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

AI Article Synopsis

  • The study assessed the performance of laboratories in testing for anti-SARS-CoV-2 antibodies to identify weaknesses in COVID-19 testing practices and improve testing reliability.
  • Eight serum samples with varying reactivity were analyzed by 16 pilot laboratories, revealing overall error rates of 2.7% for IgG, 6.9% for IgA, and 16.7% for IgM.
  • Results showed high diagnostic specificity but significant differences in sensitivity among manufacturers, highlighting the need for better standardization and participation in external quality assessment schemes to improve testing accuracy.

Article 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.

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Source
http://dx.doi.org/10.1515/cclm-2020-1183DOI Listing

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