Central lab-quality SARS-CoV-2 molecular testing in less than 30 minutes from sample to results.
Get the Talis Biomedical One Covid-19 Test System
How it works
The Talis Biomedical One workflow takes you quickly and efficiently from sample-to-answer in three easy steps.
- Label cartridge with patient ID.
- Add specimen to cartridge and insert into instrument.
- Report results in < 30 minutes.
Triage with confidence, without the wait
An 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 Biomedical 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 Biomedical One COVID-19 Test System is able to achieve central lab-quality detection of SARS-CoV-2 demonstrating PPA of 95.7% and NPA of 100% in a clinical study.5 With our on-cartridge sample extraction and purification and other proprietary technologies, the Talis Biomedical One COVID-19 Test System achieves a limit of detection (LOD) of 500 copies/mL.5
- Delivers rapid and accurate, easy-to-use lab-quality diagnostic testing results across a variety of care settings including non-acute, CLIA-waived settings in point-of-care facilities, pharmacies, and public health clinics.
- Targets SARS-CoV-2 N and ORF1ab genes for inclusivity of variants.
- Includes human beta-actin as a sample processing control.
- Add samples to a fully self-contained cartridge.
- No precision pipetting required.
- Automated sample extraction, purification, amplification, detection, and analysis.
- Hands-on time less than 2 minutes.
- Goes from sample to results in less than 30 minutes.
- Reliable NAAT results are clearly displayed and actionable.
Talis Biomedical One Covid-19 Cartridge
The Talis Biomedical One COVID-19 Test System uses isothermal technology, and proprietary on-cartridge extraction and purification to achieve the fast RNA amplification to make the SARS-CoV-2 virus detectable in nasal mid-turbinate swab specimens from individuals suspected of COVID-19 by their healthcare provider.
Test to Treat
To keep life moving forward, our path out of the pandemic is to test, treat and protect our loved ones against new transmissible COVID-19 variants and decrease the risk of the most severe outcomes.
The Talis Biomedical 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
Talis Biomedical One Covid-19 Test System Specifications5
Performance
Combined data of diluted specimens with neat clinical specimens PPA 95.7% (95% CI: 85.5%-98.9%) and NPA of 100% (95% CI: 92.4%-100%)
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 Biomedical 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 Biomedical One
• Talis Biomedical One Instrument
• Talis Biomedical One Accessories
Talis Biomedical One COVID-19 Cartridge Pack
• Talis Biomedical One COVID-19 cartridge
• 1 mL transfer pipette
Talis Biomedical One Nasal Mid-Turbinate Collection Kit
• Nylon flocked swab
• 3 mL inactivation medium
Talis Biomedical One Covid-19 Test System Technical Resources
Visit our Help & Support page for product labeling, instructions for use, and other helpful documentation.
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© Talis Biomedical Corporation. All Rights Reserved.
Talis One is a registered trademark of Talis Biomedical Corporation.
* Testing solutions are currently in development and not available for sale.
* †The Talis Biomedical One Test System is not authorized, cleared, or approved by the FDA and is not available for sale.
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