26,000 PH-developed COVID-19 test kits ready for delivery

MANILA, Philippines – The delivery of locally developed COVID-19 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test kits is finally moving after getting the nod from the Philippines’ Food and Drug Administration (FDA).

According to the weekly report of President Rodrigo Duterte to Congress, which was released on Monday, medical research company Manila HealthTek will be coordinating with hospitals that would receive the GenAmplify COVID-19 detection kits for proper training of their workers on using the test kits.

The GenAmplify kits, developed by local scientists from the Philippine Genome Center (PGC) and the University of the Philippines (UP)-National Institutes of Health (NIH), would serve around 27,000 tests.

“Following its FDA approval on 03 April 2020, the delivery of the locally-developed GenAmplify COVID-19 rRT-PCR for 26,000 tests is ongoing.

“The DOH reiterates that RT-PCR testing remains the gold standard for diagnosing COVID-19 patients and that the point-of-care rapid antibody-based test kits should not be used as standalone tests to definitely diagnose or rule out COVID-19,” the report noted.

“The DOH further states that testing asymptomatic contacts using RT-PCR is not recommended until there is surplus testing capacity,” the report added. “In this regard, the DOH is continuously studying and exploring innovations that can potentially improve the testing capacity for COVID-19.”

After the government placed Luzon under an enhanced community quarantine to limit the spread of the disease, people from various sectors called on the government to implement mass testing, especially in sectors most vulnerable to COVID-19 infection.

Several cities have vowed to implement mass testing in areas with high COVID-19 infection rates, in an attempt to flatten the curve.

As of now, the government said that the FDA has approved 33 COVID-19 test kits for commercial use, 23 of which are PCR test kits while 10 are rapid test kits.

“Out of the 394 COVID-19 test kit application received, 99 have been approved, 226 disapproved, and 69 are pending approval due to incomplete requirements,” the government noted.

As of Monday, the Luzon-wide quarantine was still in effect and is scheduled to on April 30.

Department of Health officials said that there are now 4,932 infected patients — 315 of which have already died while at least 242 have recovered.

Worldwide, over 1.8 million individuals have been infected, of whom 114,063 have died and 421,500 have recovered.

/atm