Gyeongnam Pharmaceutical Signs Sales Contract for COVID-19 Self-Test Kits with 'Rapigen'

[Asia Economy Reporter Jang Hyowon] As the fourth wave of COVID-19 has recently begun, interest in self-diagnostic kits that allow individuals to check their infection status on their own is increasing. In this context, Gyeongnam Pharmaceutical (CEO Bae Geonwoo) announced on the 15th that it has signed a sales contract with ‘Rapigen’ (CEO Park Jaegu), a company specializing in in vitro diagnostic medical devices.

Rapigen’s ‘BIOCREDIT COVID-19 Antigen Self-Test Kit’ is the first self-test kit officially approved by the Ministry of Food and Drug Safety in Korea. It is a product whose clinical performance for ‘nasal swab specimens,’ collected by rubbing the inside surface of the nostrils, has been verified to meet the domestic MFDS approval requirements.

The clinical performance evaluation was conducted under the responsibility of Professor Lee Jehun (Department of Laboratory Medicine) at Eunpyeong St. Mary’s Hospital, Catholic University. It was compared with the existing genetic test (PCR) method, showing a sensitivity of 93.15% for detecting positive patients (MFDS standard: over 90%) and a specificity of 100% for detecting negative patients.

The BIOCREDIT COVID-19 Antigen Self-Test Kit uses Rapigen’s unique second-generation Black Gold Particle technology to detect COVID-19 antigens, completing the test within 30 minutes. It is characterized by its ability to detect not only the currently prevalent Delta variant but also the existing Alpha, Beta, and Gamma variants.

This product is designed to allow individuals to easily collect specimens from the nasal cavity. It has completed usability testing for individuals aged 18 to 79 through the Medical Device Usability Test Center at Korea University Guro Hospital.

The usage method is simple. First, collect specimens from both nostrils using the swab included in the kit, mix the specimen with the enclosed extraction buffer, and apply about three drops onto the test device. The test results can be read within 30 minutes.

Professor Lee Jehun of Eunpyeong St. Mary’s Hospital, who conducted the clinical trial, said, “COVID-19 self-diagnostic kits are useful for ‘pre-testing’ purposes when visiting screening clinics is difficult or PCR testing is not possible. They offer the advantages of convenience during the testing process and minimizing the movement of infected individuals.”