TAIPEI (CNA) — 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, a company official said Thursday.
The rapid test kit for the detection of antibodies of SARS-CoV-2, the virus that causes COVID-19, has been validated by a comprehensive clinical study conducted by National Taiwan University Hospital (NTUH). The test boasts 100 percent sensitivity and 95 percent specificity, said Cooky Chen (陳作範), chairman of Excelsior Bio-System, Inc., at an event for the presentation of the results.
The method of testing is similar to that of a pregnancy test, which uses two red lines to indicate results. Two lines indicate that the test is positive for SARS-CoV-2 antibodies, which usually means people have had COVID-19, according to project manager Hsieh Szu-min (謝思民), an infectious disease specialist from NTUH.
Through the clinical trials, the hospital provides references to the company, including methods of execution and conducting of the testing, and offers SARS-CoV-2-positive patient samples and negative samples it has collected during the pandemic for a double-blind study to evaluate the sensitivity and specificity of the test, Hsieh said.
The test kit was successful in detecting antibodies in 13 COVID-19 patients, Hsieh said, adding that the test therefore has a sensitivity of 100 percent.
The kit can be used for rapid screening of carriers of the virus who may be either symptomatic or asymptomatic, said Lee Yu-chun (李宇群), the head of the company’s testing kit development division.
Lee added, however, that because patients do not produce antibodies to the virus during the initial stages of infection, the antibody test can miss the early stages of infection and should be used in conjunction with the COVID-19 antigen rapid testing technology.
It usually takes 8-10 months for the development of a rapid testing kit, but this time, the rapid antibody test kit has been developed much more quickly, since the research team only launched the project in mid-February.
The kit was sent to the Health Ministry on May 5 for approval and is ready to be put into mass production, Chen said, adding that the company plans to produce 400,000 tests 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 from abroad amid the global pandemic.