COVID-19 Diagnosis Within 1 Hour During Emergency and Delivery... Authorities "Reviewing Emergency Approval" (Update)

A research institute in Germany is conducting COVID-19 tests.<이미지출처:Yonhap News>

[Asia Economy Reporter Choi Dae-yeol] A rapid diagnostic method capable of determining infection status within one hour is expected to be introduced for suspected patients of the novel coronavirus infection (COVID-19) who require emergency surgery or are about to give birth. This measure aims to prevent cases like one in Daegu, where a patient showing pneumonia symptoms died after not receiving timely treatment while waiting to confirm COVID-19 infection status.

Jung Eun-kyung, head of the Central Disease Control Headquarters for COVID-19, said at a briefing on the 26th, "We are currently reviewing the introduction of a PCR test method that can provide results within one hour for emergency testing, while the PCR test method currently used as the standard for confirmed diagnosis domestically and internationally is being used."

The current diagnostic method, which involves sample collection followed by an amplification process, takes about six hours. Similar methods that reduce testing time have been approved overseas, such as in the United States, but none have yet been approved by our authorities. The quarantine authorities have been weighing the introduction of such rapid PCR diagnostic kits, focusing on domestic and international diagnostic kit companies, in collaboration with the Korean Society for Laboratory Medicine and the Ministry of Food and Drug Safety, which handles medical device approvals.

Jung said, "We believe the introduction of this testing method is necessary for rapid testing, and we plan to review it as quickly as possible to facilitate emergency use authorization."

Regarding serological diagnostic methods that determine infection status through the body's immune response, she stated that due to insufficient information so far, additional research will be conducted before considering their introduction. She cited that although some devices using serological diagnostic methods have been approved by agencies such as the U.S. Food and Drug Administration (FDA), their use remains limited.

Jung explained, "The antibody tests approved in the U.S. cannot be used alone for confirmed diagnosis but only as supplementary tests, and the World Health Organization recommends their use only for research purposes, not for confirmed diagnosis. There are limitations such as how COVID-19 antibodies are formed and the lack of established standard testing methods to accurately diagnose these antibodies." She added, "There is a need for antibody testing and antibody positivity rate surveys domestically as well, so we will promptly work to establish testing methods that can apply more accurate antibody tests."

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