COVID-19 Diagnostic Method Taking 45 Minutes to Be Used Domestically as Well

6-Hour to 45-Minute Reduction Diagnostic Kit
Used for Patients Requiring Emergency Treatment

A research team at Tulane University laboratory in New Orleans, USA, is preparing for a COVID-19 virus test.<이미지:Yonhap News>

[Asia Economy Reporter Choi Dae-yeol] The quarantine authorities are considering introducing a diagnostic test that takes less than an hour to determine whether a person is positive for the novel coronavirus infection (COVID-19). Currently, in South Korea, infection status is checked using the real-time RT-PCR method, which takes about six hours. The existing method will mainly be used, but it is deemed necessary to apply the rapid test selectively in urgent situations involving suspected patients who require immediate treatment.

Authorities Leaning Towards Introducing COVID-19 Rapid Diagnostic Kits

According to authorities on the 3rd, the Korea Disease Control and Prevention Agency and the Ministry of Food and Drug Safety held discussions with experts from the Korean Society for Laboratory Medicine and others the previous day to explore measures for rapid COVID-19 diagnostic methods. During the meeting, the efficacy and suitability of diagnostic kits from the US-based molecular diagnostics company Cepheid and the French company Biomerieux were evaluated. Both products had previously received emergency use authorization from the US Food and Drug Administration (FDA) last month, and the companies had already provided product information for review.

Before and around the time the first domestic case was confirmed in January, South Korean quarantine authorities conducted pan-coronavirus PCR tests, which took about two days. Subsequently, after consultations with diagnostic experts and the in vitro diagnostic industry, the method was improved to real-time RT-PCR, which is currently used. Real-time RT-PCR involves amplifying samples collected from the throat and inside the nose using appropriate diagnostic kits and equipment to confirm infection status. The authorities explain that this method has the highest sensitivity to detect positive infected patients, making it the most reliable test method to date. Another advantage is the ability to test multiple samples simultaneously.

Maintaining Accuracy with Genetic Diagnostic Methods
Needed for Emergency Patients... Mainly Existing Methods with Some Application of Rapid Tests

The diagnostic tests from Cepheid and Biomerieux currently under consideration for domestic introduction fundamentally maintain a similar method to existing PCR but significantly reduce the testing time to 45 minutes. Some domestic companies also promote products with reduced testing times, but these use immunodiagnostic methods based on antigens and antibodies. These methods detect immune responses within the body after infection, allowing rapid diagnosis but are less effective at detecting early infection and have lower sensitivity, which is a critical drawback.

The rapid diagnostic tests are expected to be used for patients requiring emergency treatment. For example, a teenager who was hospitalized at Yeungnam University Hospital last month and later died initially visited the hospital when symptoms appeared but could not be admitted due to the time taken to determine COVID-19 infection status. Even after being admitted to another hospital, the patient underwent diagnostic testing 13 times. Hospitals must repeatedly check infection status because treatment methods differ depending on whether the patient is COVID-19 positive. Since patients requiring urgent care can appear at any time, health authorities recognize the need to reduce the six-hour testing time.

The choice of which rapid diagnostic kit to use is expected to be decided considering the equipment already distributed domestically and testing costs. In the case of Cepheid, many devices have been supplied in South Korea for tuberculosis diagnosis, so only the cartridge-type diagnostic kits need to be procured, but the unit price is reportedly quite high. Biomerieux’s diagnostic equipment is said to be less widely distributed domestically.