Applied Biosystems™ TaqPath™ COVID-19, FluA, FluB Combo Kit

Description

• Features of the TaqPath COVID-19, Flu A, Flu B Combo Kit include: Single test for SARS-CoV-2, influenza A, and influenza B —detect and differentiate between disease states with similar clinical symptoms and get information needed to help monitor spread of COVID-19 and flu Affordable and scalable —add to your existing COVID-19 testing menu and infrastructure to expand your respiratory sample testing while maintaining low operational costs and workflow simplicity Multitarget assay design —helps compensate for emerging SARS-CoV-2 variants and mutations to help provide confidence in results Complete solution for clinical labs —Applied Biosystems Pathogen Interpretive Software automatically converts genetic analysis data into a readable report, helping reduce risk of user interpretation error Emergency Use Authorized The TaqPath COVID-19, Flu A, Flu B Combo Kit includes the following components: TaqPath RT-PCR COVID-19, Flu A, Flu B Kit TaqPath COVID-19, Flu A, Flu B RT-PCR Assay Multiplex —multiplexed assays that contain primer and probe sets specific to two SARS-CoV-2 targets (S gene and N gene), one influenza A target, one influenza B target, and bacteriophage MS2 MS2 Phage Control —internal process control for nucleic acid extraction TaqPath COVID-19, Flu A, Flu B Control —RNA control that contains targets specific to the SARS- CoV-2, influenza A, and influenza B genomic regions targeted by the assays TaqPath Control Dilution Buffer The TaqPath COVID-19, Flu A, Flu B Combo Kit is authorized for use on the Applied Biosystems 7500 Fast Dx Real-Time PCR and QuantStudio 5 Real-Time PCR System (96-well, 0.2 mL block) with nasopharyngeal swab and anterior nasal swab specimens only
• Intended use The TaqPath COVID-19, FluA, FluB Combo Kit is a multiplex real-time RT-PCR test intended for the simultaneous qualitative detection and differentiation of RNA from the SARS-CoV-2, influenza A, and/or influenza B viruses in nasopharyngeal swab and anterior nasal swab specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider
• Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza 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 the requirements to perform high-complexity tests
• The TaqPath COVID-19, FluA, FluB Combo Kit is intended for use in simultaneous detection and differentiation of SARS-CoV-2, influenza A, and/or influenza B nucleic acid in clinical specimens and is not intended to detect influenza C virus
• The SARS-CoV-2, influenza A, and influenza B RNA is generally detectable in upper respiratory samples 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.