MFDS: "Antibody Test Kits Cannot Confirm Antibody Generation After Vaccination"

Last August, children in Netanya, central Israel, underwent COVID-19 antibody testing ahead of the new school term. The Israeli Ministry of Education conducted antibody tests on 1.5 million children aged 3 to 12 to determine whether they had been unknowingly infected with the new coronavirus.
[Image source=AFP Yonhap News]

[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety (MFDS) has reiterated its request to refrain from misuse of COVID-19 antibody test kits, stating that "they cannot confirm whether antibodies have been produced after vaccination."

On the 21st, the MFDS announced in the 'Information Provision and Explanation on COVID-19 Antibody Diagnostic Kits' document that "currently, antibody test kits cannot verify immune status against COVID-19, infection prevention capability, or whether antibodies have been produced after vaccination." Antibody test kits are intended solely to confirm whether antibodies were generated following a past COVID-19 infection and are not in vitro diagnostic medical devices used to determine antibody production after vaccination.

Regarding this, the MFDS explained, "The antibody test kits approved by the MFDS have not been clinically evaluated for performance in individuals vaccinated against COVID-19," adding, "They are not suitable for assessing immune status against COVID-19, infection prevention capability, or confirming antibody production after vaccination." Furthermore, since immunity is evaluated not only by humoral immunity through antibodies but also by cellular immunity, it is difficult to assess immunity based solely on antibodies.

The MFDS also emphasized that all 14 types of COVID-19 antibody test kits currently approved are intended exclusively for professional use and cannot be used for self-testing. The MFDS elaborated that antibody test kits are approved only for professional use to "prevent misuse by general consumers regarding usage purposes and methods, and to avoid confusion in the quarantine system."

Moreover, the MFDS stated that even if the antibody test result is positive, quarantine rules must still be strictly followed. A positive antibody test result only indicates the possibility of past COVID-19 infection and does not reflect current infection status, individual immune condition, or infection prevention capability. Therefore, the MFDS emphasized, "Regardless of antibody test results, it is essential to comply with quarantine rules such as wearing masks, social distancing, and vaccination guidelines."

This content was produced with the assistance of AI translation services.