FDA OK’s importation of test kits

To speed up the detection of novel coronavirus disease (COVID-19) cases in the country, the Food and Drug Administration (FDA) will allow the importation of test kits provided these meet regulatory standards.

In FDA Circular No. 2020-006, FDA chief Eric Domingo said that because of the “expanding global outbreak” of COVID-19, they would start issuing a special certification for imported test kits that have either been issued a product registration by countries “with established regulation” or have been prequalified for the World Health Organization’s (WHO) emergency use listing.

The Research Institute for Tropical Medicine (RITM) currently relies on the test kits provided by WHO to detect if an individual has contracted the SARS-CoV-2 virus which causes COVID-19.

Latest information from health officials showed that there were only around 2,000 kits left at a time when the country is seeing a surge in COVID-19 cases.

Since the country recorded its fourth and fifth cases last week, total cases have soared to 52, as of writing.

Field testing to start Monday

On Monday, the University of the Philippines’ National Institutes of Health (UP NIH) will begin the field testing of its test kit to validate its result to ensure the public would not be given false negative results.

“Once we see that it produces very valid results, that’s the time we would roll it out for use by our patients and other laboratories,” Domingo told reporters on Friday.

The UP NIH earlier said the validation process might take up to three weeks.

Once the locally developed test kits have been validated, it will increase the country’s capacity to test COVID-19 cases.

Domingo earlier said local scientists could process a thousand tests a week.

Domingo said that even with the increased capacity, existing protocols would remain. That is, only symptomatic persons who went to any of the 117 infected countries or have had close contact with a confirmed case would be tested for the virus.

To ensure that only accurate test results are given to the public, Domingo also warned health care professionals and institutions against using test kits that have not been authorized by them.

He stressed that, to date, there were still no registered test kits for COVID-19 in the country.

“So far, we only have two kinds of testing kits. These are only available at RITM and UP NIH. Their tests use sophisticated machinery and are done in laboratories. So there are no home test kits that are available and registered for public use now,” he said.