Molecular Reagent Cobas® SARS-CoV-2 CLIA Waived For Cobas Liat System 20 Tests

Features

• cobas® SARS-CoV-2 is for use under the Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• cobas® SARS-CoV-2 is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Product ships with minimum 60 days dating
• In the United States (US), testing with cobas® SARS-CoV-2 is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
• The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System (cobas®SARS-CoV-2) is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of nucleic acid from SARS-CoV-2 in self-collected anterior nasal (nasal)swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal, mid-turbinate and anterior nasal (nasal)swabs from either individuals suspected of COVID-19 by their healthcare provider or from any individual, including individualswithout symptoms or other reasons to suspect COVID-19
• Positive results are indicative of the presence of SARS-CoV-2 RNA
• Positive results do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions
• Negative results must be combined with clinical observations, patient history, and/or epidemiological information
• cobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas Liat System
• Laboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
• cobas® SARS-CoV-2 assay uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) technology to rapidly (approximately 20 minutes) detect SARS-CoV-2 virusfrom nasopharyngeal, mid-turbinate and nasal swabs
• Contents: 20 Tests, 20 transfer pipettes, package insert Barcode Card

More Information

• cobas Liat SARS-CoV-2 Nucleic Acid Test FDA EUA
• cobas Liat SARS-CoV-2 Nucleic Acid Test IFU
• cobas Liat SARS-CoV-2 Healthcare Providers Fact Sheet
• cobas Liat SARS-CoV-2 Patients Fact Sheet