Two antigen products or rapid test kits currently being sold in the market to monitor Covid-19 cases and which were given Product Certifications by the Food and Drug Administration are both a threat to public health and could imperil people’s lives.
The two kits failed the sensitivity tests conducted in September 2020 by the Research Institute for Tropical Medicine (RITM).
Standard Q Covid-19 Ag Test, manufactured by SD Biosensor Inc., had a sensitivity rate of 71.43 percent, while the Quickprofile Covid-19 Ag Test Strip manufactured by Lumiquick Diagnostics Inc. registered a miserable 27.78 percent sensitivity, RITM test results showed.
Guidelines from the Department of Health (DoH) and the World Health Organization (WHO) require a minimum of 80 percent sensitivity. Sensitivity determines the level of confidence in the test result, showing whether a person is Covid-positive or negative.
The WHO guideline reads in part: “Given the relatively low prevalence of active SARS-CoV-2 infections even in settings with community transmission, WHO recommends high specificity (minimum >97 percent and ideally >99 percent) to avoid many false positive results. Ag-RDT tests should have a minimum sensitivity of 80 percent).”
At the same time, the DoH and the Department of Trade and Industry’s rules on conduct of antigen test also states in part: “Only kits with a minimum of 80 percent sensitivity and 97 percent specificity are recommended for use and that the DoH, through the RITM shall regularly publish the list of test kits that have been validated by the institute and other designated facilities.”
An anomaly by any other name
Despite this anomaly and the threat to public health, the two products were validated by RITM in September 2020. Six months have passed since the test kits were issued “Gold Standard,” but the FDA has not intervened at all to revoke the certifications of SD Biosensor and Lumiquick.
The RITM validation is a DoH requirement. Without it, no test kits are technically allowed to be sold to the public, and more particularly not to government institutions that require RITM validation before public funds can be used for the procurement of any products.
Because of this, the two inferior products have monopolized government sales to the exclusion of other test kits that could have a much higher sensitivity and could be more reliable, too. Some 75 antigen brands have been with the FDA since September 2020 awaiting its endorsement to RITM.
Even if an importer wanted to bypass FDA and go straight to RITM for validation, he could not. The importer must first apply with the FDA for certification. After receipt of the product certification, the FDA endorses the product to RITM for validation. That’s the protocol. In the meantime, while awaiting RITM validation, the product goes to the market.
Logically, one would expect that products sold in the market are compliant with the safety protocol, which is why FDA certification is a requirement. In the instance of the two failed antigen or rapid test kits, why did the FDA issue them Product Certifications ahead of the RITM tests? Why won’t FDA wait for RITM validation before it issues the certification?
When the RITM tests were conducted in September 2020, and the results turned out to be in violation of the DoH and the WHO guidelines, why did FDA not issue a Stop to Sell Order against the two antigen products immediately?
In September 2020, FDA endorsed the two antigen products to the RITM for validation.
RITM did tests on the two. They failed. SD Biosensor Inc. got a sensitivity rating of 71.43 percent, while Lumiquick Diagnostics Inc. Registered 27.78 percent. Why then did RITM validate them despite failing the DoH and WHO guidelines?
Did RITM inform FDA that SD Biosensor Inc. and Lumiquick Diagnostics Inc. did not meet the DoH and WHO benchmark? And if it did, why did FDA not revoke the Certificates of Registration issued to the two upon receipt of the information?
Does RITM coordinate with the FDA?
A threat to public health
With failed sensitivity of 71 percent and 27 percent for SD Biosensor and Lumiquick Diagnostics, respectively, the number of false negatives and false positives will increase correspondingly which could contribute to the rise in Covid-19 cases.
Not knowing you are false negative, you are emboldened to go about your business as usual putting the members of your immediate family, neighbors and friends at risk. You are a carrier, and you do not even know it.
What about false positive? You are gripped with anxiety, fear, fear of dying.
You were ordered to self-quarantine. In the end, you decided to have a PCR test in a hospital near you. While waiting for the results, you couldn’t sleep; you’re restless, anxious and still gripped with fear.
Finally, after three days, the result comes out: negative! What a relief! you tell yourself. In the meantime, you’ve paid the hospital P4,500 for the PCR test or P5,500 if you want the results in 24 hours! You were forced to spend good money and had to quarantine because the test was not accurate.
It is a truism in business that monopoly breeds inefficiency, corruption and high prices. I am not implying that Health Secretary Francisco Duque 3rd and FDA Director General Eric Domingo are corrupt. Far from it. I’ve known Duque since the time of former president Gloria Macapagal Arroyo. We were both in the Cabinet and on occasions, we were seated next to each other.
He has a reputation as a straight shooter and honest; he loves cars and wrist watches as I do. We would fantasize about exotic cars during lull moments. Duque is a Georgetown alumnus, and he used to teach medicine before joining the government.
Domingo on the other hand, belongs to a buena familia. I came to know him many years ago when I was still managing and operating a hospital in SBMA. He almost became my medical director were it not for a better offer from a government hospital. His mother Didi Domingo, former Pampanga congresswoman, former Immigration commissioner and now Philippine Amusement and Gaming Corp. chairman, managed to keep her nose clean all these years. She was never involved in any shenanigans. Eric is a cut from the same cloth as his mother.
I do not know Dr. Cecilia Carlos of the RITM and FDA’s Engr. Cecilia Matienzo. But both strike me as honest as well. I have not heard of any wrongdoings by them in and out of the FDA and RITM.
So where does the problem lie?
It’s in the system.
The clear solution is: reverse the protocol. Send the application first to RITM; test the product within 4 to 8 weeks as in other advanced countries; then if the product passes the test, RITM will refer the results and other relevant documents to FDA for processing. Within days, FDA issues Product Certification, and the product then goes to the market.
In the meantime, FDA should revoke the Product Certificates of SD Biosensor Inc. and Lumiquick Diagnostics Inc. and recall their rapid test kits from the market. This goes too for all antigen products that failed the RITM tests. Pronto!
(Disclosure: One of my companies is a distributor of one of the companies that imports antigen and other Covid-related tests.)