MANILA, Philippines – Food and Drug Administration (FDA) officer-in-charge Eric Domingo clarified the novel coronavirus test kits developed by University of the Philippines (UP) scientists will not yet be available for the public to buy by Monday, March 16.
By then what would happen is just the field testing for the UP-National Institute of Health’s (UP-NIH) 2019-nCov detection kits so the government can determine the validity of results, Domingo said in a phone interview with reporters on Friday, March 13.
Domingo said specimens will be used on the locally-produced detection kits for testing, after which results will be confirmed through gene sequencing at the Philippine Genome Center.
Results of the UP-NIH test kits will also be compared with the findings of the Research Institute for Tropical Medicine, the only laboratory in the country accredited thus far by the World Health Organization (WHO) to test 2019-nCoV samples.
“‘Yung field testing nga nila kasi kailangan munang i-test sa actual test tapos i-va-validate nila ito, titingnan nila ang resulta kung comparable doon sa kanilang ginagamit mula WHO. At the same time, titingnan din natin kung very accurate saka i-ko-confirm by gene sequencing,” Domingo said.
(The results of the field test will have to be validated and compared to the results of the current test kits they are using from the WHO. At the same time, we’re also going to confirm if the results are very accurate through gene sequencing.)
“At ‘pag nakumpleto na ‘yung datos, at mapakita na talagang very valid na ang test na ito, saka siya i-ro-roll out na maaari na iyan, puwedeng gamitin sa mga pasyente at puwede na siyang gamitin sa ibang mga laboratory,” the FDA chief added.
(Once we complete the data and determine that the tests are very valid, then that’s the only time we can roll it out among patients and let other laboratories use it.)
The FDA has so far issued only a certificate of exemption for field testing to the UP-NIH test kits. A certificate of product registration is the document needed for its commercial use, when the public can purchase the test kits on their own.
This new test kit is capable of detecting in just two hours the presence of 2019-nCoV in samples taken from patients under investigation. It will be reportedly priced at P1,320, or 6 times cheaper than its foreign counterpart, which costs around P8,500.
On Friday, Domingo also told the public not to buy any home test kits being sold online, as these are still unregistered and have no FDA approval. – Rappler.com