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.

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Availability: Commercially Available

Shannon Bennett
Quality Manager, Department of Laboratory Medicine and Pathology
200 1st Street SW
Rochester, MN 55905
USA
www.mayocliniclabs.com/test-catalog/Overview/608825
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
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