Evaluation of mobile real-time polymerase chain reaction tests for the detection of severe acute respiratory syndrome coronavirus 2.
| Title: | Evaluation of mobile real-time polymerase chain reaction tests for the detection of severe acute respiratory syndrome coronavirus 2. |
|---|---|
| Authors: | Onyilagha C; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Mistry H; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Marszal P; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Pinette M; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Kobasa D; National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Canada.; Department of Medical Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, MB, Canada.; Tailor N; National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Canada.; Berhane Y; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Nfon C; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Pickering B; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Mubareka S; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Bulir D; St. Joseph's Healthcare, Hamilton, ON, Canada.; Chong S; St. Joseph's Healthcare, Hamilton, ON, Canada.; Kozak R; Sunnybrook Health Sciences Centre, Toronto, ON, Canada. rob.kozak@sunnybrook.ca.; Ambagala A; National Centre for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, MB, Canada.; Department of Comparative Biology, Faculty of Veterinary Medicine, University of Calgary, Calgary, AB, Canada. |
| Source: | Scientific reports [Sci Rep] 2021 Apr 30; Vol. 11 (1), pp. 9387. Date of Electronic Publication: 2021 Apr 30. |
| Publication Type: | Evaluation Study; Journal Article; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : Nature Publishing Group, copyright 2011- |
| MeSH Terms: | COVID-19/*diagnosis ; Real-Time Polymerase Chain Reaction/*methods ; SARS-CoV-2/*isolation & purification; SARS-CoV-2/genetics ; Animals ; Buffers ; Cricetinae ; Humans ; Mobile Applications ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Time Factors |
| 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. |
| References: | Euro Surveill. 2020 Jan;25(3):. (PMID: 31992387); Transbound Emerg Dis. 2021 Mar;68(2):952-959. (PMID: 32762007); Virol J. 2019 May 27;16(1):69. (PMID: 31133031); Transbound Emerg Dis. 2019 Jul;66(4):1789-1795. (PMID: 31077564); Nat Struct Mol Biol. 2006 Aug;13(8):751-2. (PMID: 16845391); J Med Virol. 2020 Apr;92(4):418-423. (PMID: 31967327); J Clin Microbiol. 2020 May 26;58(6):. (PMID: 32295895); Mol Cell. 2006 Nov 3;24(3):445-56. (PMID: 17081993); Methods Mol Biol. 2015;1282:1-23. (PMID: 25720466) |
| Substance Nomenclature: | 0 (Buffers); 0 (Reagent Kits, Diagnostic) |
| Entry Date(s): | Date Created: 20210501 Date Completed: 20210505 Latest Revision: 20210505 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8087814 |
| DOI: | 10.1038/s41598-021-88625-6 |
| PMID: | 33931684 |
| Database: | MEDLINE |
Evaluation Study; Journal Article; Research Support, Non-U.S. Gov't