Only Saliva-Based Rapid COVID-19 Test in the Market Delivers Highly Accurate Results in 15 Minutes at POC

KAYA17 (Livermore, CA, USA) has developed a complete point of need testing solution for COVID-19 that comprises a new POC test platform for antigen testing with breakthrough performance, a 15 minute saliva-based antigen test, cartridge and software/app. KAYA17 provides a complete immunoassay test kit containing all disposables and reagents and controls needed, in packs of 25 or 50 tests. Its proprietary reagents are fine-tuned for ease of use by staff with minimal training while maintaining high sensitivity and specificity.

KAYA17's rapid solution is not a strip test that is based on a color changing indicator. The Kaya17 nCoVega Test, the only saliva-based rapid COVID-19 test in the market, uses a high-sensitivity reader with very low false negative information, allowing even asymptomatic patients to be detected. The reader is compact, low cost, and runs off USB power. KAYA17 has designed a proprietary one-time use Vertical Flow Cartridge (VFC) on which the sample is processed, keeping the reader free during this time. The cartridge is inserted into the electronic reader for one minute. The patient ID QR code label is placed on the cartridge to ensure that the sample can be traced at all times. KAYA17’s high sensitivity reader allows its VFF cartridges to be read with high accuracy and speed.

The reader is integrated with the company’s proprietary software which is embedded in the supplied laptop. The patient registration software gathers patient information and generates a unique patient QR code that is applied to their sample tube and cartridge used to process their sample. The software can also receive this information from a QR code from a patient portal app. The KAYA17 patient portal app has two functions. It helps make patient registration fast, seamless and contactless. Patients can enter their profile information a priori before coming for a test. The second function of the app is to display the results of a test. After the test is completed, the patient does not have to wait for their results at the test site. Results will be automatically sent to their phone. The patient portal app is available in both iOS and android platforms.

KAYA17’s system allows parallel testing with multiple readers. One patient ID computer can be connected to 10 readers operating in parallel. The results from all of the readers are transmitted to the patient ID computer where a report is generated for each patient. Results of the test can be printed as a patient test report, sent to their phone, or synched up with a central hospital or healthcare database. One KAYA17 reader can run 30 tests per hour at a testing site and can be scaled up to 300 tests per hour with 10 readers, thus making it an ideal candidate for rapid testing at airports, resorts, events, cruise lines, stations, schools, workplaces, and hospitals.

The KAYA17 technology base goes beyond COVID-19 testing, using the same platform, and has a wide range of applications. With a minor change to the reagents, rapid point-of-care tests can be developed for other medical diagnostic targets. No change will be required for the cartridge and reader. This allows the technology to be used in the rapid diagnosis of several other diseases and conditions as well, with the same level of accuracy and efficiency. KAYA17 has received the CE Mark for its Kaya17 nCoVega Test and has submitted the test for FDA EUA approval with commercial shipments commencing in the US. The company has plans for licensing the Kaya17 platform for other tests and is developing tests for hepatitis B, UTI, cardiac markers, influenza A & B, nora virus, strep throat, staph infection, and sepsis for the US and other markets. It is also developing tests for cervical cancers, UTI, hepatitis B & C, HIV, food bacteria (E. Coli, salmonella, listeria), water testing, dengue and chikungunya for the developing countries.

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