The medical community is raising concerns as the government pushes to expand self-testing for infectious diseases, including sexually transmitted infections (STIs).
Critics argue that broader self-testing could undermine accurate diagnosis and transmission control, while weakening public health surveillance systems.
The government’s plan to introduce new categories of in vitro diagnostic devices for self-testing has sparked strong calls for reversal from the medical community. (Credit: Getty Images)
On Wednesday, the Association of Korean Urologists demanded a thorough review of the Ministry of Food and Drug Safety’s proposed revision to in vitro diagnostic medical device regulations.
The group warned that expanding self-testing without robust systems for accuracy, reporting, and follow-up could lead to significant public health risks. The proposal includes new self-test categories such as immunoassay kits for respiratory viruses, STI pathogens, and drug metabolites.
The association emphasized that STIs are public health conditions requiring comprehensive management — including asymptomatic and recurrent infections, partner transmission, and risks to pregnant women and newborns.
“Self-test kits will not replace the entire clinical care process,” the group said. “They must not be treated as a consumer choice simply because they are linked to personal privacy.”
The association also warned that STI self-test kits may be less accurate than established diagnostic algorithms, particularly for syphilis and gonorrhea.
“If consumers rely on limited samples and incomplete results, they risk missing infections or experiencing unnecessary fear and stigma,” the statement said. False-negative results could lead individuals to continue sexual activity, increasing community transmission.
The group further noted that without mandatory reporting of self-test results, infection rates could be underestimated, complicating contact tracing and reinfection prevention, and creating gaps in national disease surveillance.
The association called on the MFDS to abandon what it described as a shortsighted approach and to reassess the expansion of STI immunoassay products. “Infectious disease diagnosis must remain within the professional healthcare system to ensure accurate testing, appropriate treatment, and responsible public health management,” it said.
Koh Jung Min
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