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Abstract
The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), calls for prompt and accurate diagnosis and rapid turnaround time for test results to limit transmission. Here, we evaluated two independent molecular assays, the Biomeme SARS-CoV-2 test, and the Precision Biomonitoring TripleLock SARS-CoV-2 test on a field-deployable point-of-care real-time PCR instrument, Franklin three9, in combination with Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 (M1) manual extraction system for rapid, specific, and sensitive detection of SARS-COV-2 in cell culture, human, and animal clinical samples. The Biomeme SARS-CoV-2 assay, which simultaneously detects two viral targets, the orf1ab and S genes, and the Precision Biomonitoring TripleLock SARS-CoV-2 assay that targets the 5′ untranslated region (5′ UTR) and the envelope (E) gene of SARS-CoV-2 were highly sensitive and detected as low as 15 SARS-CoV-2 genome copies per reaction. In addition, the two assays were specific and showed no cross-reactivity with Middle Eastern respiratory syndrome coronavirus (MERS-CoV), infectious bronchitis virus (IBV), porcine epidemic diarrhea virus (PEDV), transmissible gastroenteritis (TGE) virus, and other common human respiratory viruses and bacterial pathogens. Also, both assays were highly reproducible across different operators and instruments. When used to test animal samples, both assays equally detected SARS-CoV-2 genetic materials in the swabs from SARS-CoV-2-infected hamsters. The M1 lysis buffer completely inactivated SARS-CoV-2 within 10 min at room temperature enabling safe handling of clinical samples. Collectively, these results show that the Biomeme and Precision Biomonitoring TripleLock SARS-CoV-2 mobile testing platforms could reliably and promptly detect SARS-CoV-2 in both human and animal clinical samples in approximately an hour and can be used in remote areas or health care settings not traditionally serviced by a microbiology laboratory.
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Details
1 Canadian Food Inspection Agency, National Centre for Foreign Animal Disease, Winnipeg, Canada (GRID:grid.418040.9) (ISNI:0000 0001 2177 1232)
2 Sunnybrook Health Sciences Centre, Toronto, Canada (GRID:grid.413104.3) (ISNI:0000 0000 9743 1587)
3 Public Health Agency of Canada, National Microbiology Laboratory, Winnipeg, Canada (GRID:grid.415368.d) (ISNI:0000 0001 0805 4386); University of Manitoba, Department of Medical Microbiology and Infectious Diseases, Winnipeg, Canada (GRID:grid.21613.37) (ISNI:0000 0004 1936 9609)
4 Public Health Agency of Canada, National Microbiology Laboratory, Winnipeg, Canada (GRID:grid.415368.d) (ISNI:0000 0001 0805 4386)
5 St. Joseph’s Healthcare, Hamilton, Canada (GRID:grid.416721.7) (ISNI:0000 0001 0742 7355)
6 Canadian Food Inspection Agency, National Centre for Foreign Animal Disease, Winnipeg, Canada (GRID:grid.418040.9) (ISNI:0000 0001 2177 1232); University of Calgary, Department of Comparative Biology, Faculty of Veterinary Medicine, Calgary, Canada (GRID:grid.22072.35) (ISNI:0000 0004 1936 7697)