Substandard COVID-19 Test Kits Have Entered the Philippines
There are two Korean brands for Covid-19 testing that have made its way to the Philippines and have already been purchased by hospitals and clinics amid the pandemic.
SD Biosensor and RapiGen Inc companies and the reliability of their kits are being questioned abroad yet they have entered the Philippines and are currently being used.
Last June, The United States Food and Drug Administration has ordered its medical facilities to prohibit the distribution of SD Biosensor’s Standard Q Covid-10 IgM/IgG Duo.
India has also pulled out supplies from SD Biosensor following the USFDA warning. Their distribution license was suspended together with more than 12 companies.
The Institute for Medical Research (IMR) in Kuala Lumpur, which is under the Ministry of Health in Malaysia, meanwhile released its assessment for Biocredit Covid-19 whose manufacturer is RapiGen Inc.
According to IMR, Biocredit Covid-19 has a low sensitivity rate of 43.3 percent. This means that false negatives are more likely to be the outcome for each tests conducted.
The USFDA earlier said that “FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH (National Institute of Health).”
After US Congress committee findings criticized USFDA for their leniency, the agency began cracking down on “poor performance or misleading statements” and began publishing “removed” manufacturers on May 21.
The substandard test kits could possibly be putting more Filipinos at risk, as false negatives could lead to unnecessary lockdowns, not to mention the money wasted on inaccurate testing.
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