MANILA — The Philippines' Food and Drug Administration on Thursday reiterated that only laboratory test kits for COVID-19 are being approved for commercial sale in the country.
This as reports come out that imported rapid test kits are being sold in the black market.
The FDA has so far approved 12 COVID-19 test kits that are real-time polymerase chain reaction(RT-PCR)-based. These PCR test kits, which can only be used in government-accredited laboratories, are the ones solely recommended by the Department of Health.
“There is currently no clear evidence to support the use of point-of-care tests (lateral flow rapid tests) in the diagnosis of COVID-19,” the FDA said in a press statement, referring to a DOH circular.
PCR test kits are also the ones recommended by the World Health Organization. These extract the genetic material from patient samples and match it with the COVID-19 virus.
Rapid test kits, on the other hand, can be done at home like pregnancy kits. Instead of throat and nose swabs, rapid test kits use blood samples. “It measures antibodies that are not immediately measured in a person at the start of the infection,” Health Undersecretary Maria Rosario Vergeire had said, making it prone to false negatives.
“Test kits for commercial use that did not go through FDA approval are probably brought into the country by importers without proper permits, and therefore not released by the (Bureau of Customs),” FDA Director General Eric Domingo said in a statement.
“Businessmen should not import these products before they are certified by the FDA. An application for product certification of a diagnostic kit is not equal to an approval to sell or distribute,” he said.
Domingo told ABS-CBN News that those who sell unregistered products face penalties under Republic Act 9711 or the FDA Act.
CLEARANCE FOR DONATED KITS
Meanwhile, the FDA said it continues to review and expedite applications of COVID-19 test kits.
As of Wednesday, there are 636 confirmed COVID-19 cases in the Philippines. DOH is expecting the number to increase as the country gets more test kits and expands its lab testing capabilities.
“We are streamlining procedures to efficiently facilitate COVID-19-associated health commodities. We understand the urgency of the situation, but we cannot compromise the quality and safety of these kits without scientific evidence and proper documentary basis,” Domingo said.
The FDA said it does not require clearance of foreign-donated COVID-19 health products before customs release. “There are no reports that DOH-donated or -registered commercial products have difficulty with the Bureau of Customs,” the FDA said.