The Food and Drug Administration (FDA) on Thursday warned of false negative and false positive results from the use of self-administered Covid-19 test kits that did not pass through government screening.
In a televised interview, FDA office-in-charge director general Oscar G. Gutierrez, Jr. said a false negative Covid-19 test result could give the tested individual a false sense of security that he or she cannot infect others.
Meanwhile, he said “false positives” could cause a patient unnecessary panic.
Gutierrez noted such risks are greatly reduced if such “home test kits,” pass their high standards, which includes having a specificity rate of 97 percent, and a sensitivity rate of at least 80 percent.
“If a product is able to comply with this standard based on the Performance Validation Report of the RITM (Research Institute for Tropical Medicine), it will then be evaluated by FDA,” Gutierrez said.
“Once it passes these standards, it will be given a Special Certification,” he added.
Still, he noted false positive or false negative results are possible even for FDA approved products, which is why he said the guidelines to be released by the Department of Health (DOH) for self-administered Covid-19 test kits will be crucial.
He noted DOH may consider limiting the use of such kits in certain identified communities, where its use will be beneficial.
Another possible provision of the guidelines, he noted, will be the mandatory reporting of the result of the self-administered test kit as well as if the product will be made available over-the-counter or must be with medical prescription.
Currently, there are two companies–Clearbridge Medical Philippines, Inc. at MOHS Analytics, Inc.–which are applying for Special Certification for their respective self-administered Covid-19 test kits.
Gutierrez said they already referred the application of both firms to the RITM to undergo evaluation.