Article ; Online: Field-deployable, rapid diagnostic testing of saliva for SARS-CoV-2.
2021 Volume 11, Issue 1, Page(s) 5448
Abstract: ... 2 diagnostic testing is necessary. However, existing field-deployable COVID-19 testing ... validation of High-Performance Loop-mediated isothermal Amplification (HP-LAMP), a rapid, saliva-based, SARS ... To safely re-open economies and prevent future outbreaks, rapid, frequent, point-of-need, SARS-CoV ...
| Abstract | To safely re-open economies and prevent future outbreaks, rapid, frequent, point-of-need, SARS-CoV-2 diagnostic testing is necessary. However, existing field-deployable COVID-19 testing methods require the use of uncomfortable swabs and trained providers in PPE, while saliva-based methods must be transported to high complexity laboratories for testing. Here, we report the development and clinical validation of High-Performance Loop-mediated isothermal Amplification (HP-LAMP), a rapid, saliva-based, SARS-CoV-2 test with a limit of detection of 1.4 copies of virus per µl of saliva and a sensitivity and specificity with clinical samples of > 96%, on par with traditional RT-PCR based methods using swabs, but can deliver results using only a single fluid transfer step and simple heat block. Testing of 120 patient samples in 40 pools comprised of 5 patient samples each with either all negative or a single positive patient sample was 100% accurate. Thus, HP-LAMP may enable rapid and accurate results in the field using saliva, without need of a high-complexity laboratory. |
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| MeSH term(s) | COVID-19/diagnosis ; COVID-19/virology ; COVID-19 Nucleic Acid Testing ; Humans ; Limit of Detection ; Molecular Diagnostic Techniques ; Nasopharynx/virology ; Nucleic Acid Amplification Techniques ; RNA, Viral/metabolism ; SARS-CoV-2/genetics ; SARS-CoV-2/isolation & purification ; Saliva/virology ; Sensitivity and Specificity ; Temperature |
| Chemical Substances | RNA, Viral |
| Language | English |
| Publishing date | 2021-03-09 |
| Publishing country | England |
| Document type | Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2615211-3 |
| ISSN | 2045-2322 ; 2045-2322 |
| ISSN (online) | 2045-2322 |
| ISSN | 2045-2322 |
| DOI | 10.1038/s41598-021-84792-8 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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