Humasis, a company specializing in the rapid diagnostic test (RDT), said its new product, COVID-19 Ag Test, has won approval from the Ministry of Food and Drug Safety.

Humasis co-developed the test kit with Celltrion. The kit detects infection in less than 15 minutes in a single epipharynx sample, Humasis said. The test kit has 89.4 percent sensitivity to detect infected people and 100 percent specificity to identify those without the virus. 

Humasis completed the clinical trials with Covid-19 variants originating from the U.K. and South Africa. The product showed identical diagnostic ability on both mutations. 

The antibody reacted to the coronavirus's internal and external structure, increasing the specificity on mutations, a Hamasis official said.

The demand for RDT kits is rising amid the global resurgence of the novel coronavirus. The government also announced a plan to introduce rapid antigen test kits to vulnerable facilities and the Seoul metro region to respond to the surging confirmed cases. 

“We are happy to obtain the regulatory nod and also will actively develop the foreign markets as the kits showed more than 90 percent of performance in foreign countries, including the U.S., Czech Republic and Brazil,” the official said.