Final WHO SARS-CoV-2 serology test kit evaluation results - ISS-G20 Laboratorium Repository

In this report, the performance of test kits in different formats, designed to detect antibodies to SARS-CoV-2 was assessed and performance data from a range of commercially available IVDs was compared by testing each test on the same panel of samples. The concordance to RNA positivity for Rapid Diagnostic Tests (RDTs) testing for IgG and IgM ranged from 77.4 to 100% and 55.8 to 99.5% respectively, whereas the EIA reported concordance ranging from 60.1 to 100%.  Specificity of RDT IgG and IgM ranged from 81.0 to 99.0% and 34.3 to 99.0% and EIAs reported specificities of 74.0 to 100%. Precision of Enzyme Immunoassays (EIA) ranged from 3.7 to 15.5 % coefficient of variation (this was not measured for RDTs as the readout is visual). Cross reactivity and interference were detected in most assays with some having an unacceptable percentage of false reactions. This study demonstrates a wide range of performance characteristic of SARS-CoV-2 assays and highlights the need for comprehensive, comparative testing of assay performance in an emergency setting. This document does not constitute a recommendation by the WHO for specific test kits.  The selection of test kits must be assessed by the procurer to ensure the performance meets the intended use.

Entire content available on: https://www.who.int/publications/m/item/final-who-sars-cov-2-serology-test-kit-evaluation-results