Variable Sensitivity of SARS-CoV-2 Molecular Detection in European Expert Laboratories: External Quality Assessment, June and July 2020

J Clin Microbiol. 2021 Feb 18;59(3):e02676-20. doi: 10.1128/JCM.02676-20. Print 2021 Feb 18.

Abstract

During the ongoing coronavirus disease 2019 (COVID-19) outbreak, robust detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a key element for clinical management and to interrupt transmission chains. We organized an external quality assessment (EQA) of molecular detection of SARS-CoV-2 for European expert laboratories. An EQA panel composed of 12 samples, containing either SARS-CoV-2 at different concentrations to evaluate sensitivity or other respiratory viruses to evaluate specificity of SARS-CoV-2 testing, was distributed to 68 laboratories in 35 countries. Specificity samples included seasonal human coronaviruses hCoV-229E, hCoV-NL63, and hCoV-OC43, as well as Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and human influenza viruses A and B. Sensitivity results differed among laboratories, particularly for low-concentration SARS-CoV-2 samples. Results indicated that performance was mostly independent of the selection of specific extraction or PCR methods.

Keywords: COVID-19; EQA; Europe; SARS-CoV-2; diagnostics; molecular.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alphainfluenzavirus
  • Betainfluenzavirus
  • COVID-19 / diagnosis*
  • COVID-19 Testing / standards*
  • Coronavirus 229E, Human
  • Coronavirus NL63, Human
  • Coronavirus OC43, Human
  • Humans
  • Laboratories
  • Middle East Respiratory Syndrome Coronavirus
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Severe acute respiratory syndrome-related coronavirus