CORONAVIRUS/COVID-19 antibody detection kit granted emergency use authorization

Taipei, March 25 (CNA) A rapid COVID-19 antibody detection kit developed by researchers at Chang Gung University (CGU) recently received an emergency use authorization (EUA), paving the way for mass production, the university announced on Thursday.

The test kit, which was jointly developed along with Chang Gung Memorial Hospital, was authorized for use by Taiwan's Food and Drug Administration (FDA) on March 5, the university said in a statement.

According to the university, the kit uses samples of blood serum to measure the potency of neutralizing antibodies in a person who has been vaccinated against COVID-19 and can produce results with 90 percent accuracy in 1.5 hours.

Chiu Cheng-hsun (邱政洵), deputy superintendent of Linkou Chang Gung Memorial Hospital, said the tests will be vital until such time as the world reaches herd immunity to COVID-19, as they can confirm whether or not a person is adequately protected from infection.

For example, he said, if people arriving in Taiwan could present a negative PCR test, proof of vaccination and also show the presence of neutralizing antibodies, this would offer a high degree of certainty that there was no risk of them spreading or contracting the virus.

In such a scenario, it would be possible to consider shortening or even removing the quarantine requirement for incoming travelers, which would help the country re-open its border and resume various kinds of international exchanges, he said.

According to Shih Shin-ru (施信如), director of the university's Research Center for Emerging Viral Infections, the traditional method of testing for neutralizing antibodies involves placing blood serum along with virus-infected cells to see if the virus is suppressed.

The entire process takes three to five days and as it involves the cultivation of viruses, has to be carried out in a biosafety level 3 lab, she said.

Biosafety levels are used to identify the protective measures needed in a laboratory setting to protect workers, the environment and the public.

However, the test kit developed by CGU, which uses a specialized protein to detect the neutralizing antibodies of the virus that causes COVID-19, can be used in any laboratory, Shih said.

The technology for the antibody detection kit has been licensed to Formosa Biomedical Inc. and with the FDA's authorization, will soon enter mass production, the university said.