Molecular Reagent Cobas® Liat® SARS-CoV-2, Influenza A / B For Cobas Liat System 20 Tests

Features

• The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test is for use on the cobas Liat System under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Product ships from McKesson with minimum 30 days dating Emergency use of this test is limited to authorized laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. §263a
• to perform moderate or high complexity tests The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System is also 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 The new cobas SARS-CoV-2 & Influenza A/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections This test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food
• Drug
• and Cosmetic Act
• 21 U.S.C. § 360bbb-3(b)(1)
• unless the authorization is terminated or revoked sooner Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status Negative results do not preclude SARS-CoV-2
• influenza A
• and/or influenza B 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 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2
• influenza A
• and influenza B virus RNA Contains sufficient reagents to process 20 specimens or quality control samples Kit includes: 20 tests
• 20 transfer pipettes
• 1 package insert barcode card
• cobas Liat Internal Process Control
• Proteinase K
• cobas Liat Magnetic Glass Particles
• Lysis buffer
• wash buffer
• Elution buffer
• A/B Master Mix 1
• A/B Master Mix 2
• A/B Master Mix 3 This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2
• influenza A virus
• and influenza B virus and not for any other viruses or pathogens