DOH clarifies ‘faulty test kits’ not from China

Marje Pelayo   •   March 30, 2020   •   1303

MANILA, Philippines – Thousands of coronavirus disease (COVID-19) test kits from a number of countries have arrived in the Philippines specifically from China, Singapore, South Korea and India.

The latest to arrive were 40,000 test kits from Singapore which arrived Sunday evening (March 29).

The Department of Health (DOH) assured all COVID-19 test kit donations are screened and tested for accuracy before they are used for public testing.

“Nagsasagawa po ang RITM ng parallel testing ng mga tests kits natin gamit po ang protocol ng World Health Organization, (The Research Institute for Tropical Medicine has been doing parallel testing on the kits following protocols set by the World Health Organization) ” explained DOH Spokesperson Maria Rosario Vergeire.

Vergeire said donated test kits and those provided by the World Health Organization (WHO) both undergo tests using similar samples or specimen.

The DOH only recommends public use if both kits yield parallel results.

Through this process, the DOH discovered that some test kits yielded poor accuracy rate.

During a press conference, Vergeire mentioned that the first batch of test kits from China yielded only 40% accuracy and therefore did not allow its use.

In response, Beijing through its embassy in Manila clarified that the test kits passed the standards.

The Embassy said it immediately checked with DOH which clarified that the two batches of 2,000 BGI PCR-type test kits and 100,000 Sansure PCR-type test kits donated by the Chinese government have been assessed by the Research Institute for Tropical Medicine (RITM) to be at par with the World Health Organization provided kits.

“And those test kits are of high quality and standards and have no accuracy problems,” the China Embassy in Manila said in a statement.

“At this moment of crisis, we should fight in solidarity to overcome the epidemic at the earliest date. The Chinese Embassy firmly rejects any irresponsible remarks and any attempts to undermine our cooperation in this regard,” it added.

In a follow up statement, the DOH clarified that the faulty test kits referred to by Usec. Vergeire of having poor accuracy rate was a different brand of test kits “that was proposed to be donated by a private foundation.”

Those test kits were already discarded, the DOH said.

“The DOH apologizes for any confusion that previously issued statements have caused,” the Health Department said.

Meanwhile, the DOH said it is expecting more positive cases of COVID-19 with the arrival of additional test kits from donor countries.

Vergeire stressed that the DOH is not just doing a random testing to identify COVID-19 positive individuals.

“Sa pamamagitan ng contact tracing, aktibo po nating hinahanap ang mga posibleng na infect ng COVID-19, (Through contact tracing we are actively identifying all individuals who might have been infected by COVID-19)” the official said.

“Dahil dito asahan po ninyo na tataas pa ang bilang ng mga confirmed cases sa mga susunod na araw. Mainam na rin po na ating nalalaman kung ilan at sino pa ang nagpositibo para sila po ay mabigyan agad ng tamang pag-aalaga (Because of this, expect the rise in number of confirmed cases in the coming days. It is better that we are able identify them and to know the number to immediately provide them proper care),” she added.

At present, all four national testing laboratories across the country are doing 80 to 160 tests a day on top of the 900 to 1,000 tests a day being done by RITM in Manila. MNP (with details from Aiko Miguel)

PH Defense receives 50K COVID-19 swab test kits from Singapore

Robie de Guzman   •   April 16, 2021

MANILA, Philippines – The Department of National Defense (DND) and the Armed Forces of the Philippines (AFP) have received 50,000 units of COVID-19 swab test kits from the Singapore Ministry of Defense.

The donated test kits were turned over to the DND and the AFP on Thursday, April 15.

The DND said the test kits will be issued to the Veterans Memorial Medical Center (VMMC) and the AFP Medical Center (AFPMC).

The VMMC, which is mandated to provide quality medical care and treatment to veterans and their dependents, is under the purview of the Philippine Veterans Affairs Office (PVAO).

The AFPMC, meanwhile, provides medical care to the military and civilian personnel of the AFP.

“Both PVAO and AFP are government bureaus under the DND,” the department said.

Police seize unregistered COVID-19 test kits, nab 2 suspects in Navotas

Robie de Guzman   •   March 3, 2021

MANILA, Philippines – Boxes containing unauthorized COVID-19 test kits were seized in an entrapment operation in Navotas City, the Philippine National Police (PNP) said on Wednesday.

In a statement, PNP chief General Debold Sinas said police operatives recovered Tuesday 154 boxes each containing 50 pieces of Clungene rapid test kits worth P1,016,000, and marked money amounting to P436,000.

The PNP said the operation conducted at Barangay San Rafael stemmed from information shared by the Food and Drug Administration.

The operation also yielded the arrest of 40-year old Chinese trader Liset Lo Kaw and 23-year old Christian Casanova who marketed the unregistered test kits online.

Sinas said the arrested suspects are leaders of Christian CG, a criminal group engaged in online selling.

“We remind the public to be vigilant and to immediately report any suspicious online transactions. We cannot discount the risks associated with unauthorized medical products that could possibly endanger public health,” the PNP chief said.

“Also, we encourage those who are engaged in food or health product businesses to get pertinent legal documents from the FDA to avoid conflict with the law,” he added.

The PNP said the suspects were brought to Quezon City District Field Unit office for documentation and booking process.

They will face charges for violation of the Food and Drug Administration Act of 2009 in relation to FDA Circular No. 2020-016 or the prohibition of Online selling of FDA Certified COVID-19 Antibody Test Kit.

FDA recalls locally-made COVID-19 test kits for ‘minor defects’

Marje Pelayo   •   May 21, 2020

MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA). 

This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.

Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now. 

The said locally-made test kits were approved for use by the FDA in April.

Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits. 

“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said. 

As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results. 

According to Presidential Spokesperson Secretary Harry to  Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days. 

Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.

 FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)

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