By Analou De Vera and Dhel Nazario The Food and Drug Administration (FDA) has approved for commercial use the COVID-19 testing kits developed by local scientists. The test kit called GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit is the first locally manufactured test kit for COVID-19 developed in collaboration with the Philippine Genome Center (PGC) and the University of the Philippines - National Institutes of Health (UP-NIH) with support from the DOST - Philippine Council for Health Research and Development (DOST-PCHRD). The kits are manufactured by Manila HealthTek, Inc. la HealthTek, Inc. "The test kit was previously approved by the FDA for field trial with gene sequencing on 10 March 2020. Upon the company's submission of necessary requirements today (April 3), the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use," the FDA said in its advisory 2020-513 released Friday night. The agency said this is the "first locally made PCR-based COVID-19 test kit approved by the FDA." The FDA has already approved 21 PCR-based test kits and nine rapid antibody test kits. "The FDA will continue to update the public on the COVID-19 testing kits approval," the agency said Following the FDA’s approval for the commercial use of the test kits, Dr. Raul Destura and his team who developed it are now working on the production of 120,000 tests The DOST will be distributing 26,000 of the 120,000 tests to the Philippine General Hospital, Makati Medical Center, The Medical City in Pasig City, Vicente Sotto Memorial Medical Center in Cebu City, Southern Philippines Medical Center in Davao City, and Baguio General Hospital Medical Center in Baguio City for field implementation from April 4 to April 25. The remaining 94,000 tests will be sold commercially by Manila HealthTek Inc. "This is great news as the country aims to conduct mass testing of suspected COVID-19 cases starting on April 14. The mass testing will prioritize persons under investigation (PUIs) and persons under monitoring (PUMs), according to the Department of Health (DOH)," said DOST Secretary Fortunato dela Peña. The COVID-19 detection kit was developed to provide accessible and affordable testing for Filipinos. By utilizing a one-step multiplex realtime polymerase chain reaction (PCR) platform, each test is projected to cost P1,320 which is significantly cheaper than its foreign counterparts. Earlier, Health OIC-Undersecretary Maria Rosario Vergeire said the Polymerase Chain Reaction or PCR tests detects the actual presence of the virus. It determines if an individual is positive with the virus even when he/she is asymptomatic. Hence, it is the gold standard in testing for COVID-19. She explained further that the rapid antibody test kit can only detect the presence of antibodies produced by an individual to fight the virus. Antibodies are produced once a person is already infected, and sometimes, one does not develop antibodies in the early stages of infection. This means that rapid tests do not confirm if a person is truly positive or negative, especially when he/she is asymptomatic. Senator Joel Villanueva lauded the FDA’s approval of the UP-NIH testing kits for public use. "Finally, our locally-developed COVID-19 test kits have the green light for public use by the Food and Drug Administration. We commend our scientists from the University of the Philippines (UP) for coming up with this critical diagnostic tool that will help our government save lives from COVID-19," Villanueva, chair of the Senate Committee on Higher, and Technical and Vocational Education, said in a statement congratulating the UP scientists. "With this development, we can expand our testing capability, identify and treat patients with dispatch," he added. The senator said such "breakthrough" proves the importance of supporting research initiatives of state universities and colleges (SUC). Over 19,000 COVID-19 tests The Department of Health (DOH) yesterday said over 19,000 people nationwide were already tested for COVID-19. "We have 19,000 plus unique individuals that we have tested based on the report yesterday. And we have positive results coming out of 3,749 (persons)," said Vergeire in a radio interview. The number of positive results do not match with the number of positive cases reported because there are repeated tests conducted on admitted patients for monitoring, noted Vergeire. Vergeire said 15,398 individuals were found negative while 49 people have "equivocal results." "The equivocal result can be positive or negative. So it needs to be repeated to determine if the patient is really positive or negative," Vergeire added. The DOH testing protocol, however remains the same. “For now, our priority is symptomatics: those with severe cases, vulnerable groups (including) elderly persons, (those with) pre-existing conditions, pregnant, and even our health care workers who are already showing symptoms,” Vergeire added. The DOH on Friday said it can process 3,000 COVID-19 tests daily once the government's mass testing starts. “We are confident that our laboratories can do a total of 3,000 tests a day by April 14,” said Special Assistant to the Health Secretary Dr. Beverly Ho in a press briefing. The Research Institute for Tropical Medicine (RITM) currently has the capacity to run 1,000 tests daily, while the seven sub-national laboratories can process a total of 500 tests per day, Ho added. “Our testing capacity is expected to increase as we train more medtechs, to increase the shifts at our sub-national laboratories. Our expected capacity by the end of April is at least 8,000 tests per day,” Ho said. “With 40 other laboratories in the pipeline, we can expect our daily testing capacity to increase significantly within the next couple of weeks as more laboratories will be certified.” Assessing the situation The DOH official said they are intensifying their efforts to analyze the existing medical data for a more accurate assessment of the current health situation. “Malinaw po sa atin ngayon na hindi pa po bumababa ang kaso ng COVID-19 (It is clear to us that the number of COVID-19 cases have not yet decreased)," Ho said. “We expect that the number of confirmed cases in the country will continue to rise as we test more people,” she added. Ho said the public should “get used to a different kind of normal while a COVID vaccine is not yet invented, as our best weapons are our preventive measures.” “We are hoping that the good habits we cultivate now will stick with us like it is second nature," she added. The government's capability to conduct COVID-19 tests have "significantly improved," according to National Action Plan (NAP) chief Carlito Galvez, Jr., the chief implementer of the government's policy against the dreaded disease Friday night. "We are in a race against time as we try our best to flatten the curve and slow down the spread of the disease," Galvez said in a virtual briefing held at Camp Aguinaldo in Quezon City. "This is the reason why our main focus now is to ramp up the capability of the DOH to conduct mass testing for COVID-19 frontliners and also for PUIs (persons under investigation) and PUMs (persons under monitoring)," he added. “It is better to conduct mass testing so that the COVID-19 patients will be prevented from loitering and we can treat them earlier," Galvez noted. Meanwhile, the number of accredited COVID-19 testing centers in the country has increased to nine. These are: RITM in Muntinlupa City, San Lazaro Hospital and UP National Health Institute in Manila, Lung Center of the Philippines in Quezon City, Baguio General Hospital and Medical Center, Western Visayas Medical Center in Iloilo City, Vicente Sotto Memorial Medical Center in Cebu City, Southern Philippines Medical Center in Davao City, and Bicol Public Health Laboratory. The capability of the government to conduct more tests are seen to further improve as Galvez said nine more hospitals are being evaluated to identify whether or not they can be used as COVID-19 testing centers. First mobile testing site Meanwhile, Quezon City Mayor Joy Belmonte on Saturday thanked the Philippine Red Cross (PRC) for making the city its first COVID-19 testing site. “We are very thankful to the PRC, most especially to its chairman Sen. Richard Gordon, for choosing Quezon City as its first site for COVID-19 mobile testing,” Belmonte said. The number of COVID-19 cases in Quezon City have reached an alarming level and Belmonte hopes the program would arrest the upswing and boost the city’s efforts to prevent the further spread of the coronavirus. As part of the agreement, PRC will be coordinating with the city to put up multiple testing sites in areas to be identified by the QC Health Department (QCHD). “All the test samples will be gathered and handed to the Red Cross for proper testing,” Belmonte said. She added that persons under investigation (PUIs) will be prioritized for testing. Gordon said Quezon City was chosen to be the pilot area for its mobile testing program because of its dense population and due to the high number of COVID-19 cases in the city. He said the testing in Quezon City can begin next week, with the PRC using two polymerase chain reaction (PCR) machines to determine the presence of the coronavirus. One PCR machine can produce 1,500 test results per day. (With reports from Chito Chavez, Vanne Elaine Terrazola, and Martin Sadongdong)