High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling
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 i...
| Autors principals: | , , , , , , , , , , , |
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| Format: | Article |
| Idioma: | English |
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Nature Portfolio
2024-06-01
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| Col·lecció: | Communications Medicine |
| Accés en línia: | https://doi.org/10.1038/s43856-024-00531-w |
| _version_ | 1827213809158193152 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Shosh Zismanov |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2025-03-21T14:21:20Z |
| format | Article |
| id | doaj.art-a4b0f901b9b449d1b9d5ad13d523cac1 |
| institution | Directory Open Access Journal |
| issn | 2730-664X |
| language | English |
| last_indexed | 2025-03-21T14:21:20Z |
| publishDate | 2024-06-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Communications Medicine |
| spelling | doaj.art-a4b0f901b9b449d1b9d5ad13d523cac12024-06-23T22:32:26ZengNature PortfolioCommunications Medicine2730-664X2024-06-01411910.1038/s43856-024-00531-wHigh capacity clinical SARS-CoV-2 molecular testing using combinatorial poolingShosh Zismanov0Bar Shalem1Yulia Margolin-Miller2Dalia Rosin-Grunewald3Roy Adar4Ayelet Keren-Naus5Doron Amichay6Anat Ben-Dor7Yonat Shemer-Avni8Angel Porgador9Noam Shental10Tomer Hertz11Department of Microbiology and Immunology, Faculty of Health Sciences, Ben-Gurion University of the NegevDepartment of Computer Science, Bar-Ilan UniversityPoold Diagnostics ltd.Poold Diagnostics ltd.Poold Diagnostics ltd.Department of Microbiology and Immunology, Faculty of Health Sciences, Ben-Gurion University of the NegevCentral Laboratory, Clalit Health ServicesCentral Laboratory, Clalit Health ServicesDepartment of Microbiology and Immunology, Faculty of Health Sciences, Ben-Gurion University of the NegevDepartment of Microbiology and Immunology, Faculty of Health Sciences, Ben-Gurion University of the NegevDepartment of Computer Science, The Open University of IsraelDepartment of Microbiology and Immunology, Faculty of Health Sciences, Ben-Gurion University of the NegevAbstract 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.https://doi.org/10.1038/s43856-024-00531-w |
| spellingShingle | 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 High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling Communications Medicine |
| title | High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling |
| title_full | High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling |
| title_fullStr | High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling |
| title_full_unstemmed | High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling |
| title_short | High capacity clinical SARS-CoV-2 molecular testing using combinatorial pooling |
| title_sort | high capacity clinical sars cov 2 molecular testing using combinatorial pooling |
| url | https://doi.org/10.1038/s43856-024-00531-w |
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