INSTAND e.V.€¦ · Report External Quality Assessment Scheme Group 356 Virus Immunology - Mumps Virus November/December 2014 INSTAND e.V. in cooperation with: Deutsche

Report External Quality Assessment Scheme

Group 356

Virus Immunology - Mumps Virus

November/December 2014

INSTAND e.V. in cooperation with:

Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV)

Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM)

Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Issued by:

INSTAND e.V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V. Düsseldorf/Berlin, 06.03.2015

356 Mumps Virus November December 2014 Report 20150306.doc

Report about INSTAND e.V. EQAS 356 – November/December 2014 2 of 9

EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt Priv.-Doz. 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)30-81054300; Fax: +49-(0)30-81054303 Email: [email protected] Email: [email protected]

INSTAND Target Value Laboratories

Robert Koch-Institut, Abt. Infektionskrankheiten, FG 12 Virale Infektionen, Nationales Referenzzentrum für Masern, Mumps und Röteln, Berlin: Prof. Dr. A. Mankertz

Labor Enders, Institut für Virologie, Infektiologie und Epidemiologie, Stuttgart: Prof. Dr. Gisela Enders & Partner

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 Leipzig, Institut für Virologie: Prof. Dr. U. G. Liebert

Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar: Prof. Dr. S. Smola, Prof. Dr. N. Müller-Lantzsch, Dr. J. Rissland

Uniklinik Köln, Institut für Virologie, Nationales Referenzzentrum für Papillom- und Polyomaviren: Prof. Dr. H. Pfister, Prof. Dr. U. Wieland, Dr. R. Kaiser

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

Carried out by

INSTAND e.V. Ubierstr. 20 40223 Düsseldorf Tel.: +49 (0)211 - 1592 13 0 Fax: +49 (0)211 - 1592 1330 Email: [email protected] Internet: www.instand-ev.de

mailto:[email protected]

mailto:[email protected]

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



Notes to the evaluation

Guideline of the German Medical Association (RiliBÄK) The External Quality Assessment (EQA) scheme "Virus Immunology - Mumps virus" (356) is not listed in the new Guideline of the German Medical Association (Bundesärztekammer/ RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen). However, it is performed by INSTAND e.V. in accordance to the requirements of the specified RiliBÄK Section B2 "Qualitative determinations in laboratory medicine = Qualitative laboratoriumsmedizinische Untersuchungen".

For details on the new RiliBÄK, please refer to

the revision as adopted by the Executive Board of the German Medical Association on 11 April 2014 and 20 June 2014

Release of reports of EQA schemes in virus diagnostics Each participant of this EQA scheme receives an email with a table allowing to directly open and/or save the report of the corresponding EQA scheme by clicking the respective download button.

Furthermore, each 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/).

Certificate

Participation documents are sent out by post for this EQA scheme "Virus Immunology - Mumps virus" (356) as follows:

certificate of successful participation,

statement of participation,

statement of individual results.

The certificate of successful participation of this EQA scheme lists the respective measurands/tests, assigned to defined test categories, for which the requirements of the EQA scheme are met. Each test category is individually evaluated for the certificate of successful participation and separately listed in all participation and evaluation documents.

The EQA scheme "Virus Immunology - Mumps virus" (356) comprises the following test categories:

Test categories (10) Testing for anti-mumps-IgG or anti-mumps total (11) Testing for avidity of anti-mumps-IgG (20) Testing for anti-mumps-IgM

http://www.bundesaerztekammer.de/downloads/Rili-BAEK-Laboratoriumsmedizin.pdf

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

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



Receiving a certificate of successful participation The INSTAND EQA scheme "Virus Immunology – Mumps virus" (356) is not listed in the RiliBÄK, however, it is performed by INSTAND e.V. in accordance to the requirements of the specified RiliBÄK Section B 2. 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, Specified 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). Example - Program "Virus Immunology - Mumps virus" (356): Both samples of the sample set have to be tested correctly with the same method in test category 10 "Testing for anti-mumps-IgG or anti-mumps-total". The same applies for test categories 11 and 20, respectively, of this EQA scheme.

Frequency of participation to this EQA scheme and validity of the certificates

The INSTAND EQA scheme "Virus Immunology – Mumps virus" (356) is not listed in the RiliBÄK, however, it is performed by INSTAND e.V. in accordance to the requirements of the specified RiliBÄK Section B 2. This means that the laboratory should participate in the INSTAND EQA scheme "Virus Immunology – Mumps virus" (356) twice a year. As practiced for EQA schemes regulated in the Specified RiliBÄK Section B 2, the validity period for the EQA scheme "Virus Immunology – Mumps virus" (356) is 12 months. The validity of the certificates starts with the closing date of the EQA scheme (deadline for the receipt of the participants' results). This date is printed on top of the certificates.

Statement of individual results

For this EQA scheme "Virus Immunology - Mumps virus" (356) a statement of individual results is sent out by post together with the certificate of successful participation and statement of participation.

The statement of individual results lists for each measurand/test, assigned to defined test categories, the "correct result" with the target value or target value interval as "valid results" as well as the reported result of the laboratory as "your results". This information is given line by line for each sample analyzed.

In addition a "+"-symbol indicates that a certificate of successful participation is issued for a given test category if the laboratory reached 100% correct results for all samples of a sample set according to the target values or target value intervals.

Overview of results

A summary of results is given for each of the samples in a table with a specification by test categories. A success rate is depicted for each of the samples reflecting the portion of "correct" results (expressed as "percent" correct results and as "number of correct results per number of total results reported"). In addition an overall success rate - based on the results for all samples of a sample set - is given for each of the test categories.

See Table 2 of the annotation to this report.



Deployed EQA samples

Anti-mumps-positive sera of patients or healthy blood donors are deployed in the EQA scheme "Virus Immunology - Mumps virus" (356). The positive samples are diluted in a negative serum pool of healthy blood donors. Negative samples are from a negative serum pool of healthy blood donors.

Target values

The evaluation of this EQA scheme is based on the determination of target values or target value intervals for each of the samples analyzed. Please note: Reference measurement methods for the determination of target values are not applicable for virus diagnostics.

The target value of a given EQA scheme sample - preset by the EQA scheme adviser - is confirmed by the INSTAND Target Value Laboratories prior to the distribution of the samples to the participants of this EQA scheme. The above mentioned INSTAND Target Value Laboratories test the samples for a second time during the course of the EQA scheme as regular participants. The final target value for a given sample is derived from the consensus value from all qualitative results and consensus value from all avidity results in percent. For this the results reported by the INSTAND Target Value Laboratories before and during the EQA scheme are considered.

Accepted statements of results according to the respective sample property

Qualitative results - "positive", "negative" or "borderline" (nominal characteristics) for anti-mumps-IgG or anti-mumps-total as well as anti-mumps-IgM - "high", "low" or "intermediate/no avidity/not done" (nominal characteristics) for avidity testing of anti-mumps-IgG

The statement "not done" is allowed, when an analysis was not required for an anti-mumps-IgG- negative sample. - "not done" or "no avidity" for negative samples

Results in percent for avidity testing of anti-mumps-IgG

The qualitative results and the avidity results in percent are separately evaluated. The results in percent have to be linked with a qualitative statement. The statement "not done" is allowed, when an analysis was not required for an anti-mumps-IgG-negative sample.

Results in titer values or in U/ml Results in titer values or U/ml are depicted in the figures "without target value" only for orientation without disadvantage for the certificate of successful participation. See annex 3.2 to this report.

In case the results of a given EQA scheme deviate from the preset target value, it will be investigated whether the deviating results are due to the test performance in the laboratory or to test immanent problems of commercial or in-house-tests. This investigation is performed together with the INSTAND Target Value Laboratories under the auspices of the EQA scheme adviser and in cooperation with the Joint Diagnostic Council of DVV and GfV.



Determination of evaluation intervals

For anti-mumps-IgG or anti-mumps-total as well as anti-mumps-IgM: not applicable

For avidity testing of anti-mumps-IgG: Results from avidity testing are semi-quantitative statements. Therefore a final target value derived from a consensus value from all results in percent cannot be assigned to the results for avidity testing of anti-mumps-IgG. In this case the EQA scheme adviser defines - depending on the sample properties - an evaluation interval with lower and upper percent values for avidity for each of the anti-mumps-IgG-positive samples. The reported results of a laboratory will be evaluated as "correct" or "false" result in accordance to this defined evaluation interval.



Annotation of the EQAS Adviser

Dear colleagues,

Below please find a detailed comment on the EQA scheme "Virus Immunology - Mumps virus" (356) November/December 2014 with:

Information about test categories, statement of results and evaluation criteria,

Summary of sample properties, target values, results and success rates as well as

Annexes with detailed description of all reported qualitative results, titer values, values in U/ml, as well as values in percent for avidity including differentiation according to test formats, manufacturers and names of test kits.

Number of participants in this EQA scheme: 235 laboratories 1 Test categories, statement of results and evaluation criteria for this EQA scheme The following statements of results were requested for each of the test categories in this EQA scheme which were the basis of evaluation (see Table 1):

Table 1: Test categories, statement of results and evaluation criteria

Test categories Statement of results

the following statements of results were requested

Evaluation criteria no. of correctly determined

samples for receiving a certificate of successful

participation

(10) Testing for anti-mumps-IgG or anti-mumps total

positive or

negative or

borderline

2 of 2 samples

(11) Testing for avidity of anti-mumps-IgG

positive samples high or

low or

intermediate if applicable

results in percent negative samples

not done or

no avidity

2 of 2 samples

(20) Testing for anti-mumps-IgM

positive or

negative or

borderline

2 of 2 samples

Reporting of results in the protocol sheets Only statements on qualitative results as stated in Table 1 are considered for receiving a certificate of successful participation. Results in titer values or U/ml are depicted in the figures "without target value" only for orientation without disadvantage for the certificate of successful participation. See annex 3.2 to this report.

The simultaneous reporting of different results obtained with one and the same test cannot be accepted and will be evaluated as a missing value, e.g. the simultaneous reporting of a "positive" and "borderline" result for one and the same sample will not be accepted.



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

We ask 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.

2 Summary of sample properties, target values, results and success rates

Table 2: Summary of sample properties, target values, results and success rates

Sample No.

Sample properties

Considered as "correct" results (target values /

target value intervals)

Success rates for all methods per sample

Sample source Dilu-tion

IgG/ total test

category 10

Avidity

test category

11

IgM

test category

20

IgG/ total test

category 10

Avidity

test category

11

IgM

test category

20

356019*

Serum of a healthy blood donor after a past mumps infection or vaccination

---- positive

qualitative: high

percent:

≥ 30%

negative 99.6%

(242/243)

qualitative: 100% (2/2)

percent:

100% (2/2)

99.5%

(213/214)

356020*

Serum of a healthy blood donor after a past mumps infection or vaccination

---- positive

qualitative: high

percent:

≥ 20%

negative 99.6%

(242/243)

qualitative: 100% (2/2)

percent:

100% (2/2)

99.5%

(213/214)

Success rate for both samples in test categories 10, 11 and 20, respectively&

99.6%& (232/233)&

100%& (2/2)&

99.5%& (208/209)&

& The success rates for both samples in test categories 10, 11 and 20, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once in the corresponding test category.

* For the samples 356019 and 356020 different sera from healthy blood donors were used.

Results in titer values or U/ml are depicted in the figures "without target value" (without disadvantage for the certificate of successful participation) (see annexes). A detailed description of the results for all samples of this EQA scheme "Virus Immunology - Mumps virus" (356) including a differentiation according to the test formats, manufacturers and names of test kits is given in the annexes to this report (see Section 3). 3 Annexes - Tables and figures including differentiation according to test formats, manufacturers and

names of test kits

3.1 Qualitative testing for anti-mumps (Test categories 10, 11 and 20) 3.2 Testing for anti-mumps including statements on titer values, results in U/ml and percent values for avidity, respectively (Test categories 10, 11 and 20)



We thank our colleagues of the above-mentioned INSTAND-Target Value Laboratories for their cooperation. Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND e.V. for details. Thank you very much for your kind cooperation. Sincerely yours, Prof. Dr. H. Zeichhardt P.S. We would like to inform you about the new virological INSTAND EQA schemes that are performed on a regular basis starting in 2014 and 2015, respectively:

information on new virological EQA schemes (as of 10 November 2014)

http://www.instandev.de/uploads/tx_nfextinstandpdf/Information_new_virological_INSTAND_EQAS_2014_2015_20141110a.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 for anti-mumps

Anti-mumps-IgG/total (test category 10)

Avidity (test category 11)

Anti-mumps-IgM (test category 20)

Differentiation according to method, manufacturer and test name

356 Mumpsvirus Deckblatt qual EN

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 2014

Virus immunology Mumps (356)(You will find the results as Units / volume in the attached graphics.)

Qualitative results for sample 356019

10. Testing for anti-mumps-IgG or anti-mumps total : positive

Total test total positive borderline negative Success rate

243 242 0 1 99.6%

Method / Manufacturer total positive borderline negative Success rate

ELISA-anti-Mumps-IgG (10) 173 173 0 0 100.0%

Siemens - Enzygnost Anti-Parotitis IgG 66 66 100.0%Virion/Serion - ELISA classic Mumps IgG 36 36 100.0%EuroImmun - Anti-Mumps-Viren-ELISA (IgG) 28 28 100.0%Virotech - Mumps ELISA IgG/IgM 21 21 100.0%Orgentec - Anti-Mumps Virus IgG 6 6 100.0%R-Biopharm - Ridascreen Mumpsvirus IgG 5 5 100.0%NovaTec - NovaLisa Mumps IgG ELISA 3 3 100.0%DIESSE - Mumps IgG 2 2 100.0%ImmunoLab - Mumps IgG ELISA 2 2 100.0%Human - MUMPS IgG 1 1 100.0%Demeditec - Mumps IgG ELISA 1 1 100.0%Microimmune - Mumps IgG capture EIA 1 1 100.0%Mast - Mastazyme Mumps IgG 1 1 100.0%

IFT-anti-Mumps-IgG (30) 8 8 0 0 100.0%

EuroImmun - Anti-Mumps-Viren-IIFT IgG 5 5 100.0%Mast - Mastafluor MUMPS IgG 1 1 100.0%Hemagen - Virgo Mumps IgG 1 1 100.0%Viramed - Mumps IgG IFT Testkit 1 1 100.0%

ELFA-anti-Mumps-IgG (33) 10 10 0 0 100.0%

bioMerieux - VIDAS Mumps IgG 10 10 100.0%

ChLIA-anti-Mumps-IgG (34) 51 51 0 0 100.0%

DiaSorin - LIAISON Mumps IgG 51 51 100.0%

other anti-Mumps-IgG-t. (98) 1 0 0 1 0.0%

Virion/Serion - KBR Mumps 1 1 0.0%

CvirG / LgesQ Rv=1424 29.1.2015 10:59h �� Bl. 110

Grp. 356


11. Testing for avidity of anti-mumps-IgG : high

Total test total high intermed. low Success rate

2 2 0 0 100.0%

Method / Manufacturer total high intermed. low Success rate


Siemens - Enzygnost Anti-Parotitis IgG Avidität 2 2 100.0%


20. Testing for anti-mumps-IgM : negative


214 1 0 213 99.5%


ELISA-anti-Mumps-IgM (10) 159 1 0 158 99.4%

Siemens - Enzygnost Anti-Parotitis IgM 62 62 100.0%Virion/Serion - ELISA classic Mumps IgM 29 1 28 96.6%EuroImmun - Anti-Mumps-Viren-ELISA (IgM) 24 24 100.0%Virotech - Mumps ELISA IgG/IgM 20 20 100.0%Orgentec - Anti-Mumps Virus IgM 6 6 100.0%R-Biopharm - Ridascreen Mumpsvirus IgM 4 4 100.0%DIESSE - Mumps IgM 3 3 100.0%NovaTec - NovaLisa Mumps IgM ELISA 3 3 100.0%Human - MUMPS IgM 2 2 100.0%ImmunoLab - Mumps IgM ELISA 2 2 100.0%Mast - Mastazyme Mumps IgM 1 1 100.0%Demeditec - Mumps IgM ELISA 1 1 100.0%Microimmune - Mumps IgM Screen EIA 1 1 100.0%Bio-Rad - PLATELIA Mumps IgM 1 1 100.0%

IFT-anti-Mumps-IgM (30) 9 0 0 9 100.0%

EuroImmun - Anti-Mumps-Viren-IIFT IgM 5 5 100.0%Bios - Biognost Mumps virus IgM kit 2 2 100.0%Mast - Mastafluor MUMPS IgM 1 1 100.0%Viramed - Mumps IgM IFT Testkit 1 1 100.0%

ChLIA-anti-Mumps-IgM (34) 46 0 0 46 100.0%

DiaSorin - LIAISON Mumps IgM 46 46 100.0%


Grp. 356


10. Testing for anti-mumps-IgG or anti-mumps total : positive


243 242 0 1 99.6%



Siemens - Enzygnost Anti-Parotitis IgG 66 66 100.0%Virion/Serion - ELISA classic Mumps IgG 36 36 100.0%EuroImmun - Anti-Mumps-Viren-ELISA (IgG) 28 28 100.0%Virotech - Mumps ELISA IgG/IgM 21 21 100.0%Orgentec - Anti-Mumps Virus IgG 6 6 100.0%R-Biopharm - Ridascreen Mumpsvirus IgG 5 5 100.0%NovaTec - NovaLisa Mumps IgG ELISA 3 3 100.0%DIESSE - Mumps IgG 2 2 100.0%ImmunoLab - Mumps IgG ELISA 2 2 100.0%Microimmune - Mumps IgG capture EIA 1 1 100.0%Human - MUMPS IgG 1 1 100.0%Mast - Mastazyme Mumps IgG 1 1 100.0%Demeditec - Mumps IgG ELISA 1 1 100.0%

IFT-anti-Mumps-IgG (30) 8 8 0 0 100.0%

EuroImmun - Anti-Mumps-Viren-IIFT IgG 5 5 100.0%Viramed - Mumps IgG IFT Testkit 1 1 100.0%Mast - Mastafluor MUMPS IgG 1 1 100.0%Hemagen - Virgo Mumps IgG 1 1 100.0%

ELFA-anti-Mumps-IgG (33) 10 10 0 0 100.0%

bioMerieux - VIDAS Mumps IgG 10 10 100.0%

ChLIA-anti-Mumps-IgG (34) 51 51 0 0 100.0%

DiaSorin - LIAISON Mumps IgG 51 51 100.0%

other anti-Mumps-IgG-t. (98) 1 0 0 1 0.0%

Virion/Serion - KBR Mumps 1 1 0.0%


11. Testing for avidity of anti-mumps-IgG : high

Total test total high intermed. low Success rate

2 2 0 0 100.0%

Method / Manufacturer total high intermed. low Success rate


Siemens - Enzygnost Anti-Parotitis IgG Avidität 2 2 100.0%


Grp. 356


20. Testing for anti-mumps-IgM : negative


214 1 0 213 99.5%


ELISA-anti-Mumps-IgM (10) 159 1 0 158 99.4%

Siemens - Enzygnost Anti-Parotitis IgM 62 62 100.0%Virion/Serion - ELISA classic Mumps IgM 29 1 28 96.6%EuroImmun - Anti-Mumps-Viren-ELISA (IgM) 24 24 100.0%Virotech - Mumps ELISA IgG/IgM 20 20 100.0%Orgentec - Anti-Mumps Virus IgM 6 6 100.0%R-Biopharm - Ridascreen Mumpsvirus IgM 4 4 100.0%DIESSE - Mumps IgM 3 3 100.0%NovaTec - NovaLisa Mumps IgM ELISA 3 3 100.0%Human - MUMPS IgM 2 2 100.0%ImmunoLab - Mumps IgM ELISA 2 2 100.0%Microimmune - Mumps IgM Screen EIA 1 1 100.0%Mast - Mastazyme Mumps IgM 1 1 100.0%Bio-Rad - PLATELIA Mumps IgM 1 1 100.0%Demeditec - Mumps IgM ELISA 1 1 100.0%

IFT-anti-Mumps-IgM (30) 9 0 0 9 100.0%

EuroImmun - Anti-Mumps-Viren-IIFT IgM 5 5 100.0%Bios - Biognost Mumps virus IgM kit 2 2 100.0%Viramed - Mumps IgM IFT Testkit 1 1 100.0%Mast - Mastafluor MUMPS IgM 1 1 100.0%

ChLIA-anti-Mumps-IgM (34) 46 0 0 46 100.0%

DiaSorin - LIAISON Mumps IgM 46 46 100.0%


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

3.2 Testing for anti-mumps

Anti-mumps-IgG/total (test category 10)

Titer values and results as U/ml

Avidity (test category 11)

Percent values

Anti-mumps-IgM (test category 20)

Titer values and results as U/ml

Differentiation according to method, manufacturer and test name

356 Mumpsvirus Deckblatt quant EN


Virusimmunology Mumps (356) November 2014sample 356019 , anti-mumps-IgG or anti-mumps total : positive _________________________________________________

Bl. 306 Cvir2 / LH Rv=1424 29.1.2015 8:55h 20742212 ��Srt=MR, Me=, Klebe=0, Std=0, quantCB=1, nHisto=1

10. Testing for anti-mumps-IgG or anti-mumps total

Frequency of methods (qual. and U/ml) sp.356019

60 120 180 240 300N

percent N= 424

300ELISA-anti-Mumps-IgG70.8

127 w/o target value

99ChLIA-anti-Mumps-IgG23.3

48 w/o target value

14IFT-anti-Mumps-IgG3.3

6 w/o target value

10ELFA-anti-Mumps-IgG2.4

1other anti-Mumps-IgG-t.0.2

= correct (C)cert.=99.8% F=1

= false (F)

Virology, Charité-CBF, EQAS-November 2014


ELISA-Anti-Mumps-IgG sp.356019

10 20 30 40 50N

percenttiter N= 58

7 1600 .... 2047 12.151 2048 ... 3789 87.9


= false (F)




6 12 18 24N

percentU/ml N= 69

52 ..< 51 7.2

1851 ..< 101 26.1

11101 ..< 151 15.9

1 204 1.4

1 310 1.4

2351 ..< 401 2.9

2451 ..< 501 2.9

29501 ..<= 1190 42.0


= false (F)



Virusimmunology Mumps (356) November 2014sample 356019 , anti-mumps-IgG or anti-mumps total : positive


10. Testing for anti-mumps-IgG or anti-mumps totalELISA-Anti-Mumps-IgG sp.356019

Mast - Mastazyme Mumps IgG

2 4 6 8 10N

percentU/ml N= 1

1 110 100.0


= false (F)


10. Testing for anti-mumps-IgG or anti-mumps totalELISA-Anti-Mumps-IgG sp.356019Siemens - Enzygnost anti-Parotitis IgG

10 20 30 40 50N

percenttiter N= 58

7 1600 .... 2047 12.151 2048 ... 3789 87.9


= false (F)



2 4 6 8 10N

percentU/ml N= 2

1 2 50.0

1 310 50.0


= false (F)



R-Biopharm - Ridascreen Mumpsvirus IgG

2 4 6 8 10N

percentU/ml N= 5

338 ..< 51 60.0

251 ..<= 64 40.0


= false (F)



Orgentec - anti-Mumps Virus IgG

2 4 6 8 10N

percentU/ml N= 6

1 50 16.7

551 ..<= 74 83.3


= false (F)



EuroImmun - anti-Mumps-Viren-ELISA (IgG)

2 4 6 8 10N

percentU/ml N= 20

1151 ..< 101 55.0

9101 ..<= 110 45.0


= false (F)






ImmunoLab - Mumps IgG ELISA

2 4 6 8 10N

percentU/ml N= 1

1 121 100.0


= false (F)



Virion/Serion - ELISA classic Mumps IgG

6 12 18 24N

percentU/ml N= 34

1 204 2.9

2351 ..< 401 5.9

2451 ..< 501 5.9

29501 ..<= 1190 85.3


= false (F)



IFT-Anti-Mumps-IgG sp.356019

2 4 6 8 10N

percenttiter N= 6

1 40 16.73 64 ... 127 50.0

2 128 ... 160 33.3


= false (F)


10. Testing for anti-mumps-IgG or anti-mumps totalIFT-Anti-Mumps-IgG sp.356019Viramed - Mumps IgG IFT testkit

2 4 6 8 10N

percenttiter N= 1

1 160 100.0


= false (F)


10. Testing for anti-mumps-IgG or anti-mumps totalIFT-Anti-Mumps-IgG sp.356019

EuroImmun - anti-Mumps-Viren-IIFT IgG

2 4 6 8 10N

percenttiter N= 4

1 40 25.02 64 ... 127 50.0

1 128 25.0


= false (F)



Hemagen - Virgo Mumps IgG

2 4 6 8 10N

percenttiter N= 1

1 64 100.0


= false (F)






ChLIA-Anti-Mumps-IgG sp.356019

7 14 21 28N

percentU/ml N= 48

1 120 2.1

1 193 2.1

13201 ..< 251 27.1

33251 ..<= 300 68.8


= false (F)


10. Testing for anti-mumps-IgG or anti-mumps totalChLIA-Anti-Mumps-IgG sp.356019

DiaSorin - LIAISON Mumps IgG

7 14 21 28N

percentU/ml N= 48

1 120 2.1

1 193 2.1

13201 ..< 251 27.1

33251 ..<= 300 68.8


= false (F)



Virusimmunology Mumps (356) November 2014sample 356019 , avidity of anti-mumps-IgG : high , % avidity: >= 30_________________________________________________


11. Testing for avidity of anti-mumps-IgGFrequency of methods (qual. and percent) sp.356019

2 4 6 8 10N

percent N= 4



= false (F)


11. Testing for avidity of anti-mumps-IgGELISA-Anti-Mumps-IgG sp.356019 , % avidity: >= 30.0

2 4 6 8 10N

percent% avidity N= 2

1 33 50.0

1 40 50.0


= false (F)



Siemens - Enzygnost anti-Parotitis IgG avidity

2 4 6 8 10N


1 33 50.0

1 40 50.0


= false (F)



Virusimmunology Mumps (356) November 2014sample 356019 , anti-mumps-IgM : negative _________________________________________________


20. Testing for anti-mumps-IgMFrequency of methods (qual. and U/ml) sp.356019

40 80 120 160N

percent N= 255

198ELISA-anti-Mumps-IgM77.6

1 F 39 w/o target value

46ChLIA-anti-Mumps-IgM18.0

11IFT-anti-Mumps-IgM4.3

2 w/o target value


= false (F) = no target value (w/o. tv)


20. Testing for anti-mumps-IgMELISA-Anti-Mumps-IgM sp.356019

4 8 12 16 20N

percentU/ml N= 39220 ..< 1 56.4

1 1 2.6

53 ..< 5 12.8

45 ..< 7 10.3

77 ..<= 8 17.9


= false (F)



Mast - Mastazyme Mumps IgM

2 4 6 8 10N

percentU/ml N= 1

1 4 100.0


= false (F)



Virusimmunology Mumps (356) November 2014sample 356019 , anti-mumps-IgM : negative



R-Biopharm - Ridascreen Mumpsvirus IgM

2 4 6 8 10N

percentU/ml N= 4

24 ..< 5 50.0

1 5 25.0

1 8 25.0


= false (F)



Orgentec - anti-Mumps Virus IgM

2 4 6 8 10N

percentU/ml N= 610 ..< 1 16.7

23 ..< 5 33.3

1 6 16.7

27 ..<= 8 33.3


= false (F)



ImmunoLab - Mumps IgM ELISA

2 4 6 8 10N

percentU/ml N= 1

1 5 100.0


= false (F)



Virion/Serion - ELISA classic Mumps IgM

4 8 12 16 20N

percentU/ml N= 27210 ..< 1 77.8

1 1 3.7

1 6 3.7

47 ..<= 8 14.8


= false (F)


20. Testing for anti-mumps-IgMIFT-Anti-Mumps-IgM sp.356019

2 4 6 8 10N

percenttiter N= 2

2 10 .... 10 100.0


= false (F)



EuroImmun - anti-Mumps-Viren-IIFT IgM

2 4 6 8 10N

percenttiter N= 1

1 10 100.0


= false (F)





20. Testing for anti-mumps-IgMIFT-Anti-Mumps-IgM sp.356019Bios - Biognost Mumps virus IgM kit

2 4 6 8 10N

percenttiter N= 1

1 10 100.0


= false (F)



Virusimmunology Mumps (356) November 2014sample 356020 , anti-mumps-IgG or anti-mumps total : positive _________________________________________________



Frequency of methods (qual. and U/ml) sp.356020

60 120 180 240 300N

percent N= 423


127 w/o target value

99ChLIA-anti-Mumps-IgG23.4

48 w/o target value

13IFT-anti-Mumps-IgG3.1

5 w/o target value

10ELFA-anti-Mumps-IgG2.4

1other anti-Mumps-IgG-t.0.2


= false (F)




10 20 30 40 50N

percenttiter N= 58

2 3500 .... 4095 3.452 4096 ... 8191 89.7

4 8192 ... 9000 6.9


= false (F)




7 14 21 28N

percentU/ml N= 69

1 5 1.4

751 ..< 101 10.1

16101 ..< 151 23.2

8151 ..< 201 11.6

1 232 1.4

1 278 1.4

1 431 1.4

1 483 1.4

33501 ..<= 1373 47.8


= false (F)






Mast - Mastazyme Mumps IgG

2 4 6 8 10N

percentU/ml N= 1

1 528 100.0


= false (F)



10 20 30 40 50N

percenttiter N= 58

2 3500 .... 4095 3.452 4096 ... 8191 89.7

4 8192 ... 9000 6.9


= false (F)



2 4 6 8 10N

percentU/ml N= 2

1 5 50.0

1 650 50.0


= false (F)



R-Biopharm - Ridascreen Mumpsvirus IgG

2 4 6 8 10N

percentU/ml N= 5

563 ....<= 91 100.0


= false (F)



Orgentec - anti-Mumps Virus IgG

2 4 6 8 10N

percentU/ml N= 6

292 ..< 101 33.3

4101 ..<= 127 66.7


= false (F)



EuroImmun - anti-Mumps-Viren-ELISA (IgG)

2 4 6 8 10N

percentU/ml N= 20

11107 ..< 151 55.0

8151 ..< 201 40.0

1 232 5.0


= false (F)






ImmunoLab - Mumps IgG ELISA

2 4 6 8 10N

percentU/ml N= 1

1 150 100.0


= false (F)



Virion/Serion - ELISA classic Mumps IgG

6 12 18 24 30N

percentU/ml N= 34

1 278 2.9

1 431 2.9

1 483 2.9

31501 ..<= 1373 91.2


= false (F)



IFT-Anti-Mumps-IgG sp.356020

2 4 6 8 10N

percenttiter N= 5

1 100 20.01 160 20.01 320 20.0

2 1024 ... 1280 40.0


= false (F)


10. Testing for anti-mumps-IgG or anti-mumps totalIFT-Anti-Mumps-IgG sp.356020Viramed - Mumps IgG IFT testkit

2 4 6 8 10N

percenttiter N= 1

1 1280 100.0


= false (F)



EuroImmun - anti-Mumps-Viren-IIFT IgG

2 4 6 8 10N

percenttiter N= 4

1 100 25.01 160 25.01 320 25.0

1 1024 25.0


= false (F)



ChLIA-Anti-Mumps-IgG sp.356020

8 16 24 32 40N

percentU/ml N= 48

1 250 2.1

42251 ..< 301 87.5

1 301 2.1

2451 ..< 501 4.2

2501 ..<= 596 4.2


= false (F)





10. Testing for anti-mumps-IgG or anti-mumps totalChLIA-Anti-Mumps-IgG sp.356020

DiaSorin - LIAISON Mumps IgG

8 16 24 32 40N

percentU/ml N= 48

1 250 2.1

42251 ..< 301 87.5

1 301 2.1

2451 ..< 501 4.2

2501 ..<= 596 4.2


= false (F)



Virusimmunology Mumps (356) November 2014sample 356020 , avidity of anti-mumps-IgG : high , % avidity: >= 20_________________________________________________


11. Testing for avidity of anti-mumps-IgGFrequency of methods (qual. and percent) sp.356020

2 4 6 8 10N

percent N= 4



= false (F)



2 4 6 8 10N


1 22 50.0

1 60 50.0


= false (F)



Siemens - Enzygnost anti-Parotitis IgG avidity

2 4 6 8 10N


1 22 50.0

1 60 50.0


= false (F)



Virusimmunology Mumps (356) November 2014sample 356020 , anti-mumps-IgM : negative _________________________________________________


20. Testing for anti-mumps-IgMFrequency of methods (qual. and U/ml) sp.356020

40 80 120 160N

percent N= 255

198ELISA-anti-Mumps-IgM77.6

1 F 39 w/o target value

46ChLIA-anti-Mumps-IgM18.0

11IFT-anti-Mumps-IgM4.3

2 w/o target value


= false (F) = no target value (w/o. tv)



4 8 12 16 20N

percentU/ml N= 39210 ..< 1 53.8

41 ..< 3 10.3

43 ..< 5 10.3

85 ..< 7 20.5

27 ..<= 8 5.1


= false (F)



Mast - Mastazyme Mumps IgM

2 4 6 8 10N

percentU/ml N= 1

1 2 100.0


= false (F)






R-Biopharm - Ridascreen Mumpsvirus IgM

2 4 6 8 10N

percentU/ml N= 4

24 ..< 5 50.0

1 6 25.0

1 7 25.0


= false (F)



Orgentec - anti-Mumps Virus IgM

2 4 6 8 10N

percentU/ml N= 610 ..< 1 16.7

23 ..< 5 33.3

35 ..<= 6 50.0


= false (F)



ImmunoLab - Mumps IgM ELISA

2 4 6 8 10N

percentU/ml N= 1

1 2 100.0


= false (F)



Virion/Serion - ELISA classic Mumps IgM

4 8 12 16 20N

percentU/ml N= 27200 ..< 1 74.1

21 ..< 3 7.4

45 ..< 7 14.8

1 7 3.7


= false (F)



2 4 6 8 10N

percenttiter N= 2

2 10 .... 10 100.0


= false (F)



EuroImmun - anti-Mumps-Viren-IIFT IgM

2 4 6 8 10N

percenttiter N= 1

1 10 100.0


= false (F)





20. Testing for anti-mumps-IgMIFT-Anti-Mumps-IgM sp.356020Bios - Biognost Mumps virus IgM kit

2 4 6 8 10N

percenttiter N= 1

1 10 100.0


= false (F)


Documents

INSTAND e.V.€¦ · Report External Quality Assessment Scheme Group 356 Virus Immunology - Mumps Virus November/December 2014 INSTAND e.V. in cooperation with: Deutsche