© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 1 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Survey I4:2014: 4A & 4B

Final Generic Report Infectious Mononucleosis Program

Infectious Mononucleosis Serology Report prepared and collated by: RCPAQAP Serology

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 serology@rcpaqap.com.au 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.

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 2 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

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

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

Specimen Details

Specimens are of human origin and tested negative for hepatitis B surface antigen, hepatitis C antibody and HIV. (Ref. 2014 RCPAQAP Serology Program Plan section I4:2014) 4A is a pooled serum sample diluted 1 in 10 with another serum sample that tested positive to Heterophile

antibodies, EBV VCA IgM, EBV VCA IgG and EBNA IgG antibodies. [This is the same specimen as I3:2014:3A].

Source: Laverty Pathology, North Ryde, NSW and SEALS, Prince of Wales Hospital, NSW. 4B is a serum sample that tested negative to Heterophile antibodies and EBV VCA IgM, and positive to EBV VCA

IgG and EBNA IgG antibodies. Source: SEALS, Prince of Wales Hospital, NSW.

Pre-issue testing: Douglass Hanly Moir Pathology, North Ryde, NSW.

Analysis of Results

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

Results

323 participants returned results for Heterophile Antibody.

Survey Results I4:2014 Infectious Mononucleosis

Infectious Mononucleosis - Specimen 4A equ: 1 = 0.31% pos: 322 = 99.69% Total Results =323 Consensus: pos

Infectious Mononucleosis - Specimen 4B neg: 323 = 100.00% Total Results =323 Consensus: neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 3 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Inconsistencies in this Survey

Infectious Mononucleosis

Participant Comment

Specimen 4A 89202 Result inconsistent with the consensus.

Test Group 1069 Lot number provided appears inconsistent with other participants in the same user group.

1069 Kit past the expiry date.

1168 Kit details entered in 'Other' section. Please use drop down list.

21428 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.

29045 Other users of the same lot number have a different expiry date.

38000 Other users of the same lot number have a different expiry date.

39050 Kit details entered in 'Other' section. Please use drop down list.

49011 Lot number provided appears inconsistent with other participants in the same user group.

61360 Lot number provided appears inconsistent with other participants in the same user group.

61389 Kit past the expiry date.

80940 Kit past the expiry date.

Clerical Error Participant Comment

Specimen 4A 42070 Identified a clerical error - no clerical errors featured in this survey.

Comparison of Results for Duplicate Specimens I3:2014:3A and I4:2014:4A Review of the duplicate Specimens 3A and 4A yielded consistent results (positive) from the majority of participants. Participants who returned discrepant results are listed in the table below.

Part I3:2014:3A I4:2014:4A

21475 neg pos

39018 neg pos

60008 neg pos

89202 pos equ

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 4 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

1010 Alere Clearview IM IA MON4010030 Jan-16 pos neg

1035 Alere Clearview IM IA MON3120012 Nov-15 pos neg

1100 Alere Clearview IM IA MON2110005 Oct-14 pos neg

1123 Alere Clearview IM IA MON3120012 Nov-15 pos neg

1168 Inverness medical Clearview IM IA MON3070021 Jul-15 pos neg

20008 Alere Clearview IM IA MON3120012 Nov-15 pos neg

20011 Alere Clearview IM IA MON4010030 Jan-16 pos neg

20012 Alere Clearview IM IA MON3120012 Nov-15 pos neg

20013 Alere Clearview IM IA MON2100012 Oct-14 pos neg

20014 Alere Clearview IM IA MON2110005 Oct-14 pos neg

20015 Alere Clearview IM IA MON3100204 Sep-15 pos neg

20024 Alere Clearview IM IA MON4010031 Jan-16 pos neg

21005 Alere Clearview IM IA MON3120012 Nov-15 pos neg

21050 Alere Clearview IM IA MON3040012 Mar-15 pos neg

21076 Alere Clearview IM IA MON3040012 Mar-15 pos neg

21144 Alere Clearview IM IA MON3030005 Feb-15 pos neg

21177 Alere Clearview IM IA MON3120012 Nov-15 pos neg

21191 Alere Clearview IM IA MON2090008 Aug-14 pos neg

21192 Alere Clearview IM IA MON3070022 Jul-15 pos neg

21195 Alere Clearview IM IA MON3030005 Feb-15 pos neg

21200 Alere Clearview IM IA MON4010031 Jan-16 pos neg

21222 Alere Clearview IM IA MON4030027 Mar-16 pos neg

21233 Alere Clearview IM IA MCN4010031 Jan-16 pos neg

21270 Alere Clearview IM IA MON4030027 Mar-16 pos neg

21275 Alere Clearview IM IA MON4010031 Jan-16 pos neg

21336 Alere Clearview IM IA MON4010031 Jan-16 pos neg

21343 Alere Clearview IM IA MON3070021 Jul-15 pos neg

21379 Alere Clearview IM IA MON4010030 Jan-16 pos neg

21420 Alere Clearview IM IA MON3120012 Nov-15 pos neg

21428 Alere Clearview IM IA MON2110005 Oct-10 pos neg

21434 Alere Clearview IM IA MON4010030 Jan-16 pos neg

21467 Alere Clearview IM IA MON3070021 Jul-15 pos neg

21470 Alere Clearview IM IA MON3070022 Jul-15 pos neg

21475 Alere Clearview IM IA MON2110004 Oct-14 pos neg

21499 Alere Clearview IM IA MON3070022 Jul-15 pos neg

21520 Alere Clearview IM IA MON3030005 Feb-15 pos neg

21529 Alere Clearview IM IA MON3040012 Mar-15 pos neg

21538 Alere Clearview IM IA MON3070021 Jul-15 pos neg

21562 Alere Clearview IM IA MON4030027 Mar-16 pos neg

21568 Alere Clearview IM IA MON312013 Nov-15 pos neg

21583 Alere Clearview IM IA MON3100204 Sep-15 pos neg

21605 Alere Clearview IM IA MON3070021 Jul-15 pos neg

21661 Alere Clearview IM IA MON2100013 Oct-14 pos neg

21719 Alere Clearview IM IA MON3100203 Sep-15 pos neg

21723 Alere Clearview IM IA MON3100203 Sep-15 pos neg

21724 Alere Clearview IM IA MON3070022 Jul-15 pos neg

21735 Alere Clearview IM IA MON4010031 Jan-16 pos neg

21740 Alere Clearview IM IA MON4030027 Mar-16 pos neg

21748 Alere Clearview IM IA MON2110004 Oct-14 pos neg

21749 Alere Clearview IM IA MON2100012 Oct-14 pos neg

21763 Alere Clearview IM IA MON4010031 Jan-16 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 5 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

28117 Alere Clearview IM IA MON2110005 Oct-14 pos neg

28120 Alere Clearview IM IA MON4010030 Jan-16 pos neg

28228 Alere Clearview IM IA MON4030027 Mar-16 pos neg

28248 Alere Clearview IM IA MON3030005 Feb-15 pos neg

28262 Alere Clearview IM IA MON4010031 Jan-16 pos neg

28284 Alere Clearview IM IA MON 4010031 Jan-16 pos neg

28294 Alere Clearview IM IA MON 3120012 Nov-15 pos neg

28299 Alere Clearview IM IA MON2100012 Oct-14 pos neg

28302 Alere Clearview IM IA MON3030005 Feb-15 pos neg

29002 Alere Clearview IM IA MON 4030027 Mar-16 pos neg

29003 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29004 Alere Clearview IM IA MON3120012 Nov-15 pos neg

29005 Alere Clearview IM IA MON2090007 Aug-14 pos neg

29009 Alere Clearview IM IA MON2110005 Oct-14 pos neg

29010 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29011 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29012 Alere Clearview IM IA MON3040012 Mar-15 pos neg

29014 Alere Clearview IM IA MON4010031 Jan-16 pos neg

29015 Alere Clearview IM IA MON4010031 Jan-16 pos neg

29017 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29019 Alere Clearview IM IA MON3070021 Jul-15 pos neg

29023 Alere Clearview IM IA MON3120012 Nov-15 pos neg

29025 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29026 Alere Clearview IM IA MON3040012 Mar-15 pos neg

29027 Alere Clearview IM IA MON3100203 Sep-15 pos neg

29030 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29031 Alere Clearview IM IA MON4010031 Jan-16 pos neg

29032 Alere Clearview IM IA MON2110005 Oct-14 pos neg

29036 Alere Clearview IM IA MON3100203 Sep-15 pos neg

29042 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29043 Alere Clearview IM IA MON4010030 Jan-16 pos neg

29046 Alere Clearview IM IA MON3120013 Nov-15 pos neg

29047 Alere Clearview IM IA MON2090007 Aug-14 pos neg

29050 Alere Clearview IM IA MON3070021 Jul-15 pos neg

29052 Alere Clearview IM IA MON3030005 Feb-15 pos neg

29056 Alere Clearview IM IA MON3030005 Feb-15 pos neg

29057 Alere Clearview IM IA MON3070022 Jul-15 pos neg

29059 Alere Clearview IM IA MON4010031 Jan-16 pos neg

29062 Alere Clearview IM IA MON3070022 Jul-15 pos neg

29066 Alere Clearview IM IA MON4030027 Mar-16 pos neg

29078 Alere Clearview IM IA MON4030027 Mar-16 pos neg

30005 Alere Clearview IM IA MON4010031 Jan-16 pos neg

30980 Alere Clearview IM IA MON3120012 Nov-15 pos neg

31003 Alere Clearview IM IA MON3040012 Mar-15 pos neg

31005 Alere Clearview IM IA MON3120013 Nov-15 pos neg

31036 Alere Clearview IM IA MON4010031 Jan-16 pos neg

31043 Alere Clearview IM IA MON3100204 Sep-15 pos neg

31089 Alere Clearview IM IA MON3100204 Sep-15 pos neg

31097 Alere Clearview IM IA MON3070021 Jul-15 pos neg

31126 Alere Clearview IM IA MON3120013 Nov-15 pos neg

31140 Alere Clearview IM IA MON4010031 Jan-16 pos neg

31156 Alere Clearview IM IA MON3100204 Sep-15 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 6 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

31221 Alere Clearview IM IA MON4030027 Mar-16 pos neg

31259 Alere Clearview IM IA MON4030027 Mar-16 pos neg

31293 Alere Clearview IM IA MON3070021 Jul-15 pos neg

31346 Alere Clearview IM IA MON3100204 Sep-15 pos neg

31370 Alere Clearview IM IA MON4010031 Jan-16 pos neg

31409 Alere Clearview IM IA MON4030027 Mar-16 pos neg

31440 Alere Clearview IM IA MON4030027 Mar-16 pos neg

31484 Alere Clearview IM IA MON3120013 Nov-15 pos neg

31493 Alere Clearview IM IA MON3070021 Jul-15 pos neg

31667 Alere Clearview IM IA MON3070021 Jul-15 pos neg

31700 Alere Clearview IM IA MON4010031 Jan-16 pos neg

31702 Alere Clearview IM IA MON4010031 Jan-16 pos neg

31706 Alere Clearview IM IA MON4030027 Mar-16 pos neg

31708 Alere Clearview IM IA MON3040012 Mar-15 pos neg

31729 Alere Clearview IM IA MON3040012 Mar-15 pos neg

31765 Alere Clearview IM IA MON4070031 Jan-16 pos neg

38000 Alere Clearview IM IA MON4030027 Apr-16 pos neg

38300 Alere Clearview IM IA MON4030027 Mar-16 pos neg

38302 Alere Clearview IM IA MON4010031 Jan-16 pos neg

38319 Alere Clearview IM IA MON4010031 Jan-16 pos neg

38325 Alere Clearview IM IA MON3040012 Mar-15 pos neg

38326 Alere Clearview IM IA MON4030027 Mar-16 pos neg

38327 Alere Clearview IM IA MON3100203 Sep-15 pos neg

38372 Alere Clearview IM IA MON4010031 Jan-16 pos neg

38375 Alere Clearview IM IA MON3120012 Nov-15 pos neg

38378 Alere Clearview IM IA MON3100204 Sep-15 pos neg

38400 Alere Clearview IM IA MON3070021 Jul-15 pos neg

38403 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39000 Alere Clearview IM IA MON4010031 Jan-16 pos neg

39001 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39002 Alere Clearview IM IA MON3070022 Jul-15 pos neg

39004 Alere Clearview IM IA M0N4010030 Jan-16 pos neg

39006 Alere Clearview IM IA MON4010030 Jan-16 pos neg

39008 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39012 Alere Clearview IM IA MON3100204 Sep-15 pos neg

39015 Alere Clearview IM IA MON3120013 Nov-15 pos neg

39017 Alere Clearview IM IA MON4030027 Mar-16 pos neg

39018 Alere Clearview IM IA MON3040012 Mar-15 pos neg

39023 Alere Clearview IM IA MON4010031 Jan-16 pos neg

39024 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39027 Alere Clearview IM IA MON4030027 Mar-16 pos neg

39029 Alere Clearview IM IA MON4010031 Jan-16 pos neg

39031 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39037 Alere Clearview IM IA MON4010031 Jan-16 pos neg

39046 Alere Clearview IM IA MON3040012 Mar-15 pos neg

39047 Alere Clearview IM IA MON3070021 Jul-15 pos neg

39050 Alere Clearview IM 1A MON4030027 Mar-16 pos neg

39051 Alere Clearview IM IA MON3120012 Nov-15 pos neg

39052 Alere Clearview IM IA MON4030027 Mar-16 pos neg

39053 Alere Clearview IM IA MON4010030 Jan-16 pos neg

39054 Alere Clearview IM IA MON4030027 Mar-16 pos neg

39056 Alere Clearview IM IA MON4030027 Mar-16 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 7 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

41011 Alere Clearview IM IA MON3030005 Feb-15 pos neg

41018 Alere Clearview IM IA MON 4010031 Jan-16 pos neg

41021 Alere Clearview IM IA MON3120013 Nov-15 pos neg

41062 Alere Clearview IM IA MON4030027 Mar-16 pos neg

41080 Alere Clearview IM IA MON3100204 Sep-15 pos neg

41092 Alere Clearview IM IA MON4010031 Jan-16 pos neg

41123 Alere Clearview IM IA MON4010030 Jan-16 pos neg

41125 Alere Clearview IM IA MON4030027 Mar-16 pos neg

41148 Alere Clearview IM IA MON3070021 Jul-15 pos neg

41160 Alere Clearview IM IA MON3100204 Sep-15 pos neg

41181 Alere Clearview IM IA MON2090008 Aug-14 pos neg

41182 Alere Clearview IM IA MON3030005 Feb-15 pos neg

41187 Alere Clearview IM IA MON3070021 Jul-15 pos neg

41194 Alere Clearview IM IA MON3120013 Nov-15 pos neg

41195 Alere Clearview IM IA MON4010030 Jan-16 pos neg

41199 Alere Clearview IM IA MON3120013 Nov-15 pos neg

41206 Alere Clearview IM IA MON4030027 Mar-16 pos neg

41207 Alere Clearview IM IA MON3070021 Jul-15 pos neg

41210 Alere Clearview IM IA MON3120012 Nov-15 pos neg

41432 Alere Clearview IM IA MON2100012 Oct-14 pos neg

41642 Alere Clearview IM IA MON3040012 Mar-15 pos neg

42002 Alere Clearview IM IA MON3070021 Jul-15 pos neg

42013 Alere Clearview IM IA MON4010030 Jan-16 pos neg

42028 Alere Clearview IM IA MON2110005 Oct-14 pos neg

42029 Alere Clearview IM IA MON3070021 Jul-15 pos neg

42070 Alere Clearview IM IA MON3100203 Sep-15 pos neg

42129 Alere Clearview IM IA MON2100012 Oct-14 pos neg

42137 Alere Clearview IM IA MON3120012 Nov-15 pos neg

42200 Alere Clearview IM IA MON3070022 Jul-15 pos neg

42225 Alere Clearview IM IA MON3100203 Sep-15 pos neg

42239 Alere Clearview IM IA MON4010031 Jan-16 pos neg

42375 Alere Clearview IM IA MON3070021 Jul-15 pos neg

42430 Alere Clearview IM IA MON4010031 Jan-16 pos neg

42447 Alere Clearview IM IA MON4010031 Jan-16 pos neg

42492 Alere Clearview IM IA MON3120012 Nov-15 pos neg

42493 Alere Clearview IM IA MON3100203 Sep-15 pos neg

48410 Alere Clearview IM IA MON2110005 Oct-14 pos neg

48422 Alere Clearview IM IA MON4030027 Mar-16 pos neg

49000 Alere Clearview IM IA MON4030027 Mar-16 pos neg

49001 Alere Clearview IM IA MON3100204 Sep-15 pos neg

49002 Alere Clearview IM IA MON3070022 Jul-15 pos neg

49005 Alere Clearview IM IA MON4030027 Mar-16 pos neg

49008 Alere Clearview IM IA MON3120012 Nov-15 pos neg

49010 Alere Clearview IM IA MON3120012 Nov-15 pos neg

49011 Alere Clearview IM IA 3100204 Sep-15 pos neg

49012 Alere Clearview IM IA MON3120013 Nov-15 pos neg

49016 Alere Clearview IM IA MON4030027 Mar-16 pos neg

49022 Alere Clearview IM IA MON2110005 Oct-14 pos neg

49023 Alere Clearview IM IA MON3120013 Nov-15 pos neg

49028 Alere Clearview IM IA MON4030027 Mar-16 pos neg

49029 Alere Clearview IM IA MON3030005 Feb-15 pos neg

49030 Alere Clearview IM IA MON3070021 Jul-15 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 8 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

49035 Alere Clearview IM IA MON3070022 Jul-15 pos neg

49036 Alere Clearview IM IA MON3120012 Nov-15 pos neg

50005 Alere Clearview IM IA MON4010031 Jan-16 pos neg

51022 Alere Clearview IM IA MON4010030 Jan-16 pos neg

51031 Alere Clearview IM IA MON4010031 Jan-16 pos neg

51063 Alere Clearview IM IA MON 4030027 Mar-16 pos neg

51080 Alere Clearview IM IA MON3070021 Jul-15 pos neg

51082 Alere Clearview IM IA MON3040012 Mar-15 pos neg

51096 Alere Clearview IM IA MON2100013 Oct-14 pos neg

51099 Alere Clearview IM IA MON3120012 Nov-15 pos neg

51100 Alere Clearview IM IA MON3120012 Nov-15 pos neg

51118 Alere Clearview IM IA MON3070021 Jul-15 pos neg

51120 Alere Clearview IM IA MON3040012 Mar-15 pos neg

51426 Alere Clearview IM IA MON3120012 Nov-15 pos neg

51437 Alere Clearview IM IA MON4030027 Mar-16 pos neg

53003 Alere Clearview IM IA MON3120012 Nov-15 pos neg

53004 Alere Clearview IM IA MON3100204 Sep-15 pos neg

59004 Alere Clearview IM IA MON3070021 Jul-15 pos neg

59005 Alere Clearview IM IA MON3100204 Sep-15 pos neg

59006 Alere Clearview IM IA MON4010030 Jan-16 pos neg

59007 Alere Clearview IM IA MON3030005 Feb-15 pos neg

60000 Alere Clearview IM IA MON3120012 Nov-15 pos neg

60006 Alere Clearview IM IA MON3070022 Jul-15 pos neg

60007 Alere Clearview IM IA MON3100203 Sep-15 pos neg

60008 Alere Clearview IM IA MON4010031 Jan-16 pos neg

60009 Alere Clearview IM IA MON3100013 Nov-15 pos neg

61012 Alere Clearview IM IA MON3120012 Nov-15 pos neg

61020 Alere Clearview IM IA MON3120013 Nov-15 pos neg

61021 Alere Clearview IM IA MON2110004 Oct-14 pos neg

61022 Alere Clearview IM IA MON2110004 Oct-14 pos neg

61023 Alere Clearview IM IA MON3120012 Nov-15 pos neg

61024 Alere Clearview IM IA MON4010031 Jan-16 pos neg

61025 Alere Clearview IM IA MON 3030005 Feb-15 pos neg

61026 Alere Clearview IM IA MON3100203 Sep-15 pos neg

61027 Alere Clearview IM IA MON3120012 Nov-15 pos neg

61028 Alere Clearview IM IA MON3070022 Jul-15 pos neg

61035 Alere Clearview IM IA MON312012 Nov-15 pos neg

61255 Alere Clearview IM IA MON3100203 Sep-15 pos neg

61451 Alere Clearview IM IA MON4010030 Jan-16 pos neg

61455 Alere Clearview IM IA MON4010031 Jan-16 pos neg

68620 Alere Clearview IM IA MON3100203 Sep-15 pos neg

68621 Alere Clearview IM IA MON3040012 Mar-15 pos neg

68622 Alere Clearview IM IA MON2090007 Aug-14 pos neg

68634 Alere Clearview IM IA MON3120013 Nov-15 pos neg

68637 Alere Clearview IM IA MON3120013 Nov-15 pos neg

68640 Alere Clearview IM IA MON3100013 Nov-15 pos neg

68641 Alere Clearview IM IA MON4010031 Jan-16 pos neg

68643 Alere Clearview IM IA MON3070022 Jul-15 pos neg

68644 Alere Clearview IM IA MON3040012 Mar-15 pos neg

68645 Alere Clearview IM IA MON3040012 Mar-15 pos neg

71703 Alere Clearview IM IA MON3120012 Nov-15 pos neg

71704 Alere Clearview IM IA MON4010031 Jan-16 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 9 of 10

RCPA Quality Phone +61 2 9045 6000

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

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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

80940 Alere Clearview IM IA MON2060014 Jun-14 pos neg

89035 Alere Clearview IM IA MON3040012 Mar-15 pos neg

91022 Alere Clearview IM IA MON3040012 Mar-15 pos neg

91317 Alere Clearview IM IA MON3120013 Nov-15 pos neg

91482 Alere Clearview IM IA MON3100203 Sep-15 pos neg

91465 Alere Wampole ColourCard Mono Agglut 813082 Apr-15 pos neg

91493 Alere Wampole ColourCard Mono Agglut 813082 Apr-15 pos neg

92013 Alere Wampole ColourCard Mono Agglut 1113111 May-15 pos neg

21045 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

21189 Biokit Monolatex/ Monogen Latex B22895 Jan-15 pos neg

21264 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

21356 Biokit Monolatex/ Monogen Latex B22895 Jan-15 pos neg

21453 Biokit Monolatex/ Monogen Latex B22895 Jan-15 pos neg

21550 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

29028 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

29063 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

31171 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

31755 Biokit Monolatex/ Monogen Latex B22896 Jan-15 pos neg

38370 Biokit Monolatex/ Monogen Latex B22896 Jan-15 pos neg

38371 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

39005 Biokit Monolatex/ Monogen Latex B-22896 Jan-15 pos neg

39025 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

51435 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

51436 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

59000 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

61360 Biokit Monolatex/ Monogen Latex 822896 Jan-15 pos neg

61374 Biokit Monolatex/ Monogen Latex B22896 Jan-15 pos neg

61389 Biokit Monolatex/ Monogen Latex B22316 Jun-14 pos neg

61395 Biokit Monolatex/ Monogen Latex B22896 Jan-15 pos neg

61470 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

68612 Biokit Monolatex/ Monogen Latex B23191 Apr-15 pos neg

68638 Biokit Monolatex/ Monogen Latex B 23191 Apr-15 pos neg

68648 Biokit Monolatex/ Monogen Latex B22896 Jan-15 pos neg

71024 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

71025 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

71358 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

71700 Biokit Monolatex/ Monogen Latex B23285 Apr-15 pos neg

89202 DiproMed Mononucleosis ICT 304002 Mar-15 equ neg

89277 Fumouze MNI Test Agglut 8377 Sep-14 pos neg

21147 Immunostics Immuno/Lex-IM Latex 114071 Aug-15 pos neg

21238 Immunostics Immuno/Lex-IM Latex 17966 Jan-16 pos neg

21489 Immunostics Immuno/Lex-IM Latex 114071 Aug-15 pos neg

21721 Immunostics Immuno/Lex-IM Latex 813265 Jan-15 pos neg

29071 Immunostics Immuno/Lex-IM Latex 17317 Feb-15 pos neg

68646 Immunostics Monocol/Lex Clatex 1213133 May-15 pos neg

93004 Immunostics Monocol/Lex Clatex 613078 Jan-15 pos neg

© 2014 RCPA Quality Assurance Programs Pty Ltd. All rights reserved File I4-2014-im.doc Report Issued Tuesday, 12 August 2014 Page Page 10 of 10

RCPA Quality Phone +61 2 9045 6000

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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

Infectious Mononucleosis Results for Survey I4:2014:4A & 4B

Part Manufacturer Kit Name Method Lot No. Expiry Date

Result 4A

Result 4B

1014 Meridian Bioscience Monospot Latex 776150D057 Apr-15 pos neg

1069 Meridian Bioscience Monospot Latex EMS374 Sep-09 pos neg

83555 Meridian Bioscience Monospot Latex 776150D057 Apr-15 pos neg

89064 Meridian Bioscience Monospot Latex 776150D056 Jan-15 pos neg

89093 Meridian Bioscience Monospot Latex 776150D057 Apr-15 pos neg

89199 Meridian Bioscience Monospot Latex 776150D057 Apr-15 pos neg

89254 Meridian Bioscience Monospot Latex 776150D057 Apr-15 pos neg

1135 Omega Diagnostics Avitex IM Latex 7042407 Aug-15 pos neg

29045 Oxoid Infectious Mono.Test Kit Latex 368129 Dec-15 pos neg

31433 Oxoid Infectious Mono.Test Kit Latex 368129 Jan-15 pos neg

51044 Oxoid Infectious Mono.Test Kit Latex 342796 Nov-14 pos neg

53006 Oxoid Infectious Mono.Test Kit Latex 368129 Jan-15 pos neg

59001 Oxoid Infectious Mono.Test Kit Latex 368129 Jan-15 pos neg

83665 Plasmatec IM Test Kit Latex 225013 Dec-14 pos neg

83667 Plasmatec IM Test Kit Latex 268033 Jun-15 pos neg

89068 Plasmatec IM Test Kit Latex 219053 Feb-15 pos neg

89070 Plasmatec IM Test Kit Latex 239063 Jun-15 pos neg

89260 Vircell VIRapid MONO M&G ICT 14VRMONO001 Aug-15 pos neg

29063 Same lot number as previous QAP.