A rapid antibody test kit for COVID-19 developed by a local biomedical company that can deliver results in just 10 minutes has passed clinical trials and is ready for mass production, Excelsior Bio-System Inc chairman Cooky Chen (陳作範) said yesterday.
The test kit, which detects antibodies of SARS-CoV-2, the virus that causes COVID-19, passed a comprehensive clinical study conducted by National Taiwan University Hospital (NTUH), Chen told an event in Taipei to present the results of the trial.
The test boasts 100 percent sensitivity and 95 percent specificity, he said.
Photo: CNA
The kit works in a similar way to a pregnancy test, with red lines indicating the result. Two lines indicate that the test is positive for SARS-CoV-2 antibodies, which usually means that the subject has had COVID-19, project manager Hsieh Szu-min (謝思民) said.
The hospital provided the company with the methods it used in its trials, which included a double-blind study using the test kit and a control to test people known to have SARS-CoV-2 antibodies and those known to not have them, which helped evaluate the test kit’s sensitivity and specificity, said Hsieh, an NTUH infectious-diseases specialist.
The kit was successful in detecting antibodies in 13 people with COVID-19, which showed that its sensitivity is 100 percent, he said.
The kits can rapidly screen people to determine whether they are carriers of the virus, regardless of the symptoms — if any — they show, said Lee Yu-chun (李宇群), head of Excelsior’s test kit development division.
However, as people do not produce antibodies to the virus immediately after infection, the test could give a false negative in the early stages and should be used in conjunction with COVID-19 antigen rapid-testing technology, Lee said.
It usually takes eight to 10 months to develop a rapid testing kit, but Excelsior researchers launched the project in the middle of February, Chen said.
The kit on Tuesday was sent to the Ministry of Health and Welfare to be approved and is ready to begin mass production, he said, adding that the company plans to produce 400,000 per month and introduce fully automated packaging lines for the product in the second half of this year to meet strong demand at home and abroad.
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