Survey V3:2013: 3A & 3B Final Generic Report Viral...

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reservedFile V3‐2013‐fla Report Issued Wednesday, 18 September 2013Page of 28

RCPA Quality Phone +61 2 9045 6000

NATA Accredited Proficiency Testing Scheme ProviderNumber: 14863 Accredited for compliance with ISO/IEC 17043:2010

Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au

Survey V3:2013: 3A & 3B Final Generic Report Viral Program

Flavivirus Serology Report prepared and collated by: RCPAQAP SerologyComments provided by: Carmel Taylor

on behalf of RCPAQAP Serology

Public Health Virology, Queensland Health Forensic and Scientific Services, QLD, 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 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.

Clinical Notes

The “Clinical Notes” were created so as to highlight particular issues relating to interpretation of serological results. They do not necessarily reflect the clinical history of the patient from whom the sample was obtained.

3A Lydia is a 45 year old woman who has recently travelled to India with her partner. Both she and her partner have an illness with similar symptoms including headaches, arthralgia and rash.

3B Dan is a 24 year old who has travelled recently to Indonesia. He has a mild illness with headaches and

diarrhoea.

Request

Please test both specimens for Flavivirus and test 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 V3:2013) 3A is a serum sample diluted 1:2 in another serum sample that tested positive to Flavivirus IgG and IgM

antibodies and specific to Flavivirus IgM Dengue 3. Source: Queensland Health Forensic & Scientific Services (QHF&SS), QLD and SEALS, Prince of Wales Hospital, NSW.

3B is a serum sample that tested negative to Flavivirus IgG and IgM antibodies.

[This is the same specimen as V1:2013:1B]. Source: SEALS, Prince of Wales Hospital, NSW.

Pre‐issue testing: Queensland Health Forensic & Scientific Services (QHF&SS), QLD.

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

66 participants returned results for Flavivirus. Clerical Error

There was a clerical error included in this survey for Specimen 3B. 7/66 (10.6%) of participants detected the clerical error for Specimen 3B. 59/66 (89.4%) of participants did not identify the clerical error for Specimen 3B. Specimen 3B labelled: HSV Clinical notes and Test Instructions labelled: Flavivirus Dengue Virus

Survey Results V3:2013 Dengue

Dengue IgG: SERO‐PREVALENCE – NOT DUO kit ‐ Specimen 3A pos: 15 = 100.00% Total Results =15 Consensus: pos

Dengue IgG: SERO‐PREVALENCE –NOT DUO kit ‐ Specimen 3B equ: 1 = 7.69% neg: 12 = 92.31% not tested: Excluded Total Results =13 Consensus: neg

Dengue IgG: CURRENT INFECTION – NOT DUO kit ‐ Specimen 3A neg: 13 = 100.00% Total Results =13 Consensus: neg

Dengue IgG: CURRENT INFECTION – NOT DUO kit ‐ Specimen 3B neg: 12 = 100.00% not tested: Excluded Total Results =12 Consensus: neg

Dengue Virus IgM ‐ do NOT enter DUO IgG/IgM ‐Specimen 3A pos: 35 = 100.00% Total Results =35 Consensus: pos

Dengue Virus IgM ‐ do NOT enter DUO IgG/IgM ‐ Specimen 3B equ: 1 = 3.13% neg: 30 = 93.75% not tested: Excluded pos: 1 = 3.13% Total Results =32 Consensus: neg

Dengue Virus Total Antibody ‐ Specimen 3A pos: 3 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Dengue Virus Total Antibody ‐ Specimen 3B neg: 3 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Dengue Virus NS1 Antigen ‐ Specimen 3A neg: 45 = 100.00% Total Results =45 Consensus: neg

Dengue Virus NS1 Antigen ‐ Specimen 3B neg: 44 = 100.00% not tested: Excluded Total Results =44 Consensus: neg





Survey Results V3:2013 FV Dengue

Dengue Virus ICT IgG/IgM Duo‐IgG ‐ Specimen 3A equ: 4 = 10.53% N/A: Excluded neg: 20 = 52.63% not tested: Excluded pos: 14 = 36.84% Differential: N/A: 13 = 32.50% Differential: primary: 17 = 42.50% Differential: secondary: 5 = 12.50% Differential: unknown: 5 = 12.50% Total Results =38 Consensus: No

Dengue Virus ICT IgG/IgM Duo‐IgG ‐ Specimen 3B N/A: Excluded neg: 38 = 100.00% not tested: Excluded Differential: N/A: 15 = 37.50% Differential: negative: 24 = 60.00% Differential: unknown: 1 = 2.50% Total Results =38 Consensus: neg

Dengue Virus ICT IgG/IgM Duo‐IgM ‐ Specimen 3A equ: 1 = 2.50% neg: 1 = 2.50% pos: 38 = 95.00% Differential: N/A: 13 = 32.50% Differential: primary: 17 = 42.50% Differential: secondary: 5 = 12.50% Differential: unknown: 5 = 12.50% Total Results =40 Consensus: pos

Dengue Virus ICT IgG/IgM Duo‐IgM ‐ Specimen 3B equ: 1 = 2.50% neg: 39 = 97.50% Differential: N/A: 15 = 37.50% Differential: negative: 24 = 60.00% Differential: unknown: 1 = 2.50% Total Results =40 Consensus: neg

Inconsistencies in this Survey

Dengue Virus IgG Participant Comment

Specimen 3B 41302 Result inconsistent with the consensus.

Test Group 21267 Units appear inconsistent with cut‐off and result values reported.

40053 Other users of the same lot number have a different expiry date.

89061 The cut‐off is inconsistent with SQAP definition & kit insert for a value above which is positive.

89343

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

Dengue Virus IgG (Current Infection)

Participant Comment

Test Group 89058 Edit ‐ Re‐assigned kit according to lot number provided.

89100


Dengue Virus IgM Participant Comment


89343 Result inconsistent with the consensus.

Test Group 61253 Units appear inconsistent with the cut‐off value provided.





Inconsistencies in this Survey (Continued)

Dengue Virus IgM Participant Comment

Test Group 89058 Units appear inconsistent with the cut‐off value provided.

89058 Edit ‐ Re‐assigned kit according to lot number provided.

89061

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

89096

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

89100


Dengue Virus NS1 Antigen

Participant Comment

Specimens 3A & 3B 89000 Result value in incorrect format. Please see instructions on results sheet.

Test Group 21624 Cut‐off value not required as test is qualitative.

61253 Units appear inconsistent with the cut‐off value provided.

89058 Units not provided.



Dengue Virus ICT IgG/IGM Duo

Participant Comment

Test Group 1064 Kit details entered in 'Other' section. Please use drop down list.

Dengue Virus ICT IgG/IGM Duo ‐ IgM

Participant Comment

Specimen 3A 41419 Result inconsistent with the consensus.

89307 Result inconsistent with the consensus.






Dengue Virus 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

1064 In case of IgM Negative samples, we usually request for a repeat sample after 3‐4 days if clinical suspicion is high for an acute infection

41302 3B: ADD possible past infection with Dengue. A follow up sample in 7‐10 days is indicated if clinical symptoms suggest current infection





Alere PanBio Dengue kits explained

There is confusion as to the correct use of the range of Alere PanBio kits. RCPAQAP Serology would appreciate you reading the information below to ensure that you enter your results in the correct section. RCPAQAP Serology is not endorsing the use of the Alere PanBio kit (or any other kit) but is using the Alere PanBio kits as an example as they are the most prevalent and hence, appear to be causing the most confusion.

Dengue IgG Indirect ELISA Kit Results for SERO-PREVALENCE

The Alere PanBio Dengue IgG Indirect ELISA is for the qualitative detection of IgG antibodies to dengue virus serotypes (1, 2, 3 and 4) in serum as an aid in the clinical laboratory diagnosis of patients with clinical symptoms and past exposure consistent with dengue fever. It may also be used to distinguish between primary and secondary dengue virus infection. This kit is for SERO‐PREVALENCE and as a check for sero‐conversion in a non‐endemic area. This kit cross‐reacts with other flaviviruses.

Dengue IgG Capture ELISA Kit Results for CURRENT INFECTION

The Alere PanBio Dengue IgG Capture ELISA is for the qualitative detection of IgG antibodies to dengue virus (serotypes 1, 2, 3 and 4) in serum. This test is intended as an aid in the clinical laboratory diagnosis of secondary dengue virus infection, and can be used in conjunction with the Alere PanBio Dengue IgM Capture ELISA for the presumptive differentiation between primary and secondary infection. This kit is an acute marker for a CURRENT INFECTION for use in an endemic area where it is expected that the current infection is a secondary infection.

Dengue IgM Capture ELISA Kit Results for ACTIVE INFECTION

The Alere PanBio Dengue IgM Capture ELISA is for the qualitative detection of IgM antibodies to dengue antigen in serum, as an aid in the clinical laboratory diagnosis of patients with clinical symptoms (active infection) consistent with dengue fever. Detection of IgM antibodies to dengue virus by ELISA is a valuable procedure, particularly in second and subsequent infections where the occurrence of complications is high. Serum IgM antibodies can be detected from dengue patients as early as three to five days after the onset of fever and generally persist for 30 - 90 days, although detectable levels may be present eight months post-infection Dengue Duo ICT Kit Results for differentiation between PRIMARY and SECONDARY INFECTIONS

The Alere PanBio Dengue Duo Cassette is a rapid immunochromatography (ICT) test designed for the qualitative presumptive detection of IgM and IgG antibodies to dengue virus in human serum, plasma and whole blood. The assay can be used for the presumptive differentiation between primary and secondary infection.

Dengue Duo ICT Kit Results for differentiation between PRIMARY and SECONDARY INFECTIONS

The Alere PanBio Dengue Early Rapid is a dengue NS1 antigen immunochromatographic (ICT) test. It is for the qualitative detection of NS1 antigen in serum, used as an aid in the clinical laboratory diagnosis of patients with clinical symptoms consistent with dengue fever. The Alere PanBio Dengue Early Rapid should be used in conjunction with other dengue serology tests.

Dengue NS1 Antigen Test Results

The Dengue Early Rapid is a dengue NS1 antigen is for the qualitative detection of NS1 antigen in serum, used as an aid in the diagnosis of patients with clinical symptoms consistent with dengue fever.





Flavivirus

Survey Results V3:2013 Flavivirus

Flavivirus IgG ‐ Specimen 3A pos: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Flavivirus IgG ‐ Specimen 3B neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Flavivirus IgM ‐ Specimen 3A pos: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Flavivirus IgM ‐ Specimen 3B neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Flavivirus Total Antibody ‐ Specimen 3A pos: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Flavivirus Total Antibody ‐ Specimen 3B neg: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Flavivirus 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 41215 3A: comment refers to DENV‐3 specific IgM detected by Flavivirus typing ELISA.





Kunjin (West Nile) Virus

Survey Results V3:2013 Kunjin

Kunjin (West Nile) Virus IgM ‐ Specimen 3A equ: 1 = 33.33% pos: 2 = 66.67% Total Results =3 Consensus: No

Kunjin (West Nile) Virus IgM ‐ Specimen 3B neg: 2 = 100.00% not tested: Excluded Total Results =2 Consensus: Insufficient data (less than 5 results)

Kunjin (West Nile) Virus Total Antibody ‐ Specimen 3A neg: 1 = 33.33% pos: 2 = 66.67% Total Results =3 Consensus: No

Kunjin (West Nile) Virus Total Antibody ‐ Specimen 3B neg: 3 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Kunjin (West Nile) Interpretative Comments






Murray Valley Encephalitis Virus

Survey Results V3:2013 Murray Valley

Murray Valley Encephalitis Virus IgM ‐ Specimen 3A neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Murray Valley Encephalitis Virus IgM ‐ Specimen 3B neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Murray Valley Encephalitis Virus Total Antibody ‐Specimen 3A neg: 1 = 50.00% pos: 1 = 50.00% Total Results =2 Consensus: No

Murray Valley Encephalitis Virus Total Antibody ‐Specimen 3B neg: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Murray Valley Encephalitis Interpretative Comments






Yellow Fever

Survey Results V3:2013 Yellow Fever

Yellow Fever IgG ‐ Specimen 3A neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Yellow Fever IgG ‐ Specimen 3B neg: 1 = 100.00% Total Results =1 Consensus: Insufficient data (less than 5 results)

Yellow Fever IgM ‐ Specimen 3A neg: 3 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Yellow Fever IgM ‐ Specimen 3B neg: 3 = 100.00% Total Results =3 Consensus: Insufficient data (less than 5 results)

Yellow Fever Total Antibody ‐ Specimen 3A pos: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Yellow Fever Total Antibody ‐ Specimen 3B neg: 1 = 50.00% pos: 1 = 50.00% Total Results =2 Consensus: No

Yellow Fever Interpretative Comments






Comparison of Duplicate Specimens 1B and 3B

Most participants returned concordant results for Specimens 1B and 3B. Those with discrepant results are tabulated below.

Dengue Virus IgG

Part 1B 3B

41302 neg equ

Dengue Virus IgM

Part 1B 3B

49003 neg equ

89343 neg pos

Dengue Virus ICT IgG/IgM Duo

Part 1B 3B

IgG IgM Differential IgG IgM Differential

89121 neg neg N/A neg equ N/A

89277 neg equ unknown neg neg negative

Comments provided by: Carmel Taylor, Public Health Virology, Queensland Health Forensic and Scientific Services, QLD, Australia on behalf of RCPAQAP Serology

Clinical Background

The flavivirus component of this survey comprised two (2) specimens, one from a 45 year old woman who has recently returned from India with headaches, arthralgia and a rash (Specimen 3A) and the other from a 24 year old male who has returned from Indonesia with headaches and diarrhoea (Specimen 3B).

Specimen 3A is a Flavivirus IgG and IgM positive serum diluted 1:2 and Specimen 3B is a serum which tested negative to Flavivirus IgG and IgM antibodies in pre‐issue testing.

Results and Discussion

Sixty‐six participants returned results for flavivirus serology in this module.

Specimen 3A was tested for Dengue IgG by 28 participant using commercial ELISA kits. Positive results were obtained by all participants using the Alere PanBio IgG Indirect ELISA and also by participants using the Vircell and NovaTec Immunodiagnostica Dengue IgG ELISA. All participants using Alere PanBio Dengue IgG capture and the Standard Diagnostics IgG capture ELISA reported the result as negative. Specimen 3B was tested by 25 with all but one obtaining negative results. One participant obtained an equivocal result using the Alere PanBio Indirect ELISA.

Thirty‐five participants returned results for Dengue IgM testing for Specimen 3A and all obtained a positive result. Specimen 3B was tested by 32 participants with all obtaining a negative result except for an aberrant equivocal result obtained by the Alere PanBio kit, and a positive result obtained using the NovaTec Immunodiagnostica ELISA.

Three participants tested the specimens for Dengue Total Antibodies, two by HAI and one by In‐house Dengue competitive ELISA. All obtained a positive result for Specimen 3A and a negative result for Specimen 3B.

Both specimens were reported as NS1 antigen negative by all participants testing for Dengue Virus NS1 Antigen by a variety of different NS1 assays.

Ten participants used Alere PanBio Dengue IgG and IgM Duo ICT. Specimen 3A was reported as IgG and IgM positive by four of these participants, with four reporting it as IgG negative, IgM positive, one as IgG equivocal and IgM positive and one as IgG and IgM equivocal. The differential was reported varyingly as primary, secondary or unknown. Specimen 3B was reported as IgG and IgM negative by nine participants, with one participant reporting the IgM as equivocal.





Similar results were obtained by participants using the Standard Diagnostics NS1 Antigen and Antibody combo ICT. Specimen 3A was reported as IgG and IgM positive by six participants, and IgM pos and IgG negative by two participants with a further participant reporting IgG as equivocal and IgM as positive. All participants obtained negative results for Specimen 3B.

Twenty participants used Standard Diagnostics SD Bioline Dengue Duo. For Specimen 3A, 12 participants reported an IgG negative, IgM positive result; four reported it as IgG and IgM positive, one as IgG and IgM negative and one as IgG equivocal IgM positive. Two reported IgM result only and reported it as positive. All participants reported negative results for Specimen 3B.

One participant used Unicheck Dengue IgG and IgM ICT, reporting Specimen 3A as IgG negative and IgM positive, and Specimen 3B and IgG and IgM negative.

One participant tested for Flavivirus IgG and IgM using an In‐house ELISA and obtained IgG and IgM positive result for Specimen 3A and IgG and IgM negative for Specimen 3B.

Two participants used In‐house Total Antibody tests, one a HAI and the other an ELISA test. Both reported Specimen 3A as positive and Specimen 3B as negative.

Three participants tested Specimen 3A for WNV/KUNV IgM. Two obtained a positive result for Specimen 3A and one reported it at equivocal (by In‐house Kunjin IFA). Specimen 3B was reported as negative by two participants.

Kunjin Total Antibody was performed by three participants, one by In‐house ELISA and two by HAI. The ELISA produced a negative result for Specimen 3A while both participants testing by HAI reported a positive result, one with a titre of 80 and the other 640. All three participants reported Specimen 3B as negative.

One participant performed an In‐house MVEV IFA and obtained a negative result for both specimens. An In‐house MVEV total ELISA was performed by one participant that reported both specimens as negative. The MVEV HAI produced a positive result for Specimen 3A and negative for Specimen 3B.

Yellow Fever IgG was tested by one participant by In‐house IFA and a negative result was obtained for both specimens. Three participants tested for Yellow fever IgM and all reported both specimens as negative. Yellow Fever Total Antibodies were tested by IFA and HAI and the Specimen 3A was reported as positive by both test methods while Specimen 3B was reported as positive by IFA and negative by HAI.

Interpretive Comments

Where positive flavivirus results are obtained a comment should be used to suggest possible recent or past infection with a flavivirus and follow up serology requested to confirm or exclude recent infection.

Interpretation of results should take into account the possibility of serological cross‐reactivity between closely related viruses.

Where negative flavivirus results are obtained comments should reflect that there is no evidence of recent or past infection but a follow up requested to rule out current infection.





Review of Results by Methodology

Table 1. Results for Specimen 3A by Test Method

Method No. Positive No. Equivocal/Low positive

No. Negative Total

Alere PanBio Dengue IgG Capture 0 0 10 10

Alere PanBio Dengue IgG Indirect 13 0 0 13

NovaTec Immunodiagnostica Dengue IgG ELISA 1 0 0 1

Standard Diagnostics IgG ELISA 0 0 3 3

Vircell Dengue IgG ELISA 1 0 0 1

Focus Diagnostics IgM Capture DxSelect 1 0 0 1

Alere PanBio JE‐Dengue IgM Combo 1 0 0 1

Alere PanBio Dengue IgM Capture ELISA 24 0 0 24

NovaTec Immunodiagnostica Dengue IgM ELISA 1 0 0 1

Standard Diagnostics Dengue IgM Capture ELISA 5 0 0 5

In‐house Dengue IgM capture ELISA 1 0 0 1

In‐house Dengue IgM IFA 1 0 0 1

Vircell IgM capture 1 0 0 1

In‐house Dengue Total Antibody ELISA 1 0 0 1

In‐house Dengue HAI 2 0 0 2

BioRad NS1 Antigen ICT 0 0 5 5

BioRad Platelia NS1 ELISA 0 0 10 10

Alere PanBio Dengue Pan‐E‐Early ELISA 0 0 3 3

Alere PanBio Dengue Early Rapid ICT 0 0 1 1

Standard Diagnostics Dengue NS1 antigen ELISA 0 0 1 1

Standard Diagnostics Dengue NS1 Ag ICT 0 0 17 17

Standard Diagnostics NS1 Ag + Ab combo (NS1) 0 0 8 8

Alere PanBio Dengue Virus Duo IgG 4 2 4 10

Alere PanBio Dengue Virus Duo IgM 9 1 0 10

SD Bioline Dengue Duo ICT ‐ IgG 4 1 13 18

SD Bioline Dengue Duo ICT ‐ IgM 19 0 1 20

Standard Diagnostics Dengue NS1 Ag and Ab combo (IgG) 6 1 2 9

Standard Diagnostics Dengue NS1 Ag and Ab combo (IgM) 9 0 0 9

Unison Collaborative Unitest ICT ‐ IgG 0 0 1 1

Unison Collaborative Unitest ICT ‐ IgM 1 0 0 1

In‐house Flavivirus IgG ELISA 1 0 0 1

In‐house Flavivirus Capture IgM ELISA 1 0 0 1

In‐house Flavivirus Total Antibody HAI 1 0 0 1

In‐house Flavivirus Total Antibody ELISA 1 0 0 1

In‐house KUNV IgM IFA 0 1 0 1

In‐house KUNV HAI 2 0 0 2

In‐house KUNV Total Antibody ELISA 0 0 1 1

In‐house West Nile virus IgM EIA 1 0 0 1

In‐house KUNV Capture IgM EIA 1 0 0 1

In‐house MVEV Total Antibody ELISA 0 0 1 1

In‐house MVEV IgM IFA 0 0 1 1

In‐house MVEV HAI 1 0 0 1

In‐house YFV IgG IFA 0 0 1 1

In‐house YFV IgM IFA 0 0 2 2

Alere PanBio Arbovirus IgM IFA 0 0 1 1

In‐house YFV Total Antibody IFA 1 0 0 1

In‐house Yellow Fever virus Total Antibody HAI 1 0 0 1





Table 2. Results for Specimen 3B by Test Method

Method No. Positive No. Equivocal/ Low positive

No. Negative Total

Alere PanBio Dengue IgG Capture 0 0 9 9

Alere PanBio Dengue IgG Indirect 0 1 10 11

NovaTec Immunodiagnostica Dengue IgG ELISA 0 0 1 1

Standard Diagnostics IgG ELISA 0 0 3 3

Vircell Dengue IgG ELISA 0 0 1 1

Focus Diagnostics IgM Capture DxSelect 0 0 1 1

Alere PanBio JE‐Dengue IgM Combo 0 0 1 1

Alere PanBio Dengue IgM Capture ELISA 0 1 22 23

Novatec Immunodiagnostica Dengue IgM ELISA 1 0 0 1

Standard Diagnostics Dengue IgM Capture ELISA 0 0 5 5

Vircell IgM capture 0 0 1 1

In‐house Dengue Total Antibody ELISA 0 0 1 1

In‐house Dengue HAI 0 0 2 2

BioRad NS1 Antigen ICT 0 0 5 5

BioRad Platelia NS1 ELISA 0 0 9 9

Alere PanBio Dengue Pan‐E‐Early ELISA 0 0 3 3

Alere PanBio Dengue Early Rapid ICT 0 0 1 1

Standard Diagnostics Dengue NS1 Antigen ELISA 0 0 1 1

Standard Diagnostics Dengue NS1 Ag ICT 0 0 17 17

Standard Diagnostics NS1 Ag + Ab combo (NS1) 0 0 8 8

Alere PanBio Dengue Virus Duo IgG 0 0 10 10

Alere PanBio Dengue Virus Duo IgM 0 1 9 10

SD Bioline Dengue Duo ICT ‐ IgG 0 0 18 18

SD Bioline Dengue Duo ICT ‐ IgM 0 0 20 20

Standard Diagnostics Dengue NS1 Ag and Ab combo (IgG) 0 0 9 9

Standard Diagnostics Dengue NS1 Ag and Ab combo (IgM) 0 0 9 9

Unison Collaborative Unitest ICT ‐ IgG 0 0 1 1

Unison Collaborative Unitest ICT ‐ IgM 0 0 1 1

In‐house Flavivirus IgG ELISA 0 0 1 1

In‐house Flavivirus Capture IgM ELISA 0 0 1 1

In‐house Flavivirus Total Antibody HAI 0 0 1 1

In‐house Flavivirus Total Antibody ELISA 0 0 1 1

In‐house KUNV IgM IFA 0 0 1 1

In‐house KUNV HAI 0 0 1 1

In‐house KUNV Total Antibody ELISA 0 0 1 1

In‐house KUNV Capture IgM EIA 0 0 1 1

In‐house MVEV Total Antibody ELISA 0 0 1 1

In‐house MVEV IgM IFA 0 0 1 1

In‐house MVEVHi Antigen HAI 0 0 1 1

In‐house YFV IgG IFA 0 0 1 1

In‐house YFV IgM IFA 0 0 2 2

Alere PanBio Arbovirus IgM IFA 0 0 1 1

In‐house YFV Total Antibody IFA 1 0 0 1

In‐house Yellow Fever virus HAI 0 0 1 1

Conclusion

Specimen 3A was positive for Flavivirus IgG and IgM antibodies and Flavivirus IgM Dengue 3 specific. It would be expected that Dengue IgG and IgM would be detectable except by IgG capture ELISAs designed to diagnose secondary infections. Many aberrant negative results were reported for this specimen and results obtained by the ICTs were of particular concern.





It may be expected that this specimen would be non‐reactive to other flaviviruses, however owing to the cross‐reactivity between flaviviruses, positive results for some tests in this survey would not be unexpected. These positive results also illustrate the importance of referring positive specimens to a reference laboratory for confirmation.

Specimen 3B was a negative specimen which was found to be non‐reactive by all participants with the exception of two aberrant equivocal results in a the Alere PanBio IgG indirect ELISA and the Alere PanBio Dengue IgM Duo test, and an aberrant positive Dengue IgG obtained using the NovaTec Immunodiagnostica Dengue IgM ELISA.





Dengue Virus Interpretative Comments for Survey V3:2013:3A & 3B

Part 3A 3B

1064 5 9

21229 3,4 1,9

21267 4 1,9

21375 5 1

21439 4,11 1,9

21489 4,8,11 1,8

21624 4,5,9 1,9

29033 3,4,5,8 1

31126 4 1

31221 4 1,8

41018 4,11 9

41062 7,8 1,9

41133 4,11 9

41183 4,11 1,9

41302 3,4,7,8,11 8

49003 4 8

51044 4,5,11 1,9

51077 4,11 1,9

61253 4,5,8 1,9

80030 4,5,6,7 1,9

80756 3 1

81028 4 1

81325 4 12

83667 4,5,10 1,9

89012 4,8 1,9

89019 4 1,9

89021 4,8 9

89035 5,8,11 1,9

89036 4 1

89045 2,6,7 1

89046 4 1,9

89055 4 1,8,9

89058 4 1

89061 4,5 1,9

89068 2,5,6 1

89083 6,7 1

89094 2,4,5,8 1,9

89096 5 1

89111 4 9

89121 3,4,5,10,11 8,11

89125 3,7 1

89129 4 1

89260 3,4 1

89261 2,3,4,5,8 1,9

89307 3,4,5,10 1,9

89325 4 8

89343 3,4 4

91119 4,11 9

91487 5 1

92005 4,5,8,11 1,9





Flavivirus Interpretative Comments for Survey V3:2013:3A & 3B

Part 3A 3B

21229 3 1,6

41215 3,5 1,6

61253 5,8 1,6

Kunjin Interpretative Comments for Survey V3:2013:3A & 3B

Part 3A 3B

31126 6 6

61253 5,7 1,6

89111 4 6

89127 4,5,7 1,5,6

Murray Valley Encephalitis Interpretative Comments for Survey V3:2013:3A & 3B

Part 3A 3B

31126 6 6

61253 5,7 1,6

Yellow Fever Virus Interpretative Comments for Survey V3:2013:3A & 3B

Part 3A 3B

31126 5 5

61253 2,5,8 1,6

89111 6 6


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

Assurance Programs Fax +61 2 9356 2003 ABN 32 003 520 072 Suite 201, 8 Herbert Street St Leonards NSW 2065 www.rcpaqap.com.au

© 2013 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File V3‐2013‐flaReport Issued Wednesday, 18 September 2013Page of 28

Dengue Virus Results for Survey V3:2013:3A & 3B

Dengue Virus IgG

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

Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

31126 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 13022 Jan 15 OD 0.459 1.69 pos 0.06 neg

21267 Alere PanBio Dengue IgG Indirect (serop) ELISA Evolis 12149 Mar 14 S/CO 0.613 2.026 pos not tested

41018 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 13022 Jan 15 PBU 11 40.0 pos 1.74 neg

89094 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 12149 Mar 14 PBU 11 30.8 pos 2.8 neg

89261 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 12149 Mar 14 PBU 11 33.54 pos 3.07 neg

92005 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 12296 Oct 14 PBU 11 28.39 pos 2.12 neg

31221 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 13022 Jan 15 S/CO 1.1 3.210 pos 0.212 neg

40053 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 13056 Jul 15 S/CO 1.1 3.59 pos 0.14 neg

41062 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 12296 Oct 14 S/CO 1.1 3.401 pos not tested

41183 Alere PanBio Dengue IgG Indirect (serop) ELISA Freedom EVOlyzer 13056 Feb 15 S/CO 1.1 2.8 pos 0.2 neg

41302 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 13056 Feb 15 S/CO 1.1 3.90 pos 1.06 equ

89061 Alere PanBio Dengue IgG Indirect (serop) ELISA ‐ 12044 Feb 14 S/CO 1.5 2.6 pos <0.9 neg

91487 Alere PanBio Dengue IgG Indirect (serop) ELISA Triturus 12149 Mar 14 S/CO 1.1 3.55 pos 0.27 neg

89343 NovaTec Immunodiagnostica Dengue IgG EIA ‐ DENG‐100 Aug 14 OD 0.486 1.860 pos 0.134 neg

89260 Vircell Dengue IgG ELISA ‐ 13EDENG101 Apr 15 S/CO 1.1 1.91 pos 0.45 neg

Dengue Virus IgG Ci


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

89019 Alere PanBio Dengue IgG Capture (current) ELISA Personal Lab 12324 Oct 14 OD 0.571 0.608 neg 0.133 neg

89055 Alere PanBio Dengue IgG Capture (current) ELISA Personal Lab 12324 Oct 14 OD 1.152 0.188 neg 0.031 neg






Dengue Virus IgG Ci


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

49003 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 13029 Jan 15 PBU 22.0 5.00 neg 1.77 neg

89036 Alere PanBio Dengue IgG Capture (current) ELISA Personal Lab 12324 Oct 14 PBU 22 8.077 neg 1.024 neg

89094 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 13029 Jan 15 PBU 22 4.9 neg 1.9 neg

89258 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 13029 Jan 15 PBU 22 10.377 neg not tested

89261 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 11353 Nov 13 PBU 22 5.95 neg 1.91 neg

1011 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 12324 Oct 14 S/CO 2.2 0.35 neg 0.27 neg

40053 Alere PanBio Dengue IgG Capture (current) ELISA ‐ 13147 May 15 S/CO 2.2 0.75 neg 0.22 neg

89058 Standard Diagnostics Dengue IgG Capture (current) ELISA ‐ 12306 May 14 S/CO 2.2 0.7 neg 0.1 neg

21624 Standard Diagnostics Dengue IgG Capture (current) ELISA ‐ 232009 Jan 15 S/CO 1 0.3 neg 0.16 neg

89012 Standard Diagnostics Dengue IgG Capture (current) ELISA ‐ 232011 Aug 14 OD 0.338 0.253 neg 0.051 neg

89100 SD DENGUE lgG ELISA Personal Lab 232008 Aug 13 OD 0.321 0.163 neg 0.020 neg

Dengue Virus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

31126 Alere PanBio Dengue IgM Capture ELISA ‐ 13112 Oct 14 OD 0.342 2.78 pos 0.062 neg

89055 Alere PanBio Dengue IgM Capture ELISA Personal Lab 13007 Jul 14 OD 0.464 2.615 pos 0.254 neg

89058 Standard Diagnostics Dengue IgM Capture ELISA ‐ 12306 May 14 S/CO 0.3 5.7 pos 0.6 neg

41018 Alere PanBio Dengue IgM Capture ELISA Evolis 13094 Oct 14 PBU 11 73.28 pos 1.65 neg

49003 Alere PanBio Dengue IgM Capture ELISA ‐ 13007 Jul 14 PBU 11.0 50.10 pos 9.42 equ

89036 Alere PanBio Dengue IgM Capture ELISA Personal Lab 13112 Oct 14 PBU 11 57.809 pos 3.954 neg

89083 Alere PanBio Dengue IgM Capture ELISA Personal Lab 13042 Sep 14 PBU 11 80.850 pos 3.426 neg

89094 Alere PanBio Dengue IgM Capture ELISA ‐ 13112 Oct 14 PBU 11.00 63.4 pos 3.7 neg

89125 Alere PanBio Dengue IgM Capture ELISA Personal Lab 13112 Oct 14 PBU 11 65.47 pos 3.622 neg

89144 Alere PanBio Dengue IgM Capture ELISA Personal Lab 12226 Feb 14 PBU 11 54.638 pos 5.531 neg

89258 Alere PanBio Dengue IgM Capture ELISA ‐ 12306 May 14 PBU 11 60.461 pos not tested





Dengue Virus Results for Survey V3:2013:3A & 3B Dengue Virus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

89261 Alere PanBio Dengue IgM Capture ELISA ‐ 13112 Oct 14 PBU 11 67.59 pos 2.69 neg

92005 Alere PanBio Dengue IgM Capture ELISA ‐ 13037 Oct 14 PBU 11 63.61 pos 1.33 neg

1011 Alere PanBio Dengue IgM Capture ELISA ‐ 13042 Sep 14 S/CO 1.1 4.00 pos 0.33 neg

31221 Alere PanBio Dengue IgM Capture ELISA ‐ 13112 Oct 14 S/CO 1.1 4.983 pos 0.305 neg

40053 Alere PanBio Dengue IgM Capture ELISA ‐ 13127 Nov 14 S/CO 1.1 6.05 pos 0.22 neg



41183 Alere PanBio Dengue IgM Capture ELISA Freedom EVOlyzer 13094 Oct 14 S/CO 1.1 6.6 pos 0.3 neg

41302 Alere PanBio Dengue IgM Capture ELISA ‐ 13126 Nov 14 S/CO 1.1 7.02 pos 0.32 neg

81325 Alere PanBio Dengue IgM Capture ELISA ‐ 12268 Mar 14 S/CO 1.1 5.18 pos 0.35 neg

89061 Alere PanBio Dengue IgM Capture ELISA ‐ 12034 Dec 13 S/CO 1.5 4.7 pos <0.9 neg

89096 Alere PanBio Dengue IgM Capture ELISA Personal Lab 13042 Sep 14 S/CO 0.899 3.478 pos 0.595 neg

91487 Alere PanBio Dengue IgM Capture ELISA Triturus 13037 Oct 14 S/CO 1.1 6.50 pos 0.14 neg

89021 Alere PanBio JE‐Dengue IgM Combo ELISA ‐ 13007 Jan 14 PBU 11.0 77.9 pos 4.0 neg

89046 Focus Diagnostics Dengue Fever Virus IgM Capture DxSelect ELISA ‐ X22800 Feb 15 S/CO 1.0 6.096 pos 0.356 neg

21229 In house ‐ IFA ‐ DM060813 Nov 13 titre 10 80 pos not tested

89111 In house Dengue IgM Capture EIA ‐ NA NA OD 0.017481 0.7545 pos not tested

89343 NovaTec Immunodiagnostica Dengue IgM EIA ‐ DENM‐099 Jul 14 OD 0.616 2.594 pos 0.709 pos

61253 Standard Diagnostics Dengue IgM Capture ELISA ‐ 233021 Oct 14 S/CO 0.34 3.02 pos 0.10 neg

89012 Standard Diagnostics Dengue IgM Capture ELISA ‐ 233021 Oct 14 OD 0.342 2.675 pos 0.018 neg

89019 Standard Diagnostics Dengue IgM Capture ELISA Teknolabo 233021 Oct 14 OD 0.330 3.370 pos 0.037 neg





Dengue Virus Results for Survey V3:2013:3A & 3B Dengue Virus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

89100 SD DENGUE lgM ELISA PERSONAL LAB 233015 Mar 14 OD 0.324 2.611 pos 0.036 neg

21624 Standard Diagnostics Dengue IgM Capture ELISA ‐ 233015 Mar 14 S/CO 1 5.2 pos 0.13 neg

89260 Vircell Dengue IgM Capture ELISA ‐ 13EDENC104 Mar 15 S/CO 1.1 3.99 pos 0.10 neg

89021 For sample 3A both JE IgM & Dengue IgM were positive by using Panbio JE & Dengue IgM Combo Kit. However the test's result was interpretated as Dengue positive based on the JE/Dengue ratio of 0.16 (<1).

Dengue Virus Total Ab

Part Manufacturer Kit Name Method Lot No. Expiry Date Units

Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

21229 In house Dengue group specific competitive EIA EIA 25C13 Nov 13 % 40% 53.43 pos 3.06 neg

61253 In house ‐ HAI NA NA titre 40 40 pos <10 neg

89111 In house ‐ HAI NA NA titre 20 80 pos N/A neg



Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

41183 Alere PanBio Dengue Early Rapid NS1 Ag ICT ‐ 13107 Jul 14 N/A N/A N/A neg N/A neg

1011 Alere PanBio Dengue Pan‐E Early ELISA ELISA ‐ 13044 Jul 14 S/CO 1.1 0.27 neg 0.74 neg

40053 Alere PanBio Dengue Pan‐E Early ELISA ELISA ‐ 13143 Oct 14 S/CO 1.1 0.22 neg 0.23 neg

89083 Alere PanBio Dengue Pan‐E Early ELISA ELISA Personal Lab 12362 May 14 OD 0.461 0.102 neg 0.116 neg

89061 BioRad Dengue NS1 Ag Strip ICT ‐ 3C1106 Feb 14 N/A N/A N/A neg N/A neg

89125 BioRad Dengue NS1 Ag Strip ICT ‐ 3C0106 Feb 14 N/A n/a n/a neg n/a neg

89277 BioRad Dengue NS1 Ag Strip ICT ‐ 2M0103 Nov 13 N/A N/A negative neg negative neg









Cut Off

Value 3A

Result 3A

Value 3B

Result 3B


89058 BioRad Platelia Dengue NS1 Ag EIA ‐ 2L0131 May 14 N/A 0.5 0.1 neg 0.1 neg

31126 BioRad Platelia Dengue NS1 Ag EIA ‐ 2L0031 May 14 OD 0.593 0.022 neg 0.012 neg


61253 BioRad Platelia Dengue NS1 Ag EIA ‐ 2L0131 May 14 S/CO 0.86 0.04 neg 0.02 neg

21229 BioRad Platelia Dengue NS1 Ag EIA ‐ 2E0030 Oct 13 S/CO 1.0 0.06 neg 0.05 neg

41062 BioRad Platelia Dengue NS1 Ag EIA ‐ 2E0030 Oct 13 S/CO 1.0 0.108 neg 0.092 neg



89258 BioRad Platelia Dengue NS1 Ag EIA ‐ 2L0131 May 14 OD 1.0 0.074 neg not tested


21267 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127093 Oct 14 N/A N/A N/A neg N/A neg

80021 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127113 May 15 N/A N/A N/A neg N/A neg

89000 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127111 May 15 N/A N/A V3‐2013‐3A neg V3‐2013‐3B neg

89045 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127111 May 15 N/A N/A Negative neg Negative neg



89198 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127111 May 15 N/A ‐ NA neg NA neg

89261 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT ‐ 127098 Jan 15 N/A N/A N/A neg N/A neg

21375 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127111 May 15 N/A N/A N/A neg N/A neg


21624 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127094 Jan 15 N/A 1 N/A neg N/A neg

29033 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127099 Jan 15 N/A N/A N/A neg N/A neg

41031 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127097 Jan 15 N/A N/A neg neg neg neg

41419 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127098 Jan 15 N/A N/A N/A neg N/A neg

51044 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 146002 Jul 14 N/A N/A N/A neg N/A neg








Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

51077 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 127103 Mar 15 N/A n/a ‐ neg ‐ neg

80756 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133060 Jan 15 N/A ‐ ‐ neg ‐ neg

81028 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133074 Jul 15 N/A N/A N/A neg N/A neg

83667 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133069 Apr 15 N/A N/A N/A neg N/A neg

89036 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133070 May 15 N/A n/a N/A neg N/A neg

89055 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133058 Nov 14 N/A N/A N/A neg N/A neg


89129 Standard Diagnostics SD Bioline Dengue NS1 Ag ICT ‐ 133054 May 14 N/A N/A negative neg negative neg



89019 Standard Diagnostics SD Bioline Dengue NS1 Ag ELISA Teknolabo 234008 Sep 14 OD 0.310 0.010 neg 0.012 neg

Dengue Virus Duo IgG & IgM Differential Results for Survey V3:2013:3A & 3B

Part Manufacturer Kit Name Method Lot No. Expiry Date IgG IgM Differential IgG IgM Differential

1064 PANBIO INVERNESS MEDICAL Dengue DuoCassette Immunochromatography 12251 Jan‐14 neg pos primary neg neg negative

21439 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13037 Mar‐14 pos pos unknown neg neg N/A

40053 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13194 Sep‐14 neg pos primary neg neg negative

89035 Alere PanBio Dengue Virus Duo IgM & IgG ICT 12160 Oct‐13 neg pos primary neg neg negative

89083 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13015 Mar‐14 pos pos secondary neg neg negative

89121 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13084 May‐14 equ pos primary neg equ N/A

89125 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13084 May‐14 pos pos secondary neg neg negative

89277 Alere PanBio Dengue Virus Duo IgM & IgG ICT 12219 Dec‐13 pos pos secondary neg neg negative

89307 Alere PanBio Dengue Virus Duo IgM & IgG ICT 13084 May‐14 equ equ unknown neg neg negative

89325 Alere PanBio Dengue Virus Duo IgM & IgG ICT 98059 Oct‐14 neg pos primary neg neg negative







1011 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127108 Apr‐15 neg pos primary neg neg negative

41302 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127110 May‐15 pos pos unknown neg neg negative

80021 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127113 May‐15 equ pos N/A neg neg N/A

89000 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127111 May‐15 pos pos secondary neg neg negative

89045 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127111 May‐15 pos pos secondary neg neg negative

89076 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127111 May‐15 neg pos N/A neg neg N/A

89094 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127111 May‐15 pos pos primary neg neg negative

89198 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127111 May‐15 pos pos N/A neg neg N/A

89261 Standard Diagnostics Dengue NS1 Ag+Ab Combo ICT 127098 Jan‐15 pos pos primary neg neg negative

21267 Standard Diagnostics SD Bioline Dengue Duo ICT 127093 Oct‐14 N/A pos N/A N/A neg N/A

21375 Standard Diagnostics SD Bioline Dengue Duo ICT 127111 May‐15 pos pos primary neg neg negative

21489 Standard Diagnostics SD Bioline Dengue Duo ICT 127110 May‐15 neg pos N/A neg neg N/A

21624 Standard Diagnostics SD Bioline Dengue Duo ICT 127094 Jan‐15 neg pos primary neg neg negative



41419 Standard Diagnostics SD Bioline Dengue Duo ICT 127098 Jan‐15 neg neg N/A neg neg N/A

51044 Standard Diagnostics SD Bioline Dengue Duo ICT 146002 Jul‐14 neg pos primary neg neg negative

51077 Standard Diagnostics SD Bioline Dengue Duo ICT 127103 Mar‐15 neg pos primary neg neg negative

80030 Standard Diagnostics SD Bioline Dengue Duo ICT 98059 Oct‐14 pos pos unknown neg neg negative

80756 Standard Diagnostics SD Bioline Dengue Duo ICT 127113 May‐15 equ pos N/A neg neg N/A

81028 Standard Diagnostics SD Bioline Dengue Duo ICT 98059 Oct‐14 neg pos N/A neg neg N/A

83667 Standard Diagnostics SD Bioline Dengue Duo ICT 98059 Oct‐14 neg pos N/A neg neg N/A

89019 Standard Diagnostics SD Bioline Dengue Duo ICT 98054 Apr‐14 neg pos N/A neg neg N/A

89036 Standard Diagnostics SD Bioline Dengue Duo ICT 98059 Oct‐14 neg pos primary neg neg negative

89055 Standard Diagnostics SD Bioline Dengue Duo ICT 98054 Apr‐14 neg pos primary neg neg negative

89068 Standard Diagnostics SD Bioline Dengue Duo ICT 98059 Oct‐14 pos pos unknown neg neg unknown

89129 Standard Diagnostics SD Bioline Dengue Duo ICT 87051 Jan‐14 neg pos N/A neg neg N/A

89312 Standard Diagnostics SD Bioline Dengue Duo ICT 127110 May‐15 pos pos primary neg neg negative







91119 Standard Diagnostics SD Bioline Dengue Duo ICT 87053 Jan‐15 not tested pos N/A not tested neg N/A

89106 Unison Collaborative Unichek Dengue IgG & IgM ICT C20501NS1 May‐14 neg pos N/A neg neg N/A

41302 NS1 combi rapid result: 3A negative, 3B negative.FOR SAMPLE 3A: early secondary or late primary interpretation.per kit insert. without second sample or onset dates differential is unknown

Flavivirus Results for Survey V3:2013:3A & 3B

Flavivirus IgG


Cut Off

Value 3A

Result 3A

Value3B

Result 3B

41215 In house ‐ EIA N/A NA OD 0.267 0.978 pos 0.046 neg

Flavivirus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

41215 In house Capture IgM EIA N/A NA OD 0.169 1.814 pos 0.040 neg

Flavivirus Total Ab


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

21229 In house Flavivirus Ig Total ELISA 22C13 Nov 13 % 40% 40.00 pos 1.16 neg






Kunjin (west Nile) Virus Results for Survey V3:2013:3A & 3B

Kunjin (West Nile) Virus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

61253 In house Kun IFA IgM IFA IN HOUSE NA N/A Pos control N/A equ N/A neg

89111 In house West Nile Virus IgM EIA NA NA OD 0.016777 0.4355 pos not tested

89127 In house Capture IgM EIA NA NA S/CO 3.0 3.613 pos 0.864 neg

Kunjin (West Nile) Virus Total Ab


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

31126 In house ‐ EIA 6813 NA % 50 6.85 neg 3.63 neg

61253 In house Kun HI Ag HAI IN HOUSE NA titre 40 80 pos <10 neg

89111 In house ‐ HAI NA NA titre 20 640 pos N/A neg

Murray Valley Encephalitis Results for Survey V3:2013:3A & 3B

Murray Valley Encephalitis Virus IgM


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

61253 In house MVE IFA IgM IFA N/A N/A N/A Pos control N/A neg N/A neg





Murray Valley Encephalitis Results for Survey V3:2013:3A & 3B

Murray Valley Encephalitis Virus Total Ab


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

31126 In house ‐ EIA 6813 NA % 50 5.09 neg 3.40 neg

61253 In house MVE HI Ag HAI IN HOUSE NA titre 40 80 pos <10 neg

Yellow Fever Virus Results for Survey V3:2013:3A & 3B

Yellow Fever IgG


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

89111 In house ‐ IFA F120726AA Jan 14 titre 10 N/A neg N/A neg

Yellow Fever IgM


Cut Off

Value 3A

Result 3A

Value 3B Result 3B

61253 Alere PanBio Arbovirus Screen (Non‐USA) IFA F130218DK Aug 14 N/A Pos control N/A neg N/A neg

31126 In house ‐ IFA 713 Jul 14 titre 10 <10 neg <10 neg

89111 In house ‐ IFA F120726AA Jan 14 titre 10 N/A neg N/A neg

Yellow Fever Total Ab


Cut Off

Value 3A

Result 3A

Value 3B

Result 3B

31126 In house ‐ IFA 713 Jul 14 titre 10 80 pos 20 pos


Survey V3:2013: 3A & 3B Final Generic Report Viral...

Documents

Transcript of Survey V3:2013: 3A & 3B Final Generic Report Viral...