Editor’s note: This is the first article in a three-part series discussing the next generation of COVID-19 testing. Read part two: “Say Hello to the TaqPath™ COVID-19 RNase P Combo Kit 2.0“. Read part three: “Say Hello to the TaqPath™ COVID-19 Fast PCR Combo Kit 2.0“.
Continuous COVID-19 testing remains crucial for containing the spread of the SARS-CoV-2 virus and future variants. Thermo Fisher Scientific provides gold standard testing technology with a new generation of PCR-based TaqPath COVID-19 2.0 kits, developed to help laboratories quickly and accurately diagnose COVID-19. To raise your level of testing confidence even higher, we offer an instrument service plan that offers total lab support to enable reliable patient results at this critical time.
Are you planning to implement or continue COVID-19 diagnostic testing this winter? Are you concerned about the potential impact of emerging variants on the accuracy of test results? Are you interested in testing from raw saliva?
Thermo Fisher Scientific’s next generation TaqPath Covid-19 tests includes two advanced kits: the TaqPath™ COVID-19 RNase P Combo Kit 2.0 and the TaqPath™ COVID-19 Fast PCR Combo Kit 2.0. Both assays deliver the same accuracy and reliability that our existing COVID-19 assays are known for, while offering an enhanced target redundancy to compensate for all known SARS-CoV-2 mutations as well as those yet to be discovered. Each kit utilizes the RNase P gene as an endogenous control to help ensure sample integrity, quality, extraction, and RT-PCR performance. The TaqPath™ COVID-19 RNase P 2.0 supports nasopharyngeal swabs and nasal swabs1. The TaqPath™ COVID-19 Fast PCR Assay 2.0 offers the convenience of using raw saliva specimen without prior extraction to provide an even faster sample-to-result testing solution1.
An Advanced Assay Design Compensates for Known and Emerging SARS-CoV-2 Mutations
Scientists predict that SARS-CoV-2 variants will continue to emerge. Persistent, uncontrolled transmission of the virus in many parts of the world, coupled with selective pressures such as vaccines, create ideal conditions for SARS-CoV-2 to continuously evolve.2
The new TaqPath COVID-19 2.0 kits provide confidence in your results with an advanced COVID-19 assay design that covers 3 genomic regions (ORF1a, ORF1b, N gene), each with a unique fluorescence channel. A total of 8 targets are included in the new assay design while the S gene, which has a high risk of mutation, has been excluded to eliminate the risk of S-gene dropout. This increased target redundancy (multiple targets within each gene are amplified and detected) enables accurate results even in the presence of new mutations.
An in-silico analysis performed on August 27, 2021 using 832,305 complete SARS-CoV-2 genomes from the GISAID database concluded that the TaqPath™ COVID-19 2.0 kits map with 100% homology to 100% of SARS-CoV-2 genome sequences. With high sensitivity and specificity, this new advanced assay design provides you with confidence in your results now and into the future.
Improved Workflow and Sample Quality Control
In addition to an evolved assay design, both TaqPath™ COVID-19 2.0 kits feature the use of RNase P as an internal control. Not only does this improve the assay workflow by omitting external addition of the MS2 bacteriophage, but RNase P also demonstrates its invaluable role as an endogenous sample quality control.
RNase P allows you to monitor each specimen for accurate sample collection, transportation, storage, preparation, and effective RT-PCR amplification. Failure to detect RNase P may indicate a loss of RNA or RNA degradation due to poor sample collection, improper extraction, inadequate sample transportation or storage conditions, improper assay set-up and execution, reagent failure, equipment malfunction, or the presence of PCR inhibitors. As such, the internal RNase P control helps to greatly reduce the risk of false-negative results while simplifying the workflow and ensuring sample quality.
Thermo Fisher Scientific’s Service and Support Commitment
All instruments approved for use with our next-generation TaqPath Covid-19 2.0 tests are covered in our AB Platinum instrument service plan. We know that the stakes are high, and our AB Platinum instrument service plan comes with 24/7/365 Priority Technical Support and rapid-response on-site support. The plan’s features maximize the uptime of your Thermo Scientific Kingfisher and Applied Biosystems instruments. To learn more, visit thermofisher.com/uptime.
To learn more about the new TaqPath™ COVID-19 2.0 Assays, click here.
For more information about the TaqPath™ COVID-19 RNase P Combo Kit 2.0 performance and how to order it, click here.
For more information about the TaqPath™ COVID-19 Fast PCR Assay 2.0 performance and how to order it, click here.
TaqPath COVID-19 2.0 Summary:
An advanced assay design compensates for known and emerging SARS-CoV-2 mutations
Our innovative, multi-target assay design compensates for emerging SARS-CoV-2 mutations to provide more confidence in your results.
Robust specificity and high sensitivity
Thermo Fisher Scientific’s new COVID-19 2.0 tests provide reliable results, with 100% specificity to currently available SARS-CoV-2 genomes. The TaqPath™ COVID-19 RNase P Combo Kit 2.0 now has a limit of detection of 75 GCE/mL.
Improved workflow and sample quality control
Rather than spiking in exogenous bacteriophage MS2 as the extraction control prior to processing, the RNase P gene serves as an endogenous control to help ensure sample integrity and quality, in addition to proper extraction and RT-PCR performance.
Multiple workflow options
Choose from 2 kits: one utilizes a standard workflow that includes RNA extraction, and the second utilizes a fast, direct-to-PCR workflow with no RNA extraction required.
Conveniently store all the components at –20°C, as opposed to the previous generation of COVID-19 kits which require certain components to be stored at –70°C.
Affordable and scalable
Add to your existing COVID-19 test menu using your current real-time QuantStudio PCR instrumentation. Our 1,000 rxn kit allows for more samples to be run within the same lot of reagents vs running multiple lots with the smaller kit sizes.
Includes Applied Biosystems Pathogen Interpretive Software
The Applied Biosystems Pathogen Interpretive Software automatically validates each run and prepares a report for all tested specimen, decreasing analysis and interpretation time and helping reduce the risk of user interpretation error.
Trusted COVID-19 test provider
Thermo Fisher Scientific offers a complete solution for clinical labs, including real-time PCR kits, controls, the Pathogen Interpretive Software, and services and support. With the capability to manufacture >20 million COVID-19 tests per week, you can have confidence in our ability to supply kits and materials for all your laboratory needs.
1 Please refer to the Instructions for Use for more details and for the supported protocol. Deviations from the protocol are not permitted
2 Science Brief: Emerging SARS-CoV-2 Variants, United States Centers for Disease Control and Prevention (CDC), 28 Jan 2021.
Intended use and regulatory statements of products vary. For specific intended use and regulatory statements, please refer to the Instructions for Use (IFU). Product availability by country varies.