TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

The Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is a multiplex real-time PCR solution that contains the assay, master mix, and controls needed for the detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and respiratory syncytial virus (RSV) in RNA extracted from nasopharyngeal (NP) swab and anterior nasal (AN) swab specimens. Human ribonuclease P (RNase P) is included as an endogenous sample collection control.

Features of the TaqPath COVID-19, Flu A, Flu B, RSV Select Panel include:

• Single test for COVID-19, influenza A, influenza B, and RSV— detect and differentiate between infections with similar clinical signs and symptoms, with robust detection of co-infections
• Multi-target assay design—multiple gene targets for SARS-CoV-2, flu A, flu B, and RSV to compensate for emerging mutations and variants and provide increased confidence in results
• Complete integrated clinical solution—end-to-end sample to result workflow with laboratory information system (LIS) integration via Diomni Software

Each kit includes the following components:

• TaqPath COVID‐19, Flu A, Flu B, RSV Select Assay—multiplex assay that contains primer and probe sets specific to the following targets:
  • Three SARS-CoV-2 targets (Orf1a, Orf1b, and N genes)
  • Two influenza A targets (PB1 & M genes)
  • Two influenza B targets (M & NS genes)
  • Three RSV targets (NP, M, and L protein genes)
  • RNase P (human sample collection control)
• TaqPath COVID‐19, Flu A, Flu B, RSV Select Positive Control—inactivated viral control that contains SARS-CoV-2, influenza A, influenza B, and RSV
• TaqPath COVID‐19, Flu A, Flu B, RSV Select Negative Control—MS2 packaged RNA control that contains targets specific to RNase P genomic regions targeted by the assay
• TaqPath 1-Step Select Master Mix (No ROX)—ready-to-use PCR mix, including reverse transcriptase, polymerase, dNTPs, salt, and buffer
• Package insert—provides the instructions and the link to download the instructions for use
• Assay Definition File (ADF)—applicable to the instrument used in the workflow (available via download)

Intended use

The Applied Biosystems TaqPath COVID‐19, Flu A, Flu B, RSV Select Panel is a multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic test for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV A/B (undifferentiated) infections in humans and is not intended to detect influenza C virus infections.

Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Applied Biosystems TaqPath COVID‐19, Flu A, Flu B, RSV Select Panel may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections.

The Applied Biosystems TaqPath COVID‐19, Flu A, Flu B, RSV Select Panel 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.