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 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 in healthcare provider-collected nasopharyngeal and nasal swabs and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of a viral respiratory infection. cobas® SARS-CoV-2 & Influenza A/B is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleic acid in clinical specimens and is not intended to detect influenza C virus. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in respiratory specimens during the acute phase of infection. 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. The agent detected may not be the definite cause of disease. Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B 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 in Near Patient Testing, Point of Care (POC), or clinical laboratory settings. en cobas® SARS-CoV-2 & Influenza A/B 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 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

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