FDA approves 4 COVID-19 testing kits

The Food and Drug Administration (FDA) on Thursday said it had approved the first four test kits to detect SARS-CoV-2, the virus that causes the pneumonia-like disease COVID-19, which has killed at least 17 people in the country.

“These are PCR (polymerase chain reaction)-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits,” the FDA said in a statement.

The initial list of approved kits would be regularly updated, according to the agency’s director general, Eric Domingo.

The FDA is under the Department of Health (DOH).

The approved COVID-19 test kits for commercial use are:

• • Nucleic acid detection kit, manufactured by Shanghai GenoeDx Biotech Co. Ltd.-Shanghai, China. It is distributed by S&S Enterprise.

• • Novel coronavirus 2019 nucleic acid detection kit (fluorescence PCR method), manufactured by Beijing Applied Biological Technologies Co. Ltd. It is distributed by Sahar International.

• • AllplexTM 2019-nCoV Assay, manufactured by Seegene Inc. – Seoul, South Korea. It is distributed by Endure Medical Inc.

• • SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, manufactured by Solgent Co. Ltd – 3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea. It is distributed by Wellness Pro Inc.

“We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized,” Domingo said.

“During this period of emergency, safety is still of utmost priority. We need to be vigilant of the entry of counterfeit products and be watchful of those who try to take advantage of the current situation,” he said.

The FDA statement did not say how much each test kit would cost and how many were available outside Metro Manila where health workers have complained about the long time for them to receive test results from the Regional Institute for Tropical Medicine (RITM) where the tests have been centralized.

The government has said that Philippine Health Corp. (Philhealth) would shoulder expenses for COVID-19 tests.

Health Secretary Francisco Duque III said in a television interview on Thursday that the DOH expected more test kits to arrive in the country next week, including 25,000 from South Korea, 100,000 from the China and another 50,000 from Chinese billionaire Jack Ma, founder of the e-commerce and technology giant Alibaba.

He said the DOH already has 2,500 test kits—2,000 from China and 500 from South Korea.

Problem in provinces

Health workers in Western Visayas have complained that the lack of local confirmatory testing centers has been aggravated the suspension of commercial flights, which has caused delays in obtaining laboratory results that come all the way from the RITM in Manila.

The regional DOH office has to wait for available military planes to fly samples to the RITM.

“We do not know when is the next schedule because samples also need to be transported from other areas,” Dr. Glen Alonsabe, Western Visayas epidemiologist.

Alonsabe said they were able to transport several specimen samples taken from persons under investigation (PUI) on Wednesday, but one from Negros Occidental had to be sent on a cargo ship that did not arrived on time. That sample will have to wait for the next available military flight.

DOH accreditationThe DOH has not finished the process of accrediting five subnational laboratories to conduct the COVID-19 screening. They are San Lazaro Hospital in Manila, Lung Center of the Philippines in Quezon City, Baguio General Hospital in Baguio City, Vicente Sotto Memorial Medical Center in Cebu City, and Southern Philippines Medical Center in Davao City.

Iloilo City Mayor Jerry Treñas is pushing for the accreditation of the Western Visayas Medical Center (WVMC) in the city so that local suspected COVID-19 cases could be tested immediately.

Treñas said that while local governments had funds to purchase kits, the lack of supply and the need to send samples to the RITM hindered the quick identification and isolation of infected persons.

The regional DOH office has recorded 119 PUIs and 18,622 persons under monitoring, or those not exhibiting symptoms but who have traveled to areas with COVID-19 cases or have been exposed to infected persons.

Of the 17 fatalities among the 217 COVID-19 cases confirmed by the DOH as of Thursday afternoon, four died before or on the same day they were confirmed positive for the virus.

The four patients exclude the first COVID-19 death in the country and first death outside China—a 44-year-old Chinese man from Wuhan, capital of China’s central province of Hubei and the epicenter of the outbreak.

Priority to VIPs?An opposition lawmaker on Thursday called out the Inter-Agency Task Force on the Management of Emerging Infectious Diseases (IATF-EID) for focusing on tests in Metro Manila and for allegedly giving priority to VIPs.

Deputy Minority Leader and Bayan Muna Rep. Carlos Isagani Zarate lamented reports that a number of PUIs outside national capital had died while still awaiting confirmatory testing, citing alleged cases in the Davao region and Tarlac.

The reports were not immediately confirmed by the DOH.

“This could have been prevented if there were already testing and confirmatory centers, at least in regional centers, all over the country that could have been done earlier,” he said.

“Worse, it appears that it is the DOH itself that is violating its own protocol by testing asymptomatic VIPs,” Zarate said.

He said the accuracy of the DOH national tally of positive COVID-19 cases might be doubted if tests were concentrated in Metro Manila and its neighboring areas, and no “proactive and aggressive” steps were done in other regions where the disease were reported to have spread.

Protective equipmentIn addition to the lack of test kits, there has been a lack of personal protective equipment for health workers, like masks, but a Bataan-based company has pledged to help fill the demand by pledging 5 million surgical masks, according to Trade Secretary Ramon Lopez.

He said despite the large number of masks that would be available, the priority users would be the DOH and Red Cross health workers.

“The allocation for drug stores will be small,” Lopez said. –TINA G. SANTOS, MELVIN GASCON, JULIE M. AURELIO, NESTOR P. BURGOS JR. AND INQUIRER RESEARCH