Photo/Illutration Rakuten Inc.’s Novel Coronavirus PCR Testing Kit allows users to take samples on their own at home without professional supervision. (Provided by Rakuten Inc.)

Rakuten Inc.’s new coronavirus home testing kit aimed at businesses is under attack from doctors who say it is unreliable and could end up actually spreading the contagion.

Representatives of the Japan Medical Association blasted Rakuten’s new product offering as “highly problematic” at a news conference on April 22.

“The coronavirus tests should be performed only under doctors’ orders,” a JMA official said.

The product, called the Novel Coronavirus PCR Testing Kit, was developed by Genesis Healthcare Co., a Tokyo provider of genetic analysis services in which Rakuten has a stake.

It allows users to collect their own sample at home by sticking a cotton swab up their nose or into their throat, according to Rakuten.

The sample can then be put in a container and shipped to Genesis Healthcare.

The company analyzes the sample to see if it contains the genetic sequences specific to the new coronavirus. It can yield results within three days.

But the results only show if the specific genetic sequences are detected, not if a user is positive or negative for the coronavirus, Rakuten said.

The testing kit, priced at 14,900 yen ($137), tax included, was introduced for limited release on April 20 to businesses and organizations in Tokyo and four nearby prefectures.

It is aimed at people without cold symptoms.

A public relations official with Rakuten said the self-swab kit will be useful for people still required to go out to work.

“There are many infected people out there who unwittingly transmit the virus to others,” the official said. “We are hoping that our test kit will help workers perform their duty free from anxiety.”

Rakuten also said businesses would find the test kits beneficial when weighing the option of having potential virus carriers self-isolate at home. 

The official said the company is receiving inquiries from hospitals, construction companies and other businesses.

Under the standard coronavirus diagnostic testing, known as a polymerase chain reaction (PCR) test, clinical laboratory technicians or doctors take samples from patients at a medical facility or public health center.

At the news conference, Satoshi Kamayachi, a JMA executive board member, questioned the credibility of test results based on samples taken without professional supervision.

“If samples were not collected appropriately, the outcome of the test would not be reliable,” he said. “The testing method could further spread the virus.”

Experts said it is not an easy procedure to self-administer--even for medical professionals.

In addition, there is a limit to the PCR test’s ability.

Sampling error can occur when a patient is at a stage of infection where they do not yet have enough of the virus that it can be properly collected in a swab. Only 70 percent of coronavirus carriers are found to be positive for the virus during that stage of infection.

That is why some observers have raised concerns that those who test negative let their guards down and unknowingly transmit the virus to others.

Another problem is that there is always a certain percentage of people who test positive despite being virus-free.

Given a lack of accuracy already involved in the existing PCR test, critics charge that Rakuten’s self-swab test will raise further doubts about test results as samples are taken by someone other than health experts.

Kamayachi said the availability of such kits is “extremely concerning” and could lead to social “upheaval.”

Some expert panel members on the government’s task force to respond to the coronavirus voiced similar concerns when they met on April 22.

It is not easy to identify new coronavirus patients. About 80 percent of infected people display only mild symptoms or no symptoms at all.

Calls are growing for broader diagnostic testing, which currently requires a doctor's order before it can be done.

(This article was written by Ryuichi Hisanaga and Tokiko Tsuji.)