The wait is finally over. The COVID-19 testing kit invented by microbiology and biotechnology expert Dr. Raul Destura and the scientists from the University of the Philippines (UP) completed the field validation last April 1. The Food and Drug Administration Philippines (FDA) is expected to issue the Certificate of Product Registration (CPR) for GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit today, April 3, and will be ready for rollout tomorrow, April 4.
In an update posted by Department of Science and Technology (DOST) Secretary Fortunato de la Peña on his Facebook account, he said “the Manila HealthTek Inc. reported that the first batch of reagents has arrived, which will enable them to start the manufacturing process to create testing kits that can accommodate up to 120,000 tests.”
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From April 4 to 25, a certain number of testing kits, which can do up to 26,000 tests, will be prioritized by the DOST for field implementation and distribution to the Philippine General Hospital, Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Baguio General Hospital.
The said field implementation is funded under the DOST and the University of the Philippines-National Institutes of Health (UP-NIH) Project.
The remaining testing kits good for around 94,000 tests will be sold commercially by Manila HealthTek at around P1,300 per kit, which is cheaper than the units currently being used in hospitals which cost about P8,000. The Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the DOH and hospitals.
In the press conference held at the Philippine Genome Center, Dr. Destura explained that like the existing COVID-19 kits, the GenAmplify COVID-19 rRT-PCR Detection Kit uses the same PCR (polymerase chain reaction) technology to detect the 2019 novel coronavirus (SARS-CoV-2). But unlike the others that require the test to be done thrice (for a total of about six hours), this version employs a single step multiple detection system, which has a turnaround time of 1 to 2 hours. The COVID-19 test involves getting samples from inside the patient’s nose and from the back of his throat with a nasopharyngealbrush and throat swab.
Dr. Destura explained that the kit consists of three vials. “One is amber colored, because the probe is attached to a flourochrome. The second tube contains the master mix that we developed. The third one is the PCR water, which we used as negative control to make sure that the reaction is efficient. We also added an internal amplification control to ensure accuracy of the test done by the medical technologist or laboratory personnel.”
For further information, email Manila Health Tek Inc at [email protected]