PCL Inc., a South Korean in vitro diagnostics device maker, plans to bring two test kits – one that simultaneously detects COVID-19 and influenza infections and the other that measures the concentration of coronavirus antibodies – to market by the end of the year.
The company said on Thursday it is in the final stages of receiving government approval on the state insurance coverage rates for the two test kits, or cartridges, called PCLOKII ABC and PCLOKII SARS-CoV-2 Dual IgG.
“We have already manufactured about 800 units of the test equipment. We expect to supply them to some 250 public health centers and smaller hospitals across the country by year-end,” said PCL Chief Executive Kim So-youn.
The company obtained sales approval for the two cartridges from the Ministry of Food and Drug Safety last year.
If covered by government insurance fees, the new equipment will cost those receiving tests between 30,000 won and 40,000 won ($23-$30) per inspection, the company said.
COVID-19 test kits are still in great demand globally Regarding the supply of PCLOKII ABC, the company said it has signed contracts with four domestic pharmaceutical firms.
The diagnostic kit uses a biochemical testing method, called fluorescence immunoassay, to detect influenza and COVID-19 antigens in the body. It takes less than 30 minutes to get the test results, according to the company.
“Korea needs to have a rapid test system to prepare for the dreaded 'twindemic' of COVID-19 and flu this winter,” the chief executive said.
The portable device, even smaller than a home microwave oven, can also be used as a platform to check infectious diseases before cancer surgeries,” she said.
A COVID-19 testing center sign at a Korean airport WORLD’S FIRST TO DISTINGUISH S ANTIBODY, N ANTIBODY
PCL’s PCLOKII SARS-CoV-2 Dual IgG can be used to determine individuals’ immune status by measuring the antibody concentration in the body.
The company said the device is the world’s first to distinguish between an S antibody, one created by vaccination or an infection, and an N antibody, a natural antibody, when measuring their concentration in the body.
“It is important to know the remaining amount of antibody before deciding whether to get an extra vaccine shot and if so, when,” the PCL chief executive said.
In the case of COVID-19 vaccines, if an additional shot is given when the antibody concentration is high, side effects such as uterine bleeding can occur, she said.
Since its launch in 2008, PCL, a leading manufacturer of in vitro diagnostic medical devices, has developed technologies on multiplex immunodiagnostic products.
Write to Jeong-Min Nam at peux@hankyung.com In-Soo Nam edited this article.
