"We should try them here."
"We should try them here."
As the number of deaths from COVID-19 continues to rise, why can't the Department of Health prioritize the immediate procurement of on-site test kits for possible infections?
With some barangays already placed under total lockdown because of the alarming number of suspected COVID-19 cases in the country, "that's where the on-site test kits play their most important role, as people need not go to hospitals and laboratories since the tests may be conducted in their own homes," said Nico delos Angeles, country representative of Hero Pass, one of the frontline companies in China's fight against the virus as distributor of Guangzhou Wondfo Biotech's COVID-19 test kits in Macau and Hong Kong.
In a letter to Dr. Rolando Enrique D. Domingo, Director General of the Food and Drug Administration (FDA), delos Angeles appealed for an exemption from product registration for Covid-19 test kits and for it to be allowed to undertake the direct importation of Wondfo Biotech's Covid-19 on-site test kits.
The Wondfo test kits have already been approved by China's Food and Drug Administration as well as the Chinese Center for Disease Control and Prevention. The test kits have also received the CE mark for Europe.
"Our COVID-19 testing kit does not use the Real-Time Polymerase Chain Reaction (RT-PCR) method but the lateral flow method. I also understand that the WHO and DOH only uses the PCR method to account for the confirmed cases in the country. However, this does not diminish the need and use of our product," delos Angeles pointed out.
"The lateral flow method does not require a laboratory to interpret the results and can be deployed at the barangay level as first-level screening by conducting it in the homes of people. It can be deployed to save the PCR tests for those who are already confirmed positive," explained delos Angeles.
"There are valid arguments for the lateral flow method as you will only test positive on the second or third from the onset of the symptoms. First, you will only complain or seek a doctor when you have symptoms to begin with. Second, since it is simple to use as I can take the test with my household and if negative, I will not take the test after 2-3 days later to confirm if we are indeed negative. This will at least confirm that we are negative for the time being," he stated.
"For first liners such as police, military and medical professionals, I would take the test once a week because you never know when you were accidentally infected.
"As for the PCR method, although it is more accurate and is what is required by the WHO and DOH, I have concerns over the logistics and implementation. First, we only have four laboratories in the country which will be receiving all the samples. This requires logistics and there is limit as to how much a particular lab can handle.
"Second, the swab must be accurately taken at the right place or you will get a false negative. Not only that, the risk of infection is great if the patient accidentally sneezes at the medical professional while conducting the test and infecting our already limited medical staff.
"Third, the transport of the PCR test kits requires a minus 20 degrees temperature or a frozen container or truck. Delivering the PCR in ordinary trucks or containers with our hot weather may affect the efficacy of the test kits or may even totally spoil the test altogether.
"Fourth, we should decongest crowded hospital facilities and free medical professionals from conducting PCR tests so they can already begin treating patients. By letting barangay officials or non-medical staff conduct the lateral flow test as initial screening, this allows medical staff to focus only on confirmed patients," delos Angeles concluded his letter.
Our FDA has yet to approve any COVID-19 point-of-care test kit or rapid test kit similar to pregnancy test kits that show results in minutes.
What the FDA has approved as COVID-19 test kits utilize the RT-PCR method. This is a process that requires a PCR machine in the laboratory and personnel who know how to operate the machine.
The Department of Health has also issued a circular saying that there's no clear evidence on the efficacy of the use of the lateral flow (IgG/IgM) rapid test for Covid-19. The DOH insists that only laboratories accredited by the Research Institute for Tropical Medicine (DOH-RITM) can process RT-PCR-based kits.
We can understand the urgency with which the distributor of the COVID-19 on-site test kit wants health authorities to approve it as soon as possible. The disease threatens the lives of practically every Filipino. If their test kit has worked in China and Europe, why can't we try it here and see whether it can save lives?