TaqPath™ COVID-19 Diagnostic PCR Kit

The Applied Biosystems TaqPath COVID-19 Diagnostic PCR 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 in nasopharyngeal and anterior nasal specimens.

Features of the TaqPath COVID-19 Diagnostic PCR Kit include:

• Complete workflow – highly sensitive, specific, scalable solution for assessing 94 specimens using real-time PCR in as fast as 3 hours
• Multi-target assay design – multiple gene targets for SARS-CoV-2 compensate for emerging mutations and variants, enabling increased confidence in results
• Includes S gene target – may help with early identification of SARS-CoV-2 variants with S gene target failure (SGTF)

The TaqPath COVID-19 Diagnostic PCR Kit is compatible with the Applied Biosystems 7500 Fast Dx Real‐Time PCR Instrument and QuantStudio 5 Dx Real‐Time PCR Instrument. Results are analyzed and interpreted using COVID‐19 Interpretive Software IVD Edition.

Each kit includes the following components:

• Multiplexed assays that contain three primer/probe sets specific to different SARS-CoV-2 genomic regions plus primers/probes for bacteriophage MS2
• MS2 Phage Control as an internal process control for nucleic acid extraction
• TaqPath COVID‐19 Diagnostic PCR Control as a positive RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays
• TaqPath COVID‐19 Diagnostic PCR Control Dilution Buffer for use with the positive RNA control
• Package insert provides instructions and link to download the instructions for use

Intended use
The TaqPath COVID-19 Diagnostic PCR 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 and anterior nasal specimens from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory (anterior nasal and nasopharyngeal swabs) 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.

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.

The TaqPath COVID-19 Diagnostic PCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.