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

Marje Pelayo   •   May 21, 2020   •   296

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)

DOH warns against use of commercially available COVID-19 test kits

Marje Pelayo   •   April 1, 2020

MANILA, Philippines – The Department of Health (DOH) has warned the public not to purchase COVID-19 rapid test kits that are made available commercially.

“Gusto din po natin ipaalam na ang mga rapid test kits na ito ay hindi ibinebenta sa publiko. Tanging ospital at healthcare workers ang maaaring mag-administer nito. Kaya ‘wag po tayo basta magtitiwala sa mga hindi authorized mag-alok ng rapid test kits, (We would like the public to know that these rapid test kits are not sold commercially to the public. Only hospitals and authorized health care workers are allowed to administer such test. Do not easily trust unauthorized persons offering you such test kits),” said Health Undersecretary Maria Rosario Vergeire.

“Sana po ay ‘wag po kayo bibili ng ganito sa online at ipapagawa kung kani-kanino lang. Ito ay gagamitin pa din sa loob ng ospital with the guidance of a doctor, (Do not purchase such test kits online and don’t let just anybody do the test. The test kits should still be used inside the hospital with the guidance of a doctor),” she added.

At present, a total of 11 brands of rapid or anti-body test kits are registered under the Food and Drug Administration (FDA).

Meanwhile, 49 laboratories across the country are waiting DOH approval for them to operate as COVID-19 testing laboratories.

Aside from the Research Institute for Tropical Medicine (RITM), there are five sub-national laboratories authorized to conduct COVID-19 testing.

These are the Baguio General Hospital and Medical Center; San Lazaro Hospital; Vicente Sotto Memorial Medical Center; Southern Philippines Medical Center; and the UP National Institutes of Health (UP NIH). 

On Wednesday (March 31), the Lung Center of the Philippines started accepting samples after it received approval to conduct Stage 4 Proficiency Testing. MNP (with details from Aiko Miguel)

Countries sending alleged ‘faulty’ COVID-19 test kits, face masks back to China

Marje Pelayo   •   March 30, 2020

MANILA, Philippines – Several countries are sending imported medical supplies back to China after they were reportedly found defective.

The latest is the Netherlands, which ordered a recall of more than 600,000 alleged substandard face masks.

The Dutch government received on March 21 shipments of about 1.3 million face masks.

But the government’s Ministry of Health said the rest of the shipment “was immediately put on hold and has not been distributed.”

“A second test also revealed that the masks did not meet the quality norms. Now it has been decided not to use any of this shipment,” the Dutch Health Ministry said in a statement.

The imported FFP2 masks or N95 masks don’t provide full-face protection and the filters were also defective, claimed the Ministry.

Following the revealed defects, Dutch authorities said they will be stricter by doing extra standard testing to all arriving medical supplies shipment.

Prior to this, the Spanish government last week announced it would send back the rapid test kits it imported from a company in China after tests revealed only 30% detection rate.

Spain said the kits, which came from a national supplier, were ‘CE-Certified’ and passed the European standards.

However, the Chinese Embassy in Spain revealed that the supplier Shenzhen Bioeasy Biotechnology is not licensed nor registered under the National Administration of Medical Products of China to sell such medical products.

Despite the controversy, China vowed to replace the defective test kits delivered to Spain.

Countries like Turkey and the Czech Republic were also among countries that reported ‘faulty’ rapid test kits from China.

In the Philippines, meanwhile, the Department of Health (DOH) found that several COVID-19 test kits yielded only a 40% accuracy rate.

But the DOH clarified that those defective kits were not the ones from China but a brand that was said to have been donated by a private local group.

Sa ngalan po ng Kagawaran humihingi po kami ng paumanhin sa naidulot nitong pagkalito sa nasabi ko po kahapon. Sana po ay na- klaro na po namin ang isyu na ito [In behalf of the Department we apologize for the confusion caused by what I mentioned yesterday. We hope that we have clarified this issue,” said DOH Spokesperson Maria Rosario Vergeire.

The DOH stressed that the COVID-19 tests kits imported from China and were delivered to the Philippines, have passed the World Health Organization (WHO) standards. MNP (with reports from Harlene Delgado)

DOH clarifies ‘faulty test kits’ not from China

Marje Pelayo   •   March 30, 2020

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)


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