Japan authorities take measure on sale of unauthorized COVID-19 antigen test kits

The Yomiuri Shimbun

Confusion has arisen over the existence of differing types of COVID-19 antigen rapid detection kits, with which people can conveniently check by themselves to find out whether they are infected with the novel coronavirus.

Antigen detection kits that the Health, Labor and Welfare Ministry has authorized for “medical purposes,” are difficult for the general public to obtain due to various regulations, but many unauthorized test kits, whose levels of accuracy have not been confirmed, have been appearing on the market.

On Wednesday, the ministry asked prefectural governments and other authorities to give guidance to retailers that they should not sell unauthorized antigen self-test kits in a way that could let them be misunderstood as authorized, or to carry out crackdowns on those who do sell them against such guidance. But many challenges lie ahead in finding ways for high-quality COVID-19 antigen tests to be conducted widely.

‘Medical’ vs ‘research’

“There are various kinds of antigen test kits, making us wonder which one to use,” said a 53-year-old man from Tokyo. He was searching the internet for a COVID-19 antigen self-test kit for his father, who goes to a daytime care facility. To prevent infections at the facility, his father was asked to undergo an antigen test.

As the man perused test kits online, he saw various kinds at various prices. After pondering which one to choose, he decided to buy one labeled “for research purposes” at a drugstore. It cost about ¥4,000 per kit.

There are two categories of COVID-19 antigen rapid detection kits. One category is tests that have received approval following government screening under the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices; the other category is unauthorized test kits described as “for research purposes.”

The Yomiuri Shimbun
COVID-19 antigen test kits for medical purposes

Tests authorized for medical purposes cannot be sold online, due to strict legal regulations that help ensure people can obtain one only when provided with adequate information from a pharmacist at a pharmacy.

Later, the man was surprised to learn from an acquaintance that not only are authorized antigen test kits available, but also that their price is around ¥1,400 a kit. “Why aren’t the products authorized by the government on display at the store? On top of that, they’re cheaper,” said the man angrily.

Reasons for confusion

Why does such confusion occur? The authorized ones were originally developed for use at testing facilities and medical institutions to diagnose novel coronavirus infections, with their use limited only to such institutions.

On the other hand, in response to demand from individuals who wish for the reassurance of a negative test result, unauthorized antigen test kits, which are less expensive than undergoing a PCR test, have appeared on the market.

Against this background, it has been revealed that a man in Yokohama obtained negative test results on three occasions — apparently using unauthorized test kits. He did not go to any medical institution, and died of apparently COVID-related pneumonia this autumn.

Business circles, a government regulatory reform council and other parties have called for authorized COVID-19 antigen test kits, whose level of accuracy has been confirmed, to be sold more widely. In response, the health ministry lifted the ban on their sales at the end of September as a special case, allowing only in-person sales at pharmacies.

The Yomiuri Shimbun
Authorized COVID-19 antigen test kits for medical purposes are sold through in-person sales by pharmacists, as seen in this photo taken at Qol’s Ebisu store in Meguro Ward, Tokyo.

Many people are still unaware that authorized test kits can be obtained at pharmacies.

Correct information

In light of the current state of affairs, the government has now taken stronger measures. Nonetheless, there is still a mountain of challenges. As unauthorized test kits are treated as general merchandise, there is no law to restrict their sales.

According to sources, profits from the sale of unauthorized test kits are greater than those of authorized ones. At the same time, some sellers are unhappy to find themselves burdened with a stock of unauthorized kits.

A person in charge of public relations at a leading drugstore chain said: “We haven’t received any complaints from those who bought unauthorized test kits. So what’s wrong with selling them? We would like to consider it while waiting to see how our rival stores react.”

It is also necessary to review how the authorized test kits should be sold. If the requirement for in-person sales of the products by pharmacists were terminated, it would become easier for people to obtain them. But there are fears that correct information about their use could no longer be conveyed to users. “If users make mistakes in their use of the kits, a high level of accuracy could not be maintained,” a testing-related official warned.

Masumi Tobe, a professor at Osaka University of Economics who is knowledgeable about public administration concerning infectious diseases, said: “The present law cannot go so far as to ban the sales of unauthorized test kits, thus raising the question of how to craft a framework under which authorized products can be obtained more easily. The government should continue giving serious guidance to retailers while making efforts to have correct information conveyed to the people.”