COVID-19 Diagnosis Within 1 Hour... To Be Used in Medical Settings Starting Next Month

Foreign Importers Also Eligible to Apply

On the 15th, a citizen is passing in front of Yeongdeungpo Hospital in Yeongdeungpo-gu, Seoul, which was closed after a confirmed case of COVID-19 worked there. Yeongdeungpo-gu closed the hospital on the 14th due to a COVID-19 confirmation of an occupational therapist at the hospital who had visited an Itaewon club. Photo by Kim Hyun-min kimhyun81@

[Asia Economy Reporter Choi Dae-yeol] Rapid diagnostic kits to quickly determine whether a patient has contracted the novel coronavirus infection (COVID-19) in emergency treatment or urgent situations such as childbirth are expected to be used at frontline medical sites starting next month. Currently, COVID-19 diagnostic tests take about six hours, and this measure aims to reduce the damage caused by delayed treatment while waiting for test results.

According to related industries on the 25th, the Korea Disease Control and Prevention Agency recently announced a "Call for Applications for Emergency Use of Genetic Testing Reagents" and decided to accept applications starting from the 1st of next month. Both domestic manufacturers and foreign importers are eligible to apply. Only products that can prove efficacy and safety will be accepted, reviewed, and evaluated, and are expected to be used as early as next month. The product must be able to provide results within one hour from specimen collection to confirm infection status to be eligible for application.

Unlike the United States and China, our quarantine authorities recognize only molecular diagnostic methods that amplify genes obtained from specimens as the standard testing method.

The rapid diagnostic kits to be introduced this time also use the molecular diagnostic method. The antibody diagnostic method, which determines infection by checking whether antibodies have formed in the body after infection, is not recognized as an official diagnostic method due to its lower accuracy.

Molecular diagnostics have high sensitivity (the ability to correctly identify positives) and specificity (the ability to correctly identify negatives), making them accurate, whereas antibody testing has limitations such as difficulty in detecting infection during the early stage when antibodies are not yet present.

However, the results are produced quickly. In March, in Gyeongbuk, a patient whose pneumonia worsened and required hospitalization died because COVID-19 was suspected and timely treatment was not provided. Although this was a measure to prevent in-hospital infection, the medical community believes that if COVID-19 test results had been available sooner, emergency treatment could have been administered more quickly.

According to the industry, rapid diagnostic kits from domestic in vitro diagnostic companies such as Seasun Biomaterials, as well as some foreign companies like the US-based Cepheid and France-based bioM?rieux, are highly likely to receive emergency approval. It is expected that factors such as accuracy, domestic supply availability, and compatibility with existing diagnostic equipment will be comprehensively considered.

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