TaqPath COVID-19 2.0 Assays

 

Advanced assay design to compensate for SARS-CoV-2 mutations

 

The next-generation TaqPath COVID-19 2.0 tests were developed with an advanced assay design to compensate for emerging mutations of the SARS-CoV-2 virus.

Viruses mutate, and SARS-CoV-2 is no exception. Early in the COVID-19 pandemic, SARS-CoV-2 mutated at a rate of about 1–2 mutations per month [1]. Beginning in mid- to late-2020, however, multiple SARS-CoV-2 variants began to emerge that had accumulated significantly more mutations in short periods of time, causing concern around the globe [2].

Scientists predict that SARS-CoV-2 variants will continue to emerge, as persistent uncontrolled transmission of SARS-CoV-2 in many parts of the world and selective pressures, such as vaccines, are creating ideal conditions for additional, significant virus evolution [3].

In order to provide increased confidence in our COVID-19 test results as SARS-CoV-2 continues to mutate, our Applied Biosystems TaqPath COVID-19 2.0 tests employ an advanced assay design with increased target redundancy to compensate for both currently known and future SARS-CoV-2 mutations.

The new TaqPath assay designs cover three genomic regions and eight total targets.

This design is used across both of our TaqPath COVID-19 2.0 tests.

 

TaqPath 2.0 test assays

Evolved for choice and longevity

 

TaqPath COVID-19 2.0 test assay

Thermo Fisher Scientific continues to provide gold standard testing technology with our evolved PCR-based TaqPath COVID-19 2.0 tests, which were developed to help laboratories quickly diagnose COVID-19 caused by SARS-CoV-2 infection. 

Features of the TaqPath COVID-19 2.0 test assays:

  • Same accuracy and reliability you’ve grown to trust—an advanced assay design compensates for current and emerging mutations, helping provide continued confidence in results now and into the future
  • Multiple workflow options—choose from 2 tests options: one utilizing a standard workflow that includes RNA extraction, and the second utilizing a fast, direct-to-PCR workflow with no RNA extraction required
  • Affordable and scalable—add to your existing COVID-19 test assays using your current real-time PCR instrumentation
  • Easier storage—store your TaqPath COVID-19 2.0 combo kits at -20°C

 

TaqPath COVID-19 2.0 assay details

 

Internal control

Sample type

Limit of detection

Turnaround time
(sample to result)

Approved sample
preparation

Approved system
and software

TaqPath COVID-19 Fast PCR Combo Kit 2.0

RNase P

Symptomatic individuals:

Raw saliva

750–1,000 GCE/mL*

~2 hours

Lysis (Applied Biosystems
SalivaReady Solution–
Assay design, included in the combo kit)

 

  • QuantStudio 5 Real-Time PCR System
    (96-well, 0.2 mL)
  • QuantStudio 7 Flex Real-Time PCR System
    (384-well)
  • Applied Biosystems Pathogen Interpretive Software (v1.1.0)

TaqPath COVID-19 RNase P Combo Kit 2.0

Symptomatic and asymptomatic individuals:
  • Nasopharyngeal swab (NPS)
  • Anterior nasal (nasal) swab

75 GCE/mL LOD*

~3 hours

Thermo Scientific KingFisher
Flex Purification System with

Applied Biosystems MagMAX
Viral/Pathogen II Nucleic Acid Isolation Kit

*LOD of 750 GCE/mL using QuantStudio 7 Flex instrument (384-well); LOD of 1,000 GCE/mL using QuantStudio 5 instrument (96-well, 0.2 mL)

Are you looking for a COVID-19 test that can aid in the potential early identification of B.1.1.7?

Our original COVID-19 test, the TaqPath COVID-19 CE-IVD RT-PCR Kit, employs a different assay 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 U.S. FDA have noted this pattern of detection may help with early identification of the Alpha variant (B.1.1.7) [3, 4]

Find out more

 

Product details

 

The TaqPath 2.0 test menu: TaqPath COVID-19 Fast PCR Combo Kit

Now available: TaqPath COVID-19 Fast PCR Combo Kit 2.0

Fast, trusted COVID-19 test results from raw saliva ideal for widespread, high frequency testing

Features of the TaqPath COVID-19 Fast PCR Combo Kit 2.0:

  • Fast, direct-to-PCR workflow from raw saliva—increased speed from raw saliva samples to results, enabling widespread, high-frequency testing
  • Simple and affordable—go from raw saliva collection direct to PCR (no RNA extraction), helping save supplies, reagents, and personnel costs
  • Gold standard technology—a sensitive, PCR-based test offering a limit of detection of 750–1,000 GCE/mL from raw saliva
  • Innovative, multi-target design—multiple targets on orf1a, orf1b, and N genes compensate for emerging SARS-CoV-2 mutations, helping provide increased confidence in results

Fast, direct-to-PCR workflow

The TaqPath COVID-19 Fast PCR Combo Kit 2.0 workflow does not require RNA extraction and provides results in ~2 hours.

Receive samples

Prepare samples (lysis solution)

Bypass extraction

Prepare plate and run PCR

Analyze and report

Raw saliva
(no preservatives)

  • TaqPath COVID-19 Fast PCR Combo Kit 2.0
  • Real-time PCR instruments:
    • QuantStudio 5 System (96-well, 0.2 mL)
    • QuantStudio 7 System (384-well)

Applied Biosystems Pathogen Interpretive Software (v1.1.0)

Advantages of saliva collection [5]

  • Recent studies have shown no statistically significant difference in sensitivity between nasopharyngeal swab (NPS) and saliva collection for SARS-CoV-2 detection
  • Saliva is easily self-collected, reducing both the exposure to health care providers and the need for personal protective equipment (PPE)
  • When including the cost of swabs, transport media, containers, PPE, and labor costs, saliva collection can save significant amounts of money compared to using NPS for SARS-CoV-2 detection

Find your IFU

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

Find out more

The TaqPath 2.0 test menu: TaqPath COVID-19 RNase P Combo Kit

Now available: TaqPath COVID-19 RNase P Combo Kit 2.0

Advanced PCR-based COVID-19 test design for NPS and nasal swabs using RNase P, to detect infections in symptomatic and asymptomatic patients

Features of the TaqPath COVID-19 RNase P Combo Kit 2.0:

  • Human sample confirmation—the RNase P gene serves as an endogenous control to help ensure sample integrity, quality, and extraction
  • Innovative, multi-target assay design—multiple targets on orf1a, orf1b, and N genes compensate for emerging SARS-CoV-2 mutations to help provide increased confidence in results
  • Sensitive detection for symptomatic or asymptomatic cases—PCR-based test detects active infections from individuals suspected of having COVID-19 by their health care provider as well as asymptomatic individuals; 75 GCE/mL LOD
  • Affordable and scalable—add to your existing COVID-19 test assays using some of the most widely used qPCR systems in the world
  • Easier storage—store your Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0 at –20°C

Standard workflow

The TaqPath COVID-19 RNase P Combo Kit 2.0 utilizes a standard workflow that provides results in ~3 hours.

Receive samples

Prepare samples (lysis solution)

Prepare plate and run 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 Fast PCR Combo Kit 2.0
  • Real-time PCR instruments:
    • QuantStudio 5 System (96-well, 0.2 mL)
    • QuantStudio 7 System (384-well)

Applied Biosystems Pathogen Interpretive Software (v1.1.0)

 

Ordering information

 

TaqPath COVID-19 2.0 test assays

Product

Components included

Qty

Cat. No.

TaqPath COVID-19 Fast PCR Combo Kit 2.0

TaqPath COVID-19 Fast PCR Assay 2.0 (1 tube)

1,000 rxn

A51606

TaqPath COVID-19 Plus Control (10 tubes)

TaqPath Control Dilution Buffer (1 box with 10 tubes)

SalivaReady Solution (1 bottle with 20 mL)

TaqPath 1-Step Multiplex Master Mix, No ROX (1 bottle with 10 mL) (required, but not included in kit)

TaqPath COVID-19 RNase P Combo Kit 2.0

TaqPath COVID-19 RNase P Assay 2.0 (1 tube)

1,000 rxn

A51333

TaqPath COVID-19 Plus Control (10 tubes)

TaqPath Control Dilution Buffer (1 box with 10 tubes)

TaqPath 1-Step Multiplex Master Mix, No ROX (1 bottle with 10 mL) (required, but not included in kit)

 

Simple analysis and reporting

 

PI CE-IVD Splash Without Version

Applied Biosystems Pathogen Interpretive Software (v1.1.0) is part of the required workflow and must be downloaded prior to instrumentation use.

Pathogen Interpretive Software helps your lab decrease analysis and interpretation time and reduce risk of user interpretation error. 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 “Technical Support” as category
  • Enter product name or SKU and select your country
  • Call the local number displayed on the screen

References

  1. Callaway, Ewen. News Feature:The coronavirus is mutating — does it matter? Nature, 16 Sept 2020.
  2. Threat Assessment Brief: Rapid increase of a SARS-CoV-2 variant with multiple spike protein mutations observed in the United Kingdom. European Centre for Disease Prevention and Control (ECDC), 20 Dec 2020.
  3. Science Brief: Emerging SARS-CoV-2 Variants, United States Centers for Disease Control and Prevention (CDC), 28 Jan 2021.
  4. FDA News Release: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff. U.S. Food and Drug Administration (FDA), 8 Jan 2021. 
  5. Bastos, M. et al. (2021) The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs. Annals of Internal Medicine. 174(4):501-510.

For In Vitro Diagnostic Use.  For Emergency Use Authorization (EUA) Only | Rx Only 

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