Features

• cobas® SARS-CoV-2 control kit for use with the cobas liat SARS-CoV-2 assay
• cobas® SARS-CoV-2 nucleic acid test for use on the cobas® liat analyzer has successfully completed its transition from Emergency Use Authorization (EUA) product to 510(k) cleared product
• The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2) is an automated, real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection (i.e., symptomatic); additionally, this test is intended to be used with nasal and nasopharyngeal swab specimens collected from individuals without signs and symptoms suspected of COVID-19 (i.e., asymptomatic)
• The cobas® SARS-CoV-2 performed on the cobas® Liat® System is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings; SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection
• Positive results are indicative of the presence of SARS-CoV-2 RNA; positive results do not rule out co-infection with other microorganisms
• A negative result from an asymptomatic individual is presumptive
• A negative result obtained with a nasal swab collected from an asymptomatic patient should be followed up by testing at least twice over three days with at least 48 hours between tests
• Negative results do not preclude SARS-CoV-2 infection
• 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 virus from nasopharyngeal and nasal swabs
• The automation, small footprint, and easy-to-use interface of the cobas® Liat® System enable performance of this test to occur at the POC or in a clinical laboratory setting
• Kit includes: 8 Transfer Pipettes, 1 control kit barcode card, 3 X 0.25 mL Positive Control, 3 X 0.3 mL Dilution UTM
• Requires: cobas® Liat® Analyzer (P/N 07341920190) including cobas® Liat® System Software (Core) Version 3.3 or higher and cobas® SARS CoV-2 Assay Script v1.0 or higher

Product Specifications