A collaboration project led by Taiwan’s Ministry of Science and Technology (MOST) has produced a new chip device that is capable of detecting COVID-19 cases with a very low viral load, as well as those who are asymptomatic, in three minutes.
The rapid testing chip received an Emergency Use Authorisation from Taiwan’s Food and Drug Administration at the end of 2021, following the completion of clinical trials on 142 cases at Kaohsiung Veterans General Hospital . The innovative semiconductor product is expected to go to market as soon as February, with planned EUA applications in the United States and Japan in the works.
MOST had funded the project between Academia Sinica, the National Applied Research Laboratories (NARLabs), and Taipei-based semiconductor solution provider. According to the NARLabs, there are currently two kinds of rapid tests — antibody and antigen — for SARS-CoV-2, the virus that causes COVID-19, and a polymerase chain reaction (PCR) test available on the market.
Though the rapid tests yield results in 15 minutes, the tests can sometimes provide false negatives and positives, while polymerase chain reaction (PCR) tests take at least 90 minutes to reveal a result even though these are more accurate as they examine cycle threshold (CT) values.
The results of clinical trials with the new computer chip in COVID-19 rapid testing indicated the device had a 96.8% accuracy rate in sensitivity and a 95.1% rate in specificity. Moreover, the chip was 100% consistent in identifying COVID-19 positive samples with a CT value below.
The chip can detect the virus when the viral load is very low and in the incubation period, Chen said, noting that this feature can help epidemic control significantly. The chip device was developed based on the field-effect transistor biosensor (Bio-FET) developed by Academia Sinica’s Quantum Electronics Laboratory.
The company applied the ultra-high sensitivity biomedical detection technology to COVID-19 testing with the support of NARLab’s Taiwan Instrument Research Institute in regulatory certification to create the computer chip. The chip has more than 10,000 testing points, which means it has a super high sensitivity so the process of amplifying nucleic acid is no longer needed.
As a result, the device has a 95-percent accuracy rate in testing samples taken from the nose and throat, Chu said, adding that the company is looking to improve it to the point where saliva samples could replace the current nasal swabs. While the device was developed using older strains of the virus, it is still capable of detecting the Delta and Omicron variants. Moreover, the chip can be adjusted within a week to enable it to detect new variants.
The cost of a COVID-19 test using the chip device is between that for PCR and rapid testing. The company hopes the device can be introduced to the market as soon as possible through the government’s epidemic control programme so that people can benefit from the new tech.
As reported by OpenGov Asia, Central Epidemic Command Center (CECC) stated that Taiwan was in the process of preparing its digital COVID-19 certificate. Digital COVID-19 certificates issued by Taiwan would be accepted as equivalent to the EU Digital COVID Certificate.
People who have received the domestic Medigen vaccine will be eligible to obtain the certificate, even though Medigen is not authorised for use in the European Union. That does not mean, however, that such travellers would be granted quarantine or COVID-19 test waivers, based on their vaccination status.
The European Commission’s decision to accept Taiwan’s digital COVID-19 certificate under the same conditions as the EU Digital COVID Certificate means that the information on Taiwan’s certificates will be recognised as valid, but quarantine and testing protocols for travellers are still decided by individual countries.
