TaqPath™ COVID-19, FluA/B, RSV Combo Kit

The TaqPath COVID-19, Flu A/B, RSV Combo Kit contains the reagents and controls for a real-time RT-PCR test for the qualitative detection of nucleic acid from the SARS-CoV-2 virus, the influenza A/B (flu A/B) viruses, and the respiratory syncytial (RSV) virus in nasopharyngeal swabs from individuals showing symptoms of respiratory tract infection.

Features of the TaqPath COVID-19, Flu A/B, RSV Combo Kit include:
• Single test for SARS-CoV-2, influenza A/B, and RSV—detect and differentiate between disease states with similar clinical symptoms and get the information needed to help monitor the spread of these respiratory illnesses
• Affordable and scalable—add to your existing COVID-19 testing menu and infrastructure to expand your respiratory sample testing while maintaining low operational costs and workflow simplicity
• Sensitive and specific—robust performance for detecting flu A/B and RSV, providing increased confidence in results
• Complete solution for clinical labs—Applied Biosystems Pathogen Interpretive Software CE-IVD Edition automatically converts genetic analysis data into a readable report, helping reduce risk of user interpretation error

TaqPath COVID-19, Flu A/B, RSV Combo Kit includes the following components:
• TaqPath COVID-19, Flu A/B, RSV Assay Kit
   --TaqPath COVID-19, Flu A/B, RSV Multiplex Assay—multiplex assays that contain primer and probe sets specific to two SARS-CoV-2 targets (N gene and S gene), two influenza targets (influenza A and influenza B), two RSV targets (RSV A and B), and bacteriophage MS2
   --MS2 Phage Control—internal process control for nucleic acid extraction
• TaqPath COVID-19, Flu A/B, RSV Control—an RNA control that contains targets specific to the SARS-CoV-2, influenza A/B, and RSV genomic regions targeted by the assays
• TaqPath COVID-19, Flu A/B, RSV Control Dilution Buffer
• TaqPath 1-Step Multiplex Master Mix (No ROX)

Access the Instructions for Use approved for your country › 

Intended use
The TaqPath COVID-19, Flu A/B, RSV Combo Kit contains the reagents and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus, the influenza A/B (Flu A/B) viruses, and the respiratory syncytial virus (RSV) in nasopharyngeal swabs from individuals showing symptoms of respiratory tract infection.

Results are for the identification of SARS-CoV-2, influenza A/B viruses (undifferentiated), and Respiratory Syncytial Virus (RSV) nucleic acids. The SARS-CoV-2, influenza A/B, and RSV RNA are generally detectable in upper respiratory specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2, influenza virus, and/or RSV; 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 not tested. The agent detected may not be the definite cause of disease.

Laboratories may be required to report all positive SARS-CoV-2 results to the appropriate Competent Health Authorities. Laboratories may also be required to report negative SARS-CoV-2 results, positive and/or negative influenza results, and positive and/or negative RSV results to the appropriate Competent Health Authorities.Negative results do not preclude SARS-CoV-2, influenza A/B, or RSV A/B 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, Flu A/B, RSV 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.

In rare circumstances where there is co-infection with significantly different viral loads of Flu A and Flu B, the test may report a false negative result for Flu A/B.