SARS-CoV-2 Molecular Detection Assay
The SARS-CoV-2 Molecular Detection Assay is a real-time PCR test using TaqMan chemistry and is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal swabs, throat swabs, nasal swabs, sputum, tracheal secretions, BAL fluid, and bronchial washings) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Mayo Clinic Laboratories, Rochester, MN, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.
Availability: Commercially Available
| Manufacturer |
| Mayo Clinic Laboratories |
| Product Name |
| SARS-CoV-2 Molecular Detection Assay |
| Detection Category |
| Biological |
| Detection Principle |
| Molecular; |
| Detection Method |
| Assays;Nucleic Acid Amplification;Polymerase Chain Reaction; |
| Application |
| Diagnostics; |
| Equipment Type |
| Diagnostic |
| Product Synopsis |
| The SARS-CoV-2 Molecular Detection Assay is a real-time PCR test using TaqMan chemistry and is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal swabs, throat swabs, nasal swabs, sputum, tracheal secretions, BAL fluid, and bronchial washings) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Mayo Clinic Laboratories, Rochester, MN, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. |
| Availability |
| Commercially Available |
| Technology Readiness Level (TRL) |
| 9 |
| Market Entry Date |
| April 2020 |
| User Feedback Sources |
| Indifferent/No user feedback |
| No Information Is Available |
| Transportability |
| Pocket Size |
| Other Biological Targets |
| SARS-CoV-2 |
| Sample Introduction |
| Biological sample; nasopharyngeal swabs, throat swabs, nasal swabs, sputum, tracheal secretions, BAL fluid, and bronchial washings |
| Training Required |
| <1 day training |
