FDA approves 5 COVID-19 rapid test kits
THE PHILIPPINE Food and Drug Administration (FDA) on Monday said it had approved five rapid test kits for the coronavirus disease 2019 to be used by health professionals.
The test kits are registered and used in countries with advanced technology and experience with COVID-19 including China and Singapore, FDA Director General Rolando Enrique D. Domingo said in a statement on Monday.
The agency also approved a test kit from Abbott Laboratories that can detect the coronavirus in five minutes.
The FDA has approved 17 test kits that use the so-called reverse transcriptase polymerase chain reaction technique (RT-PCR), which is more accurate than the rapid version, for commercial use.
PCR-based test kits are used in laboratories to extract genetic material from throat and nose swabs to diagnose a patient for the COVID-19 virus.
On the other hand, rapid test kits only measure the antibodies in a patient’s blood sample.
“The rapid test kits will yield a faster result compared with PCR-based kits, but it is important that a trained health professional will evaluate and interpret the results,” Mr. Domingo said.
“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself,” he added.
Mr. Domingo said a confirmatory test was still required because the test may yield a negative result because it takes the human body some time to develop antibodies.
“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR-based test is still required,” he said.
The Department of Health (DoH) earlier said it does not recommend rapid testing because it could lead to false negative results.
Aside from the Research Institute for Tropical Medicine, the laboratories in San Lazaro Hospital, Baguio General Hospital and Medical Center, Vicente Sotto Memorial Medical Center and Southern Philippines Medical Center are also testing samples of COVID-19 virus.
More than 30 public and private hospitals have also expressed a desire to become COVID-19 testing laboratories.
The FDA asked health facilities to follow only the recommended treatment guidelines endorsed by DoH and medical societies.
Claims have circulated that Procaine and Dexamethasone with Vitamin B called “Prodex-B” are an effective treatment against viral infections. Prodex-B had not been unregistered with FDA, the agency said.
“All consumers who have received the aforementioned drug are advised to monitor for any adverse reactions,” according to the FDA advisory.
FDA said Procaine is an anesthetic used to reduce pain from injections, while Dexamethasone must be used cautiously due to its side effects including a weaker immune system that could lead to a higher risk of infections.
“Unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm,” it said. — Vann Marlo M. Villegas
