I N S T A N D e. V. INSTAND-Geschäftsstelle Gesellschaft ... · EQAS Adviser: Assistant EQAS...

I N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) in cooperation with Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM)

EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt doc. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.V. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, 40223 Düsseldorf Hindenburgdamm 27, 12203 Berlin Tel.: +49-(0)30-688197730; Fax: +49-(0)30-688197741 Tel.: +49-(0)30-84453625/23; Fax: +49-(0)30-84453626 Email: [email protected] Email: [email protected]

28 February 2014

Final Report External Quality Assessment Scheme (EQAS) – November/December 2013 Virus Immunology - Epstein Barr Virus (352)

(Tests for anti-EBNA, anti-EA, anti-VCA, anti-EBV and heterophilic antibodies) INSTAND-Target Value Laboratories: Medizinische Hochschule Hannover, Institut für Virologie, Nationales Konsiliarlaboratorium für Epstein Barr Virus (EBV) und humanes Herpes-Virus (HHV) 6, 7, 8, Prof. Dr. T Schulz, Dr. W. Puppe, Dr. C. Schmitt Labor Enders, Institut für Virologie, Infektiologie und Epidemiologie, Stuttgart: Prof. Dr. G. Enders & Partner Uniklinik Köln, Institut für Virologie, Nationales Referenzzentrum für Papillom- und Polyomaviren: Prof. Dr. H. Pfister, Prof. Dr. U. Wieland, Dr. R. Kaiser Universität Duisburg-Essen, Universitätsklinikum Essen, Institut für Virologie, Nationales Referenzzentrum für Hepatitis-C-Viren, Nationales Konsiliarlaboratorium für Tollwut: Prof. Dr. U. Dittmer, Prof. Dr. S. Ross, Prof. Dr. M. Roggendorf Universität Regensburg, Institut für Medizinische Mikrobiologie und Hygiene, Bereich Klinische Virologie und Infektionsimmunologie, Nationales Konsiliarlaboratorium für HAV und HEV: Prof. Dr. W. Jilg, Dr. J. Wenzel Universitätsklinikum Jena, Institut für Virologie und Antivirale Therapie, Nationales Konsiliarlaboratorium für HSV und VZV: Prof. Dr. A. Sauerbrei, Prof. Dr. P. Wutzler Universitätsklinikum Frankfurt, Institut für Medizinische Virologie, Frankfurt/Main, Nationales Referenzzentrum für Retroviren: Prof. Dr. O. T. Keppler, Prof. Dr. H. Rabenau, PD Dr. A. Berger, PD Dr. M. Stürmer Universitätsklinikum Freiburg, Institut für Medizinische Mikrobiologie und Hygiene, Abteilung Virologie: Dr. D. Huzly, PD Dr. M. Panning, Prof. Dr. D. Neumann-Haefelin Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar; Prof. Dr. S. Smola, Prof. Dr. N. Müller-Lantzsch

INSTAND-Geschäftsstelle Ubierstr. 20 40223 Düsseldorf Telefon: +49 (0)211 1592 13 0 Fax: +49 (0)211 1592 1330 E-mail: [email protected] Internet: www.instand-ev.de

352 Epstein Barr Virus November December 2013 Letter 20140228c 1

mailto:[email protected]

mailto:[email protected]

http://www.instand-ev.de/

Dear colleagues, Below please find the final report of the INSTAND External Quality Assessment (EQA) scheme

"Virus Immunology - Epstein Barr virus" (352) November/December 2013.

we would like to inform you again about the new virological INSTAND EQA schemes that are performed on a regular basis from 2014 on:

• Four additional training programs for virus genome detection of CMV, HBV, HCV and HIV-1 (RNA), respectively, containing low virus concentrations

• 15 new EQA schemes • Survey for planned EQA schemes We refer for more details to • the attached information on new virological EQA schemes

(as of 03 February 2014) • the INSTAND ordering documents 2014

For the EQA scheme "Virus Immunology - Epstein Barr virus" (352) November/December 2013 you receive the following participation documents by mail:

• certificate of successful participation, • statement of participation, • statement of individual results. Release of final reports of EQA schemes in virus diagnostics Each final report of a defined EQA scheme will be released on the INSTAND homepage immediately after completion as PDF file under "EQAS / Reports / Year and Category (Virus immunology)" in English language (http://www.instandev.de/en/eqas/reports/ ) and in German language (http://www.instandev.de/ringversuche/kommentare/ ). Information on new RiliBÄK (Guideline of the German Medical Association) You have already been informed about changes as to the INSTAND External Quality Assessment (EQA) schemes in virus diagnostics in recent final EQA scheme reports and postal mailings.

We refer for more details to • the information INSTAND EQA schemes in virus diagnostics

and the new RiliBÄK (as of 24 January 2014)


http://www.instandev.de/uploads/tx_nfextinstandpdf/Information_about_the_new_virological_INSTAND-EQAS_20140203b.pdf

http://www.instandev.de/en/eqas.html

http://www.instandev.de/en/eqas/reports/

http://www.instandev.de/ringversuche/kommentare/

http://www.instandev.de/uploads/tx_nfextinstandpdf/Info_virol_EQASs_-_new_RiliBAEK_and_organisation_as_of_24_January_2014_20140124a.pdf

http://www.instandev.de/uploads/tx_nfextinstandpdf/Information_about_the_new_virological_INSTAND-EQAS_20140203b.pdf�

http://www.instandev.de/en/eqas.html�

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1 Evaluation criteria for the results of this EQA scheme

The certificate of successful participation of a defined EQA scheme in virus diagnostics is assigned to a defined test category. This EQA scheme comprises the following test categories:

10. anti-EBNA total IgG 15. anti-EBNA 1-IgG 20. anti-EBNA 1+2-IgG 25. anti-EBNA-IgM 29. other tests for anti-EBNA 30. anti-EA-IgG 35. anti-EA-IgA 40. anti-EA-IgM 49. other tests for anti-EA 50. anti-VCA-IgG 55. anti-VCA-IgA 60. anti-VCA-IgM 69. other tests for anti-VCA 70. anti-EBV-IgG (without differentiation of antigen specificity) 75. anti-EBV-IgA (without differentiation of antigen specificity) 80. anti-EBV-IgM (without differentiation of antigen specificity) 81. other tests for anti-EBV 82. immunoblot assays for anti-EBV (without differentiation of antibody classes) 83. strip immunoblot assay (Strip IA) for anti-EBV-IgG 85. strip immunoblot assay (Strip IA) for anti-EBV-IgA 87. strip immunoblot assay (Strip IA) for anti-EBV-IgM 90. heterophilic antibodies 110. avidity of anti-EBNA total 115. avidity of anti-EBNA 1 120. avidity of anti-EBNA 1+2 130. avidity of anti-EA 150. avidity of anti-VCA 170. avidity of anti-EBV (without differentiation of antigen specificity) 182. avidity of anti-EBV (without differentiation of antibody classes) 183. avidity of anti-EBV 199. clinical interpretation of the tested samples

These test categories are individually evaluated in the certificate of successful participation and listed in all participation documents and final reports.

The evaluation criteria for the results of EQA schemes for the detection of virus specific antibodies follow the new Guideline of the German Medical Association, RiliBÄK section E 2 (specific requirements on EQA schemes for qualitative laboratory medical analyses = Spezielle Anforderungen an Ringversuche bei qualitativen laboratoriumsmedizinischen Untersuchungen). For receiving a certificate of successful participation for a defined EQA scheme it is required that you analyzed all samples of the sample set correctly with the same method in the corresponding test categories (100% correct results according to the target values).

Please note: A corresponding proceeding is applied for tests for virus antigen and genome detection. Specifications will follow.

Example - Program "Virus immunology - Epstein Barr virus" (352): Both samples of the sample set have to be tested correctly with the same method in test category 10 "anti-EBNA total IgG". The same applies for test categories 15 to 199 of this EQA scheme.


2 Sample properties, target values, results and success rates

Below please find the requirements for reporting the results in respect to the listed test categories. Details on sample properties, target values, results and success rates for all methods are displayed in Table 1.

Test categories 10 to 90: You were requested to report the results qualitatively as "positive“, "negative“ or "borderline“ and additionally as titer values or units/ml (U/ml). You were asked to link the results as titer values or U/ml with a qualitative statement.

The reporting of values as titer or U/ml with >= or <= was not considered.

Please note that we asked you to report also the raw data of your test results (e.g. s/co, index etc.). We will start to show the evaluations of these raw data in due time.

Only qualitative results were considered for receiving a certificate of successful participation in this EQA scheme.

Test category 110 to 183: You were requested to report the avidity for antibody positive samples qualitatively as "high" and "low", respectively, and as percent value. Avidity results were not required for negative samples.

A result was not considered for evaluation in case you had specified that this result should only be taken as additional information and ignored as valid result.

Test category 199: You were requested to give a clinical interpretation of the status of infection for each of the tested samples on the basis of your results in test categories 10 to 183.

It should be stated if the sample was characteristic for: - a primary EBV infection (sample from acute infection), - a past EBV infection (convalescent sample) or - a negative sample.

A statement on an EBV reactivation was not required.

The Joint Diagnostic Council of the Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) and the Gesellschaft für Virologie (GfV) recommended for the serological differentiation between a primary and past EBV infection and negative status, respectively, that tests for anti-EBNA-1-IgG (test category 15), anti-VCA-IgG (test category 50) and anti-VCA-IgM (test category 60) as well as heterophilic antibodies (test category 90) should be applied primarily.

Please see Table 1 for a summary of sample properties, target values, results and success rates.


Table 1: Summary of sample properties, target values, results and success rates

Performed tests (Test category)

Sample 352015* Sample 352016* Success rates

for both samples

in each test category&

Pool serum; sera of two healthy blood donors characteristic for a

past EBV infection

Pool serum; sera of two healthy blood donors characteristic for a

past EBV infection considered as "correct" result

success rates for all methods per sample Anti-EBNA total IgG Test category 10

positive 100% (25/25)

positive 92.0% (23/25)

92.0%& (23/25)&

Anti-EBNA 1-IgG Test category 15

positive 100% (272/272)

positive 100% (272/272)

100%& (264/264)&

Anti-EBNA 1+2-IgG Test category 20 no results reported no results reported ----

Anti-EBNA-IgM Test category 25

negative 100% (4/4)

negative 100% (4/4)

100%& (4/4)&

Anti-EA-IgG Test category 30 not evaluated#

negative 98.9% (93/94)

----

Anti-EA-IgA Test category 35 not evaluated not evaluated ----

Anti-EA-IgM Test category 40

negative 100% (4/4)

negative 100% (4/4)

100%& (4/4)&

Anti-VCA-IgG Test category 50

positive 100% (287/287)

positive 99.7% (286/287)

99.6%& (277/278)&

Anti-VCA-IgA Test category 55 not evaluated# not evaluated ----

Anti-VCA-IgM Test category 60

negative 99.7% (293/294)

negative 99.3% (292/294)

99.3%& (279/281)&

Anti-EBV-IgG (without diff.)§ Test category 70

positive 100% (35/35)

positive 100% (35/35)

100%& (35/35)&

Anti-EBV-IgA (without diff.)§ Test category 75 not evaluated# not evaluated ----

Anti-EBV-IgM (without diff.)§ Test category 80

negative 100% (32/32)

negative 96.9% (31/32)

96.9%& (31/32)&

Strip IA for anti-EBV-IgG Test category 83

positive 100% (132/132)

positive 100% (132/132)

100%& (132/132)&

Strip IA for anti-EBV-IgA Test category 85 not evaluated not evaluated ----

Strip IA for anti-EBV-IgM Test category 87

negative 98.9% (86/87)

negative 98.9% (86/87)

98.9%& (86/87)&

Heterophilic antibodies Test category 90

negative 100% (130/130)

negative 100% (130/130)

100%& (130/130)&

Avidity of anti-VCA Test category 150

qualitative: high 100% (14/14)

percent: 40-100% 100% (6/6)


percent: 40-100% 100% (6/6)

100%& (13/13)&

Avidity of anti-EBV (without diff.)§ Test category 170


percent: 40-100% 100% (2/2)


percent: 40-100% 100% (2/2)

100%& (2/2)&

Avidity of anti-EBV Test category 183


percent: ----

qualitative: high 95.2% (20/21)

percent: ----

95.2%& (20/21)&

Clinical interpretation Test category 199

past infection 98.4% (249/253)

past infection 98.8% (250/253)

98.4%& (249/253)&


Legend to Table 1:

& The success rates for both samples of the corresponding sample set of test each category refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once in the corresponding test category.

* The samples 352015 and 352016 consist of sera of different blood donors.

# The results reported revealed inconsistent and were not evaluated (marked without target value; without disadvantage for your certificate of successful participation).

§ without diff. = without differentiation of antigen specificity ________________________________________________________________________________________ Please note: A detailed description of the qualitative results for all samples including a differentiation according to the test formats and manufacturers is given in the annex to this report.

3 Annex - Tables including differentiation according to test formats, manufacturers and names of test kits:

3.1 Qualitative testing of anti-EBV (test categories 10, 15, 25, 30, 35, 40, 50, 55, 60, 70, 75, 80, 83, 85, 87, 90, 150, 170, 183 and 199) Further information on the reported values as titer, avidity in percent and U/ml, respectively, are graphically summarized for test categories 10 - 183 and available for download at the INSTAND homepage.

• Additional figures for antibody determinations

The reported titer values and U/ml, respectively, are depicted in these diagrams and are, however, not assessed due to the large variations of the individual methods (marked without target value). Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND for details. Thank you very much for your kind cooperation. Prof. Dr. H. Zeichhardt


http://www.instandev.de/uploads/tx_nfextinstandpdf/352_Epstein_Barr_Virus_November_December_2013_Zusatzgraphiken_EN_20140207.pdfhttp:/www.instandev.de/uploads/tx_nfextinstandpdf/352_Epstein_Barr_Virus_November_December_2013_Zusatzgraphiken_EN_20140207.pdf

http://www.instandev.de/uploads/tx_nfextinstandpdf/352_Epstein_Barr_Virus_November_December_2013_Zusatzgraphiken_EN_20140207.pdfhttp:/www.instandev.de/uploads/tx_nfextinstandpdf/352_Epstein_Barr_Virus_November_December_2013_Zusatzgraphiken_EN_20140207.pdf�

INSTAND e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) - www.instandev.de in cooperation with Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM)

Annex

3.1 Qualitative testing of anti-EBV

Anti-EBNA-total IgG

(Test category 10)

Anti-EBNA 1-IgG (Test categoryn 15)

Anti-EBNA-IgM

(Test category 25)

Anti-EA-IgG (Test category 30)

Anti-EA-IgA

(Test category 35)

Anti-EA-IgM (Test category 40)

Anti-VCA-IgG

(Test category 50)

Anti-VCA-IgA (Test category 55)

Anti-VCA-IgM

(Test category 60)

Anti-EBV-IgG (without differentiation of antigen specificity) (Test category 70)

Anti-EBV-IgA (without differentiation of antigen specificity)

(Test category 75)

Anti-EBV-IgM (without differentiation of antigen specificity) (Test category 80)

Strip immunoblot assay (Strip IA) for anti-EBV-IgG

(Test category 83)

Strip immunoblot assay (Strip IA) for anti-EBV-IgA (Test category 85)

Strip immunoblot assay (Strip IA) for anti-EBV-IgM

(Test category 87)

Heterophilic antibodies (Test category 90)

Avidity of anti-VCA (Test category 150)

Avidity of anti-EBV (without differentiation of antigen specificity)

(Test category 170)

Avidity of anti-EBV (Test category 183)

Clinical interpretation of the tested samples

(Test category 190)

Differentiation according to method, manufacturer and test name

352 EBV qual Deckblatt EN.doc

Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (INSTAND)in cooperation withDeutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV)Gesellschaft für Virologie e. V. (GfV)Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM)

EQAS Virology November 2013

Virus immunology Epstein-Barr virus (352)Qualitative results for sample 352015

10. Testing for anti-EBNA total-IgG : positive

Total test total positive borderline negative Success rate

25 25 0 0 100.0%

Method / Manufacturer total positive borderline negative Success rate

ELISA-anti-EBNA-tot. IgG (10) 3 3 0 0 100.0%

DIESSE - Epstein-Barr EBNA IgG 2 2 100.0%Vircell - Epstein-Barr EBNA ELISA IgG 1 1 100.0%

IFT-anti-EBNA-tot. IgG (20) 8 8 0 0 100.0%

EuroImmun - Anti-EBNA-IIFT 5 5 100.0%EuroImmun - BIOCHIP-Sequenz EBV 3 3 100.0%

ACIF-anti-EBNA-tot. IgG (30) 1 1 0 0 100.0%

in house 1 1 100.0%

other anti-EBNA-tot. IgG (99) 13 13 0 0 100.0%

bioMerieux - VIDAS EBV EBNA IgG 13 13 100.0%

Qualitative results for sample 352015

15. Testing for anti-EBNA 1-IgG : positive


272 272 0 0 100.0%


ELISA-anti-EBNA 1-IgG (10) 103 103 0 0 100.0%

EuroImmun - Anti-EBNA-1-ELISA (IgG) 26 26 100.0%Virion/Serion - ELISA classic EBNA1 IgG 19 19 100.0%NovaTec - Novagnost EBV-EBNA IgG 15 15 100.0%Virotech - EBV EBNA-1 IgG ELISA 8 8 100.0%Biotest - Anti-EBV EBNA IgG ELISA 8 8 100.0%Medac - EBV EBNA-1-IgG-ELISA PKS medac 6 6 100.0%DiaSorin - ETI-EBNA-G 5 5 100.0%Vidia - ELISA-VIDITEST anti-EBNA-1 IgG 2 2 100.0%GenBio - ImmunoWELL EBNA IgG 2 2 100.0%R-Biopharm - Ridascreen EBV EBNA IgG 2 2 100.0%in house 2 2 100.0%Orgentec - Anti-EBV (EBNA-1) IgG 2 2 100.0%Trinity Biotech - Captia EBNA-1 IgG 1 1 100.0%DRG - EBV (EBNA) IgG ELISA 1 1 100.0%TestLine - EIA EBV EBNA-1 IgG 1 1 100.0%Mikrogen - recomWell EBV EBNA IgG 1 1 100.0%IBL - EBV (EBNA-1) IgG ELISA 1 1 100.0%ImmunoLab - EBNA-1 IgG ELISA 1 1 100.0%

CvirG / LgesQ Rv=1324 7.2.2014 14:51h �� Bl. 75

Grp. 352

Qualitative results for sample 35201515. Testing for anti-EBNA 1-IgG


IFT-anti-EBNA 1-IgG (20) 2 2 0 0 100.0%

in house 2 2 100.0%

ChLIA-anti-EBNA 1-IgG (21) 127 127 0 0 100.0%

DiaSorin - LIAISON EBNA IgG 121 121 100.0%Siemens - Immulite 2000 EBV-EBNA IgG 5 5 100.0%Siemens - Immulite EBV-EBNA IgG 1 1 100.0%

CMIA-anti-EBNA 1-IgG (34) 19 19 0 0 100.0%

Abbott - Architect EBV EBNA-1 IgG 19 19 100.0%

Immunobl.-anti-EBNA 1-IgG (40) 14 14 0 0 100.0%

Mikrogen - recomLine EBV IgG 8 8 100.0%Viramed - EBV ViraStripe Test Kit IgG 3 3 100.0%EuroImmun - EBV-Profil 2 IgG EUROLINE 2 2 100.0%Virotech - EBV LINE IgG 1 1 100.0%

other anti-EBNA 1-IgG (99) 7 7 0 0 100.0%

Bio-Rad - RDT EBV IgG Assay 2 2 100.0%Bio-Rad - BioPlex 2200 EBV IgG 2 2 100.0%Virion/Serion - KBR EBV 1 1 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1 100.0%Meridian - TRU EBV G 1 1 100.0%


25. Testing for anti-EBNA-IgM : negative


4 0 0 4 100.0%


ELISA-anti-EBNA IgM (10) 4 0 0 4 100.0%

TestLine - EIA EBV EBNA-1 IgM 1 1 100.0%other manufacturers 1 1 100.0%ImmunoLab - EBNA-1 IgM ELISA 1 1 100.0%DRG - EBV (EBNA) IgM ELISA 1 1 100.0%


30. Testing for anti-EA-IgG : no evaluation


94 7 25 62


ELISA-anti-EA-IgG (10) 35 6 1 28

EuroImmun - Anti-EBV-EA-D-ELISA (IgG) 12 12Virotech - EBV EA-D IgG ELISA 6 6Virion/Serion - ELISA classic EBV EA IgG 6 6Biotest - Anti-EBV EA IgG ELISA 5 4 1TestLine - EIA EBV EA-D IgG 1 1ImmunoLab - EBV EA IgG ELISA 1 1DiaSorin - ETI-EA-G 1 1IBL - EBV EA IgG ELISA 1 1


Grp. 352

Qualitative results for sample 352015 30 Testing for anti-EA-IgG


ELISA-Anti-EA-IgG (10)

Mikrogen - recomWell EBV EA IgG 1 1in house 1 1

IFT-anti-EA-IgG (20) 12 0 0 12

EuroImmun - EBV-EA (IgG) 7 7in house 3 3EuroImmun - BIOCHIP-Sequenz EBV 2 2

ChLIA-anti-EA-IgG (21) 44 1 24 19

DiaSorin - LIAISON EA IgG 44 1 24 19

other anti-EA-IgG (99) 3 0 0 3

Bio-Rad - BioPlex 2200 EBV IgG 2 2Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1


35. Testing for anti-EA-IgA : no evaluation


4 0 0 4


ELISA-anti-EA-IgA (10) 2 0 0 2

EuroImmun - Anti-EBV-EA-D-ELISA (IgA) 1 1ImmunoLab - EBV EA IgA ELISA 1 1

IFT-anti-EA-IgA (20) 2 0 0 2

in house 2 2


40. Testing for anti-EA-IgM : negative


4 0 0 4 100.0%


ELISA-anti-EA-IgM (10) 4 0 0 4 100.0%

EuroImmun - Anti-EBV-EA-D-ELISA (IgM) 2 2 100.0%ImmunoLab - EBV EA IgM ELISA 1 1 100.0%Biotest - Anti-EBV EA IgM ELISA 1 1 100.0%


Grp. 352


50. Testing for anti-VCA-IgG : positive


287 287 0 0 100.0%


ELISA-anti-VCA-IgG (10) 94 94 0 0 100.0%

EuroImmun - Anti-EBV-CA-ELISA (IgG) 30 30 100.0%Virion/Serion - ELISA classic EBV VCA IgG 18 18 100.0%NovaTec - Novagnost EBV (VCA) IgG-ELISA 10 10 100.0%Virotech - EBV VCA IgG ELISA 7 7 100.0%DiaSorin - ETI-VCA-G 5 5 100.0%Biotest - Anti-EBV VCA IgG ELISA 4 4 100.0%Medac - EBV VCA-IgG-ELISA PKS medac 2 2 100.0%DIESSE - Epstein-Barr VCA IgG 2 2 100.0%Vidia - ELISA-VIDITEST anti-VCA EBV IgG 2 2 100.0%R-Biopharm - Ridascreen EBV VCA IgG 2 2 100.0%IBL - EBV VCA IgG ELISA 1 1 100.0%nal von Minden - LUCIO-Sero ELISA EBV VCA IgG 1 1 100.0%Orgentec - Anti-EBV (VCA) IgG 1 1 100.0%ImmunoLab - EBV VCA IgG ELISA 1 1 100.0%Trinity Biotech - Captia EBV VCA/P18 IgG 1 1 100.0%GenBio - ImmunoWELL EBV VCA IgG 1 1 100.0%TestLine - EIA EBV VCA IgG 1 1 100.0%Mast - Mastazyme VCA-IgG 1 1 100.0%Mikrogen - recomWell EBV VCA IgG 1 1 100.0%in house 1 1 100.0%DRG - EBV (VCA) IgG ELISA 1 1 100.0%Vircell - Epstein-Barr VCA ELISA IgG 1 1 100.0%

IFT-anti-VCA-IgG (20) 19 19 0 0 100.0%

in house 7 7 100.0%EuroImmun - EBV-CA (IgG) 6 6 100.0%EuroImmun - BIOCHIP-Sequenz EBV 2 2 100.0%Meridian - Merifluor EBV-VCA IgG IFA 2 2 100.0%ViroImmun - IFA EBV-(VCA) IgG 1 1 100.0%Mast - Mastfluor EBV (VCA) 1 1 100.0%

ChLIA-anti-VCA-IgG (21) 133 133 0 0 100.0%

DiaSorin - LIAISON VCA IgG 125 125 100.0%Siemens - Immulite 2000 EBV-VCA IgG 7 7 100.0%Siemens - Immulite EBV-VCA IgG 1 1 100.0%

CMIA-anti-VCA-IgG (34) 21 21 0 0 100.0%

Abbott - Architect EBV VCA IgG 21 21 100.0%

other anti-VCA-IgG (99) 20 20 0 0 100.0%

bioMerieux - VIDAS EBV VCA/EA IgG 13 13 100.0%Bio-Rad - RDT EBV IgG Assay 3 3 100.0%Bio-Rad - BioPlex 2200 EBV IgG 2 2 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1 100.0%Meridian - TRU EBV G 1 1 100.0%


Grp. 352


55. Testing for anti-VCA-IgA : no evaluation


10 4 1 5


ELISA-anti-VCA-IgA (10) 3 0 1 2

EuroImmun - Anti-EBV-CA-ELISA (IgA) 1 1ImmunoLab - EBV VCA IgA ELISA 1 1NovaTec - NovaLisa EBV (EBV-VCA) IgA 1 1

IFT-anti-VCA-IgA (20) 7 4 0 3

in house 5 2 3EuroImmun - EBV-CA (IgA ) 1 1other manufacturers 1 1


60. Testing for anti-VCA-IgM : negative


294 1 0 293 99.7%


ELISA-anti-VCA-IgM (10) 102 0 0 102 100.0%

EuroImmun - Anti-EBV-CA-ELISA (IgM) 32 32 100.0%Virion/Serion - ELISA classic EBV VCA IgM 19 19 100.0%NovaTec - Novagnost EBV (VCA) IgM-ELISA 11 11 100.0%Virotech - EBV VCA IgM ELISA 10 10 100.0%Biotest - Anit-EBV VCA IgM ELISA 5 5 100.0%Medac - EBV VCA-IgM-ELA PKS medac 4 4 100.0%DiaSorin - ETI-EBV-M reverse 4 4 100.0%DIESSE - Epstein-Barr VCA IgM 2 2 100.0%R-Biopharm - Ridascreen EBV VCA IgM 2 2 100.0%Orgentec - Anti-EBV (VCA) IgM 2 2 100.0%GenBio - ImmunoWELL EBV VCA IgM 2 2 100.0%ImmunoLab - EBV VCA IgM ELISA 1 1 100.0%IBL - EBV VCA IgM ELISA 1 1 100.0%Trinity Biotech - Capia EBV VCA IgM 1 1 100.0%Vircell - Epstein-Barr VCA ELISA IgM 1 1 100.0%Mast - Mastazyme VCA-IgM 1 1 100.0%in house 1 1 100.0%DRG - EBV (VCA) IgM ELISA 1 1 100.0%Vidia - ELISA-VIDITEST anti-VCA EBV IgM 1 1 100.0%TestLine - EIA EBV VCA IgM 1 1 100.0%

IFT-anti-VCA-IgM (20) 18 0 0 18 100.0%

EuroImmun - BIOCHIP-Sequenz EBV 4 4 100.0%in house 4 4 100.0%EuroImmun - Anti-EBV-CA-IIFT (IgM) 4 4 100.0%Meridian - Merifluor EBV-VCA IgM IFA 3 3 100.0%Viramed - Epstein-Barr Virus VCA IgM IFA 1 1 100.0%ViroImmun - IFA EBV-(VCA) IgM 1 1 100.0%Mast - Mastfluor EBV (VCA) 1 1 100.0%


Grp. 352

Qualitative results for sample 35201560. Testing for anti-VCA-IgM


ChLIA-anti-VCA-IgM (21) 132 1 0 131 99.2%

DiaSorin - LIAISON EBV IgM 125 1 124 99.2%Siemens - Immulite 2000 EBV-VCA IgM 6 6 100.0%Siemens - Immulite EBV-VCA IgM 1 1 100.0%

CMIA-anti-VCA-IgM (34) 20 0 0 20 100.0%

Abbott - Architect EBV VCA IgM 20 20 100.0%

other anti-VCA-IgM (99) 22 0 0 22 100.0%

bioMerieux - VIDAS EBV VCA IgM 14 14 100.0%Bio-Rad - RDT EBV IgM Assay 4 4 100.0%Bio-Rad - BioPlex 2200 EBV IgM 2 2 100.0%Meridian - TRU EBV M 1 1 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgM 1 1 100.0%


70. Testing for anti-EBV-IgG : positive


36 36 0 0 100.0%


ELISA-anti-EBV-IgG (10) 36 36 0 0 100.0%

Siemens - Enzygnost Anti-EBV/IgG 30 30 100.0%Virotech - EBV IgG/IgM ELISA 5 5 100.0%Human - EBV IgG ELISA 1 1 100.0%


75. Testing for anti-EBV-IgA : no evaluation


5 3 0 2


ELISA-anti-EBV-IgA (10) 5 3 0 2

Siemens - Reag Enzygnost Anti-EBV/IgM II IgA 5 3 2


Grp. 352


80. Testing for anti-EBV-IgM : negative


33 0 0 33 100.0%


ELISA-anti-EBV-IgM (10) 33 0 0 33 100.0%

Siemens - Enzygnost Anti-EBV/IgM II 27 27 100.0%Virotech - EBV IgG/IgM ELISA 4 4 100.0%Human - EBV IgM ELISA 1 1 100.0%Mikrogen - recomWell EBV IgM 1 1 100.0%


83. Strip immunoblot assay (Strip IA) for anti-EBV-IgG : positive


133 133 0 0 100.0%


Strip-Immunobl-IgG (10) 133 133 0 0 100.0%

Mikrogen - recomLine EBV IgG 84 84 100.0%Viramed - EBV ViraStripe Test Kit IgG 27 27 100.0%Virotech - EBV LINE IgG 12 12 100.0%EuroImmun - EBV-Profil 2 IgG EUROLINE 8 8 100.0%GenID - Anti-EBV-IgG-Immunoblot 1 1 100.0%EuroImmun - Anti-EBV-WESTERNBLOT (IgG) 1 1 100.0%


85. Strip immunoblot assay (Strip IA) for anti-EBV-IgA : no evaluation


21 20 0 1


Strip-Immunobl-IgA (10) 21 20 0 1

Mikrogen - recomLine EBV IgA 18 17 1Virotech - EBV LINE IgA 1 1GenID - Anti-EBV-IgM/IgA-Immunoblot 1 1Viramed - ViraStripe IgG+Anti-Hum-IgA-Konj 1 1


Grp. 352


87. Strip immunoblot assay (Strip IA) for anti-EBV-IgM : negative


88 1 0 87 98.9%


Strip-Immunobl-IgM (10) 88 1 0 87 98.9%

Mikrogen - recomLine EBV IgM 55 55 100.0%Viramed - EBV ViraStripe Test Kit IgM 16 16 100.0%Virotech - EBV LINE IgM 10 10 100.0%EuroImmun - EBV-Profil 2 IgM EUROLINE 5 5 100.0%GenID - Anti-EBV-IgM/IgA-Immunoblot 1 1 0.0%Euroimmun - Anti-EBV-WESTERNBLOT (IgM) 1 1 100.0%


90. Testing for heterophilic antibodies : negative


130 0 0 130 100.0%


Slide aggl.tests (10) 84 0 0 84 100.0%

Biokit - Monogen 35 35 100.0%Omega Diagnostics - AVITEX IM 11 11 100.0%Microgen Bioproducts - IM Absorption Kit 8 8 100.0%Lab 21 - IM Latex Test Kit 6 6 100.0%Siemens - Cellognost-Mononucleosis 6 6 100.0%Bios - Biosave IM ab latex kit 6 6 100.0%bioMerieux - Monoslide-Test EBV 3 3 100.0%Biocon - IMslide Infect. Mononucleosis 3 3 100.0%Hitado - Hitado mono 2 2 100.0%other manufacturers 2 2 100.0%Meridian - Monospot Latex 2 2 100.0%

other tests (99) 46 0 0 46 100.0%

Alere - Clearview IM 29 29 100.0%Diagonal - DiaView Mononucleose 7 7 100.0%other manufacturers 6 6 100.0%Genzyme - OSOM Mono Test 1 1 100.0%Bio-Rad - BioPlex 2200 EBV IgM 1 1 100.0%Vircell - VIRAPID MONO M&G 1 1 100.0%in house 1 1 100.0%


Grp. 352


150. Testing for avidity of anti-VCA : high

Total test total high intermed. low Success rate

14 14 0 0 100.0%

Method / Manufacturer total high intermed. low Success rate


EuroImmun - Anti-EBV-CA-ELISA Avidität 4 4 100.0%Hiss - Novitec EBV VCA IgG Avidität 2 2 100.0%Medac - EBV VCA-IgG-ELISA PKS Avidität 1 1 100.0%

IFT-anti-VCA-IgG (20) 7 7 0 0 100.0%

EuroImmun - EBV-CA (IgG) Avidität 6 6 100.0%in house 1 1 100.0%


170. Testing for avidity of anti-EBV (without diff. of Ag-spec.) : high


2 2 0 0 100.0%



Siemens - Enzygnost Anti-EBV/IgG Avidität 2 2 100.0%


183. Testing for avidity of anti-EBV : high


21 21 0 0 100.0%


Strip - Immunoblot (50) 21 21 0 0 100.0%

Mikrogen - recomLine EBV IgG Avidität 20 20 100.0% 1 1 100.0%


Grp. 352


199. Clinical interpretation of the tested samples : past infection

13

negativeacute infection past infection

Results in total: 253

249

Success rate: 98.4%


Grp. 352


10. Testing for anti-EBNA total-IgG : positive


25 23 2 0 92.0%


ELISA-anti-EBNA-tot. IgG (10) 3 3 0 0 100.0%

DIESSE - Epstein-Barr EBNA IgG 2 2 100.0%Vircell - Epstein-Barr EBNA ELISA IgG 1 1 100.0%

IFT-anti-EBNA-tot. IgG (20) 8 6 2 0 75.0%

EuroImmun - Anti-EBNA-IIFT 5 3 2 60.0%EuroImmun - BIOCHIP-Sequenz EBV 3 3 100.0%

ACIF-anti-EBNA-tot. IgG (30) 1 1 0 0 100.0%

in house 1 1 100.0%

other anti-EBNA-tot. IgG (99) 13 13 0 0 100.0%

bioMerieux - VIDAS EBV EBNA IgG 13 13 100.0%


15. Testing for anti-EBNA 1-IgG : positive


272 272 0 0 100.0%


ELISA-anti-EBNA 1-IgG (10) 103 103 0 0 100.0%

EuroImmun - Anti-EBNA-1-ELISA (IgG) 26 26 100.0%Virion/Serion - ELISA classic EBNA1 IgG 19 19 100.0%NovaTec - Novagnost EBV-EBNA IgG 15 15 100.0%Virotech - EBV EBNA-1 IgG ELISA 8 8 100.0%Biotest - Anti-EBV EBNA IgG ELISA 8 8 100.0%Medac - EBV EBNA-1-IgG-ELISA PKS medac 6 6 100.0%DiaSorin - ETI-EBNA-G 5 5 100.0%GenBio - ImmunoWELL EBNA IgG 2 2 100.0%R-Biopharm - Ridascreen EBV EBNA IgG 2 2 100.0%Vidia - ELISA-VIDITEST anti-EBNA-1 IgG 2 2 100.0%Orgentec - Anti-EBV (EBNA-1) IgG 2 2 100.0%in house 2 2 100.0%DRG - EBV (EBNA) IgG ELISA 1 1 100.0%Trinity Biotech - Captia EBNA-1 IgG 1 1 100.0%ImmunoLab - EBNA-1 IgG ELISA 1 1 100.0%IBL - EBV (EBNA-1) IgG ELISA 1 1 100.0%Mikrogen - recomWell EBV EBNA IgG 1 1 100.0%TestLine - EIA EBV EBNA-1 IgG 1 1 100.0%

IFT-anti-EBNA 1-IgG (20) 2 2 0 0 100.0%

in house 2 2 100.0%

ChLIA-anti-EBNA 1-IgG (21) 127 127 0 0 100.0%

DiaSorin - LIAISON EBNA IgG 121 121 100.0%Siemens - Immulite 2000 EBV-EBNA IgG 5 5 100.0%Siemens - Immulite EBV-EBNA IgG 1 1 100.0%


Grp. 352

Qualitative results for sample 35201615. Testing for anti-EBNA 1-IgG


CMIA-anti-EBNA 1-IgG (34) 19 19 0 0 100.0%

Abbott - Architect EBV EBNA-1 IgG 19 19 100.0%

Immunobl.-anti-EBNA 1-IgG (40) 14 14 0 0 100.0%

Mikrogen - recomLine EBV IgG 8 8 100.0%Viramed - EBV ViraStripe Test Kit IgG 3 3 100.0%EuroImmun - EBV-Profil 2 IgG EUROLINE 2 2 100.0%Virotech - EBV LINE IgG 1 1 100.0%

other anti-EBNA 1-IgG (99) 7 7 0 0 100.0%

Bio-Rad - BioPlex 2200 EBV IgG 2 2 100.0%Bio-Rad - RDT EBV IgG Assay 2 2 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1 100.0%Virion/Serion - KBR EBV 1 1 100.0%Meridian - TRU EBV G 1 1 100.0%


25. Testing for anti-EBNA-IgM : negative


4 0 0 4 100.0%


ELISA-anti-EBNA IgM (10) 4 0 0 4 100.0%

TestLine - EIA EBV EBNA-1 IgM 1 1 100.0%other manufacturers 1 1 100.0%ImmunoLab - EBNA-1 IgM ELISA 1 1 100.0%DRG - EBV (EBNA) IgM ELISA 1 1 100.0%


30. Testing for anti-EA-IgG : negative


94 0 1 93 98.9%


ELISA-anti-EA-IgG (10) 35 0 0 35 100.0%

EuroImmun - Anti-EBV-EA-D-ELISA (IgG) 12 12 100.0%Virion/Serion - ELISA classic EBV EA IgG 6 6 100.0%Virotech - EBV EA-D IgG ELISA 6 6 100.0%Biotest - Anti-EBV EA IgG ELISA 5 5 100.0%ImmunoLab - EBV EA IgG ELISA 1 1 100.0%TestLine - EIA EBV EA-D IgG 1 1 100.0%IBL - EBV EA IgG ELISA 1 1 100.0%in house 1 1 100.0%Mikrogen - recomWell EBV EA IgG 1 1 100.0%DiaSorin - ETI-EA-G 1 1 100.0%

IFT-anti-EA-IgG (20) 12 0 0 12 100.0%

EuroImmun - EBV-EA (IgG) 7 7 100.0%in house 3 3 100.0%EuroImmun - BIOCHIP-Sequenz EBV 2 2 100.0%


Grp. 352

Qualitative results for sample 35201630. Testing for anti-EA-IgG


ChLIA-anti-EA-IgG (21) 44 0 1 43 97.7%

DiaSorin - LIAISON EA IgG 44 1 43 97.7%

other anti-EA-IgG (99) 3 0 0 3 100.0%

Bio-Rad - BioPlex 2200 EBV IgG 2 2 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1 100.0%


35. Testing for anti-EA-IgA : no evaluation


4 0 0 4


ELISA-anti-EA-IgA (10) 2 0 0 2

EuroImmun - Anti-EBV-EA-D-ELISA (IgA) 1 1ImmunoLab - EBV EA IgA ELISA 1 1

IFT-anti-EA-IgA (20) 2 0 0 2

in house 2 2


40. Testing for anti-EA-IgM : negative


4 0 0 4 100.0%


ELISA-anti-EA-IgM (10) 4 0 0 4 100.0%

EuroImmun - Anti-EBV-EA-D-ELISA (IgM) 2 2 100.0%Biotest - Anti-EBV EA IgM ELISA 1 1 100.0%ImmunoLab - EBV EA IgM ELISA 1 1 100.0%


50. Testing for anti-VCA-IgG : positive


287 286 1 0 99.7%



EuroImmun - Anti-EBV-CA-ELISA (IgG) 30 30 100.0%Virion/Serion - ELISA classic EBV VCA IgG 18 18 100.0%NovaTec - Novagnost EBV (VCA) IgG-ELISA 10 10 100.0%Virotech - EBV VCA IgG ELISA 7 6 1 85.7%DiaSorin - ETI-VCA-G 5 5 100.0%Biotest - Anti-EBV VCA IgG ELISA 4 4 100.0%Medac - EBV VCA-IgG-ELISA PKS medac 2 2 100.0%


Grp. 352

Qualitative results for sample 352016 50 Testing for anti-VCA-IgG


ELISA-Anti-VCA-IgG (10)

DIESSE - Epstein-Barr VCA IgG 2 2 100.0%Vidia - ELISA-VIDITEST anti-VCA EBV IgG 2 2 100.0%R-Biopharm - Ridascreen EBV VCA IgG 2 2 100.0%IBL - EBV VCA IgG ELISA 1 1 100.0%GenBio - ImmunoWELL EBV VCA IgG 1 1 100.0%TestLine - EIA EBV VCA IgG 1 1 100.0%Trinity Biotech - Captia EBV VCA/P18 IgG 1 1 100.0%Vircell - Epstein-Barr VCA ELISA IgG 1 1 100.0%ImmunoLab - EBV VCA IgG ELISA 1 1 100.0%DRG - EBV (VCA) IgG ELISA 1 1 100.0%in house 1 1 100.0%Mikrogen - recomWell EBV VCA IgG 1 1 100.0%nal von Minden - LUCIO-Sero ELISA EBV VCA IgG 1 1 100.0%Orgentec - Anti-EBV (VCA) IgG 1 1 100.0%Mast - Mastazyme VCA-IgG 1 1 100.0%

IFT-anti-VCA-IgG (20) 19 19 0 0 100.0%

in house 7 7 100.0%EuroImmun - EBV-CA (IgG) 6 6 100.0%Meridian - Merifluor EBV-VCA IgG IFA 2 2 100.0%EuroImmun - BIOCHIP-Sequenz EBV 2 2 100.0%Mast - Mastfluor EBV (VCA) 1 1 100.0%ViroImmun - IFA EBV-(VCA) IgG 1 1 100.0%

ChLIA-anti-VCA-IgG (21) 133 133 0 0 100.0%

DiaSorin - LIAISON VCA IgG 125 125 100.0%Siemens - Immulite 2000 EBV-VCA IgG 7 7 100.0%Siemens - Immulite EBV-VCA IgG 1 1 100.0%

CMIA-anti-VCA-IgG (34) 21 21 0 0 100.0%

Abbott - Architect EBV VCA IgG 21 21 100.0%

other anti-VCA-IgG (99) 20 20 0 0 100.0%

bioMerieux - VIDAS EBV VCA/EA IgG 13 13 100.0%Bio-Rad - RDT EBV IgG Assay 3 3 100.0%Bio-Rad - BioPlex 2200 EBV IgG 2 2 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgG 1 1 100.0%Meridian - TRU EBV G 1 1 100.0%


55. Testing for anti-VCA-IgA : no evaluation


10 1 0 9


ELISA-anti-VCA-IgA (10) 3 0 0 3

NovaTec - NovaLisa EBV (EBV-VCA) IgA 1 1ImmunoLab - EBV VCA IgA ELISA 1 1EuroImmun - Anti-EBV-CA-ELISA (IgA) 1 1

IFT-anti-VCA-IgA (20) 7 1 0 6

in house 5 5other manufacturers 1 1EuroImmun - EBV-CA (IgA ) 1 1


Grp. 352


60. Testing for anti-VCA-IgM : negative


294 1 1 292 99.3%


ELISA-anti-VCA-IgM (10) 102 0 1 101 99.0%

EuroImmun - Anti-EBV-CA-ELISA (IgM) 32 1 31 96.9%Virion/Serion - ELISA classic EBV VCA IgM 19 19 100.0%NovaTec - Novagnost EBV (VCA) IgM-ELISA 11 11 100.0%Virotech - EBV VCA IgM ELISA 10 10 100.0%Biotest - Anit-EBV VCA IgM ELISA 5 5 100.0%DiaSorin - ETI-EBV-M reverse 4 4 100.0%Medac - EBV VCA-IgM-ELA PKS medac 4 4 100.0%GenBio - ImmunoWELL EBV VCA IgM 2 2 100.0%R-Biopharm - Ridascreen EBV VCA IgM 2 2 100.0%Orgentec - Anti-EBV (VCA) IgM 2 2 100.0%DIESSE - Epstein-Barr VCA IgM 2 2 100.0%TestLine - EIA EBV VCA IgM 1 1 100.0%Vircell - Epstein-Barr VCA ELISA IgM 1 1 100.0%Vidia - ELISA-VIDITEST anti-VCA EBV IgM 1 1 100.0%Trinity Biotech - Capia EBV VCA IgM 1 1 100.0%ImmunoLab - EBV VCA IgM ELISA 1 1 100.0%IBL - EBV VCA IgM ELISA 1 1 100.0%Mast - Mastazyme VCA-IgM 1 1 100.0%in house 1 1 100.0%DRG - EBV (VCA) IgM ELISA 1 1 100.0%

IFT-anti-VCA-IgM (20) 18 0 0 18 100.0%

EuroImmun - BIOCHIP-Sequenz EBV 4 4 100.0%EuroImmun - Anti-EBV-CA-IIFT (IgM) 4 4 100.0%in house 4 4 100.0%Meridian - Merifluor EBV-VCA IgM IFA 3 3 100.0%Mast - Mastfluor EBV (VCA) 1 1 100.0%Viramed - Epstein-Barr Virus VCA IgM IFA 1 1 100.0%ViroImmun - IFA EBV-(VCA) IgM 1 1 100.0%

ChLIA-anti-VCA-IgM (21) 132 1 0 131 99.2%

DiaSorin - LIAISON EBV IgM 125 1 124 99.2%Siemens - Immulite 2000 EBV-VCA IgM 6 6 100.0%Siemens - Immulite EBV-VCA IgM 1 1 100.0%

CMIA-anti-VCA-IgM (34) 20 0 0 20 100.0%

Abbott - Architect EBV VCA IgM 20 20 100.0%

other anti-VCA-IgM (99) 22 0 0 22 100.0%

bioMerieux - VIDAS EBV VCA IgM 14 14 100.0%Bio-Rad - RDT EBV IgM Assay 4 4 100.0%Bio-Rad - BioPlex 2200 EBV IgM 2 2 100.0%Zeus Scientific - Athena Multi-Lyte EBV IgM 1 1 100.0%Meridian - TRU EBV M 1 1 100.0%


Grp. 352


70. Testing for anti-EBV-IgG : positive


36 36 0 0 100.0%



Siemens - Enzygnost Anti-EBV/IgG 30 30 100.0%Virotech - EBV IgG/IgM ELISA 5 5 100.0%Human - EBV IgG ELISA 1 1 100.0%


75. Testing for anti-EBV-IgA : no evaluation


5 0 0 5


ELISA-anti-EBV-IgA (10) 5 0 0 5

Siemens - Reag Enzygnost Anti-EBV/IgM II IgA 5 5


80. Testing for anti-EBV-IgM : negative


33 0 1 32 97.0%


ELISA-anti-EBV-IgM (10) 33 0 1 32 97.0%

Siemens - Enzygnost Anti-EBV/IgM II 27 27 100.0%Virotech - EBV IgG/IgM ELISA 4 1 3 75.0%Human - EBV IgM ELISA 1 1 100.0%Mikrogen - recomWell EBV IgM 1 1 100.0%


83. Strip immunoblot assay (Strip IA) for anti-EBV-IgG : positive


133 133 0 0 100.0%


Strip-Immunobl-IgG (10) 133 133 0 0 100.0%

Mikrogen - recomLine EBV IgG 84 84 100.0%Viramed - EBV ViraStripe Test Kit IgG 27 27 100.0%Virotech - EBV LINE IgG 12 12 100.0%EuroImmun - EBV-Profil 2 IgG EUROLINE 8 8 100.0%


Grp. 352

Qualitative results for sample 352016 83 Strip immunoblot assay (Strip IA) for anti-EBV-IgG


Strip-Immunobl-IgG (10)

EuroImmun - Anti-EBV-WESTERNBLOT (IgG) 1 1 100.0%GenID - Anti-EBV-IgG-Immunoblot 1 1 100.0%


85. Strip immunoblot assay (Strip IA) for anti-EBV-IgA : no evaluation


21 1 0 20


Strip-Immunobl-IgA (10) 21 1 0 20

Mikrogen - recomLine EBV IgA 18 18Viramed - ViraStripe IgG+Anti-Hum-IgA-Konj 1 1GenID - Anti-EBV-IgM/IgA-Immunoblot 1 1Virotech - EBV LINE IgA 1 1


87. Strip immunoblot assay (Strip IA) for anti-EBV-IgM : negative


88 1 0 87 98.9%


Strip-Immunobl-IgM (10) 88 1 0 87 98.9%

Mikrogen - recomLine EBV IgM 55 55 100.0%Viramed - EBV ViraStripe Test Kit IgM 16 16 100.0%Virotech - EBV LINE IgM 10 10 100.0%EuroImmun - EBV-Profil 2 IgM EUROLINE 5 5 100.0%Euroimmun - Anti-EBV-WESTERNBLOT (IgM) 1 1 100.0%GenID - Anti-EBV-IgM/IgA-Immunoblot 1 1 0.0%


90. Testing for heterophilic antibodies : negative


130 0 0 130 100.0%


Slide aggl.tests (10) 84 0 0 84 100.0%

Biokit - Monogen 35 35 100.0%Omega Diagnostics - AVITEX IM 11 11 100.0%Microgen Bioproducts - IM Absorption Kit 8 8 100.0%Siemens - Cellognost-Mononucleosis 6 6 100.0%Bios - Biosave IM ab latex kit 6 6 100.0%Lab 21 - IM Latex Test Kit 6 6 100.0%Biocon - IMslide Infect. Mononucleosis 3 3 100.0%bioMerieux - Monoslide-Test EBV 3 3 100.0%


Grp. 352

Qualitative results for sample 352016 90 Testing for heterophilic antibodies


Slide aggl.tests (10)

other manufacturers 2 2 100.0%Meridian - Monospot Latex 2 2 100.0%Hitado - Hitado mono 2 2 100.0%

other tests (99) 46 0 0 46 100.0%

Alere - Clearview IM 29 29 100.0%Diagonal - DiaView Mononucleose 7 7 100.0%other manufacturers 6 6 100.0%Bio-Rad - BioPlex 2200 EBV IgM 1 1 100.0%Vircell - VIRAPID MONO M&G 1 1 100.0%in house 1 1 100.0%Genzyme - OSOM Mono Test 1 1 100.0%


150. Testing for avidity of anti-VCA : high


14 14 0 0 100.0%



EuroImmun - Anti-EBV-CA-ELISA Avidität 4 4 100.0%Hiss - Novitec EBV VCA IgG Avidität 2 2 100.0%Medac - EBV VCA-IgG-ELISA PKS Avidität 1 1 100.0%

IFT-anti-VCA-IgG (20) 7 7 0 0 100.0%

EuroImmun - EBV-CA (IgG) Avidität 6 6 100.0%in house 1 1 100.0%


170. Testing for avidity of anti-EBV (without diff. of Ag-spec.) : high


2 2 0 0 100.0%



Siemens - Enzygnost Anti-EBV/IgG Avidität 2 2 100.0%


Grp. 352


183. Testing for avidity of anti-EBV : high


21 20 1 0 95.2%


Strip - Immunoblot (50) 21 20 1 0 95.2%

Mikrogen - recomLine EBV IgG Avidität 20 19 1 95.0% 1 1 100.0%


199. Clinical interpretation of the tested samples : past infection

12

negativeacute infection past infection

Results in total: 253

250

Success ratete: 98.8%


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