MFDS: "Antibody Test Kits Should Not Be Used to Confirm Antibody Generation After Vaccination"

[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) and the Korean Society for Laboratory Medicine have urged the accurate use of COVID-19 antibody test kits.

On the 20th, the MFDS and the Korean Society for Laboratory Medicine jointly announced that they have prepared and distributed a safety letter requesting that COVID-19 antibody test kits not be used to determine an individual's (test subject's) immune status, infection prevention capability, or to verify antibody production after vaccination.

COVID-19 antibody test kits are professional in vitro diagnostic medical devices developed to detect specific antibodies against the COVID-19 virus in specimens (blood). The MFDS explained that the antibody test kits currently approved domestically were developed for this purpose, and therefore, clinical performance data regarding immunity or infection prevention capability against COVID-19 are still insufficient, and the correlation between the degree of antibody production and actual immunity has not been fully verified.

Furthermore, since COVID-19 vaccines induce antibody production targeting specific proteins, vaccinated individuals who have not been infected may test negative depending on the product, so antibody testing for immune confirmation is not recommended, and result interpretation should be cautious, according to the MFDS.

Accordingly, the MFDS added that medical institutions must inform those who have undergone antibody testing that regardless of the test results, they must strictly follow COVID-19 prevention guidelines such as wearing masks, social distancing, and post-vaccination instructions.

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