1. Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing
- Author
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Verena Haselmann, Mustafa Özcürümez, Michael Neumaier, Wolf J. Geilenkeuser, Gerhard Dobler, Volker Ast, Romy Eichner, Roman Wölfel, Catharina Gerhards, Victor Costina, Frank Klawonn, and HZI,Helmholtz-Zentrum für Infektionsforschung GmbH, Inhoffenstr. 7,38124 Braunschweig, Germany.
- Subjects
0301 basic medicine ,Quality Control ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Clinical Biochemistry ,Diagnostic Specificity ,external quality assessment scheme ,Pilot Projects ,Antibodies, Viral ,Serology ,03 medical and health sciences ,Betacoronavirus ,0302 clinical medicine ,Internal medicine ,External quality assessment ,medicine ,Humans ,Serologic Tests ,030212 general & internal medicine ,biology ,proficiency testing ,business.industry ,SARS-CoV-2 ,Biochemistry (medical) ,COVID-19 ,General Medicine ,Replicate ,Test (assessment) ,030104 developmental biology ,biology.protein ,ring trial ,Antibody ,business - Abstract
Objectives Assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prevalence and immunity is cornerstones in the fight against COVID-19 pandemic. For pandemic control, reliable assays for the detection of anti-SARS-CoV-2 antibodies are required. This pilot external quality assessment (EQA) scheme aimed to independently assess the participants’ clinical performance of anti-SARS-CoV-2 testing, to identify shortcomings in clinical practice and to evaluate the suitability of the scheme format. Methods The EQA scheme consisted of eight serum samples with variable reactivity against SARS-CoV-2 intended for the analysis of anti-SARS-CoV-2 immunoglobulin (Ig)G, IgA, and IgM antibodies. Laboratories reported: (1) results for each sample and the respective method, (2) raw data from replicate testing of each sample. Results The 16 selected pilot EQA participants reported 294 interpreted results and 796 raw data results from replicate testing. The overall error rate for the anti-SARS-CoV-2 IgG, IgA, and IgM tests was 2.7, 6.9, and 16.7%, respectively. While the overall diagnostic specificity was rated as very high, sensitivity rates between 67 and 98% indicate considerable quality differences between the manufacturers, especially for IgA and IgM. Conclusions Even the results reported by the small number of participants indicate a very heterogeneous landscape of anti-SARS-CoV-2 serological testing. Differences of available tests and the individual performance of laboratories result in a success rate of 57.1% with one laboratory succeeding for all three antibody-classes. These results are an incentive for laboratories to participate in upcoming open EQA schemes that are needed to achieve a harmonization of test results and to improve serological testing.
- Published
- 2020