Although sensitivity is lower compared with RT-PCR, these tests enable reliable detection of high viral loads associated with the presence of infectious viral particles, making them important public health tools.
However, the majority of Ag-RDT validation studies were done before the emergence of SARS-CoV-2 variants of concern.
We previously performed an analytical sensitivity testing of nine commercially available Ag-RDTs for the first three identified variants of concern (alpha, beta, and gamma) and one former variant of interest (zeta).
The starting dilution of infectious titres for viruses used in this study was 4·24 log10 plaque-forming units per mL and corresponded to 8·15 log10 RNA copies per mL, 6·70 log10 RNA copies per mL, 7·18 log10 RNA copies per mL, 8·30 log10 RNA copies per mL, and 6·00 log10 RNA copies per mL of virus stocks for B.1.610, the alpha variant, the beta variant, the gamma variant, and the delta variant.
Ag-RDT buffer without virus was used as a negative control. Results were read independently by two individuals. Any visible test band in the presence of a visible control band was considered as a positive result.
In this study, the accuracy of 11 Ag-RDTs to detect variants of concern was determined. Analytical validation with cultured virus might be a proxy for clinical accuracy, but it is not a replacement for clinical evaluations. Nevertheless, we showed that, despite slight differences in sensitivity, Ag-RDTs remain, in principle, effective to detect variants of concern, including the now-dominant delta variant.
We declare no competing interests. This work was supported by the Swiss National Science Foundation (grant number 196383), the Fondation Ancrage Bienfaisance du Groupe Pictet, and FIND, the global alliance for diagnostics. The Swiss National Science Foundation and the Fondation Ancrage Bienfaisance du Groupe Pictet had no role in data collection, analysis, or interpretation. Antigen rapid diagnostic tests were provided by FIND and FIND was involved in methodology, data analysis, and interpretation. CE is an employee of FIND. MB and KA contributed equally.
SARS-CoV-2 rapid antigen test: high sensitivity to detect infectious virus.
J Clin Virol. 2021; 140104846
SARS-CoV-2 rapid diagnostic tests for emerging variants.
Lancet Microbe. 2021; 2: e351
Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays.
Rethinking COVID-19 test sensitivity—A strategy for containment.
N Engl J Med. 2020; 383: e120
Weekly epidemiological update on COVID-19.
Published: November 24, 2021
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Publish date : 2021-11-24 23:31:03