In response to the novel coronavirus (SARS-CoV-2) outbreak, Thermo Fisher Scientific has worked rapidly to develop a multiplex real-time PCR diagnostic kit to enable clinical and public health laboratories to quickly diagnose COVID-19 caused by SARS-CoV-2 infection.

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S-gene advantage for potential early identification of the Omicron variant (B.1.1.529)

This test uses a multi-target design that includes an S-gene target. If a sample with the 69-70del S-gene mutation is tested using the TaqPath COVID-19 CE-IVD RT-PCR Kit, it will result in an S-gene dropout. The European CDC and WHO have noted this pattern of detection may help with early identification of the Omicron variant (B.1.1.529)

 

TaqPath COVID-19 Combo Kit targets 3 areas of SARS-CoV-2 virus

 

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  • Built-in redundancy (3 targets) compensates for emerging SARS-CoV-2 mutations and variants, helping provide confidence in your results
  • Targets areas unique to SARS-CoV-2* virus to reduce detection of other coronaviruses

  *GISAID and GenBank databases as of May 7, 2021

 

Concerned about impact of new variants on your COVID-19 test performance? There is peace of mind with the TaqPath COVID-19 2.0 Assays.

Prepare yourself for flu season with the TaqPath COVID-19, Flu A/B, RSV Combo Kit, a single test to detect SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV).

 

Features of the TaqPath COVID-19 CE-IVD RT-PCR Kit

 

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The following instruments are compatible with this kit:

  • Applied Biosystems 7500 Fast Dx Real-Time PCR instrument
  • Applied Biosystems 7500 Fast Real-Time PCR Instrument
  • Applied Biosystems 7500 Real-Time PCR Instrument
  • QuantStudio 5 Real-Time PCR Instrument, 96-well, 0.2 mL block
  • QuantStudio 5 Real-Time PCR Instrument, 96-well, 0.1 mL block
  • QuantStudio 5 Dx Real-Time PCR Instrument, 384-well block
  • QuantStudio 7 Flex Real-Time PCR Instrument, 384–well block

Seven specimen types have been validated, requiring only 200 to 400 μL of sample

  • Bronchoalveolar lavage (BAL)
  • Mid-turbinate swabs
  • Nasal swabs
  • Nasopharyngeal swabs
  • Nasopharyngeal aspirate (nasal aspirate)
  • Oropharyngeal swabs
  • Saliva collected with the Spectrum Solutions™ SpectrumDNA™ SDN

 

Workflow

 

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Intended use of this workflow may vary. To view approved workflow in your region, please refer to the Instructions for Use (IFU) for your product.

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Clinical Evaluation of the TaqPath COVID‑19 CE‑IVD RT‑PCR Kit for Detection of SARS-CoV-2

This technical bulletin discusses a study conducted to determine the clinical performance of the TaqPath COVID‑19 CE‑IVD RT‑PCR Kit. The study compared results obtained with the Cobas SARS‑CoV-2 Test or the TaqPath COVID‑19 CE‑IVD RT‑PCR Kit from a total of 446 retrospective upper respiratory samples from patients of all ages.

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Applied Biosystems COVID-19 Interpretive Software CE-IVD Edition

Decrease analysis and interpretation time and help reduce risk of user interpretation error with our COVID-19 Interpretive Software CE-IVD Edition. This software automatically converts genetic analysis data into a readable report.

You may download the COVID-19 Interpretive Software CE-IVD Edition 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 SKU and select your country
  • Call the local number displayed on the screen

 

Education

 

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Understanding the differences between two of the leading testing technologies

PCR and RADT are two testing technologies used to detect COVID-19. It’s important to understand what they each do best and how their attributes fit your testing scenario. Here is a helpful infographic that summarizes their differences.

Infographic: COVID-19 PCR and antigen testing: get the facts

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Learn more about SARS-CoV-2 biology and COVID-19 testing

Learn about SARS-CoV-2 infection and replication, disease progression and spread of COVID-19, and the importance and types of COVID-19 testing

Infographic: SARS-CoV-2 biology and COVID-19 testing: get the facts

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Discover more about variant impact and mutation detection

As we continue to navigate the needs for pathogen detection Emerging Mutation Surveillance and Confirmation becomes more prevalent and our portfolio of COVID-19 Testing Solutions is ready to help

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For in vitro diagnostic use. Regulatory requirements vary by country. Product may not be available in your geographic region.
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