A rapid COVID-19 antibody detection kit developed by researchers at Chang Gung University has received an emergency use authorization, paving the way for mass production, the university said on Thursday.
The test kit, which Chang Gung Memorial Hospital helped develop, was authorized on March 5 by the Food and Drug Administration, the university said in a statement.
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 one-and-a-half hours, it said.
Photo courtesy of Chang Gung Memorial Hospital via CNA
Linkou Chang Gung Memorial Hospital deputy superintendent Chiu Cheng-hsun (邱政洵) said that the tests would be vital until the world reaches herd immunity to COVID-19, as they can confirm whether a person is adequately protected from infection.
For example, if people arriving in Taiwan were to present a negative polymerase chain reaction test, proof of vaccination and also show that they have neutralizing antibodies, it would offer a high degree of certainty that there was no risk of them spreading or contracting the virus, Chiu said.
In such a scenario, it would be possible to consider shortening or even removing quarantine requirements for arrivals, which would help the country reopen its borders and resume international exchanges, he said.
Shih Shin-ru (施信如), director of the university’s Research Center for Emerging Viral Infections, said that the traditional method of testing for neutralizing antibodies involves placing blood serum along with virus-infected cells to evaluate whether the virus has been suppressed.
The entire process takes three to five days, and as it involves the cultivation of viruses, has to be carried out in a lab rated biosafety level 3, Shih 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 university’s test kit, which uses a specialized protein to detect the antibodies, can be used in any laboratory, Shih said.
The kit’s technology has been licensed to Formosa Biomedical Inc, and mass production would start soon, the university said.
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