Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing

What is it about?

For reliable assessment of SARS-CoV-2 infection prevalence and immunity, quality assurance of serologic tests is mandatory, in particular due to relaxed requirements for test approval in the context of emergency use authorization. Therefore, the RfB conducted the first pilot EQA for detection of SARS-CoV-2 antibodies. Evaluation of 796 results revealed an overall good diagnostic performance for SARS-CoV-2 IgG. For IgA and IgM, the diagnostic sensitivity was below manufacturer´s specifications and considerable differences were seen between kits. Here, we provide first guidance. Overall, a lack of harmonization in this new diagnostic area becomes obvious revealing an urgent need for international EQAs.

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