For in vitro diagnostic use. Others cobas liat SARS-CoV-2 Influenza A B and RSV IVD cobas® liat SARS-CoV-2, Influenza A/B & RSV PID00000730 nucleic acid test 09 731 261 190 9 731 261 190 09731261190 9731261190 09731261190 KIT C LIAT SARS COV2 FLU AB RSV KIT C LIAT SARS COV2 FLU AB RSV 00875197007299 Reagents, kits 1 pack 20 tests true US-IVD The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription 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 virus, influenza B virus and respiratory syncytial virus (RSV) nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens from individuals exhibiting signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV infections in humans and is not intended to detect influenza C virus infections. Nucleic acids from the viral organisms identified by this test are generally detectable in nasopharyngeal and nasal swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus, and aid in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organisms. The organism(s) detected by the cobas® liat SARS- CoV-2, Influenza A/B & RSV nucleic acid test may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. EUA The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription 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 virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test 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. Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas® liat system and the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization. en cobas® liat SARS-CoV-2, Influenza A/B& RSV nucleic acid test (cobas® liat SARS-CoV-2, Influenza A/B & RSV) The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testis an automated rapid multiplex real-time reverse transcription 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 virus, influenza B virus and respiratory syncytial virus (RSV) nucleic acids in self-collected anterior nasal (nasal) swab specimens (directly observed by a healthcare-provider) and healthcare provider-collected nasal swab and nasopharyngeal swab specimens from individuals with signs or symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza and RSV can be similar. The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. SARS-CoV-2, influenza A, influenza B and RSV nucleic acids are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Negative results do not preclude SARS-CoV-2, influenza and/or RSV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other organisms. The agent(s) detected may not be the definite cause of disease. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for professional use in a point of care location, near-patient setting or clinical laboratory. cobas® liat SARS-CoV-2, Influenza A/B & RSV control kit cobas® liat SARS-CoV-2, Influenza A/B & RSV control kit is intended for assay tube Lot Validation with the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. en CE-IVD Test principle The test 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 membrane protein gene that are unique to SARS-CoV-2, a well-conserved region of the matrix gene of influenza A (Flu A target), the nonstructural protein 1 (NS1) gene of influenza B (Flu B target), and the matrix gene of RSV (RSV target). An Internal Control is included to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR processes. The sample to result time is approximately 20 minutes. en EUA The test 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 membrane protein gene that are unique to SARS-CoV-2, a well-conserved region of the matrix gene of influenza A (Flu A target), the nonstructural protein 1 (NS1) gene of influenza B (Flu B target), and the matrix gene of RSV (RSV target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR processes. The sample to result time is approximately 20 minutes. US-IVD Test principle The test 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 membrane protein gene that are unique to SARS-CoV-2, a well-conserved region of the matrix gene of influenza A (Flu A target), the nonstructural protein 1 (NS1) gene of influenza B (Flu B target), and the matrix gene of RSV (RSV target). An Internal Control is included to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR processes. The sample to result time is approximately 20 minutes. en

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