SARS-CoV-2 PCR Test
The SARS-CoV-2 assay is a PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal swabs, nasopharyngeal swabs/wash, oropharyngeal swabs/throat swabs, bronchial aspirates, or sputum from individuals in which identification of SARS-CoV-2 would provide relevant clinical information to the individual and to the healthcare provider. Testing is limited to Diatherix Laboratories, LLC, a College of American Pathologists (CAP)-accredited, and Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratory.
Availability: Commercially Available
| Manufacturer |
| Diatherix Eurofins Laboratory |
| Product Name |
| SARS-CoV-2 PCR Test |
| 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 assay is a PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal swabs, nasopharyngeal swabs/wash, oropharyngeal swabs/throat swabs, bronchial aspirates, or sputum from individuals in which identification of SARS-CoV-2 would provide relevant clinical information to the individual and to the healthcare provider. Testing is limited to Diatherix Laboratories, LLC, a College of American Pathologists (CAP)-accredited, and Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratory. |
| 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; nasal swabs, nasopharyngeal swabs/wash, oropharyngeal swabs/throat swabs, bronchial aspirates, or sputum |
| Training Required |
| <1 day training |
