Limang Rapid Test Kits para sa COVID-19 aprubado na ng FDA

By Dona Dominguez-Cargullo March 30, 2020 - 01:04 PM

Inaasahang mas mapapabilis pa ang pagsasagawa ng testing sa mga hinihinalang COVID-19 patient.

Ito ay makaraang aprubahan ng Food and Drug Administration (FDA) ang paggamit ng 5 Rapid Test Kits para sa COVID-19.

Ayon sa FDA ang mga inaprubahang point-of-care test kits ay rehistrado din sa ibang bansa at nagamit na sa China at Singapore.

“We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place,” ayon kay Director General Eric Domingo ng FDA.

Inaprubahan din ng FDA ang SARS Cov2 kit ng Gene Xpert mula sa Abbott Laboratories na kayang ma-detect ang virus sa loob lang ng limang minuto.

Sa kabuuan ang FDA ay mayroon nang naaprubahan na 17 PCR based test kits.

Bilang safety precaution, ang Rapid Test Kits ay dapat sumunod sa FDA requirements kabilang ang paglalagay ng label na nagsasaad na “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

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