The cooperation project led by Taiwan’s technology agency (MOST) has produced a device that detects cases of COVID-19 with very low viral load as well as as asymude cases in just 3 minutes.
MOST said taiwan’s Food and Drug Administration (TFDA) has granted emergency use permits for fast-test chips, after clinical trials on 142 infections at The Gaocheng Veterans General Hospital were completed.
The product is expected to hit the market as early as February. Applications for emergency use permits in the U.S. and Japan are being prepared.
The rapid test chip development project is the result of a collaboration between the Taiwan Central Research Institute (Academia Sinica), the Taiwan Institute of Experimental Research (NARLabs) and the Molecular Sensing Technology Company (Molsentech). MOST is the sponsor.
Currently on the market there are 2 types of rapid antibody and antigen tests that help detect infections, along with polymerase chain reaction (PCR) tests.
The test results after only 15 minutes, but sometimes there are cases of false negatives or false positives. PCR is much more accurate, but it takes at least 90 minutes to get results.
Molsentech said the newly launched chip device is based on bio-magnetic field-effect (FET) biosensitive sensors that directly or indirectly measure interactions between biological components (detector elements) mounted on the sensor surface and the agent to be detected (target element).
Deputy director of The General Hospital for Veterans Affairs Of The General Hospital of Veterans Of Clinical Trials Tran Nghio Sinh said the device achieved 96.8% accuracy in sensitivity and 95.1% in specificity. Moreover, the CT value of less than 35 devices tested positive – proving that the chip detecting the infection has a very low viral load and is in the incubation period, helping to control the disease.
Molsentech CEO Cuc Gia Dung introduced a fast-test chip with up to 10,000 test points, meaning it has super-high sensitivity so there is no need to amplified nucleic acids anymore. The company is making improvements to test saliva samples instead of samples taken from the nose.
Although developed to detect the old variant virus, the chip detects Delta or Omicron, and it only takes a week of adjustment to detect the new variant.