KAYA17 Technology

The Future of Diagnostics is Point of Care Testing

Today, a majority of diagnostic occurs in centralized labs. Samples are collected in physicians' clinics, hospitals or other testing locations, and then shipped to remote centralized labs. Typically, results are only available after a few days. This delay prevents patients from receiving timely, often life-saving, therapies.

Point of Care Testing (POCT) represents a transformative trend in the medical industry – allowing primary care doctors, ER physicians to make life-changing decisions in real time diagnostic testing. On reason for the slow progress in this field is that very few tests can maintain the accuracy and sensitivity of the professional diagnostic test with providing a rapid, compact and flexible test at the point of care. Using innovations in the test format, new tools from molecular biology and novel electronic imaging tools, Kaya17 has hit a home run for a test platform that uniquely checks all the features needed for a successful point of care test – high accuracy, speed, ease of use for untrained operators, and very cost -effective.

Sample to Result in 15 Minute

For efficient and accurate COVID-19 diagnosis, clinicians need a portable or an on-site, real- time diagnostic test so they can triage patients and offer needed care. Schools need to know which student in the pooled test was positive so they can quarantine right away. Entertainment venues need an on-site test for those that could not get a PCR test done or prefer saliva over a nasal swab. All of these places need confidence in the test result for accuracy counts as you open after a pandemic.

KAYA17's 15-minute, accurate, on-site COVID testing solution offers a complete solution with high throughput for groups or individual patients. The system consists of a lightweight and portable reader that is powered by USB, software and a patient app for patient data recording, reporting and storage, a complete assay kit with all disposables and reagents, and a patient portal app.

KAYA17's rapid solution is NOT a strip test that is based on a color changing indicator.

It uses a high-sensitivity reader which results in the high-performance assay with very low false negative information, so quick decisions can be taken with confidence.

The KAYA17 Workflow

KAYA17's Patient ID Software

KAYA17 has designed a patient registration software that 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.

KAYA17 COVID Assay Kit

KAYA17 provides a complete immunoassay test kit. The test kit contains 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 untrained staff while maintaining high sensitivity and specificity. The kit is designed to operate with the Kaya17 Vega-200 reader to achieve a very low Limit of Detection, avoiding false negatives even at very low levels of the antigen.

KAYA17's Cartridge System

KAYA17 has designed a proprietary one-time use Vertical Flow Filter (VFF) cartridge on which the sample is processed, keeping the reader free during this time. The cartridge is inserted into an electronic reader for 1 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 VEGA-200 Reader

KAYA17 has designed a high sensitivity reader to allow its VFF cartridges to be read with high accuracy and speed. The reader is integrated with our proprietary software which is embedded in the supplied laptop. The reader is compact, low cost, and runs off USB power.

KAYA17's Results Manager

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.

KAYA17's Patient Results Portal

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. At the test site a QR code scan transfers their profile information into the patient ID manager and they are registered instantly. 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.

Medical Diagnostics Technology

A demonstration of our technology can be seen in the video link below. Although Kaya17 has developed both saliva and nasal swab tests, the saliva test represents a far more patient - friendly solution compared to painful deep nasopharyngeal swabs or error-prone sample collection with anterior nasal swabs.

01. The COVID-19 Diagnosis Gap

Existing tests take too long to deliver accurate results and do not have rapid test solutions with satisfactory accuracy that can match accuracy of PCR. The expense and complexity of the equipment still leaves a need for high accuracy easy test format at the last mile solution for opening schools or offices.

02. Advantage of KAYA17

Immediacy of qualitative, highly-accurate results is critical to effective containment, care and treatment. Pooled test positives can be identified in 15 minutes with confidence in the result’s accuracy, providing a real last-mile testing solution for concerts, cruise ships, schools, colleges and hospitals.

03. Needs of Today's Healthcare System

Reduced burden on the overall healthcare system is vital to optimize patient outcomes and to continue to open public work and entertainment spaces safely.

KAYA17 Antigen Test Demonstration

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