On the morning of the 14th, citizens waiting for specimen tests at the temporary COVID-19 screening clinic set up at Seoul Station Plaza. [Photo by Yonhap News]
[Asia Economy Reporter Seoyoung Kwon] The distribution of COVID-19 antibody test kits in pharmacies, which had sparked misuse controversies, has been halted.
On the 17th, the Ministry of Food and Drug Safety (MFDS) announced that it has taken measures to prevent the COVID-19 antibody test kits developed by Mikrobiomed from being sold in pharmacies and other places accessible to individuals. It also banned advertisements encouraging personal purchases of antibody test kits and stated that it is continuously monitoring the sales status.
Mikrobiomed's COVID-19 antibody test kit, 'COVID-19 Biokit IgG/IgM,' was approved by the MFDS on July 13 as a professional-use product. However, unlike the other 13 types of professional-use antibody test kits, this product has been used as a so-called 'half-personal-use' product because individuals can collect their own specimens.
In March, the MFDS established approval standards for antigen and antibody-based COVID-19 self-test kits. However, on August 6, due to concerns about possible errors in neutralizing antibody diagnosis and consumer misuse, the policy was changed to approve antibody test kits only for professional use, not for personal use.
Therefore, Mikrobiomed's antibody test kit, which applied for approval in June, was exceptionally approved to allow non-medical personnel to collect specimens, considering that clinical performance tests had already been conducted. Subsequently, this kit was sold to general consumers in pharmacies, similar to antigen-based personal COVID-19 test kits.
However, during this process, problems arose with professional-use products being indiscriminately used by the general public beyond their intended purpose. For example, baseless rumors spread such as "After using the antibody test kit, certain vaccine recipients had no antibodies." According to experts, antibody test kits are only for confirming infection history and should not be used to check antibody production after vaccination.
Earlier, on the 8th, the issue of pharmacy distribution of professional-use COVID-19 antibody test kits was raised during the National Assembly Health and Welfare Committee's audit of the MFDS. At that time, MFDS Commissioner Kanglip Kim stated, "We will review this immediately and take necessary measures."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
