"The locally developed test kits will be commercially available starting today."
"The locally developed test kits will be commercially available starting today."
We're glad that the Food and Drug Administration (FDA) has already approved the use of rapid test kits as another weapon in the fight against the dreaded COVID-19.
It's about time.
The Department of Health (DOH) and its attached agencies, among them the FDA and the Research Institute for Tropical Medicine (RITM), had balked at utilizing the lateral flow assay technology behind the onsite test kits. They claimed that this did not focus on finding out whether a person had already been infected with the new coronavirus, but on the antibodies produced by the body when infection had already set in.
But those who were adamant in their insistence that onsite or rapid testing is just as important as the Real-Time Polymerase Chain Reaction (RT-PCR) technology eventually won, as the FDA has approved the application of five suppliers to distribute their products here.
Of the five rapid test kits approved by the FDA, one is manufactured by a Singapore-based firm under license from a Chinese company, the four others by China-based firms. These are: (1) Nanjing Vazyme COVID-19 Detection Kit manufactured by Biolidics Limited, Singapore; (2) Novel Coronavirus Detection Kit (Colloidal Gold Method) manufactured by Nanjing Vazyme Medical Technology Co. Ltd. based in Nanjing, China; (3) Diagnostic Kit for IgM/IgG Antibody (Colloidal Gold Method) manufactured by Zhuhai Livzon Diagnostics, Inc. Guangdong, China; (4) 2019 COVID-19 Test (Colloidal Gold Method) manufactured by Innovita BioTechnology Co. based in Tangshan, China; and (5) SARS COVID-19 (Lateral Flow Method) manufactured by Guangzhou Wondfo Biotech, Co. Ltd., based in Guangzhou, China. These companies are listed on the website of the National Medical Products Administration of China as of March 16, 2020 as among those approved to produce test kits for COVID-19.
The five rapid test kits are to be used only under the supervision of trained health professionals as these may show false positive or negative results.
The FDA decision came a day after more than 30 business leaders and heads of chambers of commerce proposed the use of rapid test kits to curb the pandemic.
The FDA decision was hailed by Joey Concepcion, presidential adviser for entrepreneurship, who said: “To win this war, we have to have a clearer view of COVID-19 in the country. We cannot emphasize enough; it is critical that we do rapid testing now. Hopefully, this rapid testing will help prevent another lockdown from happening.”
FDA Director General Eric Domingo pointed out that the results from the use of the rapid antibody test kits would still need confirmatory testing to verify if the patient really contracted the disease. “Interpreting the results of these rapid test kits is not simple. This is why it is important for a doctor to read the results so that he could give the patient the right advice and guidance on what should be done after the test. Equally important is the confirmatory testing [for positive cases] using the PCR- based kits in our laboratories to be certain of the results."
The locally developed test kits will be commercially available starting today (April 3) after field validation, according to Science Secretary Fortunato de la Peña
The massive roll-out of rapid test kits for the novel coronavirus is no doubt a positive development.
As Health Secretary Francisco Duque has pointed out, current statistics on the number of COVID-19 cases may not reflect the current situation on the ground because of the limited number of test kits since the crisis began. With rapid test kits to be made available, then authorities can find out the real score as to the scope of the public health menace and map out the appropriate responses.
Apart from the RITM, laboratories that can test for COVID-19 are San Lazaro Hospital, Lung Center of the Philippines and the University of the Philippines National Institute of Health in Metro Manila; Baguio General Hospital in Baguio City; Vicente Sotto Memorial Medical Center in Cebu; and Southern Philippines Medical Center in Davao City.
The RITM can conduct up to a thousand tests a day, while the other laboratories can process a total of 200 tests daily. Results from the RITM typically come out in two to three days, according to news reports.
While we're at this, a DOH consultant, Dr. Edsel Salvaña, told DZMM radio that private hospitals now charge at least P5,000 to as much as P10,000 for testing for COVID-19. But what about the test kits donated by China and other countries to government hospitals, will they be free of charge or not? The PhilHealth has already said they would shoulder the full cost of hospitalization of all COVID-19 patients. We take that to mean that all those hospitalized COVID-19 would not have to pay a centavo for treatment.
Dr. Salvaña's price quote should send shivers down the spine of the poor and the disadvantaged as they cannot expect any free lunch if they fall prey to COVID-19. How's that for Duterte's pledge that the government has enough money to deal with the COVID-19 crisis?
