Applied Biosystems™ TaqPath™ COVID-19 Combo Kit

Description

• The Applied Biosystems TaqPath COVID-19 Combo Kit is a fast, highly sensitive multiplex diagnostic solution that contains the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus
• Features of the newly developed multiplex diagnostic kit: • A complete workflow from viral RNA extraction from up to 94 specimens and genetic analysis using real-time PCR to diagnostic report generation in under 4 hours • Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2 • Assay targets spike (S), nucleocapsid (N), and Orf1ab (ORF1ab) protein regions having higher specificity and exhibiting lower risk for mutation • COVID-19 Interpretive Software, which automatically converts genetic analysis data into diagnosis, helping reduce risk of user interpretation error The TaqPath COVID-19 Combo Kit consists of both the TaqPath RT-PCR COVID-19 Kit and the TaqPath COVID-19 Control Kit for simplified ordering
• The kit can be used by clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under 3 hours
• The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19 (see product label for Intended Use Statement and product information)
• The TaqPath COVID-19 Combo Kit is a single, high-throughput (1,000 reactions) kit and is recommended for use with either the Applied Biosystems 7500 Fast Dx Real-Time PCR System or the 7500 Fast Real-Time PCR System (RUO version) and the associated Applied Biosystems COVID-19 Interpretive Software
• The TaqPath COVID-19 Combo Kit includes the following components: • TaqPath RT-PCR COVID-19 Kit --COVID-19 real-time PCR assay multiplex—multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for bacteriophage MS2 --MS2 phage control—internal process control for nucleic acid extraction • TaqPath COVID-19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays • TaqPath COVID-19 Control Dilution Buffer—dilution buffer for the IVT RNA control as defined in the IFU (information for use) Intended use The TaqPath COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider
• The TaqPath COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA)
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
• §263a, to perform high complexity tests
• Results are for the identification of SARS-CoV-2 RNA
• The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection
• Positive results are indicative of the presence of SARS-CoV-2 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 viruses
• The agent detected may not be the definite cause of disease
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2 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 epidemiological information
• Testing with the TaqPath COVID-19 Combo Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
• The TaqPath COVID-19 Combo Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.