[Graphics by Minu Kim and Song Ji-yoon]
Korean Covid-19 kits delivering results in less than a half an hour are in hot demand as the globe fights with another wave of the virus outbreak in colder climate.
According to the Ministry of Food and Drug Safety on Wednesday, antigen-based products topped the list of Covid-19 test kits approved for export from September to Nov. 13. A total of 21 antigen-based products were approved in the period versus 20 RT-PCR products and 11 antibody-based products. This contrasts sharply with the first half of this year when there were overwhelmingly more RT-PCR and antibody-based products than antigen-based ones.
Under the antigen-based diagnosis, it takes only 15-30 minutes to determine if a person is positive for the virus. On the other hand, it takes 5-6 hours for RT-PCR as this method requires a gene amplification process after specimen collection. The accuracy of rapid antigen tests is generally lower than RT-PCR. In clinical trials, SD Biosensor’s Covid-19 test kit, the first antigen-based product approved by the Ministry of Food and Drug Safety on Nov. 11, shows 90 percent sensitivity and 96 percent specificity. But PCR test kit manufacturers face a limit in exports because of fierce competition among 130 products and the need of separate assay equipment for analysis.
In contrast, exports of antigen-based test kits are on the rise. Celltrion shipped 210 billion won ($188 million) worth of antigen-based test kits to the United States earlier this month, which marks the single largest export deal for Covid-19 test kits in Korea.
Celltrion’s antigen-based test kit called Sampinute co-developed by local biotech firm BBB is a quick diagnostic product that show test results in 10 minutes. According to Celltrion, Sampinute has the 94.4 percent sensitivity and 100 percent specificity, which is almost similar to the accuracy of PCR test kits (99 percent).
Boditech Med, which exported 8.3 billion won worth of antigen-based test kits in September, won another contract to supply 12.3 billion won of antigen-based test kits to Italy on Nov. 17.
On the other hand, Sugentech dedicated to antibody test kits reported poor performance in the third quarter of this year. The company’s Q3 operating profit tumbled 94.7 percent on-quarter to 1.1 billion won over sales of 4.1 billion won, down 83.2 percent.
By Kim Byung-ho and Minu Kim
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