syphilis serology -...

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File AN3-2014-syp.doc Report Issued Wednesday, 30 July 2014 Page of 31

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Survey AN3:2014: 3C & 3D

Final Generic Report Antenatal Program

Syphilis Serology Report prepared and collated by: RCPAQAP Serology Comments 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 6070 Facsimile +61 2 9356 2003 Email [email protected] Web 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 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.

mailto:[email protected]

http://www.rcpaqap.com.au/serology





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 (undiluted, diluted and pooled serum and plasma) 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. 2014 RCPAQAP Serology Program Plan section AN3:2014) 3C is a serum sample that tested non-reactive to Syphilis VDRL, TPPA, FTA-Abs and CMIA.

Source: SEALS, Prince of Wales Hospital, NSW.

Pre-issue testing: ICPMR, Westmead Hospital, NSW. 3D is a plasma sample that tested reactive to Syphilis RPR, TPPA, Total Antibody (EIA) and IgM.

Source: Physicians Plasma Alliance, Tennessee, USA. Pre-issue testing: VIDRL, VIC.

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’.

http://www.rcpaqap.com.au/serology





Results

168 participants returned results for syphilis.

Survey Results AN3:2014 Syphilis

Syphilis RPR - Specimen 3C not tested: Excluded NR: 80 = 97.56% R: 2 = 2.44% Total Results =82 Consensus: NR

Syphilis RPR - Specimen 3D insuff: Excluded not tested: Excluded NR: 3 = 2.75% R: 106 = 97.25% Total Results =109 Consensus: R

Syphilis VDRL - Specimen 3C not tested: Excluded NR: 5 = 100.00% Total Results =5 Consensus: NR

Syphilis VDRL - Specimen 3D R: 6 = 100.00% Total Results =6 Consensus: R

Syphilis Agglut(TPHA,TPPA,PaGIA) - Specimen 3C not tested: Excluded NR: 65 = 98.48% R: 1 = 1.52% Total Results =66 Consensus: NR

Syphilis Agglut(TPHA,TPPA,PaGIA) - Specimen 3D NR: 1 = 1.08% R: 92 = 98.92% Total Results =93 Consensus: R

Syphilis FTA-abs - Specimen 3C not tested: Excluded NR: 10 = 100.00% Total Results =10 Consensus: NR

Syphilis FTA-abs - Specimen 3D R: 14 = 100.00% Total Results =14 Consensus: R

Syphilis ICT - Specimen 3C NR: 7 = 100.00% Total Results =7 Consensus: NR

Syphilis ICT - Specimen 3D R: 7 = 100.00% Total Results =7 Consensus: R

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

Syphilis Total Antibody Screening Assay - Specimen 3D R: 105 = 100.00% Total Results =105 Consensus: R

Syphilis IgG - Specimen 3C not tested: Excluded NR: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

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





Survey Results AN3:2014 Syphilis

Syphilis IgM - Specimen 3C not tested: Excluded NR: 5 = 100.00% Total Results =5 Consensus: NR

Syphilis IgM - Specimen 3D NR: 2 = 33.33% R: 4 = 66.67% Total Results =6 Consensus: No

Syphilis Immunoblot Confirmation - Specimen 3C not tested: Excluded NR: 5 = 100.00% Total Results =5 Consensus: NR

Syphilis Immunoblot Confirmation - Specimen 3D R: 8 = 100.00% Total Results =8 Consensus: R

Syphilis Immunoblot Confirmation IgM - Specimen 3C neg: 2 = 100.00% not tested: Excluded Total Results =2 Consensus: Insufficient data (less than 5 results)

Syphilis Immunoblot Confirmation IgM - Specimen 3D neg/NR: 2 = 66.67% pos: 1 = 33.33% Total Results =3 Consensus: No

Inconsistencies in this Survey

Syphilis RPR Participant Comment

Specimen 3C 61247 Result inconsistent with the consensus.

89065 Result inconsistent with the consensus.

Specimen 3D 51063 Result inconsistent with the consensus.


89056 A transcription error appears to have been made with the result value.


Test Group 1094 Edit - A duplicate entry in another screen was deleted by SQAP.

21147 Other users of the same lot number have a different expiry date.

80003 Kit past the expiry date.

83667

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


Syphilis VDRL Participant Comment

Test Group 81325 Kit details entered in 'Other' section. Please use drop down list.

89151 Kit details entered in 'Other' section. Please use drop down list.

89343 Edit - Re-assigned kit according to lot number provided.





Inconsistencies in this Survey (continued)

Syphilis Agglut (TPHA,TPPA,PaGIA)

Participant Comment

Specimens 3C & 3D 20009 Results inconsistent with the consensus; specimens appear to be reversed.

Test Group 89058 Other users of the same lot number have a different expiry date.


Syphilis ICT Participant Comment

Test Group 89350 Kit past the expiry date.

Syphilis Total Ab EIA Screening Assay

Participant Comment

Specimen 3C 89072 Result assigned is inconsistent with the cut-off and result value provided.

Specimen 3D 89262 Result lower than majority of participants performing this test.

Test Group 1000 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.

1000

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

1123


21439



31089 Edit - A duplicate entry in another screen was deleted by SQAP.

31234


39038


61457


68646


80930 Cut-off value not provided.

89000


89058



89114


89145






Inconsistencies in this Survey (continued)

Syphilis Total Ab EIA Screening Assay

Participant Comment

Test Group 89306 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.

92014


Syphilis Immunblot Participant Comment

Specimens 3C & 3D 89061 Result values reported under incorrect manufacturer.

Syphilis Immunoblot Confirmation IgM

Participant Comment

Specimens 3C & 3D 89061 Result value not provided.

Test Group 80030 Edit - Entered results in incorrect data entry screen; moved by SQAP to correct section.

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

61501 RPR is no longer performed in this laboratory, all THPA reacts are referred.





0

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20

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50

1 2 4 8 16 32 64

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Titre

Specimen 3D RPR titre frequency (n=90)

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

167 participants took part in this survey.

Non-treponemal Tests Overall, 82 participants reported RPR results in this survey for Specimen 3C, which gave consensus non-reactive RPR, VDRL & treponemal test results. One participant (61247) reported Specimen 3C as reactive with a titre of 2, another participant (89065) reporting a reactive RPR did not report a titre.

One hundred and nine participants reported RPR results for Specimen 3D, which also had positive treponemal serology. Frequency of RPR titres (when reported) is shown in the chart below. Three participants reported an NR result, two with reported reactive treponemal serology (51063 and 89300), and 83850 who did not perform any treponemal testing. It was pleasing to see that only ten participants screened with RPR alone in this survey. Treponemal Tests Agglutination Assays (TPHA, TPPA) Sixty six participants tested Specimen 3C using agglutination assays and all except one (20009) achieved a non-reactive result; however this participant may have transposed the results of Specimens 3C and 3D. The other 92 participants who tested Specimen 3D reported a reactive result. FTA Of the 14 participants using FTA, 10 (100%) reported a non-reactive result for Specimen 3C and 14 (100%) reported a reactive result for Specimen 3D. ICT All seven participants using ICT tests returned non-reactive results for Specimen 3C and reactive results for Specimen 3D. Syphilis Total Antibody Screening Assay Of the 105 participants using EIA tests, all provided non-reactive results for Specimen 3C and reactive results for Specimen 3D.





IgM assays There were seven participants who reported IgM results, six using five different EIAs, and three using two different IgM western blots. Five participants returned non-reactive results for Specimen 3C (one participant did not test Specimen 3C for IgM), and two participants returned negative western blot results for Specimen 3C. Four participants using BioRad, Euroimmun, IBL or Lab21 Diagnostic EIAs all reported Specimen 3D as IgM reactive, however the two participants using the Trinity Biotech IgM EIA reported non-reactive results for Specimen 3D. The two participants using the Trinity western blot reported negative result, and the participant using the Euroimmun western blot reported a positive result for Specimen 3D. Given the numbers are small; it is difficult to comment on the significance of this. Test Combinations and Interpretation Clearly, Specimen 3C was consensus non-reactive by all tests, and the most appropriate comment is Comment 1 “No evidence of treponemal infection”. Use of Comment 5 “If primary syphilis is being investigated, serology should be repeated in two weeks” is also appropriate as participants were not supplied any risk factors for the patient. Specimen 3D was consensus reactive for both treponemal and non-treponemal antibodies, and this may represent a number of common scenarios:

1. Recent onset early syphilis 2. Untreated latent syphilis 3. Old treated serofast status

As Specimen 3D was IgM positive, possibility one is the most likely and participants performing IgM testing could use Comment 2 “Results indicate a current or recent treponemal infection” alone, however most participants do not have this capacity so it would be reasonable to use Comment 3 “Results indicate a past or current treponemal infection” combined with Comment 9 “Send to a reference laboratory” or alternatively Comment 5. Final Comments Syphilis PCR studies we have performed at VIDRL indicate that IgM is usually (but not always) present before other serological markers in early primary syphilis, but is usually present in secondary disease, in up to half of re-infections, and has also been recorded as positive in patients with tertiary disease, hence it is a useful marker of disease activity and an indicator for treatment. However, as with all IgM assays, low titre false-positive results occur not infrequently (especially in pregnant women), and the assay should not be used for primary screening. Isolated positive IgM results should be treated with caution, and if necessary a second bleed should be obtained to demonstrate an evolving immune response if risk factors exist. Overall, participants performed very well in this survey.





Syphilis Summary for Survey for Survey AN3:2014:3C & 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 R R R 3,8

1058 NR NR 1 R R 3

1086 NR NR 1 R R 2,3

1094 NR NR R R

1099 NR NR 1 R R 2,3,4

1113 NR R

1114 NR R

1117 NR NR 1 R R 3,4

1121 NR R

1123 NR 1 R 9

1135 NR R

1148 NR NR NR R R R

20008 NR NR 1 R R 3,9

20009 R 3,9 NR 1

21000 NR 1 R 9

21147 not tested not tested NR 1,5 R R R 2,8

21164 NR 1 R 9

21189 NR 1,5 R 3,9

21229 not tested not tested not tested NR 1 R R R R 3,4

21238 NR NR 1 R R 9

21267 not tested not tested NR 1 R R R 3,5

21292 not tested not tested NR 1,5 R R R 2

21338 NR 1 R 3,9


21375 not tested not tested not tested NR 1 R R R R 2,5

21398 NR 1 R 3,9

21401 not tested NR 1 R R 3,9







Part



21439 not tested NR NR 1 R R R 3

21452 NR 1 R 3,9

21489 NR 1 R 9


21550 NR 1 R 3,9

21624 NR NR 1 R R 2,3

21763 NR 1 R 9


29069 NR NR 1 R R 2,9

29083 NR 1,5 R 3,9

31008 NR NR 1 R R 3,9

31010 NR 1 R 9

31013 NR 1,5 R 3,9

31043 NR not tested 1 R R 2,9

31089 NR R

31126 NR NR NR not tested 10 R R R R 2

31171 NR NR 1 R R 9

31221 NR NR NR NR 1 R R R R 2

31234 not tested not tested NR 1 R R R 3


31293 NR 1 R 9

31342 NR 1 R 9


31378 NR NR NR 1 R R R 3,9


39009 not tested NR NR R R R

39038 NR 1 R 3,8,9

40075 NR NR 1 R R 2,9

41002 NR 1,5 R 3,9






Part







41179 NR NR NR 1 R R R 3,5


41432 NR R

49006 NR NR NR 1 R R R 3,8

51044 NR NR NR 1 R R R 2

51063 not tested not tested not tested NR 1 NR R R R 4,5

51077 not tested not tested NR 1,5 insuff R R 3

51434 NR 1 R 9

51436 NR 1 R 2,9

51632 NR R

59000 NR R

59006 not tested not tested not tested NR 1 R R R R 3

61247 R not tested NR 1 not tested R R 3,5


61360 NR NR 1,8 R R 9

61455 NR 1 R 3,9

61457 NR R

61501 NR 1 R 9

68646 NR R

71131 NR 1 R 3,9

71246 NR NR 1 R R 4,9

71358 NR 1,5 R 9


80003 NR R

80030 NR not tested not tested 1 R R NR 3,4






Part



80756 NR NR R R

80800 NR NR 1 R R 3


80940 NR NR 1 R R 3,5

81030 NR R

81325 NR NR NR 1,5 R R R 2

83618 NR NR NR 1 R R R 3

83667 NR NR 1 R R 3

83850 NR NR

83909 NR NR 1 R R 2

89000 NR R

89002 NR NR 1 R R 2

89012 NR NR 1 R R 3,9

89019 NR R

89027 NR R

89035 NR R

89036 NR NR 1 R R 3

89054 NR NR 1 R R 3,4

89055 NR NR 1 R R 2

89056 NR NR NR 1 R R R 3,5

89058 NR NR NR 1 R R R 2

89061 NR NR NR NR 1 R R R NR 4

89063 NR NR 1 R R 2,4

89065 R NR 5,6,8 R R 3

89066 NR NR 1 R R 2

89068 NR 1 R 2

89071 NR NR R R

89072 NR NR NR NR R R R R

89096 NR NR 1 R R 2






Part



89104 NR NR 1 R R 3

89114 NR NR 1 R R 3,9

89117 NR R

89123 NR R

89130 NR R


89139 NR NR NR 1 R R R 2

89144 NR R

89145 NR NR NR R R R

89146 NR NR R R

89147 NR NR R R

89148 NR NR NR 1 R R NR 4

89151 NR NR NR 1,5 R R R 4,8

89152 NR NR NR NR NR NR 1 R R R R R R 2

89153 NR NR R R


89174 NR NR 1 R R 2

89201 NR NR 1 R R 2

89212 NR R

89259 NR R

89262 NR R

89279 NR R

89300 NR NR 1 NR R 3

89301 NR NR R R

89303 NR NR R R

89304 NR R

89306 NR 1 R 3

89318 NR NR NR NR 1 R R R R 3,4

89321 NR NR 1 R R 2






Part



89328 NR NR R R

89329 NR NR 1 R R 3

89334

NR R

89340 NR NR NR NR R R R R

89343 NR NR NR 1 R R R 2

89348

NR R

89350

NR R

91089 NR NR NR 1 R R R 3,8

91119 NR NR NR 1,5 R R R 2



91458

NR 1 R 9

91461

NR 1,5 R 2

91462

NR 1 R 3,5,9

91465 NR NR 1,5 R R 4

91469 NR NR 1 R R 3

91482 NR NR 1 R R 3,9


91493 NR NR NR 1 R R R 3

92007

NR R

92009

NR 1 R 3

92010

NR 1,5 R 2,9






Syphilis RPR Results for Survey AN3:2014:3C & 3D

Part Manufacturer Kit Name Lot No. Expiry Date

Value 3C

Result 3C

Value 3D

Result 3D

21238 Alere Wampole Impact RPR 3322226 Nov-15 N/A NR N/A R

31369 Alere Wampole Impact RPR 1979 Jan-15 <1 NR 4 R

1000 Arlington Scientific RPR Card Test 4B21R6 Dec-15 0 NR 2 R

1148 Axis-Shield SyphScreen RPR 802896587 Jan-15 N/A NR 4 R

31433 Axis-Shield SyphScreen RPR 802895383 Jan-15

not tested 2 R


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

91089 Axis-Shield SyphScreen RPR 802896587 Jan-15 NR 1 R

91180 Axis-Shield SyphScreen RPR 802894896 Nov-14

not tested 2 R

91267 Axis-Shield SyphScreen RPR 802894896 Nov-14

not tested 2 R



not tested 2 R



not tested 1 R

1117 Becton Dickinson Macro-Vue RPR Card 3232388 Aug-15 0 NR 2 R

20008 Becton Dickinson Macro-Vue RPR Card 3322226 Nov-15 N/A NR >=64 R

21147 Becton Dickinson Macro-Vue RPR Card 3336185 Sep-14

not tested 8 R

21267 Becton Dickinson Macro-Vue RPR Card 3154133 Jun-15

not tested 4 R

21347 Becton Dickinson Macro-Vue RPR Card 3336185 Dec-15

not tested 2.0 R

21375 Becton Dickinson Macro-Vue RPR Card 4008407 Jan-16

not tested 2 R


not tested 2 R

21412 Becton Dickinson Macro-Vue RPR Card 3130062 May-15

not tested 1 R


not tested 2 R

21500 Becton Dickinson Macro-Vue RPR Card 3232388 Aug-15

not tested 2 R


not tested 2 R

31043 Becton Dickinson Macro-Vue RPR Card 3322226 Nov-15 N/A NR 8 R







Value 3C

Result 3C

Value 3D

Result 3D

31126 Becton Dickinson Macro-Vue RPR Card 403407 Feb-16 N/A NR 2 R

31171 Becton Dickinson Macro-Vue RPR Card 4008407 Jan-16 N/A NR N/A R

31234 Becton Dickinson Macro-Vue RPR Card 3130062 May-15

not tested 2 R


not tested 2 R


39009 Becton Dickinson Macro-Vue RPR Card 3084389 Apr-15

not tested 2 R

40075 Becton Dickinson Macro-Vue RPR Card 4034047 Feb-16 N/A NR N/A R

41018 Becton Dickinson Macro-Vue RPR Card 3154133 Jun-15

not tested 8 R


not tested 2 R

41125 Becton Dickinson Macro-Vue RPR Card 3322226 Nov-15

not tested 2 R


not tested 4 R


not tested 4 R

51044 Becton Dickinson Macro-Vue RPR Card 3154133 Jun-15 N/A NR 2 R


not tested

insuff

61247 Becton Dickinson Macro-Vue RPR Card 4008407 Jan-16 2 R

not tested

71246 Becton Dickinson Macro-Vue RPR Card 3130062 May-15 N/A NR 4 R

71683 Becton Dickinson Macro-Vue RPR Card 4034047 Feb-16

not tested 2 R

80003 Becton Dickinson Macro-Vue RPR Card 2017268 Jan-14 0 NR 4 R

83618 Becton Dickinson Macro-Vue RPR Card 2275482 Oct-14 N/A NR 2 R

89012 Becton Dickinson Macro-Vue RPR Card 4008407 Jan-16 N/A NR 4 R

89054 Becton Dickinson Macro-Vue RPR Card 2339123 Dec-14 0 NR 2 R

89055 Becton Dickinson Macro-Vue RPR Card 3336185 Dec-15 N/A NR 4 R

89056 Becton Dickinson Macro-Vue RPR Card 4034047 Feb-16 N/A NR <=2 R

89063 Becton Dickinson Macro-Vue RPR Card 3232388 Aug-15 N/A NR N/A R

89071 Becton Dickinson Macro-Vue RPR Card 3130062 May-15 N/A NR 4 R


89138 Becton Dickinson Macro-Vue RPR Card 2214041 Aug-14 0 NR 4 R

89139 Becton Dickinson Macro-Vue RPR Card 3031428 Feb-15 0 NR 4 R

89144 Becton Dickinson Macro-Vue RPR Card 4008407 Jan-16 N/A NR N/A R







Value 3C

Result 3C

Value 3D

Result 3D

89259 Becton Dickinson Macro-Vue RPR Card 2339123 Dec-14 0 NR 4 R



89329 Becton Dickinson Macro-Vue RPR Card 3336185 Dec-15 N/A NR 2 R

89340 Becton Dickinson Macro-Vue RPR Card 3232388 Aug-15 N/A NR 1 R

29069 Biokit RPR reditest B23466 Jan-15 0 NR 2 R

31008 Biokit RPR reditest B23466 Jan-15 N/A NR 2 R

31221 Biokit RPR reditest B23466 Jan-15 N/A NR 2 R

41179 Biokit RPR reditest B22946 Jan-15 <1 NR 2 R

49006 Biokit RPR reditest B23467 Jul-15 0 NR 2 R

89304 Biokit RPR reditest B22946 Jan-15 0 NR 2 R

89300 Cortez Diagnostics Syphilis InstaTest 48589 Nov-14 N/A NR 2 NR

80940 Human Syphilis RPR 12010 Jun-14 N/A NR 4 R

89058 Human Syphilis RPR 14003 Jul-15 N/A NR N/A R

89279 Human Syphilis RPR 13004 Jul-14 N/A NR 4 R

89303 Human Syphilis RPR 13007 Oct-15 N/A NR N/A R

91119 Immunostics Immuno/syphilis RPR 0214183 Jul-15 0 NR 4 R

91469 Immunostics Immuno/syphilis RPR 0613034 Dec-14 N/A NR 4 R

91482 Immunostics Immuno/syphilis RPR 0214183 Jul-15 N/A NR N/A R

51063 Lab21 Healthcare Ltd. Lab 21 RPR500 102632 Jan-15

not tested N/A NR

61253 Lab21 Healthcare Ltd Lab21 103631 Oct-15

not tested 1 R

89146 LAB 21 HEALTHCARE LAB 21 RPR ANTIGEN 100442 Sep-14 N/A NR N/A R

89152 Linear Chemicals Cromatest RPR-Carbon 25251X Jun-16 <2 NR 2 R







Value 3C

Result 3C

Value 3D

Result 3D

21292 Newmarket Laboratories RPR 125741 Jul-15

not tested 2 R

59006 Newmarket Laboratories RPR 101140 Jun-14

not tested 1 R

61360 Newmarket Laboratories RPR 102632 Jan-15 N/A NR 1 R

89061 Newmarket Laboratories RPR 100468 Jul-14 N/A NR 2 R

89147 Newmarket Laboratories RPR 103951 Mar-16 N/A NR 4 R

89173 Newmarket Laboratories RPR 103961 Mar-16 0 NR 2 R

89201 Newmarket Laboratories RPR 103951 Mar-16 N/A NR 2 R

1058 Omega Diagnostics Immutrep RPR 7041715 Feb-16 0 NR 4 R

1099 Omega Diagnostics Immutrep RPR 7042780 May-16 1 NR 4 R

80800 Omega Diagnostics Immutrep RPR 7042646 May-16 0 NR 8 R

81030 Omega Diagnostics Immutrep RPR 7042380 Mar-16 N/A NR N/A R

83667 Omega Diagnostics Immutrep RPR 303033 Oct-15 <1 NR 2 R

83909 Omega Diagnostics Immutrep RPR 7041808 Feb-16 N/A NR N/A R

89002 Omega Diagnostics Immutrep RPR 7043925 Jun-16 0 NR 4 R

89027 Omega Diagnostics Immutrep RPR 7042527 Apr-16 1 NR 8 R

89036 Omega Diagnostics Immutrep RPR 7043427 Jun-16 0 NR 16 R

89065 Omega Diagnostics Immutrep RPR 7042717 May-16 N/A R N/A R

89066 Omega Diagnostics Immutrep RPR 7043028 Jun-16 N/A NR 4 R

89072 Omega Diagnostics Immutrep RPR 7038190 Mar-15 N/A NR 2 R

89104 Omega Diagnostics Immutrep RPR 7041808 Feb-16 N/A NR 4 R

89145 Omega Diagnostics Immutrep RPR 7038575 Apr-15 N/A NR 4 R

89343 Omega Diagnostics Immutrep RPR 7040653 Oct-15 N/A NR 2 R

1121 Plasmatec RPR Test Kit 294053 Oct-15 N/A NR 0.5 R

80030 Plasmatec RPR Test Kit 279053 Sep-15 N/A NR 2 R

1086 Plasmatec VDRL Carbon Antigen Test Kit 001024 Oct-15 1 NR 2 R

1094 Plasmatec VDRL Carbon Antigen Test Kit 303033 Oct-15 N/A NR N/A R







Value 3C

Result 3C

Value 3D

Result 3D

80756 Plasmatec VDRL Carbon Antigen Test Kit 274053 Sep-15 0 NR 2 R

89068 Plasmatec VDRL Carbon Antigen Test Kit 001024 Oct-15 0 NR 2 R

89174 Plasmatec VDRL Carbon Antigen Test Kit 114064 Sep-15 N/A NR 1 R

89301 Plasmatec VDRL Carbon Antigen Test Kit 103951 Mar-16 0 NR 8 R

89328 Plasmatec VDRL Carbon Antigen Test Kit 001024 Oct-15 N/A NR 4 R

80930 Rapid Labs RPR Kit 674302 Aug-14

not tested 2 R

83850 Spinreact RPR-carbon 112094 Apr-15 N/A NR N/A NR

Syphilis VDRL Results for Survey AN3:2014:3C & 3D


Value 3C

Result 3C

Value 3D

Result 3D

21229 Becton Dickinson Difco VDRL Antigen Test 4002040 Dec-15

not tested 2 R

89151 Becton Dickinson VDRL Antigen 3255327 Sep-15 N/A NR 2 R

81325 Becton, Dickinson and Company BD VDRL Antigen 3255327 Sep-15 <1 NR 1 R

89343 Omega Diagnostics Immutrep VDRL 3018162 Feb-16 N/A NR 8 R

89072 Omega Diagnostics Immutrep VDRL 7041368 Nov-17 N/A NR N/A R

89340 Omega Diagnostics Immutrep VDRL 7042416 May-18 N/A NR N/A R

89072 Sample was insufficient to perform titre on reactive sample for 3D





Syphilis Agglutination Results for Survey AN3:2014:3C & 3D


Value 3C

Result 3C

Value 3D

Result 3D

89065 ALERE DETERMINE SYPHILIS TP 56691K100 Mar-15 N/A NR N/A R

89321 Axis-Shield MicroSyph TPHA 802896627 Nov-14 N/A NR N/A R

91469 Axis-Shield MicroSyph TPHA 80296627 Nov-14 N/A NR 1280 R

31010 Beckman Coulter Olympus PK TP System UR00055 Oct-14 N/A NR N/A R

41002 Beckman Coulter Olympus PK TP System UR00055 Oct-14 N/A NR N/A R

61501 Beckman Coulter Olympus PK TP System UR00054 Sep-14 N/A NR N/A R

21292 Biokit Syphagen TPHA B22631 Sep-14

not tested 1 R

89152 Biokit Syphagen TPHA B23316 Apr-15 <80 NR >80 R

89173 Biokit Syphagen TPHA B23316 Apr-15 <80 NR 320 R

80930 BioRad TPHA 200 102981 Apr-15

not tested N/A R

80940 Bio-Rad Bio-Rad TPHA 200 103084 Apr-15 N/A NR 320 R

1058 Fujirebio Serodia TPPA WN31111 Oct-14 0 NR 640 R

1086 Fujirebio Serodia TPPA WN40211 Feb-15 <80 NR 1280 R

1099 Fujirebio Serodia TPPA VN40111 Jan-15 N/A NR N/A R

1117 Fujirebio Serodia TPPA VH40111 May-15 N/A NR N/A R

1135 Fujirebio Serodia TPPA VN30816 Aug-14 0 NR 160 R

1148 Fujirebio Serodia TPPA VN40111 Jan-15 N/A NR 640 R

20008 Fujirebio Serodia TPPA VN40111 Jan-15 N/A NR >=640 R

20009 Fujirebio Serodia TPPA XN30802 Jul-14 2560 R <80 NR

21147 Fujirebio Serodia TPPA WN31111 Oct-14

not tested N/A R

21229 Fujirebio Serodia TPPA XN30802 Jul-14

not tested N/A R


not tested 640 R

21347 Fujirebio Serodia TPPA VN40111 Jan-15

not tested >80 R







Value 3C

Result 3C

Value 3D

Result 3D


not tested >320 R

21439 Fujirebio Serodia TPPA WN30808 Aug-14 <80 NR 640 R


not tested N/A R


not tested N/A R

29069 Fujirebio Serodia TPPA VN40111 Jan-15 0 NR 640 R

31043 Fujirebio Serodia TPPA VN30846 Aug-14

not tested >80 R


31171 Fujirebio Serodia TPPA XN30802 Jul-14 N/A NR N/A R

31221 Fujirebio Serodia TPPA VN40111 Jan-15 <80 NR >1280 R

31234 Fujirebio Serodia TPPA VN40514 Apr-15

not tested >640 R


not tested 640 R

31369 Fujirebio Serodia TPPA VN30816 Aug-14 <80 NR >80 R



40075 Fujirebio Serodia TPPA WN31111 Oct-14 N/A NR N/A R


not tested N/A R


not tested N/A R

41125 Fujirebio Serodia TPPA WN40211 Feb-15

not tested N/A R


not tested N/A R

41179 Fujirebio Serodia TPPA VN40111 Jan-15 <80 NR 80 R


not tested N/A R

49006 Fujirebio Serodia TPPA WN31111 Oct-14 <80 NR 640 R



not tested 80 R


not tested >80 R


not tested N/A R


not tested 1280 R








Value 3C

Result 3C

Value 3D

Result 3D


not tested 2560 R

80756 Fujirebio Serodia TPPA WN31111 Oct-14 0 NR 640 R

81325 Fujirebio Serodia TPPA VN40111 Jan-15 <80 NR >=80 R


83667 Fujirebio Serodia TPPA WN40211 Feb-15 <80 NR 1280 R

83909 Fujirebio Serodia TPPA VN 30808 Aug-14 N/A NR N/A R

89012 Fujirebio Serodia TPPA WN40211 Feb-15 N/A NR N/A R

89036 Fujirebio Serodia TPPA WN40211 Feb-15 N/A NR N/A R

89054 Fujirebio Serodia TPPA VN40514 Apr-15 N/A NR N/A R

89055 Fujirebio Serodia TPPA VN 30816 Aug-14 N/A NR N/A R

89058 Fujirebio Serodia TPPA VN30816 Aug-15 N/A NR N/A R


89066 Fujirebio Serodia TPPA VN 40111 Jan-15 N/A NR 80 R


89104 Fujirebio Serodia TPPA VN30816 Aug-14 N/A NR N/A R

89138 Fujirebio Serodia TPPA VN40111 May-15 0 NR 640 R


89145 Fujirebio Serodia TPPA VN40514 Apr-15 N/A NR 20480 R



89303 Fujirebio Serodia TPPA VN40514 Apr-15 N/A NR N/A R

89318 Fujirebio Serodia TPPA YN40111 Dec-14 N/A NR N/A R


91089 Fujirebio Serodia TPPA WN40211 Feb-15 NR 640 R

91119 Fujirebio Serodia TPPA WN40211 Feb-15 <40 NR >1280 R

91180 Fujirebio Serodia TPPA WN30808 Aug-14

not tested >320 R

91267 Fujirebio Serodia TPPA WN30808 Aug-14

not tested 2560 R

91465 Fujirebio Serodia TPPA WN31111 Oct-14 <80 NR 1280 R







Value 3C

Result 3C

Value 3D

Result 3D

91487 Fujirebio Serodia TPPA WN40211 Feb-15

not tested N/A R

91493 Fujirebio Serodia TPPA WN40211 Feb-15 N/A NR 160 R


not tested N/A R

59006 Newmarket Laboratories TPHA 101557 Jul-14

not tested 80 R

89061 Newmarket Laboratories TPHA 100780 Dec-14 N/A NR 80 R

1000 Omega Diagnostics Immutrep TPHA 7044023 Dec-15 0 NR 320 R

89002 Omega Diagnostics Immutrep TPHA 103900 Jun-15 N/A NR N/A R

89056 Omega Diagnostics Immutrep TPHA 7038430 Sep-14 N/A NR N/A R

1094 Plasmatec TPHA Test Kit 303033 Oct-15 N/A NR N/A R

89146 Plasmatec TPHA Test Kit 324033 Jan-15 N/A NR N/A R

89147 Plasmatec TPHA Test Kit 324033 Jan-15 N/A NR 1280 R



89328 Plasmatec TPHA Test Kit 324033 Jan-15 N/A NR N/A R

Syphilis ICT Results for Survey AN3:2014:3C & 3D


Result 3C

Result 3D

80800 Abon Biopharm (Hangzhou) Co., Ltd. Syphilis Ultra Rapid Test Device SYP4010002 Nov-15 NR R

1114 Alere Determine Syphilis TP 54150K100 Nov-14 NR R

41432 Alere Determine Syphilis TP 56076K100 Mar-15 NR R

89071 Alere Determine Syphilis TP 53563K100 Aug-14 NR R

89348 Alere Determine Syphilis TP 53272K100 Nov-14 NR R





Syphilis ICT Results for Survey AN3:2014:3C & 3D


Result 3C

Result 3D

89350 Alere Determine Syphilis TP 50705K100 May-06 NR R

89300 Standard Diagnostics SD Bioline Syphilis 3.0 25107 Aug-14 NR R

Syphilis FTA Results for Survey AN3:2014:3C & 3D

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

Expiry Date Manufacturer-Conjugate Lot No

Expiry Date

Result 3C

Result 3D

21375 bioMerieux 1002692300 Oct-14 bioMerieux 1306108353 May-15 bioMerieux 1002143210 Dec-14 not tested R

51063 bioMerieux 1002454090 Jul-14 bioMerieux 1308108981 Aug-15 bioMerieux 1002227770 Feb-15 not tested R

59006 bioMerieux 100183270 Dec-14 bioMerieux 1301107492 Dec-14 bioMerieux 1001677080 Jul-14 not tested R

89061 bioMerieux 1001831270 Dec-14 bioMerieux 1001831270 Dec-14 BioRad 2D0065 Dec-14 NR R

89173 bioMerieux 1002981230 Mar-15 bioMerieux 1311109417 Dec-15 BioRad 3G0063 Jul-15 NR R

89056 Diagnostic and Technical Services TP30931 Aug-14 Diagnostic and Technical Services 131119 Dec-14 Diagnostic and Technical Services 332700 Oct-14 NR R

89072 Diagnostic and Technical Services TP40131 Dec-14 Diagnostic and Technical Services 131127 Feb-15 Diagnostic and Technical Services 326791 Oct-14 NR R

89152 Diagnostic and Technical Services TP31131 Oct-14 Diagnostic and Technical Services 131127 Feb-15 Diagnostic and Technical Services 327216 Oct-14 NR R

89318 Diagnostic and Technical Services TP31031 Sep-14 Diagnostic and Technical Services 131127 Feb-15 Diagnostic and Technical Services 326791 Oct-14 NR R

89138 Euroimmun F130612DH Dec-14 Euroimmun F130612DH Dec-14 Euroimmun F130612DH Dec-14 NR R

31221 MarDx 2015 May-15 MarDx L-572 Sep-15 MarDx L-429 Apr-15 NR R

21229 Zeus Scientific 13090052 Mar-15 Zeus Scientific 13090052 Mar-15 Zeus Scientific 13090052 Mar-15 not tested R

31369 Zeus Scientific 13090052 Mar-15 Zeus Scientific 13090052 Mar-15 Zeus Scientific 13090052 Mar-15 NR R

89340 Zeus Scientific 14030052 Nov-15 Zeus Scientific JM965 Oct-16 bioMerieux 1002227770 Feb-15 NR R





Syphilis Total Antibody EIA Screening Assay Results for Survey AN3:2014:3C & 3D

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

Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

1113 Abbott Diagnostics Syphilis TP CMIA Architect 37683LI00 Jan-15 S/CO 1.00 0.14 NR 18.97 R


21147 Abbott Diagnostics Syphilis TP CMIA Architect 37682LI00 Jan-15 S/CO 1 0.14 NR 21.63 R


21229 Abbott Diagnostics Syphilis TP CMIA Architect 37684L100 Jan-15 S/CO 1.0 0.18 NR 22.31 R













21763 Abbott Diagnostics Syphilis TP CMIA Architect 37684LI00 Jan-15 S/CO 1 0.17 NR 22 R



31089 Abbott Diagnostics Syphilis TP CMIA Architect 38817LI00 Aug-15 S/CO 1.0 0.15 NR 26.68 R








41125 Abbott Diagnostics Syphilis TP CMIA Architect 35694LI00 Nov-14 S/CO 1.00 0.13 NR 24.13 R







Cut Off

Value 3C

Result 3C

Value 3D

Result 3D










83618 Abbott Diagnostics Syphilis TP CMIA Architect 3768IL00 Jul-15 S/CO 1.0 0.15 NR 21.27 R


89019 Abbott Diagnostics Syphilis TP CMIA Architect 33451LI00 Jun-14 S/CO 1.0 0.11 NR 23.52 R

89035 Abbott Diagnostics Syphilis TP CMIA Architect 34814L100 Oct-14 S/CO 1.0 0.12 NR 20.3 R

89072 Abbott Diagnostics Syphilis TP CMIA Architect 38817L100 Aug-15 S/CO 1.00 1.15 NR 27.9 R

89117 Abbott Diagnostics Syphilis TP CMIA Architect 34814LI00 Oct-14 S/CO 1 0.12 NR 23.49 R

89123 Abbott Diagnostics Syphilis TP CMIA Architect 34927LI00 Oct-14 S/CO 1 0.14 NR 23.97 R

89138 Abbott Diagnostics Syphilis TP CMIA Architect 33193LI00 Sep-14 S/CO 1.00 0.17 NR 21.13 R




89212 Abbott Diagnostics Syphilis TP CMIA Architect 37683LIOO Jan-15 S/CO 1 0.16 NR 22.8 R


89306 Abbott Diagnostics Syphilis TP CMIA Architect 37682LI00 Feb-13 S/CO 1.0 0.19 NR 19.12 R













Cut Off

Value 3C

Result 3C

Value 3D

Result 3D







92007 Abbott Diagnostics Syphilis TP CMIA Architect 38817 Jan-15 S/CO 1.0 0.2 NR 25.74 R



91487 Biokit bioelisa Syphilis 3.0 ELISA Triturus B23392 Dec-14 S/CO 1.0 0.03 NR 5.04 R

31126 bioMerieux Trepanostika TP recombinant EIA Triturus D34LA Oct-14 OD 0.423 0.069 NR 3.746 R

59006 BioRad Syphilis Total Antibody II EIA - 102642 May-15 S/CO 1.0 0.11 NR 12.24 R

80930 BioRad Syphilis Total Antibody II EIA - 101229 Sep-14 S/CO N/A 0.06 NR 3.03 R

21267 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 091049 Jul-14 Index 1.10 <0.10 NR >70 R

31234 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91051 Jan-15 Index 1.0 <0.100 NR >70.0 R

39038 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 91052 Oct-14 Index 1.0 <0.100 NR >70.0 R


59000 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 091052 Oct-14 Index 1.1 <0.10 NR 66.8 R

89114 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 091052 Oct-14 Index 1 <0.1 NR >70 R

89130 DiaSorin Liaison Treponema Screen ChLIA Liaison/Liaison XL 091052 Oct-14 S/CO 1.1 0.1 NR 70 R


39009 DiaSorin Murex ICE Syphilis (IgG, IgM) EIA - D212610 Oct-14 OD 0.306 0.131 NR 4.000 R

21624 Lab21 Diagnostic Syphilis Total Antibody EIA - 102510 Mar-15 S/CO 1 0.1 NR 15 R







Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

29083 Ortho-Clinical Diagnostics Syphilis TPA ECi Vitros 310 Aug-14 S/CO 1.20 0.02 NR 314 R

89148 Phoenix Bio-Tech Trep-Sure Anti-Treponema EIA Screen EIA DSX System 115 Nov-14 Index 1.2 0.08 NR 18.11 R

91482 ROCHE Syphilis ECLIA Cobas e601 00175936 Oct-14 S/CO 1.0 0.100 NR 117.3 R

21000 Sekisui Medical Mediace TPLA ITA Cobas c501/c502 681932 May-15 TU 10.0 1.0 NR >200 R

31013 Sekisui Medical Mediace TPLA ITA Cobas c501/c502 681926 Apr-15 TU 10 <7 NR >150 R

71131 Sekisui Medical Mediace TPLA ITA Cobas c501/c502 681824 Jan-15 TU 10.0 0 NR >250 R

71358 Sekisui Medical Mediace TPLA ITA Modular Analytics 681932 May-15 TU 10.0 2.6 NR 214.6 R

89058 Sekisui Medical Mediace TPLA ITA Modular e601 681926-00 Apr-15 S/CO 10.00 0.4 NR 277 R

1000 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 34904017 Jan-14 Index 1 0.1 NR 45 R

1123 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 016 Sep-14 Index 0.9 0.10 NR >45 R

21164 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 017 Jan-15 Index 1.1 0.10 NR >45.0 R

21292 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 017 Jan-15 Index 1.1 <0.10 NR >45.0 R



41183 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 34904017 Jan-15 Index 1.1 0.10 NR 45.00 R

51063 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 016 Sep-14 Index 1.1 0.1 NR 45.00 R

51077 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 017 Jan-15 Index 1.1 0.11 NR >45 R

51436 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 26782015 Jul-14 Index 1.1 0.13 NR 45 R

51632 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 34904017 Jan-15 Index 1.1 0.13 NR >45 R

61247 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 34361017 Jan-15 Index 1.1 0.1 NR 45.00 R

61457 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 017 Jan-15 Index 0.9 0.1 NR 45 R


92014 Siemens Healthcare Diagnostics Advia Centaur Syphilis ChLEIA Advia Centaur XP 017 Jan-15 Index 1.0 0.10 NR >45.00 R

68646 Siemens Healthcare Diagnostics Syphilis Screen ChLEIA Immulite 2000 254 Jan-15 Index 1.0 0.1 NR 41.0 R







Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

21398 Sample 3D was retested in duplicate and the values were 24.02(reactive) and 23.35(reactive). This would be sent to another laboratory for confirmation.

39009 The Syphilis total antibody testing strategy for unscreened specimens is to retest reactive specimens in duplicate on the DiaSorin Murex ICE* Syphilis EIA. The repeat OD results for specimen 3D were 4.000 and 4.000, cut off = 0.304. Both results reactive. The kit batch used was D212610, expiry 31/10/2014

Syphilis IgG EIA Results for Survey AN3:2014:3C & 3D

Part Manufacturer Kit Name

Method Automation Lot No. Expiry Date Units

Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

89152 Euroimmun Anti-Treponema pallidum IgG ELISA - E140218BR Feb-15 S/CO 1.1 0.139 NR 4.058 R

89148 Trinity Biotech Captia Syphilis-G EIA - 097 Aug-15 Index 1.10 0.12 NR 2.15 R

80030 Vircell Vircell Microbiologist ELISA Manual 13ESYPG101 Dec-14 OD 0.55

not tested 54.38 R

Syphilis IgM EIA Results for Survey AN3:2014:3C & 3D

Part Manufacturer Kit Name

Method Automation Lot No. Expiry Date Units

Cut Off

Value 3C

Result 3C

Value 3D

Result 3D

89173 BioRad Syphilis IgM Multiplex BioPlex 2200 122141 Jun-15 Index 0.8 <0.2 NR 2.2 R

89152 Euroimmun Anti-Treponema pallidum IgM ELISA - E131025AE Oct-14 S/CO 1.10 0.268 NR 4.186 R

21624 IBL Treponema pallidum IgM ELISA - 129M/K083 Aug-14 S/CO 10 3 NR 18 R

31126 Lab21 Diagnostic Syphilis IgM EIA - 103543 Mar-15 OD 0.12

not tested 0.46 R

89061 Trinity Biotech Captia Syphilis-M EIA - 23 Dec-14 Index 1.1 <0.9 NR <0.9 NR

89148 Trinity Biotech Captia Syphilis-M EIA - 033 Nov-14 Index 1.10 0.27 NR 0.58 NR





Syphilis Immunoblot Results for Survey AN3:2014:3C & 3D

Syphilis Immunoblot Confirmation IgG Euroimmun 3C

Result 3C

Euroimmun 3D

Result 3D Part Manufacturer Kit Name Method Lot No.

Expiry Date p15 p17 p22 p45 p47 p15 p17 p22 p45 p47

1000 Euroimmun Euroline Anti-Treponema pallidum IgG WB D131217AB Jun-15

not tested 1+ 3+ - 2+ - R

89152 Euroimmun Euroline Anti-Treponema pallidum IgG WB D140219AA Aug-15 - - - - - NR 1+ 1+ - 1+ +/- R

Syphilis Immunoblot Confirmation IgG Trinity Biotech 3C

Result 3C

Trinity Biotech 3D


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

89061 Trinity Biotech T.pallidum IgG MARBLOT WB 8050J Dec-14 NR 2+ 2+ 2+ R

Syphilis Immunoblot Confirmation IgG LIA 3C

Result 3C

LIA 3D


Expiry Date TpN47 TpN17 TpN15 TmpA TpN47 TpN17 TpN15 TmpA

1027 Innogenetics INNO-LIA Syphilis Score LIA 235547 Sep-14 - - - - NR 2+ 2+ 2+ 2+ R

21267 Innogenetics INNO-LIA Syphilis Score LIA 236322 Oct-14

not tested 2+ 3+ 2+ 1+ R

89058 Innogenetics INNO-LIA Syphilis Score LIA 236322 Oct-14

not tested 2+ 3+ 2+ 2+ R

89306 Innogenetics INNO-LIA Syphilis Score LIA 239370 Feb-15 - - - - NR 1+ 3+ 2+ 1+ R

89343 Innogenetics INNO-LIA Syphilis Score LIA 239370 Feb-15 - - - - NR 2+ 3+ 2+ 2+ R





Syphilis Immunoblot Results for Survey AN3:2014:3C & 3D

Syphilis Immunoblot Confirmation IgM Euroimmun 3C

Result 3C

Euroimmun 3D


Expiry Date p15 p17 p22 p45 p47 p15 p17 p22 p45 p47

89152 Euroimmum Euroline Anti-Treponema pallidum IgM WB D130214AE Aug-14 - - - - - neg - - - 1+ 1+ pos

Syphilis Immunoblot Confirmation IgM Other Manufacturer 3C Value

Result 3C

Other Manufacturer 3D Value

Result 3D Part Manufacturer Kit Name Method Lot No. Expiry Date

80030 Trinity Biotech Marblot T. pallidum Western blot 8716K Oct-14 N/A not tested N/A NR

89061 Trinity Biotech T.pallidum IgG MARBLOT WB 8050J Dec-14

NR

R

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