N/A NR N/A NR

89301 Plasmatec VDRL Carbon Antigen Test Kit 100442 Sep‐14 0 NR 0 NR

89328 Plasmatec VDRL Carbon Antigen Test Kit 70033 Feb‐15 N/A NR N/A NR

81030 Span Diagnostics Ltd. RPR TEST 4000008522 Sep‐13 N/A NR N/A NR

89300 Tulip Diagnostic CARBOGEN 674208 Dec‐13 N/A NR N/A NR

Syphilis VDRL Results for Survey AN3:2013:3C & 3D


Value 3C

Result 3C

Value 3D

Result 3D

89151 Becton Dickinson VDRL Antigen 1283350 May‐14 N/A NR N/A NR

81325 Becton, Dickinson and Company BD VDRL Antigen 1298822 Sep‐16 <1 NR <1 NR

89072 Omega Diagnostics Immutrep VDRL 7037918 Apr‐17 N/A NR N/A NR

89340 Omega Diagnostics Immutrep VDRL 7037893 Apr‐17 N/A NR N/A NR

89343 Omega Diagnostics Immutrep VDRL 1LOV May‐15 N/A NR N/A NR

80930 PLASMTEC VDRL Carbon Antigen 215021 Jul‐13 N/A NR N/A NR





Syphilis Agglutination Results for Survey AN3:2013:3C & 3D


Value 3C

Result 3C

Value 3D

Result 3D

89321 Axis‐Shield MicroSyph TPHA 802894051 Mar‐14 N/A NR N/A NR



20500 Beckman Coulter Olympus PK TP System UR 00047 Nov‐13 N/A NR N/A NR

31010 Beckman Coulter Olympus PK TP System UR00047 Nov‐13 N/A NR N/A NR

41002 Beckman Coulter Olympus PK TP System UR00046 Sep‐13 N/A NR N/A NR

61501 Beckman Coulter Olympus PK TP System UR00046 Sep‐13 N/A NR N/A NR

89152 Biokit Syphagen TPHA J‐2212 Mar‐14 <80 NR <80 NR

89173 Biokit Syphagen TPHA J2212 Mar‐14 <80 NR <80 NR

21721 DiaLab Syphillis TPHA 969/080312A Aug‐13 N/A NR N/A NR

71246 Diamed ID Syphilis Antibody 51000.62.02 Nov‐13 N/A R N/A NR

20008 Fujirebio Serodia TPPA VN21117 Nov‐13 N/A NR N/A NR

20009 Fujirebio Serodia TPPA XN30301 Feb‐14 <80 NR <80 NR


21439 Fujirebio Serodia TPPA WN20807 Aug‐13 <80 NR <80 NR

21550 Fujirebio Serodia TPPA VN30307 Mar‐14 0 NR 0 NR

29069 Fujirebio Serodia TPPA VN30307 Mar‐14 0 NR 0 NR

31171 Fujirebio Serodia TPPA XN30301 Feb‐14 N/A NR N/A NR

31221 Fujirebio Serodia TPPA VN30307 Mar‐14 <80 NR <80 NR

31369 Fujirebio Serodia TPPA VN30307 Mar‐14 <80 NR <80 NR

31378 Fujirebio Serodia TPPA VN30307 Mar‐14 N/A NR N/A NR

39038 Fujirebio Serodia TPPA WN30202 Feb‐14 40 NR 40 NR

40075 Fujirebio Serodia TPPA WN30202 Feb‐14 N/A NR N/A NR

41179 Fujirebio Serodia TPPA VN21117 Nov‐13 <80 NR <80 NR







Value 3C

Result 3C

Value 3D

Result 3D



83618 Fujirebio Serodia TPPA VN21117 Nov‐13 <40 NR <40 NR

83667 Fujirebio Serodia TPPA WN30202 Feb‐14 <80 NR <80 NR

83909 Fujirebio Serodia TPPA VN30102 Jan‐14 N/A NR N/A NR

89027 Fujirebio Serodia TPPA VN21117 Nov‐11 2 NR 2 NR



89055 Fujirebio Serodia TPPA VN 30102 Jan‐14 N/A NR N/A NR

89058 Fujirebio Serodia TPPA VN20912 Sep‐13 N/A NR N/A NR



89066 Fujirebio Serodia TPPA VN 21117 Nov‐13 N/A NR N/A NR

89104 Fujirebio Serodia TPPA VN20709 Jul‐13 N/A NR N/A NR





89301 Fujirebio Serodia TPPA VN30102 Jan‐14 0 NR 0 NR


89318 Fujirebio Serodia TPPA YN30402 Mar‐14 N/A NR N/A NR


91089 Fujirebio Serodia TPPA WN30202 Feb‐14 <80 NR <80 NR

91119 Fujirebio Serodia TPPA WN30202 Feb‐14 N/A NR N/A NR


91461 Fujirebio Serodia TPPA WN20807 Aug‐13 0 NR 0 NR

91465 Fujirebio Serodia TPPA WN30405 Apr‐14 80 NR 80 NR

91482 Fujirebio Serodia TPPA WN20807 Aug‐13 N/A NR N/A NR

91493 Fujirebio Serodia TPPA WN20807 Aug‐13 N/A NR N/A NR







Value 3C

Result 3C

Value 3D

Result 3D

81025 Human Syphilis TPHA 12003 Jan‐14 N/A NR N/A NR

1000 Newmarket Laboratories TPHA T101312 Apr‐14 0 NR 0 NR

89002 TPHA 100 Lab 21 100396 Dec‐13 N/A NR N/A NR

89045 Newmarket Laboratories TPHA 101557 Jul‐14 N/A NR N/A NR

89061 Newmarket Laboratories TPHA 100772 Apr‐14 N/A NR N/A NR

89056 Omega Diagnostics Immutrep TPHA 7034884 Dec‐13 N/A NR N/A NR

81024 Plasmatec TPHA Test Kit 296032 Nov‐13 N/A NR N/A NR

89146 Plasmatec TPHA Test Kit 176082 Sep‐13 N/A NR N/A NR

89147 Plasmatec TPHA Test Kit 176082 Sep‐13 N/A NR N/A NR

89174 Plasmatec TPHA Test Kit 9023 Apr‐14 N/A NR N/A NR



81023 Randox Laboratories Randox TPHA 256793 Aug‐13 N/A NR N/A NR

21000 SEKISUI TPLA 628292 May‐20 0 NR 3.4 NR

80930 Spinreact TPHA 320 Jun‐14 N/A NR N/A NR





Syphilis ICT Results for Survey AN3:2013:3C & 3D


Result 3C

Result 3D

41432 Alere Determine Syphilis TP 47325K100 Dec‐13 NR NR

1057 SD Bioline SD Bioline 25086 Oct‐30 NR NR

89300 Standard Diagnostics SD Bioline Syphilis 3.0 025091 Nov‐13 NR NR

Syphilis FTA Results for Survey AN3:2013:3C & 3D

Part Manufacturer‐Antigen Lot No. Expiry Date Manufacturer‐Sorbent Lot No

Expiry Date Manufacturer‐Conjugate

Lot No

Expiry Date

Result 3C

Result 3D

89061 bioMerieux 1001831270 Dec‐14 bioMerieux 1001831270 Dec‐14 BioRad 2D0062 Apr‐14 NR NR

89173 bioMerieux 1001992030 Feb‐14 bioMerieux 1301107492 Dec‐14 BioRad 2D0062 Apr‐14 NR NR

89056 Diagnostic and Technical Services TP21031 Sep‐13 Diagnostic and Technical Services 119474 Aug‐13 Diagnostic and Technical Services 322719 Jun‐14 NR NR

89072 Diagnostic and Technical Services TP30331 Feb‐14 Zeus Scientific HJ577 Aug‐15 Diagnostic and Technical Services 320791 Oct‐14 R NR

89152 Diagnostic and Technical Services TP30531 Apr‐14 Diagnostic and Technical Services 130226 Jun‐14 Diagnostic and Technical Services 326791 Oct‐14 NR NR

89318 Diagnostic and Technical Services TP30431 Mar‐14 Diagnostic and Technical Services 130226 Jun‐14 Diagnostic and Technical Services 326791 Oct‐14 NR NR

89138 Euroimmun F120705DD Jan‐14 Euroimmun F120705DD Jan‐14 Euroimmun F120705DD Jan‐14 NR NR

31221 MarDx 1780 May‐14 MarDx L‐301 Nov‐14 MarDx L‐300 Nov‐14 NR NR

89340 Zeus Scientific 13030065 Sep‐14 Zeus Scientific IK879 Sep‐14 bioMerieux 1001217250 Feb‐14 NR NR





Syphilis Total Antibody EIA Screening Assay Results for Survey AN3:2013:3C & 3D

Part Manufacturer Kit Name Kit

Method Automation Lot No. Expiry Date Units

Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

1027 Abbott Diagnostics Syphilis TP CMIA Architect 23716LI00 Nov‐13 S/CO 1 0.13 NR 0.17 NR

1060 Abbott Diagnostics Syphilis TP CMIA Architect 26133LP23 Jan‐14 S/CO 1 0.15 NR 0.19 NR


21189 Abbott Diagnostics Syphilis TP CMIA Architect 26131LP22 Dec‐13 S/CO 1 0.14 NR 0.16 NR


21238 Abbott Diagnostics Syphilis TP CMIA Architect 22133LP19 Aug‐13 S/CO 1 0.13 NR 0.14 NR






21412 Abbott Diagnostics Syphilis TP CMIA Architect 21137LP30 Jul‐13 S/CO 1 0.12 NR 0.12 NR


21452 Abbott Diagnostics Syphilis TP CMIA Architect 23131LP20 Sep‐13 S/CO 1 0.15 NR 0.15 NR























Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

















80930 Abbott Diagnostics Syphilis TP CMIA Architect 22131LP19 Aug‐13 S/CO 1 neg NR neg NR

81325 Abbott Diagnostics Syphilis TP CMIA Architect 24131LP21 Oct‐13 S/CO 1 0.13 NR 0.14 NR


89000 Abbott Diagnostics Syphilis TP CMIA Architect 26133LP22 Dec‐13 S/CO 0.8 0.14 NR 0.17 NR







89139 Abbott Diagnostics Syphilis TP CMIA Architect 27543LI00 Apr‐14 S/CO 1 0.2 NR 0.24 NR










Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

89212 Abbott Diagnostics Syphilis TP CMIA Architect 27544LI00 Apr‐13 S/CO 1 0.19 NR 0.21 NR



89318 Abbott Diagnostics Syphilis TP CMIA Architect 26133LP23 Jan‐14 S/CO 1 0.16 NR 1.06 equ




91119 Abbott Diagnostics Syphilis TP CMIA Architect 24133LP21 Oct‐13 S/CO 1 N/A NR N/A NR



91317 Abbott Diagnostics Syphilis TP CMIA Architect 2317L100 Nov‐13 S/CO 1 0.12 NR 0.15 NR







92007 Abbott Diagnostics Syphilis TP CMIA Architect 23719LI Nov‐13 S/CO 1 0.25 NR 0.16 NR

92009 Abbott Diagnostics Syphilis TP CMIA Architect 23716L100 Nov‐13 S/CO 1 0.14 NR 0.19 NR


91487 Biokit bioelisa Syphilis 3.0 ELISA Triturus J‐2112 Nov‐13 S/CO 1 0.02 NR 0.11 NR

31126 bioMerieux Trepanostika TP recombinant EIA Triturus D34BC Feb‐14 OD 0.437 0.088 NR 0.075 NR

59006 BioRad Syphilis Total Antibody II EIA ‐ 216302 Feb‐14 S/CO 1 0.31 NR 0.22 NR

21267 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91045 Jan‐14 S/CO 1.1 <0.10 NR <0.10 NR

51434 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91045 Jan‐14 S/CO 1 <0.1 NR 0.109 NR








Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

59000 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91045 Jan‐14 S/CO 1 0.1 NR 0.1 NR

89114 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91046 Jan‐14 S/CO 1 <0.1 NR <0.1 NR

89130 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91045 Jan‐14 S/CO 1.1 0.1 NR 0.1 NR

39009 DiaSorin Murex ICE Syphilis (IgG, IgM) EIA ‐ D127910 Sep‐13 OD 0.304 0.0952 NR 0.09 NR

29033 Diesse Diagnostica Chorus Syphilis Screen Recombinant EIA Chorus 896 Dec‐13 S/CO 1.2 0.1 NR 0.1 NR

89152 Humor Diagnostica Liaison Treponema Screen CMIA Liaison 91046 Jan‐14 S/CO 1.1 <0.10 NR <0.10 NR

21624 Lab21 Diagnostic Syphilis Total Antibody EIA ‐ 100328 Feb‐14 S/CO 1 0.1 NR 0.1 NR

29083 Ortho‐Clinical Diagnostics Syphilis TPA ECi Vitros 230 Apr‐14 S/CO 1.2 0.01 NR 0.02 NR

89148 Phoenix Bio‐Tech Trep‐Sure Anti‐Treponema EIA Screen EIA DSX System 93 Apr‐14 S/CO 1.2 0.06 NR 0.06 NR

31013 Sekisui Medical Mediace TPLA ITA Cobas c501/c502 628298 Jul‐14 S/CO 10 0 NR 5.4 NR

71131 Sekisui Medical Mediace TPLA ITA Cobas c501/c502 628280 Jan‐14 TU 10 0.8 NR 7 NR

89058 Sekisui Medical Mediace TPLA ITA Modular e601 628286 Mar‐14 S/CO 10 0 NR 4.7 NR

1000 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 20270013 Apr‐14 S/CO 0.9 0,17 NR 0,15 NR

51077 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 12 Jan‐14 S/CO 1.1 0.11 NR 0.1 NR

51632 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 13052010 Oct‐13 S/CO 1.1 0.11 NR 0.1 NR

61457 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 10 Oct‐13 S/CO 0.9 0.12 NR 0.1 NR

89145 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 17851012 Jan‐14 S/CO 1 0.1 NR 0.12 NR

92014 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Advia Centaur XP 12 Jan‐14 S/CO 1 0.14 NR 0.11 NR

21164 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Immulite 2000 237 Feb‐14 S/CO 1.1 0.043 NR 0.061 NR









Cut Off

Value 3C

Result 3C

Value 3D

Result 3D


68646 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Immulite 2000 231 Oct‐13 S/CO 1 0.1 NR 0.1 NR

89340 Reverse Screening Algorithmn

Syphilis IgG EIA Results for Survey AN3:2013:3C & 3D

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

Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

89152 Euroimmun Anti‐Treponema pallidum IgG ELISA E130212BH Feb‐14 S/CO 1.1 0.307 NR 0.259 NR

89148 Trinity Biotech Captia Syphilis‐G EIA 087 Jul‐14 S/CO 1.10 0.18 NR 0.52 NR

Syphilis IgM EIA Results for Survey AN3:2013:3C & 3D



Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

89173 BioRad Syphilis IgM Multiplex BioPlex 2200 105304 Feb‐14 S/CO 0.8 <0.8 NR <0.8 NR

89152 Euroimmun Anti‐Treponema pallidum IgM ELISA ‐ E130227AK Feb‐14 S/CO 1.10 0.043 NR 0.157 NR

89318 Euroimmun Anti‐Treponema pallidum IgM ELISA ‐ E121101AD Oct‐13 S/CO 1.1 0.096 NR 0.268 NR

21624 IBL Treponema pallidum IgM EIA ‐ 130/K012 Jan‐14 S/CO 10 3 NR 2 NR

89061 Trinity Biotech Captia Syphilis‐M EIA ‐ 21 Oct‐13 S/CO 1.1 <0.9 NR <0.9 NR

89148 Trinity Biotech Captia Syphilis‐M EIA ‐ 025 Dec‐13 S/CO 1.10 0.3 NR 0.3 NR





Syphilis Immunoblot Results for Survey AN3:2013:3C & 3D

Syphilis Immunoblot Confirmation LIA 3C

Result 3C

LIA 3D

Result 3D Part Manufacturer Kit Name Method Lot No.

Expiry Date TpN47 TpN17 TpN15 TmpA TpN47 TpN17 TpN15 TmpA

1027 Innogenetics INNO‐LIA Syphilis Score LIA 229723 Jan‐14 ‐ ‐ ‐ ‐ NR ‐ ‐ ‐ ‐ NR

89058 Innogenetics INNO‐LIA Syphilis Score LIA 229040 Oct‐13 ‐ ‐ ‐ ‐ NR ‐ ‐ ‐ ‐ NR

89306 Innogenetics INNO‐LIA Syphilis Score LIA 229723 Jan‐14 ‐ ‐ ‐ ‐ NR ‐ ‐ ‐ ‐ NR

89343 Innogenetics INNO‐LIA Syphilis Score LIA 229040 Oct‐13 ‐ ‐ ‐ ‐ NR ‐ ‐ ‐ ‐ NR

Syphilis Immunoblot Confirmation Trinity Biotech 3C

Result 3C

Trinity Biotech 3D

Result 3D Part Manufacturer Kit Name Method Lot No.

Expiry Date p15.5 p17 p47 p15.5 p17 p47

89061 Trinity Biotech T.pallidum IgG MARBLOT WB 8050K Dec‐13 ‐ ‐ ‐ NR ‐ ‐ ‐ NR

survey an3:2013: 3c & 3d final generic report antenatal...

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