Advanced assay design to compensate for emerging SARS-CoV-2 mutations
In order to provide increased confidence in our COVID-19 test results as SARS-CoV-2 continues to mutate, our 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.
Assay design
Blog series: The Next Generation of COVID-19 Testing
This design is used across both of our TaqPath COVID-19 2.0 tests.
TaqPath COVID-19 2.0 assay details
CE-IVD Kit
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
Download flyer ›
RNase P
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
TaqPath COVID-19 RNase P Combo Kit 2.0
Download flyer ›
- Nasopharyngeal swab (NPS)
- Anterior nasal (nasal) swab
75 GCE/mL**
~3 hours
Thermo Scientific KingFisher
Flex Purification System with
Applied Biosystems MagMAX
Viral/Pathogen II Nucleic Acid Isolation Kit
- QuantStudio 5 Real-Time PCR System
(96-well, 0.2 mL) - QuantStudio 5 Dx Real-Time PCR System (96-well, 0.2 mL)
- QuantStudio 7 Flex Real-Time PCR System
(384-well) - Applied Biosystems Pathogen Interpretive Software
CE-IVD Kit | Internal control | Sample type | Limit of detection | Turnaround time | Approved sample | Approved system |
|---|---|---|---|---|---|---|
TaqPath COVID-19 Fast PCR Combo Kit 2.0Download flyer › | RNase P
| Raw saliva | 750–1,000 GCE/mL* | ~2 hours | Lysis (Applied Biosystems |
|
TaqPath COVID-19 RNase P Combo Kit 2.0Download flyer › |
| 75 GCE/mL**
| ~3 hours | Thermo Scientific KingFisher Applied Biosystems MagMAX |
|
*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). LOD was determined using pooled, contrived raw saliva samples that were spiked with gamma-irradiated SARS-CoV-2, Isolate USA-WA1/2020 (BEI Resources, PN NR-52287, LN 70033322).
** A bridging study yielded 100% positivity (20/20) at 1x LoD for the QuantStudio 5 Instrument (96-well, 0.2 mL)
TaqPath COVID-19 2.0 test assays
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 menu using your current real-time PCR instrumentation
- Easier storage—Store your TaqPath COVID-19 2.0 combo kits at -20°C
Find your IFU
Find the approved Instructions for Use (IFU) for your country. (Note: Product availability varies by country.)
For In Vitro Diagnostic Use. Regulatory requirements vary by country. Product may not be available in your geographic region. © 2021 Thermo Fisher Scientific Inc.
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