Health Authorities: "COVID Antibody Test Kits Insufficient for Immunity Assessment... Should Be Used Restrictively"
[Asia Economy Reporter Eunmo Koo] On the 5th, health authorities announced that COVID-19 rapid antibody test kits sold on the market can only be used in a limited way as an auxiliary tool to check a patient's infection history.
Rapid antibody test kits are simple testing devices developed to allow individuals to check their COVID-19 infection history by themselves. They work by dropping a small amount of blood to determine whether COVID-19 antibodies have been produced.
Kim Gapjeong, head of the diagnostic team at the Central Disease Control Headquarters, explained during a back briefing that "the COVID-19 antibody test kits can be used in a limited way, such as to estimate how many asymptomatic infected individuals are within a group, to estimate prevalence within a group, or to confirm past infection history."
He added, "Not much has been clarified about COVID-19 antibody testing. So far, there is insufficient scientific evidence to judge an individual's immunity or the possibility of virus transmission based on these results."
The authorities especially warned that the test results from these kits cannot be used to check whether antibodies have formed after vaccination. Kim said, "Although antibody testing can be used to estimate COVID-19 infection history, even for vaccinated individuals, antibodies may not be detected depending on the vaccine type, antibody test type, timing of the test, and other factors. Therefore, the test results should not be used as evidence to judge vaccine effectiveness."
He also stated, "Not only the Korea Disease Control and Prevention Agency but also authorized organizations such as the Ministry of Food and Drug Safety, the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and the European Centre for Disease Prevention and Control (ECDC) clearly communicate this information through their websites and other channels."
Kim emphasized, "Decisions on vaccination targets or whether to administer booster shots are not made based on antibody testing. Antibody testing requires accurate understanding by experts." He further noted, "Currently, the kits approved by the Ministry of Food and Drug Safety have only been evaluated for COVID-19 infected patients and have not been evaluated for vaccinated individuals, so using these kits on vaccinated people is inappropriate."
He added, "Since each product has different characteristics and antibodies below the detection limit cannot be confirmed, it is difficult to assess individual immunity using these tests."
Experts also agree that antibody testing should be used only as an auxiliary tool. The Korean Society for Laboratory Medicine issued a statement the day before, saying, "There are still many difficulties in interpreting antibody test results. Currently, antibody tests are limited to estimating the scale of the epidemic and serving as an auxiliary role in diagnosing past COVID-19 infection in some patients. Using them to evaluate the immune status of actual patients is not recommended."
The society explained, "Self-administered antibody tests have several drawbacks, including lower accuracy and practicality. A large amount of antibodies is required to confirm results, so there is a high possibility of false negatives in the early stages of infection. There is also a high chance of false positives due to cross-reactivity with other viruses or substances, and the interpretation can vary depending on the reader."
They continued, "The necessity of antibody testing for vaccinated individuals is very low, and under no circumstances should vaccination be skipped or adjusted based on antibody test results. Some claim that vaccines are ineffective based on cases where antibody tests after vaccination were negative, but this is completely untrue."
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The society emphasized, "Although extremely rare, some individuals may not produce antibodies due to illness or other reasons. In such cases, vaccination still activates cellular immunity and can reduce severity, so vaccination remains important."
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