Applied Biosystems™ TaqPath™ COVID-19 Combo Kit 

Description

• 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
• 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
• 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)

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.