The technology behind the Talis One molecular point-of-care test
A new paradigm for infectious diseases
At Talis, we are pioneering a new paradigm for infectious diseases testing, bringing the accuracy of a central lab molecular test to a variety of care settings. With tests like the Talis One™ COVID-19 Test System, healthcare professionals can confidently run point-of-care tests with minimal training, delivering results to patients within 30 minutes of obtaining a sample. Our system is able to deliver accurate, sensitive results quickly due to the unique engineering and design of our nucleic acid amplification test (NAAT) chemistry.
HOW TALIS ONE MOLECULAR POINT-OF-CARE TEST TECHNOLOGY WORKS
LEVERAGING LAMP FOR SPEED AND ACCURACY
The Talis One Test System relies on real-time loop-mediated isothermal amplification (rtLAMP) for DNA targets and real-time reverse transcription loop-mediated isothermal amplification (rtRT-LAMP) for RNA targets (Figure 1).
Loop-mediated isothermal Amplification (LAMP) is a well-studied technique known for sensitivity and specificity, especially when nucleic acid is first extracted from the sample.1 LAMP is also fairly resistant to inhibitors in the sample,1 making it a good technique for diagnostic applications.
WE’RE BRINGING MOLECULAR TESTING TO THE POINT OF CARE
While there are many kinds of nucleic acid amplification technologies (NAAT), many are not suited to point-of-care applications. Conventional polymerase chain reaction (PCR) based methods like qPCR need to cycle between multiple temperatures 20 or more times, which results in turnaround times of approximately 4 hours.1 Isothermal NAAT uses biochemistry that operates at a single temperature; therefore, these tests can deliver accurate results on a much faster timeline.
WE’VE MADE LAMP MORE SENSITIVE
By including an on-cartridge sample extraction step, we’ve improved the sensitivity of LAMP. Our proprietary OCEP™ technology uses a unique sample extraction method via a solid matrix column-based approach which maximizes nucleic acid recovery, and the fully enclosed design of the Talis One cartridge ensures that all fluids remain contained within the cartridge.
TALIS TECHNOLOGY IS EASY TO USE
Talis One’s easy-to-use, sample-to-answer workflow enables infectious disease testing by healthcare professionals in a variety of point-of-care settings. The single-use test cartridge is a critical part of the system and where all the LAMP reactions take place. One of the key advantages of our testing workflow is the inclusion of a solid phase sample extraction step, which maximizes the sensitivity of our system.
EXCELLENT PERFORMANCE AT THE POINT OF CARE
TALIS DELIVERS HIGH PERFORMANCE WITH OUR PROPRIETARY MOLECULAR POINT-OF-CARE TESTING
Compared to other isothermal NAAT methods such as the nicking and extension amplification reaction (NEAR) used in another point-of-care SARS-CoV-2 test, the proprietary NAAT molecular test technology used in Talis One’s COVID-19 Test System delivers higher sensitivity levels, while achieving a measure of analytic sensitivity or limit-of-detection (LoD) of 500 copies/mL.2
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The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.
*Additional testing solutions are currently in development and not available for sale.
- Khan P, Aufdembrink LM, Engelhart AE. Isothermal SARS-CoV-2 Diagnostics: Tools for Enabling Distributed Pandemic Testing as a Means of Supporting Safe Reopenings. ACS Synth Biol. Published online September 23, 2020:acssynbio.0c00359. doi:10.1021/acssynbio.0c00359
- Evaluation Of The Talis One™ Covid-19 Test System For The Rapid Detection (< 30 Minutes) Of Sars-cov-2 From Nasal Swab Specimens. Accessed August 31, 2021.
- Talis One COVID-19 Test System Instructions For Use 152-0028851 REV.01