High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling

Autor: Shosh Zismanov, Bar Shalem, Yulia Margolin-Miller, Dalia Rosin-Grunewald, Roy Adar, Ayelet Keren-Naus, Doron Amichay, Anat Ben-Dor, Yonat Shemer-Avni, Angel Porgador, Noam Shental, Tomer Hertz
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Communications Medicine, Vol 4, Iss 1, Pp 1-9 (2024)
Druh dokumentu: article
ISSN: 2730-664X
DOI: 10.1038/s43856-024-00531-w
Popis: Abstract Background The SARS-CoV-2 pandemic led to unprecedented testing demands, causing major testing delays globally. One strategy used for increasing testing capacity was pooled-testing, using a two-stage technique first introduced during WWII. However, such traditional pooled testing was used in practice only when positivity rates were below 2%. Methods Here we report the development, validation and clinical application of P-BEST - a single-stage pooled-testing strategy that was approved for clinical use in Israel. Results P-BEST is clinically validated using 3636 side-by-side tests and is able to correctly detect all positive samples and accurately estimate their Ct value. Following regulatory approval by the Israeli Ministry of Health, P-BEST was used in 2021 to clinically test 837,138 samples using 270,095 PCR tests - a 3.1fold reduction in the number of tests. This period includes the Alpha and Delta waves, when positivity rates exceeded 10%, rendering traditional pooling non-practical. We also describe a tablet-based solution that allows performing manual single-stage pooling in settings where liquid dispensing robots are not available. Conclusions Our data provides a proof-of-concept for large-scale clinical implementation of single-stage pooled-testing for continuous surveillance of multiple pathogens with reduced test costs, and as an important tool for increasing testing efficiency during pandemic outbreaks.
Databáze: Directory of Open Access Journals