MANILA - A test kit developed by Filipino scientists for the detection of the new strain of coronavirus will have to undergo field validation first before it is allowed for commercial use, the Food and Drug Administration (FDA) said Thursday.
Around 500 tests using the SARS CoV-2 PCR detection kit developed by the University of the Philippines-National Institutes of Health (UP-NIH) will have to be conducted to ensure its safety and efficacy, said FDA director general Eric Domingo.
To monitor the quality of the results, a parallel test using the gene sequencing technology at the Philippine Genome Center will also be conducted, he added.
The state regulator earlier issued a certificate of exemption to the test kit, also funded by the Department of Science and Technology (DOST), for field testing due to the increasing cases of coronavirus disease 2019 (COVID-19).
"Hindi pa aprubado for commercial use. Hindi pa po ito puwede ibenta sa mga private laboratories," Domingo told radio DZMM.
(It's not yet approved for commercial use. It's not yet allowed to be sold to private laboratories.)
If results from the test kit will be satisfactory, it can apply for a certificate of product registration for wide distribution, he said.
The World Health Organization (WHO) can validate the efficacy of the test kits, but it will take some 3 months.
But Domingo said, "Hindi naman requirement ng ating bansa ang validation from the WHO... Kung 'yun ang hihintayin natin, walang makakapasok na test kit sa atin."
(The WHO validation is not required in our country... If we will wait for it, no test kit can come in.)
Dr. Raul Destura of the UP-NHI's Institute of Molecular Biology and Biotechnology said the test kit could release results in less than 2 hours using a "multiplex technology," which simultaneously detects the strain of coronavirus and its specificity.
He said they developed the test kit for several few weeks after China, where the outbreak originated, released the full sequence of the novel coronavirus.
"It took us around 21 days to put the entire assay, and several weeks for revalidation sa laboratory performance as required by the WHO," the infectious disease specialist told radio DZMM in a separate interview.
Destura, also president and chief executive officer of private research firm Manila Healthtek, Inc., said the test kits could be rolled out to the public in the next few weeks if approved by FDA.
The analytical specificity of the test kit, which refers to its ability to identify specific substance, is 100 percent, he said.