FDA warns against unauthorized sale of COVID-19 test kits

Marje Pelayo   •   March 13, 2020   •   956

MANILA, Philippines – The Food and Drugs Administration (FDA) warns individuals and establishments taking advantage of the current health emergency to exploit consumers through unauthorized sales of coronavirus disease (COVID-19) test kits.

FDA Administrator Director-General Eric Domingo said they received several reports regarding merchants offering the said test kits not only in Metro Manila but in other provinces as well.

There are online sellers who also do the same, the official said.

To curb this unauthorized practice, the FDA issued a warning to the public not to be swayed by unauthorized sellers of COVID-19 test kits.

“Ang babala lang natin kahit po gamitin ninyo ito, hindi naman natin alam kung valid at acceptable ang mga resulta na ito,” Domingo warned.

“Sino naman po ang doktor na maniniwala sa resulta ng mga ito at gagamitin siya to manage a patient?” he added.

Domingo said only the Research Institute for Topical Medicine (RITM) and the University of the Philippines (UP) National Institute of Health are the two authorized institutions to distribute the COVID-19 test kits.

The FDA in its official website warns concerned establishments not to distribute, advertise, or sell COVID-19 testing kit unless authorized by FDA.

Otherwise, the FDA said, regulatory actions and sanctions shall be strictly pursued.

“This is to ensure the provision of accurate and reliable information regarding result of the COVID­-19 test to be conducted” the FDA said.

Domingo said they are coordinating with the Bureau of Customs (BOC) to block the entry of COVID-19 testing kits from abroad because at present, no imported COVID-19 test kits are authorized for use in the Philippines at present.

“Kasi every time naman na may darating na testing kit or medical device kailangan hihingan nila ito ng Certificate of Product Registration or ang Certificate of Exemption, (Every time testing kits or medical devices are delivered to the country, (the BOC) would ask for the items’ certificate of product registration o certificate of exemption,)” the Official said.

So far, only a certificate of exemption was issued for the COVID-19 testing kits produced by the UP-NIH after evidence that the kits are beneficial for the early detection of COVID-19 cases in the Philippines.

“Para lang po alam ng lahat talagang wala pang registered na COVID-19 test kit po dito sa Pilipinas lalong-lalo na po itong mga imported na mga produkto na makikita natin, (Just so you know, there is no registered COVID-19 test kit yet here in the Philippines especially these imported products that we see in local markets,)” Domingo stressed.

Field testing of the UP-invented test kits will begin on Monday (March 16).

READ: PH to start validating Filipino-made COVID-19 test kits

Once approved, a total of 1,000 test kits will be made available weekly, Domingo assured.

The locally made COVID-19 test kits may help in testing asymptomatic patients, in tracing the patients’ travel history abroad especially in coronavirus-affected countries, and those with exposure to a coronavirus-infected patient.

For now, the FDA is still waiting for the government’s approval for the locally-made test kits before the agency can issue a certificate of product registration that will signal its use by hospital laboratories.

The FDA emphasized that COVID-19 test kits are no similar to pregnancy kits and blood sugar test kits that are readily available in markets which can be used at home and yield instant results. – MNP (with inputs from Aiko Miguel)

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)

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)

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