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Emergency Use Authorized—designed to detect and differentiate​

Because influenza and COVID-19 share symptoms, accurate testing is needed to distinguish one from the other. This Emergency Use Authorized (EUA) multiplex PCR test is specifically designed to detect and differentiate between multiple respiratory viruses as the ongoing COVID-19 pandemic overlaps with respiratory virus season. The test uses an assay design with two SARS-CoV-2 targets to compensate for emerging variants and mutations and help provide confidence in results.

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Incidence of respiratory infections such as influenza increase in the colder months, creating a challenge for medical systems and diagnostics alike.

Differentiate respiratory diseases with a single test

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Multi-target assay design helps compensate for emerging SARS-CoV-2 mutations and variants

Workflow and performance of the TaqPath COVID-19, Flu A,  Flu B Combo Kit

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

  • Single test for SARS-CoV-2, influenza A, and influenza B
    • Simultaneously differentiates respiratory diseases
    • Helps identify cases of co-infection
  • Affordable and scalable
    • Increases testing throughput and lab efficiency
  • Sensitive and specific RT-PCR detection
    • Robust performance for detecting SARS-CoV-2, flu A and flu B
  • Results automated by Applied Biosystems Pathogen Interpretive Software
    • Quickly interprets results to expedite reporting
    • Helps reduce risk of user interpretation error
TaqPath-COVID19-Flu-Kit_EUA

Infographic: The latest in coronavirus and flu testing

  • Similarities and differences between coronavirus and the flu
  • The importance of simultaneously testing for multiple viruses
  • The basics of respiratory viruses
  • Treatments, vaccines, and testing recommendations

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Solution workflow

Turnaround time from sample to interpreted results is approximately 3 hours. The required workflow consists of sample extraction and preparation, real-time RT-PCR genetic analysis, and automated translation of data into patient diagnosis.

Sample collection

Sample prep

Real-time PCR

Analyze and report

Nasopharyngeal swabs
Anterior nasal swabs

Thermo Scientific KingFisher Flex Purification System with Applied Biosystems MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit
  • TaqPath COVID-19 Flu A, Flu B Combo Kit
  • Real-time PCR instruments:
    • 7500 Fast Dx Real-Time PCR System
    • QuantStudio 5 System (96-well, 0.2 mL)

Applied Biosystems Pathogen Interpretive Software EUA Edition

Simple analysis and reporting

PI EUA Splash Without Version

The Applied Biosystems Pathogen Interpretive Software EUA Edition is part of the required workflow and must be downloaded prior to instrumentation use.

You may download the software upon kit purchase. Labs following the authorized workflow are required to complete an eLearning course and pass an exam to download.

Follow the instructions below to obtain the software from your local support team:

  • Go to thermofisher.com/contactus
  • Select “Instrument Service” as category
  • Enter product name or Cat. No. and select your country
  • Call the local number displayed on the screen

Product details

Targets

  • SARS-CoV-2 (S gene and N gene)
  • Influenza A (matrix gene)
  • Influenza B (matrix gene)

Internal control

  • MS2 phage control

Authorized sample types

  • Nasopharyngeal (NP) swab
  • Anterior nasal (nasal) swab

Authorized sample preparation

Authorized instruments

Limit of detection (LOD)

  • SARS-CoV-2: 100 GCE/mL
  • Influenza A: 200–500 GCE/mL
  • Influenza B: 500–1,000 GCE/mL

Ordering information

Product

Included component

Qty

Cat. No.

TaqPath COVID-19, Flu A, Flu B Combo Kit

TaqPath COVID-19, Flu A, Flu B RT-PCR Assay (1 tube)

1,000 rxns

A49868

MS2 Phage Control (10 tubes)

TaqPath COVID-19, Flu A, Flu B Control Kit (10 tubes)

TaqPath COVID-19 Control Dilution Buffer (10 tubes)

Find your IFU

Find the approved Instructions for Use (IFU) for your country. (Note: Product availability varies by country.)

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For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use. Product availability varies by country.