For in vitro diagnostic use. Others cobas SARS-CoV-2 and Influenza A B Test Liat IVD cobas® SARS-CoV-2 & Influenza A/B RMD-Liat-SARS-001 Nucleic acid test for use on the cobas® liat system 09 211 101 190 9 211 101 190 09211101190 9211101190 09211101190 KIT COBAS LIAT SARS-COV-2/FLU cobas SARS-CoV-2 & Influenza A/B 00875197006360 Reagents, kits 1 pack 20 tests true 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 rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.Positive results do not rule out co-infection with other organisms. The agent(s) detected by the cobas SARS-CoV-2 & Influenza A/B may not be the definite cause of disease.Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. en The cobas® SARS-CoV-2 & Influenza A/B assay is performed on the cobas® Liat® Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time RT-PCR assays. The assay targets both the ORF1 a/b non-structural region and nucleocapsid protein gene that are unique to SARS-CoV-2, a well-conserved region of the matrix gene of influenza A, and the non-structural protein gene of influenza B. An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through steps of sample purification, nucleic acid amplification, and to monitor the presence of inhibitors in the RT-PCR processes. en

Instrument	cobas® liat system
Targets	SARS-CoV-2, Influenza A, Influenza B
Registration	FDA 510(k) cleared, CLIA-waived
Time to result	~20 minutes
Sample type	Nasopharyngeal swab, nasal swab
Reagents	Ready-to-use, pre-packed tube format
Kit Storage	2–8°C
Collection media	Universal Transport Media (UTM), 0.9% saline
Technology	Real-time PCR
Sample extraction	Fully automated and integrated
Control	Internal sample processing control, positive and negative controls

Material Number	Alternative Catalog Number	Material Description	Pack Size	Pack size Description
09211101190		KIT COBAS LIAT SARS COV2 FLU AB	1 pack	20 tests
09211120190		COBAS LIAT SARSCOV2 FLU AB QC	1 pack	3 sets

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cobas® SARS-CoV-2 & Influenza A/B

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cobas® SARS-CoV-2 & Influenza A/B specifications