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

Marje Pelayo   •   April 1, 2020   •   472

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)

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 admits COVID-19 testing capacity still below 8,000 to 10,000 daily target

Marje Pelayo   •   April 29, 2020

MANILA, Philippines — The Department of Health (DOH) on Wednesday admitted that the country’s testing capacity for coronavirus disease (COVID-19) is still below the target.

The Department had planned to expand its mass testing to 8,000 – 10,000 tests daily starting Thursday (April 30).

But, according to Health Undersecretary Maria Rosario Vergeire, they may not be able to achieve the target as scheduled.

Mukhang hindi po aabot dito sa walong libo for April 30, though sinusubukan natin dahil ngayon po dumating na ang cartridges natin for GeneXpert [I don’t think we can achieve the 8,000 target for April 30 though we are trying, especially with the arrival of the cartridges for GeneXpert,]” the official said.

The DOH was able to conduct a total of 6,320 tests on Tuesday (April 28) in 19 licensed testing laboratories across the country. 

Vergeire noted the recent scaling down of operations at the Research Institute for Tropical Medicine (RITM) as one reason for the delay in testing of samples which left the processing of results pending for about a week.

The RITM has just resumed full operations on Sunday after more than 30 of its COVID-19 positive medical staff recovered from the disease.

With the use of GeneXpert test kits, the DOH expects the results to be out within 45 minutes which will definitely improve the country’s testing capacity and hopefully achieve its daily target.

“But ngayon po itong ating goal ay pilit na maabot, aabutin [We will try hard to achieve our goal in] the coming days as all the resources had been falling in coming from private side and coming from the government,” Vergeire said.

Meanwhile, the Food and Drug Administration (FDA) has added a polymerase chain reaction (PCR) test kit from Singapore and two brands of rapid antibody test kit from Germany and China among the list of approved test kits that may be used in hospitals across the country.

To date, the country has a total of 33 FDA-approved PCR-based test kits and 24 rapid antibody test kits. 

The DOH reminds the public, however, that these test kits may only be administered by licensed doctors and experts who are also authorized to interpret test results. –MNP (with details from Aiko Miguel)

DOH doesn’t recommend rapid antibody test kits for expanded mass testing

Marje Pelayo   •   April 15, 2020

MANILA, Philippines — President Rodrigo Duterte has ordered the procurement of two million rapid antibody test kits and directed the Office of the Civil Defense (OCD) to facilitate the process.

“I will clear the way by ordering the purchase, tutal walang FDA local (since the local FDA doesn’t have kits). But what we are trying to buy outside, it is approved by the US-FDA. So, in a sense almost all: what we eat, the products of all sorts that we buy, if it is FDA-approved, galing Amerika, kampante tayo niyan (it comes from America, we are confident),” the President said.

But for the Department of Health (DOH), this kind of test kit is not recommendable for mass testing and warns that they might yield inaccurate results.

“Nakapaloob sa Department Circular No. 2020-160 na ang rapid test kit ay hindi po recommended para sa mass testing (Department Circular No. 2020-160 states that rapid test kits are not recommended for mass testing), ” explained DOH Undersecretary Maria Rosario Vergeire.

Over the counter ay hindi rin po at hindi rin puwede sa self-testing (Over the counter test kits are not recommended. Self-testing is also not allowed),” she added.

Vergeire said results shown by rapid antibody test kits must still be confirmed through the polymerase chain reaction (PCR) based test used in laboratories like the Research Institute for Tropical Medicine (RITM) and the subnational laboratories.

Ang paggamit ng rapid antibody test ay maaring mag-resulta sa [The use of rapid antibody test kits may yield] false negative results,” the official explained.

Ibig pong sabihin nito ay kahit negative ang lumabas na resulta sa rapid test kit maaaring positibo pa rin ang pasyente sa (It might appear that the results are negative when in fact the person is positive for) COVID-19,” she added.

Meanwhile, the FDA already approved 37 kinds of test kits — 26 are PCR based and 11 are rapid antibody test kits.

Currently, the country has 16 Stage-5 accredited laboratories where confirmatory tests for COVID-19 are being done. MNP (with details from Aiko Miguel)

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