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© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File P3-2014-mea.doc Report Re-issued Friday, 29 August 2014 Page Page 1 of 18

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Survey P3:2014: 3E & 3F

Final Generic Report Vaccine Preventable Program

Measles Serology Report prepared and collated by: RCPAQAP Serology Comments provided by: Michaela Riddell on behalf of RCPAQAP Serology DEPM, Monash University, The Alfred, 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.

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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.

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. 3E 38 year old male reports fever and faint rash and states he visited the airport arrivals hall 10 days ago during

the time a confirmed case of measles was present.

3F 18 month old child newly adopted from South East Asia arrived 2 days ago presented febrile, with blotchy

rash on trunk.

Request

Please test both specimens for Measles serology and treat in the same manner as routine patient samples.

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 P3:2014) 3E is a serum sample that tested positive to Measles IgG and negative to Measles IgM antibodies. 3F is a serum sample that tested positive to Measles IgG and negative to Measles IgM antibodies.

Source: SEALS, Prince of Wales Hospital, NSW. 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

85 participants returned results for Measles.

Survey Results P3:2014 Measles

Measles IgG - Specimen 3E equ: 1 = 1.30% neg: 1 = 1.30% not tested: Excluded pos: 75 = 97.40% Total Results =77 Consensus: pos

Measles IgG - Specimen 3F not tested: Excluded pos: 77 = 100.00% Total Results =77 Consensus: pos

Measles IgM - Specimen 3E neg: 59 = 100.00% not tested: Excluded Total Results =59 Consensus: neg

Measles IgM - Specimen 3F equ: 1 = 1.69% neg: 58 = 98.31% not tested: Excluded Total Results =59 Consensus: neg

Measles Total - Specimen 3E NS: 2 = 100.00% Total Results =2 Consensus: Insufficient data (less than 5 results)

Measles Total - Specimen 3F AC: Excluded Total Results =0

Inconsistencies in this Survey

Measles IgG Participant Comment

Specimen 3E 41018 Result inconsistent with the consensus.

89125 Result inconsistent with the consensus.

Test Group 1061 The cut-off is inconsistent with SQAP definition & kit insert for a value above which is positive.

21439 The cut-off is inconsistent with SQAP definition & kit insert for a value above which is positive.

21439 Other users of the same lot number have a different expiry date.

31293

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

31293 Units appear inconsistent with manufacturer’s instructions.

31369 Units appear inconsistent with cut-off and result values reported.

41133 Kit past the expiry date.



82143 Cut-off in incorrect format. Please see instructions on results sheet.





Inconsistencies in this Survey (continued)

Measles IgG Participant Comment

Test Group 82143 Units not provided.

89058 Units not provided.

89061 Lot number provided appears inconsistent with other participants in the same user group.

89125


89132


89149



89178 Other users of the same lot number have a different expiry date.


89305





Measles IgM Participant Comment

Specimen 3F 89312 Result inconsistent with the consensus.




89057 Units appear inconsistent with the cut-off value provided.

89149




89312







Inconsistencies in this Survey (continued)

Measles IgM Participant Comment


Measles Total Participant Comment

Specimen 3F 89132 Result assigned is inconsistent with the cut-off and result value provided.

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 21412 Refer to another Lab. for testing.

61253 In addition to comment 2 our comment states reinfection or infection post vaccination may not produce detectable IgM. If acute infection is suspected, a dry throat swab for PCR and convalescent serology is recommended.

89342 Due to manufacturer shortages in test kit reagents survey samples were not tested.





Comments provided by: Michaela Riddell, DEPM, Monash University, The Alfred, VIC, Australia on behalf of the RCPAQAP Serology.

Background Several participants were unable to participate in this survey due to manufacturing and kit supply issues. Specimen 3E The clinical notes are consistent with possible acute measles and the visit to a known location from which previous measles cases have been associated should heighten suspicion of acute measles. The patient is from a cohort of adults born between 1975 – 1981 who have been identified as having the lowest age specific population immunity due to changes in measles vaccine schedules (1). The report of this patient having been in a location in which previous cases of measles infection were identified and confirmed increases the suspicion of measles infection. Thus the critical diagnostic tests required is the measles IgM antibody assay accompanied by the measles IgG antibody assay to determine the patient’s immune status to measles and if necessary alert the referring doctor of the need for the patient to be offered a measles containing vaccine. The measles IgG antibody test alone however cannot be used for the diagnosis of acute measles infection since a positive IgG response cannot differentiate between past or current infection (see diagram below). Specimen 3F The clinical symptoms of blotchy rash and fever can typically occur during measles virus infection. This patient is from a population cohort in which numerous infections of measles have been identified. A child presented for adoption in an Asian country may not have received all necessary vaccinations prior to arriving in their new home country and there have been several outbreaks associated with newly adopted children from Asian and African countries (2). Critical serological tests required in this instance are a measles IgM antibody test. The first dose of measles containing vaccine is usually administered at 12 months; a measles IgG test will identify ongoing measles infection risk in this child and may lead to a recommendation for providing a measles containing vaccine.

Typical Measles Immune Response This figure taken from the WHO Manual for the Laboratory Diagnosis of Measles and Rubella Virus Infection(3), shows the appearance of measles clinical symptoms and the immune response with respect to time after infection. Approximately eight to ten days after infection the prodromal symptoms of fever, conjunctivitis and cough begin. At approximately the same time there is a rapid activation and expansion of virus specific CD8+ and CD4+ cells. The appearance of the

rash several days later coincides with the development of the IgM response, although IgM may not be detectable for up to four days after the initial appearance of the rash. The IgG immune response may begin at the same time as the IgM response and is detectable approximately four to five days after the IgM response the IgG sustained post recovery and thus can be used as a marker of previous exposure to the virus through infection or vaccination. Thus





the detection of IgM in a sample indicates recent infection or vaccination, and may often be detected in the presence of IgG. The presence of measles IgG alone indicates previous exposure to the virus through vaccination or past infection. Measles IgM Results and Discussion Fifty nine participants undertook testing for measles virus IgM while 13 participants indicated the specimen would be referred-on for IgM testing. Testing for measles virus IgG alone, without referral on for IgM testing, as practiced by eight participants, has previously been highlighted as an unacceptable standard of laboratory practice. Specimen 3E This specimen, which was IgM negative on pre-issue testing and by consensus among participants, was well handled. Of the fifty nine participants who tested this specimen for IgM, all agreed the specimen was negative for IgM. Twenty one participants who provided results for this survey did not test this specimen for IgM, of these 21 participants, only 13 recommended referral of this specimen to another laboratory for IgM testing which was the correct and appropriate action to take. Five participants did not test any further and provided a comment based on the IgG result alone and the remaining three participants did not test any further nor did they provide a comment. Specimen 3F This specimen, which was IgM negative on pre-issue testing and by consensus among participants, was well handled with 58 participants (98%) obtaining a negative result. Participant 89312 recorded an equivocal result; however, there appears to have been an inconsistency with the cut-off associated with this participant. Twenty one participants who provided results for this survey did not test this specimen for IgM, of these 21 participants, only 13 recommended referral of this specimen to another laboratory for IgM testing which was the correct and appropriate action to take. Five participants did not test any further and provided a comment based on the IgG result alone and the remaining three participants did not test any further nor did they provide a comment. Review of Results by Methodology The majority of participants used immunoassay technology either with enzyme or chemiluminescence detection for investigating measles virus IgM serology. Two of the 59 participants employed IFA testing. As previously noted several inconsistencies were observed with those participants testing for measles IgM. Please ensure that the cut-off used is in accordance with that stated in the kit insert in particular Participants 1061, 21092, 89277 and 89319 (DiaSorin Liaison/Liaison XL ChLIA kit), 59006 and 89343 (Siemens Healthcare Diagnostics Enzygnost), 89312 (Euroimmun), and 89149 (IBL). Provision of accurate kit information including lot number, expiry date and units is important for good laboratory practice and contributes to the accreditation process. Participants should be mindful that it is important to carefully document kit and test details to enable auditing and review of good laboratory procedures and practices. Measles IgG Results and Discussion Seventy seven participants undertook measles virus IgG testing. Measles IgG alone cannot provide sufficient information to determine whether or not a patient with a rash or clinical symptoms or potential exposure to measles virus is currently or recently infected with the virus. Thus measles IgG test result in the absence of a measles IgM result cannot accurately determine the infected status of an individual. Specimen 3E Seventy seven participants returned results from measles IgG testing of this specimen. This specimen, which was measles IgG positive in pre-issue testing and by consensus among participants, was well handled with a positive result obtained by 75 (97%) participants. Two participants returned results inconsistent with the consensus (41018 - equivocal, 89125 - negative).





Specimen 3F Seventy seven participants returned results from measles IgG testing of this specimen. This specimen, which was measles IgG positive in pre-issue testing and by consensus among participants, was well handled with a positive result reported by all participants. Review of Results by Methodology Two participants used commercial IFA assays. Both participants determined both specimens to be IgG positive. Other participants utilised EIA, ELFA, Multiplex and Chemiluminescence platforms using the BioRad Platelia, DiaSorin Liaison/Liaison XL, Diesse Diagnostica Chorus, Euroimmun Triturus, Genzyme Virotech, Siemens Healthcare Diagnostics Enzygnost, bioMerieux Vidas-Mini Vidas and Trinity Biotech Captia kits. It was noted that several participants provided inconsistent/inaccurate information relating to kit lot details and expiry dates. Provision of accurate kit information including lot number, expiry date and units is important for good laboratory practice and contributes to the accreditation process. Participants should be mindful that it is important to carefully document kit and test details to enable auditing and review of good laboratory procedures and practices. Review of Results and Conclusions The concordance of results for both specimens was very high. More than 75% of the participants performed IgM or referred specimen to another laboratory for IgM testing on both specimens. According to the WHO recommended actions (3) when investigating a suspected measles case, a laboratory may use one of the following methods for investigating a case of suspected measles:

1. Detection of measles specific IgM 2. IgG seroconversion or a 4-fold or greater rise in titre to measles virus where the 2nd sample is collected >10

days after the first acute sample (acute and convalescent sample should be tested in parallel) Furthermore specimens which are positive for suspected measles infection should be sent to an approved or certified reference laboratory for confirmation. Global measles elimination is a WHO recommended and adopted policy and all suspected cases of measles should be tested rapidly and results (especially IgM positive results) conveyed to appropriate health authorities as soon as possible. Interpretative Comments Interpretative comments should be based on the combined IgG and IgM results and if possible in conjunction with any clinical symptoms provided by the clinician. As can be seen from the diagram above, in the majority of cases IgM is detectable before (or at the same time) as IgG. Thus detection of IgG alone (i.e. IgM negative) is usually indicative of past exposure (through infection or vaccination) and thus immunity to infection. The presence of IgM in the absence of IgG should be reported to health authorities as soon as possible and the specimen retested for confirmation of IgM status (to rule out false positive). Specimen 3E This specimen was by consensus determined to be IgG positive and IgM negative, thus the appropriate comment was Comment 2 “serological evidence of past infection or vaccination/immunisation”. Inclusion of Comment 3 “no serological evidence of recent infection” could also have been included by those participants who performed both IgG and IgM testing. For those participants who did not perform IgM testing, the specimen should have been referred to another laboratory and thus in this case Comment 8 “refer to another laboratory for IgM testing, await IgM result for appropriate comment” should have been returned to the requesting physician. For those participants who only perform IgG testing the most appropriate comment would have been Comment 5 “send repeat specimen in 10-14 days if clinically indicated” in addition to Comment 2. Nine participants (1061, 1148, 89057, 89149, 89153, 89178, 89237, 89305 and 89312) chose not to make any interpretative comments. Interpretative comments can be a critical aspect of diagnostic testing for the clinician and patient and should be considered an essential component of the overall result.





Participant 89125 obtained an incorrect test result, but provided the correct interpretation and comment related to the test result obtained. Specimen 3F This specimen was by consensus determined to be IgG positive and IgM negative, thus the appropriate comment was Comment 2. Inclusion of Comment 3 could also have been included by those participants who performed both IgG and IgM testing. The presence of IgG in conjunction with IgM reflects the development of the immune response (see diagram above) and not a previous and current infection at the same time. For those participants who did not perform IgM testing, the specimen should have been referred to another laboratory and thus in this case Comment 8 should have been returned to the requesting physician. For those participants who only perform IgG testing the most appropriate comment would have been Comment 5. Nine participants (1061, 1148, 89057, 89149, 89153, 89178, 89237, 89305 and 89312) chose not to make any interpretative comments. Interpretative comments can be a critical aspect of diagnostic testing for the clinician and patient and should be considered an essential component of the overall result. References 1.Kelly HA, et al. Measles immunity among young adults in Victoria. Commun Dis Intell. 2001;25(3):129-32.

2.Nyangoma EN, et al. Measles outbreak associated with adopted children from China--Missouri, Minnesota, and Washington, July 2013. MMWR Morb Mortal Wkly Rep. 2014;63(14):301-4. Epub 2014/04/11.

3.World Health Organization. Manual for the laboratory diagnosis of measles and rubella virus infection 2nd edition. Geneva2007 [cited 2009 February]; 2nd:[109]. www.who.int/ihr/elibrary/manual_diagn_lab_mea_rub_en.pdf (Accessed 26/8/14).





Measles Result Summary for Survey P3:2014:3E & 3F

Part.

Specimen 3E Specimen 3F

IgG IgM Total Interp IgG IgM Total Interp

1000 pos neg 2 pos neg 2

1061 pos neg pos neg

1109 neg 3 neg 3


21000 pos 2 pos 2




21292 pos neg 2,5 pos neg 2


21375 pos neg NS 2,5 pos neg AC 2,5


21412 not tested 9 not tested 9

21439 pos neg 2,3 pos neg 2,3





31008 pos 8 pos 8

31013 pos 8 pos 2,8





31293 pos 2 pos 2

31342 pos 8 pos 8


31378 pos 8 pos 8

31433 pos 8 pos 8

41018 equ neg 7 pos neg 2

41125 pos 8 pos 8




51044 not tested not tested



61100 pos 8 pos 8




61455 pos 2,8 pos 2,8

71683 not tested not tested

80930 pos 2,5,8 pos 2,8



82143 pos 8 pos 8







Measles Result Summary for Survey P3:2014:3E & 3F

Part.

Specimen 3E Specimen 3F

IgG IgM Total Interp IgG IgM Total Interp

89035 pos 2,8 pos 2,8


89045 pos 2 pos 2


89057 neg 9 neg 9



89110 pos neg 2,3,5 pos neg 2,3,5



89125 neg 1 pos 2

89127 neg 3,5 neg 3,5,6

89132 pos neg NS 2,3 pos neg AC 2,3,5





89178 pos pos

89237 pos pos





89305 pos pos

89312 pos neg pos equ

89318 pos neg 2,6 pos neg 2




91089 pos 8 pos 8





92014 pos 2 pos 2

92018 pos 8 pos 8




© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File P3-2014-mea.doc Report Re- issued Friday, 29 August 2014 Page Page 12 of 18

Measles IgG for Survey P3:2014:3E & 3F

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

Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

89110 Alere Wampole Measles (Rubeola) IgG EIA - 13110016 Nov-14 S/CO 1.10 1.615 pos 5.678 pos

21412 bioMerieux Measles IgG ELFA Vidas-Mini Vidas 1001452610 Jul-13 S/CO 0.70

not tested

not tested

21452 bioMerieux Measles IgG ELFA Vidas-Mini Vidas N/A Jan-15 S/CO 0.70

not tested

not tested

51044 bioMerieux Measles IgG ELFA Vidas-Mini Vidas N/A Jul-14 S/CO 0.70

not tested

not tested

71683 bioMerieux Measles IgG ELFA Vidas-Mini Vidas 1001702430 Oct-13 S/CO 0.70

not tested

not tested

21092 BioRad MMRV IgG Multiplex BioPlex 2200 116980 Jan-15 AI 1.1 1.7 pos 7.8 pos

92014 BioRad MMRV IgG Multiplex BioPlex 2200 116980 Aug-14 AI 1.1 1.7 pos 7.5 pos

89045 BioRad Platelia Measles IgG EIA Evolis 075A Jan-15 S/CO 1.2 3.30 pos 6.60 pos

89237 BioRad Platelia Measles IgG EIA Evolis 075-A Jan-15 OD 0.598 0.965 pos 2.459 pos

92018 BioRad Platelia Measles IgG EIA Evolis 075-A Jan-15 S/CO 1.2 3.00 pos 6.23 pos

1000 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010X/2 Apr-15 AU/mL 16.5 28.5 pos 300 pos

1061 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159011 Oct-15 AU/mL 13.5 24.6 pos 300 pos

21000 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 16.5 29.7 pos 300 pos

21267 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 16.5 40.3 pos >300 pos

21292 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 16.5 28.7 pos 300.0 pos



21439 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Mar-15 AU/mL 16.4 33.2 pos >300.0 pos


21763 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010X/2 Apr-15 AU/mL 16.5 28.7 pos >300 pos



31252 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 16.5 36.4 pos >300.0 pos

31378 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 16.5 40 pos >300 pos

31433 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010X/2 Apr-15 AU/mL 16.5 28.3 pos >300 pos







Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

41183 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010X Apr-15 AU/mL 16.5 28.2 pos >300.0 pos



61100 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010X Apr-15 AU/mL 16.5 36.4 pos 300.00 pos



89061 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 100008 Apr-15 AU/mL 16.5 22.9 pos > 300 pos



89277 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 15 24.8 pos 301 pos

89318 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159009 Sep-14 AU/mL 16.5 30.1 pos 300.0 pos

89319 DiaSorin Liaison Measles IgG ChLIA Liaison/Liaison XL 159010 Apr-15 AU/mL 15 27 pos >300 pos

31342 Diesse Diagnostica Chorus Measles IgG EIA Chorus 030 Apr-15 S/CO 1.21 4.2 pos 8.2 pos

41133 Diesse Diagnostica Chorus Measles IgG EIA Chorus 031 Apr-14 Index 1.1 3.9 pos 7.4 pos

80930 Euroimmun Anti-Measles IgG ELISA Triturus E131023AM Oct-14 S/CO 1.1 1.2 pos 4.5 pos


89035 Euroimmun Anti-Measles IgG ELISA Triturus E131023AM Oct-14 IU/L 275 527 pos 25558.55 pos

89312 Euroimmun Anti-Measles IgG ELISA Triturus E140224BG Feb-15 IU/L 250 516.03 pos 4548.87 pos


89114 Genzyme Virotech Measles IgG ELISA Eti-Max 3000 183-01 Sep-14 S/CO 1.1 2.088 pos 6.171 pos

89123 Genzyme Virotech Measles IgG ELISA - 18302 Apr-15 S/CO 1.1 1.856 pos 6.301 pos

89125 Genzyme Virotech Measles IgG ELISA - 183-02 Apr-15 S/CO 1 0.446 neg 1.963 pos

89153 Genzyme Virotech Measles IgG ELISA Eti-Max 3000 183-02 Apr-15 OD 0.289 0.667 pos 1.732 pos

89046 Hemagen Diagnostics Virgo Measles IFA IgG IFA - 3105185 Nov-14 titre 10 >=10 pos >=10 pos







Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

89149 IBL Measles IgG ELISA Triturus MEG-127 Nov-14 titre 1 1.82 pos 4.11 pos

21624 MRL BION Measles IFA - ME-0573 Mar-16 titre 10 >10 pos >10 pos

21375 NovaTec Immundiagnostica Measles IgG EIA Eti-Max 3000 MEAG-069 Feb-15 S/CO 1.10 1.92 pos 2.87 pos

31008 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43392 Jan-15 OD 0.200 0.495 pos 2.252 pos

82143 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43024 Sep-14 N/A Pos>0.20 0.324 pos 2.254 pos

89012 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43243 Nov-14 OD 0.2 0.25 pos 2.10 pos

89021 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43656 Mar-15 OD 0.20 0.363 pos 2.31 pos

89058 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43243 Nov-14 N/A 0.2 0.36 pos 2.7 pos

89258 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43589 Feb-15 OD 0.2 0.291 pos 2.154 pos

89299 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43243 Nov-14 OD 0.2 0.321 pos 2.134 pos

89343 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA - 43392 Jan-15 OD 0.100 0.340 pos 1.876 pos

1148 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA BEP 2000 43243 Nov-14 OD 0.200 0.322 pos 2.254 pos

21229 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA BEP 2000 43392 Jan-15 OD 0.201 0.38 pos 1.82 pos



31293 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA BEP 2000 43392 Jan-15 mIU/mL 0.100 0.404 pos 1.780 pos

31369 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA BEP 2000 43243 Nov-14 OD 340 428 pos 14083 pos

89178 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgG EIA BEP 2000 43243 Nov-17 OD 0.2 0.272 pos 2.114 pos

41018 Trinity Biotech Captia Measles IgG ELISA - 2326000-578 Apr-15 S/CO 1.1 1.098 equ 2.962 pos

41125 Trinity Biotech Captia Measles IgG ELISA - 579 Jul-15 S/CO 1.1 1.45 pos 3.78 pos



89148 Trinity Biotech Captia Measles IgG ELISA - 578 Apr-15 S/CO 1.10 1.32 pos 3.01 pos








Cut Off

Value 3E

Result 3E

Value 3F

Result 3F


91317 Trinity Biotech Captia Measles IgG ELISA - 2326000-578 Apr-15 S/CO 1.1 1.41 pos 2.95 pos

61360 Trinity Biotech Captia Measles IgG ELISA Triturus 578 Apr-15 S/CO 1.1 1.95 pos 2.32 pos

61455 Trinity Biotech Captia Measles IgG ELISA Triturus 579 Jul-15 S/CO 1.1 1.58 pos 3.17 pos

91487 Trinity Biotech Captia Measles IgG ELISA Triturus 578 Apr-15 S/CO 1.10 1.28 pos 2.81 pos

89260 Vircell Measles ELISA IgG/IgM ELISA - 14EMEA101 Feb-16 S/CO 1.1 2.14 pos 2.19 pos

89305 Vircell Measles ELISA IgG/IgM ELISA - 13EMEA101 Mar-15 S/CO 1.242 1.719 pos 1.598 pos

89036 VIROTECH SEKISUI VIROTECH ELISA - 183-01 Sep-15 OD 11 31.46 pos 81.93 pos

21412 Unable to perform testing due to BioMerieux production issues

21452 KIT UNAVAILABLE

51044 ASSAY CURRENTLY UNAVAIABLE

71683 Testing not performed - kits unavailable

Measles IgM for Survey P3:2014:3E & 3F


Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

1000 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174007X/1 Jul-14 Index 1.1 0.068 neg 0.078 neg

1061 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174008 Jul-15 Index 0.9 0.079 neg 0.093 neg

21092 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174008X Jul-15 Index 1.00 0.14 neg 0.11 neg

21267 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174008 Jul-15 Index 1.1 <0.5 neg <0.5 neg













Cut Off

Value 3E

Result 3E

Value 3F

Result 3F







89061 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174008 Jul-15 S/CO 1.1 <0.9 neg <0.9 neg


89152 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174009 Dec-14 Index 1.1 0.094 neg 0.1 neg

89277 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174007 Jul-14 Index 1 0.096 neg 0.087 neg

89318 DiaSorin Liaison Measles IgM ChLIA Liaison/Liaison XL 174009 Dec-14 Index 1.1 0.064 neg 0.093 neg


89057 Diesse Rubeola IgM EIA - 096 Jul-15 S/CO 0.79 0.37 neg 0.42 neg

21375 Diesse Diagnostica Chorus Measles IgM EIA Chorus 962 Aug-14 S/CO 1.10 0.3 neg 0.4 neg

41133 Diesse Diagnostica Chorus Measles IgM EIA Chorus 986 Nov-14 Index 1.1 0.5 neg 0.2 neg

80940 Euroimmun Anti-Measles IgM ELISA - E130903AD Sep-14 S/CO 1.1 0.21 neg 0.75 neg

89312 Euroimmun Anti-Measles IgM ELISA - E130903AD Sep-14 S/CO 1.00 0.23 neg 0.82 equ

89123 Genzyme Virotech Measles IgM ELISA - 11502 Apr-15 S/CO 1.1 0.200 neg 0.175 neg

89153 Genzyme Virotech Measles IgM ELISA - 115-01 Aug-14 OD 0.2305 0.057 neg 0.064 neg

89110 Hemagen Diagnostics Virgo Measles IFA IgM IFA - 3105185 Nov-14 titre 40 <10 neg <10 neg

89149 IBL Measles IgM ELISA Triturus MEM-131 Dec-14 titre 1 0.2 neg 0.2 neg

89342 Microimmune Measles IgM Capture EIA - K53-173 Oct-14 OD 0.213

not tested

not tested






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

Value 3E

Result 3E

Value 3F

Result 3F

21624 MRL BION Measles IFA - ME-0573 Mar-16 titre 10 <10 neg <10 neg

1109 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgM EIA - 43244 Sep-14 OD 0.2 0.001 neg 0.005 neg







89046 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgM EIA - 43393 Feb-15 OD 0.201 0.009 neg 0.008 neg






1148 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgM EIA BEP 2000 43025 Sep-14 OD 0.200 0.011 neg 0.017 neg





61360 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgM EIA Triturus 43244 Sep-14 OD 0.2 0.02 neg 0.01 neg

89343 Siemens Healthcare Diagnostics Enzygnost Anti-Measles IgM EIA Evolis 43025 Sep-14 OD 0.100 0.008 neg 0.015 neg

89114 Trinity Biotech Captia Measles IgM ELISA Eti-Max 3000 095 Aug-14 S/CO 1.1 0.047 neg 0.075 neg

89127 Trinity Biotech Captia Measles IgM ELISA - 2326060-032 Jan-15 S/CO 1.10 0.155 neg 0.344 neg

89148 Trinity Biotech Captia Measles IgM ELISA - 034 Dec-14 S/CO 1.10 0.05 neg 0.15 neg

91267 Trinity Biotech Captia Measles IgM ELISA - 093 Aug-14 S/CO 1.10 0.06 neg 0.11 neg







Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

91487 Trinity Biotech Captia Measles IgM ELISA Triturus 93 Aug-14 S/CO 1.10 0.06 neg 0.11 neg

89260 Vircell Measles ELISA IgG/IgM ELISA - 14EMEA101 Feb-16 S/CO 1.1 0.09 neg 0.24 neg

89036 VIROTECH SEKISUI VIROTECH ELISA - 115-02 Feb-15 OD 11 2.5 neg 3.9 neg

89342 Due to manufacturer shortages in test kit reagents survey samples were not tested

Measles Total Antibody for Survey P3:2014:3E & 3F

Part Manufacturer Kit Name Method Lot No. Expiry Date Units

Cut Off

Value 3E

Result 3E

Value 3F

Result 3F

21375 Siemens Healthcare Diagnostics Measles CF Antigen CFT SIB.BS Sep-21 titre 32 <8 NS N/A AC

89132 Virion Measles CFT CFT SIB.B5 Aug-14 titre 80 <10 NS 160 AC

Documents

Survey P3:2014: 3E & 3F Final Generic Report Vaccine ...dataentry.rcpaqap.com.au/serology/admin/documentadmin/documen… · Pre-issue testing: VIDRL, VIC. Analysis of Results For