High-sensitivity SARS-CoV-2 group testing by digital PCR among symptomatic patients in hospital settings

Martin, Alexandra, Storto, Alexandre, Hingrat, Quentin Le, Collin, Gilles, André, Barbara, Mallory, Allison, Dangla, Rémi, Descamps, Diane, Visseaux, Benoit and Gossner, Olivier ORCID: 0000-0003-3950-0208 (2021) High-sensitivity SARS-CoV-2 group testing by digital PCR among symptomatic patients in hospital settings. Journal of Clinical Virology, 141. ISSN 1386-6532

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Abstract

Background Worldwide demand for SARS-CoV-2 RT-PCR testing is still high as testing remains central to follow the disease spread and vaccine efficacy. Group testing has been proposed as a solution to expand testing capabilities but sensitivity concerns may limit its impact on the management of the pandemic. Digital PCR (RT-dPCR) has been shown to be highly sensitive and could help by providing larger testing capabilities without compromising sensitivity. Methods We implemented RT-dPCR based COVID-19 group testing on a commercially available system and assay (naica® system from Stilla Technologies) and investigated the sensitivity of the method in real life conditions of a university hospital in Paris, France, in May 2020. We tested the protocol in a direct comparison with reference RT-PCR testing on 448 samples split into groups of 8, 16 and 32 samples for RT-dPCR analysis. Results Individual RT-PCR testing identified 25/448 positive samples. Using 56 groups of 8, RT-dPCR identified 23 groups as positive, corresponding to 26 positive samples by individual PCR (positive percentage agreement 95.2% [95% confidence interval: 76.2–99.9%]) and including 2 samples not detected by individual RT-PCR but confirmed positive by further investigation. 15 of 28 groups of 16 tested positive, corresponding to 25 positive samples by individual PCR (positive percentage agreement 87.5% [95% confidence interval: 61.7–98.4%]). 14 groups of 32 were fully concordant with individual PCR testing but will need to be confirmed on larger datasets. Conclusions Our proposed approach of group testing by digital PCR has similar diagnostic sensitivity compared to individual RT-PCR testing for group up to 16 samples. This approach reduces the quantity of reagent needed by up to 80% while reducing costs and increasing capabilities of testing up to 10-fold.

Item Type:	Article
Official URL:	https://www.sciencedirect.com/journal/journal-of-c...
Additional Information:	© 2021 Elsevier B.V.
Divisions:	Mathematics
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine H Social Sciences > HV Social pathology. Social and public welfare. Criminology
Date Deposited:	07 Jul 2021 14:57
Last Modified:	23 Nov 2024 05:15
URI:	http://eprints.lse.ac.uk/id/eprint/111002

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