Technology Summary

Covid-19 Rapid Point-Of-Care Molecular Test

AmplifiDX is launching a covid-19 rapid test. The test uses real-time reverse transcription isothermal amplification with an RNA extraction free protocol. The test is designed to specifically detect the RNA of the SARS-CoV-2 virus in nasal swabs from patients with symptoms of infection, who are suspected of COVID-19. Testing results are available in less than 45 minutes.

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Process

Samples can be taken from the anterior (tip) of the nose. The swab sample is then placed into a credit-card sized cartridge. This low-cost single-use disposable unit requires no specialized sample handling.

The swab specimen is inserted directly into the cartridge, the long end is snapped off at the breakpoint and the cartridge is capped off. The cartridge is pre-loaded with all required reagents, inserted and processed in the instrument. Once the test is complete, the cartridge is removed and disposed.

Simplicity

The instrument is a compact, low-cost system for use at the point of care. The LEDs on the lid provide easy to read and immediate test results or the instrument can communicate via Bluetooth to a smart phone.

Since the instrument is low cost and runs one test at a time, multiple instruments can be employed to increase throughput. The system can multiplex tests and therefore other flu and respiratory virus tests will follow.

96%

ACCURACY

95%

SUCCESS-RATE

92%

BETTER DATA

98%

COST-EFFECTIVE

AmplifiDX

Documents

System testing for the EUA approval is in process. The chemistry has already received EUA approval through Atila Biotsystems, Inc.