FDA ready to revoke license of ‘non-performing’ rapid test kits

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    THE Food and Drug Administration (FDA) yesterday said it is ready to revoke the license of approved Rapid Antibody Test Kits if they are found to be non-performing in determining patients with the dreaded coronavirus disease (COVID-19).

    FDA Director General Eric Domingo said they are continuously conducting post-marketing surveillance to check the performance of approved Rapid Antibody Test Kits.

    “Companies with issued special certifications are required to submit samples of their rapid antibody test kits to the Research Institute of Tropical Medicine (RITM) for evaluation,” said Domingo.

    “Special certifications of rapid antibody test kits, which are found not performing according to their indicated technical specifications, shall be revoked,” he added.

    The FDA issued the statement after Anakalusugan party-list Rep Mike Defensor received numerous complaints about the alleged unreliability and inaccuracy of several rapid test kit brands.

    Defensor questioned the FDA for allegedly allowing the sale of various brands of rapid test kits for COVID-19 without validating their effectivity or requiring them to be approved by regulators from their countries of origin.

    According to Domingo, the gravity of the COVID-19 pandemic as well as the novelty of the virus make it necessary for the FDA to adopt an “expedited process” in approving the rapid test kits.

    “COVID-19 Rapid Antibody Test Kits are approved upon submission of minimum required quality and safety of the products,” he explained.

    The FDA has approved a total of 155 COVID-19 Test Kits, including 60 rapid antibody test kits.

    COVID-19 TOLL

    The Department of Health said 490 new COVID-19 cases were reported on Monday, bringing the country’s total to 26,420 cases.

    Of the newly-reported cases, 348 are considered “fresh cases” while 142 are “late cases.”

    “Fresh cases” refer to test results that came out and were validated by the DOH – Epidemiology Bureau in the last three days while “late cases” are the results that came out four days ago or more but were just recently validated by the DOH.

    Ten new fatalities were recorded Monday, bringing to 1,098 the total number of COVID-19 deaths in the country.

    The DOH also reported 298 new cases of recoveries, meaning there are now a total of 6,252 COVID-19 patients that have recovered from the dreaded disease.

    TIMELY REPORTING NEEDED

    Amid concerns raised over its management and reporting of coronavirus disease-related data, the DOH called on local government units to come up with reports that are timely and accurate.

    The DOH said it is necessary for LGUs as well as other frontline service providers to submit timely and accurate reports to the national government to ensure the proper response to the pandemic.

    “As we have stated in previous occasions, the fight against COVID-19 entails a whole-of-government and whole-of-society approach. The DOH cannot do it alone, neither can the Executive Branch. We need the leadership and cooperation of the LGUs, our frontliners on the grassroots in this battle, as well as our health care providers, and laboratories,” the DOH said.

    “The timeliness and integrity of the national data are only as good as the submission of our partners on the ground —laboratories, hospitals, and LGUs,” it added.

    Over the weekend, the DOH said the recent spike in COVID-19 mortality can be attributed to the late reporting of LGUs.

    2 MORE COPS DIE

    Two more cops were added to the list of PNP fatalities due to COVID-19 as of Sunday, bringing to seven the total number of cops claimed by the virus.

    A report from the PNP Health Service said the latest fatalities, aged 29 and 46, were both assigned in Cebu City.

    PNP chief Archie Gamboa said the families of both police officers will receive full financial support and social benefits.

    As of June 15, the COVID-19 data of the PNP Health Service showed there were 414 confirmed cases recorded, with seven deaths and 240 having recovered. Among the confirmed cases, 136 are in quarantine facilities, 15 are in hospitals, while 16 are under home quarantine.

    The Bureau of Corrections, meanwhile, said about 130 inmates who have tested positive for COVID-19 have recovered.

    BuCor spokesman Gabriel Chaclag said included in the latest batch are 21 inmates who have been returned to their detention cells Monday. At least 15 inmates have died due to the deadly virus, according to Chaclag.

    INCOMING PMA CADETS ‘CLEAR’

    All the 350 members of the Philippine Military Academy class of 2024 have passed the safety and health protocols against COVID-19 and were formally received by the academy yesterday.

    The cadets – 280 males and 70 females – took their oath and underwent reception rites at Fort Del Pilar, home to the PMA in Baguio City, while wearing face masks and observing physical distancing, said PMA spokeswoman Maj. Cherryl Tindog.

    PMA superintendent Vice Adm. Allan Ferdinand Cusi said the reception ceremony was “very different” from the past in view of the COVID-19 “that has forced all of us to the ‘new normal’.” – With Raymond Africa, Ashzel Hachero and Victor Reyes

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