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.