MANILA, Philippines — President Rodrigo Duterte ordered the “immediate” purchase of rapid test kits for the new coronavirus to boost the country’s testing capability despite the lack of guidelines from health authorities.
In a late night speech Monday, Duterte said he “will take the risk” and order the procurement of the rapid test kits despite the absence of clearance from the country’s Food and Drug Administration and approval from the Health and Technology and Assessment Council.
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“I’m clearing the way. I will ask Secretary [Francisco] Duque to talk to the people in charge, si Secretary [Carlito] Galvez. And they can proceed to buy it immediately as fast as you can really to the procurement at this time,” he said.
But the DOH cannot directly procure the rapid test kits due to the absence of approval from the Health Technology Assessment Council, a group of health experts tasked to facilitate provision of financing and recommendations on health technologies to be financed.
Section 34 of the Universal Health Care Act states that “investments on any health technology or development of any benefit package by the DOH and PhilHealth shall be used on the positive recommendations of the HTA.”
Cabinet Secretary Karlo Nograles said the government could bypass the restrictions by ordering the Office of Civil Defense to make the purchase.
“So hindi lang pwede ang DOH and PhilHealth but because we are in the state of calamity, OCD can do the purchase,” the spokesperson of the government’s coronavirus task force.
Need to buy both rapid test kits and PCR-based kits
National Task Force against COVID-19 chief implementer Carlito Galvez Jr. said the government will need to purchase 900,000 polymerase chain reaction-based kits to confirm the validity of results obtained from the use of rapid test kits.
PCR-based kits are expected to cost around P3.2 billion. Galvez said the government is eyeing to buy two million rapid test kits but the approximate cost of the said kits is not yet available.
The DOH earlier said it does not recommend the use of rapid test kits because such kits can produce false positive and false negative.
FDA Director General Eric Domingo earlier said that while rapid test kits yield faster results that PCR-based kits, a trained health professional should evaluate and interpret the results.
"We have to be very cautious is using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but bodies have not yet developed antibodies," Domingo said in a statement released March 30.
The Philippine College of Physicians and the Philippine Society of Microbiology and Infectious Diseases, in a joint position paper, said using rapid antibody tests may pose harm to healthcare workers and the public through false reassurance and inadvertent exposure.
According to the World Health Organization, which says the tests have limited utility for clinical diagnosis, "these test kits detects the presence of antibodies in the blood of people believed to have been infected with COVID-19."
Last month, the country’s Food and Drug Administration approved the use of five rapid tests for COVID-19 but stressed that a confirmatory PCR-based test is still required.
The Philippines has so far reported 4,932 COVID-19 infections, with 315 deaths and 242 recoveries.
There are now 15 testing facilities across the archipelago. Over 35,804 individuals have been tested. — Gaea Katreena Cabico