Testing the test kits

It is rather strange, it would seem, for the Food and Drug Administration (FDA) to have approved recently different brands of rapid test kits but apparently are just stacked at the pharmacy inventory. And why is this so amid persistent calls being made for the government to conduct mass testing for “suspects” carrying the deadly and contagious 2019 coronavirus disease, or COVID-19?

The Department of Health (DOH) has not made or taken a definitive stand whether or not to encourage the private sector conduct their own COVID-19 testing and leave the decision to them which brand or brands of rapid test kits to use.  

I often hear Health Secretary Dr. Francisco Duque III repeatedly declares he only wanted the best medical products for Filipinos. The reason, he even said this before the media, he has given instructions to FDA director general Dr. Eric Domingo to screen the submitted rapid test brands for exemption thoroughly.

Notably, at least three of these rapid test kits were not among those in the list of the National Medical Products Administration (NMPA) of China for Nucleic Acid Reagent Test Kits for the SARS-nCOV. Beijing submitted this NMPA list to the Department of Foreign Affairs (DFA) for reference and guidance as earlier announced by both sides. Rapid test kits were developed after China’s experience with the deadly flu-like contagion that erupted in Wuhan in December last year. 

In particular, the three brands are namely, the Wantai SARS-CoV Rapid Test Kit; Alltest Rapid Test Kit; and, Hightop SAR-COV2 Rapid Test.  

These brands therefore have no business applying for exemption with FDA and yet they were reportedly approved by our own FDA. It’s against the very guidelines of FDA that stated only foreign products approved by the FDA in their source country may apply for exemption with Philippine FDA. So these test kit brands pose a great danger to public health safety and should be recalled pronto and their local approval revoked.

Are we not risking a repeat of the Spain episode wherein a brand of antibody rapid test kit not included in the list of NMPA was ordered by Madrid and therefore was later proven substandard? Did not China clarify that Bioeasy, the brand ordered by Spain, was not in its NMPA list? 

Wasn’t it the very reason DOH Undersecretary Maria Rosario Vergeire cited the Spain experience as springboard to block the use of rapid test kit in the Philippines for mass testing?  

The Chinese Embassy in Manila even issued a diplomatically couched unsolicited advice to our DOH to be more responsible in giving statements that may mislead the public as the rapid test kits and real-time polymerase chain reaction (RT-PCR) kits donated and, or brought by Beijing to Manila, were above standard and in fact, was attested to by the Research Institute for Tropical Medicine RITM and FDA itself? 

Sec. Duque is a known critic of antibody rapid testing and an open endorser for RT-PCR testing kits. As I said, it may not be the case. But perhaps, it is more likely a case of an overlook on the part of FDA? 

Then why is it our FDA, an attached agency of the DOH, suddenly seems to ease its rules on these test kits? 

Meanwhile, Department of Interior and Local Government (DILG) Secretary Eduardo Año recently announced local government units (LGUs) are now allowed to purchase and deploy COVID-19 rapid test kits for mass testing. Año himself underwent COVID-19 test and was found asymptomatic or without symptoms even when his results turned positive.

Nonetheless, Año made the announcement after President Rodrigo Duterte approved the extension of Luzon-wide enhanced community quarantine (ECQ) up to April 30, 2020 subject to the regular assessment of the Inter-Agency Task Force for Emerging Infectious Disease (IATF-EID).

The DILG Secretary is a member of the IATF-EID and vice-chairman at the National Action Task Force in the government’s overall campaign to stop the spread of COVID-19 in the Philippines. 

As a declared policy, Año reiterated antibody rapid test kits will be made available on first priority basis on persons under monitoring (PUMs) in LGUs and arriving overseas Filipino workers (OFWs) from countries with high incidence of the disease. Makes sense!

While LGUs can already purchase antibody rapid test kits for PUMs, Año, however, clarified RT-PCR test kits may be used on persons under investigation (PUIs).

Well, South Korea and China seemed to be both succeeding “to flatten the curve” of COVID-19 cases in their respective countries with the use of rapid test kits. In South Korea, they even launched drive-through COVID-19 test sites. This is being duplicated in the United States with their own walk-through COVID-19 test sites situated at parking lots in a number of popular American supermarkets. 

The same rapid test kits are also being used now in the United Kingdom, Australia, Taiwan, Singapore, Indonesia and in Europe for their ability to come up with the test results on whether a person is negative or positive of the disease within only 15 minutes. That’s how rapid it is!

Sec. Año disclosed there is budget available to the LGUs that may be used for the purchase of COVID-19 test kits. This is in accordance to a joint memorandum circular issued by the DILG and the Department of Budget and Management, addressed to the LGUs on “Additional Guidelines on the Utilization of the 20% of their Annual Internal Revenue Allotment for Development Projects in View of the Coronavirus Disease 2019 Situation.” 

It provides that: “The 20% DF (development fund) shall likewise be allowed to be used for the following COVID-19 related purposes . . . (2.1.2) Procurement of equipment, reagents, and kits for COVID-19 testing.” As per Año, the DILG is targeting to test up to 200,000 individuals during the quarantine period using both antibody rapid test kits and RT-PCR kits. 

Testing the test kits will give clearer and more science-based decision if indeed the ECQs to contain COVID-19 infection and penetration in the Filipino population across the country are really working.