Talis One™
Central lab quality SARS-CoV-2 molecular testing
for a variety of care settings—less than 30 minutes
from sample to results.
Because fast results should also be accurate
As SARS-CoV-2 continues to evolve, new variants may become more transmissible. As such reliable testing is one of the more effective ways to identify individuals who may need to quarantine and to prevent transmission of the disease.1,2
The Talis One™ COVID-19 Test System is a rapid point-of-care COVID-19 test that enables highly sensitive SARS-CoV-2 RNA detection from nasal mid-turbinate swabs in less than 30 minutes. With its dual-gene target design, test sensitivity and inclusivity of variants is optimized.3
Triage with confidence, without the wait
The easy to use sample-to-answer workflow and small instrument footprint bring all the benefits of molecular testing to a variety of care settings, maximizing the impact of testing on patient health and the containment of disease spread.
The Talis One COVID-19 Test System uses proprietary technology to deliver Nucleic Acid Amplification Test (NAAT) results quickly. Unlike other rapid point-of-care COVID-19 tests4 that may not be as sensitive, the Talis One COVID-19 Test System is able to achieve central lab quality detection of SARS-CoV-2 due to our patented on-cartridge sample purification step. With the on-cartridge sample extraction and purification and other proprietary technologies, the Talis One Covid-19 Test System achieves a limit of detection (LOD) of 500 copies/mL.5
Accurate
- Delivers lab-quality results in a variety of care settings including non-acute, CLIA-waived settings in educational facilities, workplaces, public health clinics, etc.
- Targets SARS-CoV-2 N and ORF1ab genes for inclusivity of variants
- Includes human beta actin as a sample processing control
Easy-to-use
- Samples are added to a fully self-contained cartridge
- Precision pipetting is not required
- Sample extraction, purification, amplification, detection, and analysis is automated
Rapid
- Goes from sample to results in less than 30 minutes
- Hands-on time less than 2 minutes
- Reliable NAAT results are clearly displayed and actionable immediately upon completion of test
Access lab-quality testing at the point of care.
Easy Sample-to-Answer Workflow
Designed for use in a variety of healthcare settings including those that are CLIA-waived, the Talis One COVID-19 Test System delivers clear and actionable results with a streamlined workflow.
- Label with patient ID: Barcode or handwritten
- Add specimen to cartridge
- Report results in < 30 minutes
Talis One Covid-19 Test System Specifications5
Targets
N gene, ORF1ab gene
Human beta actin (sample processing control)
Technology
Nucleic acid amplification technology (NAAT)
Sample Types
Nasal mid-turbinate swab specimens
Precision Pipetting
Not required
Sample Input Volume
~1 mL
Hands-On Time
<2 minutes
Run Time
~27 minutes
Talis One Instrument Dimensions (L x W x H)
14 in x 10 in x 7 in
Test Storage
Room temperature (15 – 30°C)
Product Components Needed to Run a COVID-19 Test
Talis One
• Talis One Instrument
• Talis One Accessories
Talis One COVID-19 Cartridge Pack
• Talis One COVID-19 cartridge
• 1 mL transfer pipette
Talis One Nasal Mid-Turbinate Collection Kit
• Nylon flocked swab
• 3 mL inactivation medium
Talis One Covid-19 Cartridge
The Talis One COVID-19 Test System, performed on the Talis One instrument, is a qualitative in vitro real-time nucleic acid amplification test (NAAT) for the automated detection of nucleic acid from SARS-CoV-2 in nasal mid-turbinate swab specimens from individuals suspected of COVID-19 by their healthcare provider.
Talis One Covid-19 Test System Technical Resources
Product Information
Package Inserts
Technical Documentation
Patient Information
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; this product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
REFERENCES:
- https://www.cdc.gov/coronavirus/2019-ncov/variants/variant.html Accessed July 27, 2021
- https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html Accessed July 27, 2021
- https://journals.asm.org/doi/abs/10.1128/JCM.00075-21 Accessed August 3, 2021
- https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests Accessed July 27, 2021
- https://talisbio.com/spring-2021/covid-19-assay-whitepaper Accessed August 2, 2021
Our Growing Test Menu
With a focus on improving health in underserved communities through rapid point-of-care testing, we will be expanding our test menu with tests to address sexual and women’s health.
Respiratory
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Sexual + Women’s Health
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‡In development and not available for sale.
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