5 rapid test kits get FDA nod

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    COVID test kit from China (photo from pna.gov.ph)

    — With Jocelyn Montemayor, Christian Oineza and Ashzel Hachero

    THE Food and Drug Administration on Monday said it has approved the use of five rapid test kits for the new coronavirus disease (COVID-19), with four coming from China and one from Singapore.

    “The FDA supports all efforts to address this pandemic. We approve kits that are registered and used in countries with advanced technology and wide experience with COVID-19,” said Health Undersecretary Eric Domingo, concurrent FDA director general.

    The FDA-approved rapid test kits are Nanjing Vazyme 2019-nCov IgG/IgM Detection Kit of Biolidics Limited from Singapore; Novel Coronavirus (2019 NCOV) IgM/IgG Antibody Detection Kit Colloidal Gold Method of Nanjing Vazyme Medical Technology Co. Ltd. from Nanjing, China; Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) Colloidal Gold of Zhuhai Livzon Diagnostic Inc. from Guangdong, China; 2019-nCOV Antibody Test (Colloidal Gold) Innovita (Tangshan) of Biological Technology Co., Ltd. from Hebei, China; and SARS-CoV-2 Antibody Test (Lateral Flow Method of Guangzhou Wondfo Biotech Co. Ltd. from Guangzhou, China.

    “These point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore,” Domingo said.

    The approval comes amid persistent calls from different sectors for the Department of Health (DOH) to conduct mass testing for COVID-19. The DOH earlier said there were not enough test kits for the mass testing.

    Domingo said despite the approval, there is a need to establish guidelines and protocols in the use of the kits because these are not meant to be for the personal use of the patient.

    “We want the people to have access to testing. But, of course, proper evaluation and safeguards will still be in place,” he said.

    Primarily, he said, a trained health professional must be at hand to evaluate and interpret results of the tests.

    He also said that the results of the rapid test kits must not be taken as 100 percent accurate, without confirmatory testing.

    “A positive result due to cross-reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” Domingo said.

    Finally, Domingo said, the FDA will require the approved products to put in their labels the statement: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

    PROTECTIVE GEAR

    Health Secretary Francisco Duque III said the DOH has bought a million sets of personal protective equipment (PPE).

    “1 million PPE sets worth P1.8 billion for our health workers,” said Duque in his Twitter account (@SecDuque).

    Health Undersecretary Maria Rosario Vergeire said a each has a headgear, goggles, N95 mask, gloves, apron, and gown.

    “We are just awaiting for their delivery and they will immediately be deployed to our health workers,” said Vergeire in a press briefing.

    Priority will be given to health workers in public hospitals, according to Vergeire, but that private hospital medical personnel will also be provided

     MEDICAL SUPPLIES

     Customs assistant commissioner Vincent Maronilla said the Bureau of Customs has approved the release and delivery of some 2,000 shipments of medical supplies, food, medicines, and other items essential in the fight against COVID-19.

    Maronilla, during the “Laging Handa” public briefing in Malacañang, said BOC has processed the release of 2,865 shipments of PPE, emergency medical supplies, and equipment as of March 29, and are now prioritizing the release of essential goods like food and medicines.

     DONATING SEIZED ITEMS

     Maronilla also said the BOC is working with the Department of Justice and the National Bureau of Investigation on plans to release medical and health items confiscated in raids and smuggled shipments for donation to frontline workers.

    Maronilla said the smuggled and confiscated items include alcohol, masks and PPE.

    Last week, the BOC raided a store in Binondo, Manila and seized some P5 million worth of alcohol, face masks, gloves, and thermal scanners that were sold at almost four times the suggested retail price.

     COVID-19 FACILITIES

     Marikina Mayor Marcelino Teodoro said a two-storey building is being prepared as a testing facility for COVID-19, in place of the one rejected earlier by the DOH.

    Teodoro said the facility is in the less-populated area of Bayan Bayanan in Barangay Concepcion Uno and has no office nearby.

    The DOH disapproved the first proposed testing center located at the Marikina City Health Office, saying facility should be separate to avoid cross-infection.

    The Quezon City government is set to open on Tuesday a second temporary quarantine facility for persons under investigation (PUI).

    Mayor Joy Belmonte disclosed that the quarantine facility, dubbed as Hope II, will be housed at the sprawling Quezon City University Complex in Novaliches, Quezon City.

    “The quarantine facility has a 168-bed capacity for PUIs who are unable to undergo self-quarantine in their respective homes,” said Belmonte.