Applied Biosystems™ TaqPath™ COVID-19, FluA, FluB Combo Kit

The TaqPath COVID-19, Flu A, Flu B Combo Kit includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, and influenza B viruses in nasopharyngeal and anterior nasal swabs from individuals suspected of COVID-19 by their healthcare provider.

Supplier:  Applied Biosystems™ A49868

Catalog No. A49868

Description

Features of the TaqPath COVID-19, Flu A, Flu B Combo Kit include:

• Single test for SARS-CoV-2, influenza A, and influenza B—detect and differentiate between disease states with similar clinical symptoms and get information needed to help monitor spread of COVID-19 and flu
• 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
• Multitarget assay design—helps compensate for emerging SARS-CoV-2 variants and mutations to help provide confidence in results
• Complete solution for clinical labs—Applied Biosystems Pathogen Interpretive Software automatically converts genetic analysis data into a readable report, helping reduce risk of user interpretation error
• Emergency Use Authorized

The TaqPath COVID-19, Flu A, Flu B Combo Kit includes the following components:

• TaqPath RT-PCR COVID-19, Flu A, Flu B Kit
  • TaqPath COVID-19, Flu A, Flu B RT-PCR Assay Multiplex—multiplexed assays that contain primer and probe sets specific to two SARS-CoV-2 targets (S gene and N gene), one influenza A target, one influenza B target, and bacteriophage MS2
  • MS2 Phage Control—internal process control for nucleic acid extraction
• TaqPath COVID-19, Flu A, Flu B Control—RNA control that contains targets specific to the SARS- CoV-2, influenza A, and influenza B genomic regions targeted by the assays
• TaqPath Control Dilution Buffer

The TaqPath COVID-19, Flu A, Flu B Combo Kit is authorized for use on the Applied Biosystems 7500 Fast Dx Real-Time PCR and QuantStudio 5 Real-Time PCR System (96-well, 0.2 mL block) with nasopharyngeal swab and anterior nasal swab specimens only.

Intended use

The TaqPath COVID-19, FluA, FluB Combo Kit is a multiplex real-time RT-PCR test intended for the simultaneous qualitative detection and differentiation of RNA from the SARS-CoV-2, influenza A, and/or influenza B viruses in nasopharyngeal swab and anterior nasal swab specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high-complexity tests.

The TaqPath COVID-19, FluA, FluB Combo Kit is intended for use in simultaneous detection and differentiation of SARS-CoV-2, influenza A, and/or influenza B nucleic acid in clinical specimens and is not intended to detect influenza C virus. The SARS-CoV-2, influenza A, and influenza B RNA is generally detectable in upper respiratory samples during the acute phase of infection.

Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Specifications

• Content And Storage: • TaqPath RT-PCR COVID-19, Flu A, Flu B RT-PCR Assay Multiplex (1 tube), store at -10 to -30°C
  • MS2 Phage Control (10 tubes), store at -10 to -30°C
  • TaqPath COVID-19, Flu A, Flu B Control Kit (1 box with 10 tubes), store at ≤ -70°C
  • TaqPath Control Dilution Buffer (1 box with 10 tubes), store at -10 to -30°C
  
  
• Detection Method: Primer-Probe Detection
• For Use With (Application): COVID-19 / Flu Diagnostic Testing
• Quantity: 1000 reactions
• Target Organism Class: SARS-CoV-2 (S & N genes), Influenza A, Influenza B

• Control Sets: Internal: MS2 Process Control
  
  Positive: RNA Control
  
  
• Sample Type: Nasopharyngeal (NP) swabs, anterior nasal swabs
• Product Line: TaqPath™
• Software: • Applied Biosystems™ Pathogen Interpretive Software
  
  • SAE Administrator Console Dx
  
  

For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.