Low-cost COVID-19 home test kit gets FDA nod

MANILA, Philippines — A low-cost, home testing kit for the coronavirus disease that can generate results in 15 minutes is being introduced in the country.

The Corona Antigen Instant Test for 1 or CAI-1 was introduced yesterday at the virtual Kapihan sa Manila Bay media forum by LABx Corp., which specializes in cutting-edge diagnostics.

“Our goal here is to bring it affordable to the masa,” said LABx Corp. founder and chief executive officer Thomas Navasero.

Navasero said CAI-1 was already approved by the Food and Drug Administration (FDA) and would cost around P500 per test.

He said this low-cost antigen test is suitable for home use with the aid of a licensed medical practitioner via telemedicine. However, it is not yet available locally.

The CAI-1 is done by collecting throat or nasal swab specimens from an individual and works by measuring the sensitivity and specificity of the virus in one’s body.

Navasero said the CAI-1 box contains two antigen tests that can detect the virus without the use of machines, so the results can be expected in about 15 minutes.

“A home antigen test, which is very similar to ours, was already approved in the US,” he added.

LABx Corp. said in its website that the CAI-1 has a sensitivity of 95 percent and specificity of 98 percent, making it an alternative to the “gold standard” RT-PCR tests in detecting COVID-19.

The standard rate for sensitivity for antigen test kit is 80 percent while the specificity rate should be 97 percent.

“Here in the Philippines, we still use a nurse and a doctor to administer the test to make sure that the swab is done properly and that an image of the test is provided to the medical practitioner, that’s the difference,” Navasero said.

He said their company has a small manufacturing pilot plant in the country, which produces about 1,000 antigen CAI-1 test kits per day.

“Antigen testing has become very popular with the population and we’ve basically provided about a million antigen tests in the last nine months,” he said.

Pathologist and immunogenetics expert Emilio Villanueva III and Navasero called for mass testing following the discovery of a new and more contagious strain of COVID-19 in the country.

Villanueva, who was also a guest at the forum, said the UK variant can spread easily from person to person.

For his part, testing czar Vince Dizon said he would discuss the CAI-1 test kit with the Department of Health (DOH).

Asked if he would endorse the use of home antigen test in the country, Dizon said: “As for the endorsement, it’s actually the first time I saw it. I’ll discuss it with the DOH right away.”

Dizon said the country now has the capacity to conduct 30,000 to 40,000 swab tests a day.

“As far as testing is concerned our numbers are still high,” he told the same forum.

Meanwhile, saliva COVID-19 tests are expected to be approved by the government this week, the Philippine Red Cross (PRC) said.

PRC biomolecular laboratories chief Paulyn Ubial said the Red Cross has already submitted 1,000 samples for the pilot test to the DOH and FDA.

She added that the PRC had previously submitted an application before the FDA to approve the saliva test kits.

“We are expecting that within this week, we are going to earn the approval from the Food and Drug Administration and the Department of Health,” said in an interview aired over TeleRadyo.

Ubial said the PRC found the saliva tests to be 98.11 percent accurate as compared to PCR swab tests.

“The swab test is the gold standard. But this also means we have a cheaper, faster and more convenient alternative which is just as accurate,” she said. — Neil Jayson Servallos