TOKYO – Fujirebio, a subsidiary of Japanese diagnostics and laboratory testing service provider Miraca Holdings, applied on Monday for government approval for Japan’s first antigen coronavirus testing kits, a health ministry official said.
Japan’s sole official test for coronavirus diagnosis is a polymerase chain reaction, or PCR, test. Antigen tests can be conducted more quickly, in about half an hour, potentially making virus tests more accessible to the public if approved.
The application will be fast-tracked, the official said.
“We usually aim to complete our review for approval within a year. But we will tackle this one as swiftly as possible,” Takuma Kato, deputy director of the ministry’s tuberculosis and infectious diseases control division, told Reuters.
Approval will likely be issued by the end of May, Kyodo news agency said, without citing sources.
There has been widespread criticism that phone lines for public health centres, tasked with conducting screening for PCR test candidates, are always busy and test results are slow to come by.
Critics say the low rate of testing in Japan has made it difficult to trace the new coronavirus, which can cause the COVID-19 respiratory disease, as it spreads and that this has led to a series of in-hospital infections, crippling some facilities.
Japan conducted about 52,000 PCR tests in March, or just 16% of the number carried out in South Korea, according to data from Oxford University.
A Miraca Holdings spokeswoman confirmed Fujirebio had filed for government approval but declined to give details, saying an official announcement would be made soon.
An antigen test targets the virus’s protein to establish whether a person has the disease. An antibody test is used to detect those who have been infected with the virus and therefore had immunity.
Japan had reported 13,613 coronavirus infections as of late Monday evening, with 394 deaths, public broadcaster NHK said.