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FDA still evaluating 2 test kits for home use

/ 05:40 AM January 14, 2022

Health authorities have started evaluating two self-administered COVID-19 test kits that are under evaluation for special certification, according to Oscar Gutierrez, officer in charge of the Food and Drug Administration (FDA).

Gutierrez said the Research Institute for Tropical Medicine (RITM) was now evaluating the kits distributed by Clearbridge Medical Philippines Inc. and MOHS Analytics Inc.

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Gutierrez said at the Laging Handa briefing that he could not say when the RITM would complete its review, “but once the FDA receives the validation performance report, the special certification will be given to the applicant within 48 hours.”

To meet the standard and get the special certification, Gutierrez said the self-administered test kits must have a sensitivity of 80 percent and specificity of 97 percent. The RITM will also continuously evaluate these kits, even after their approval for use, to determine if they are performing up to standards.

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He explained that these test kits are simpler to use and have instructions in layman’s terms, unlike the other test kits approved by the FDA, which must be used by health-care workers trained to get the swab.

The Department of Health (DOH) would release guidelines on the use of the self-administered test kits to guide people on their proper use, including the timing, as well as on the interpretation of results, he said.

There should be a reporting system in place because users of the test kits have to take certain steps after getting their results, especially if they are experiencing symptoms, he added.

False results

He also said there could be instances of false negatives or false positives, which is why it would be important to follow DOH guidelines on their use. A false negative could give the user a false sense of security, while a false positive could cause unnecessary panic, he said.

At the same time, Gutierrez said the FDA had asked the manufacturers of Sinovac and Sinopharm to submit requirements so that their vaccines could be approved for the vaccination of children.

“I do not know all the details, but we will try to have more vaccines for pediatric vaccination,” he said.

The government has started inoculating children age 12 to 17 years old, and allowed the use of the Pfizer and Moderna vaccines on them.

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Heath experts also recently approved the vaccination of the 5 to 11 age group.

However, the vaccination of this younger age group has yet to begin because the government is still procuring the Pfizer doses.

The government has also been drawing up plans for the vaccination of babies and toddlers 0 to 4 years old, though experts have yet to recommend this.

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TAGS: COVID-19 test kits, FDA, home use test kits, test kits
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