Rapigen earns 1st full nod for Covid-19 antigen self-test kit in Korea

Rapigen said Wednesday it obtained approval for BIOCREDIT COVID-19 Ag Home Test Nasal, a rapid Covid-19 antigen self-test device.

The product is the first Covid-19 self-test kit to win full permission from the Ministry of Food and Drug Safety.

Existing rapid home test kits by Humasis and SD Biosensor had won conditional approval on the condition that the developers conduct clinical trials to verify the effectiveness and submit data later.

Under the authorization of the Seoul government, Rapigen tested its rapid self-test kit in Covid-19 patients at community treatment centers starting from May.

Professor Lee Je-hoon of laboratory medicine at the Catholic University of Korea Eunpyeong St. Mary’s Hospital was the study's principal investigator, jointly working with professor Lee Sang-hak at the hospital’s pulmonology and allergy department.

Rapigen’s Covid-19 home test kit won the regulatory nod in Korea Wednesday.

When using Rapigen’s test device, a user can collect a sample by rubbing the surface of the nostril with a tool and get the result within 30 minutes, the company said. The test kit has high sensitivity using a second-generation “black gold particle technology,” it said.

The clinical trial outcome showed that the device showed 93.15 percent sensitivity to detect positive cases and 100 percent specificity to screen out negative cases.

“We raised the sensitivity by utilizing black gold nanoparticles that react to a small number of the viruses,” an official at Rapigen said.

Rapigen’s diagnostic kit can also detect the Delta variant, becoming the dominant Covid-19 strain, and other variants including the Alpha, Beta, and the Gamma.

The company verified the device’s suitability by testing it on 100 people aged between 18 and 79 at the Korea University Guro Hospital’s medical device test center.

Rapigen plans to roll out the product later this month.

“We will launch the product on July 21,” an official at Rapigen said. The company will supply the test kit for online shopping malls and pharmacies through wholesalers, companies and medical institutions, and government agencies.”

Professor Lee Je-hoon said it was challenging to conduct the clinical trial of the home test kit because it was a prospective study. However, he could complete the study quickly thanks to the MFDS’ advanced performance test criteria, the Seoul government’s active support, and participation of Covid-19 patients, he said.

“This device has achieved much progress from conventional self-test kits in terms of performance. In addition, its performance and reliability are nearly at the level of PCR testing,” Lee said.

He went on to say that people who cannot visit a test facility or get a PCR test can use Rapigen’s self-test device for “prior detection.”

As the test kit is convenient to use and minimizes the suspected Covid-19 patient’s movement, it can be used for quick Covid-19 detections, he added.