COVID 19 diagnostic test hindi pa rehistrado — FDA

WALA pang nakarehistrong COVID 19 diagnostic test na available sa publiko.

Ito ang paglilinaw ng Food and drugs Administration (FDA).

Ang polymerase chain reaction (PCR) based lab kits na donasyon ng World Health Organization – Research Institute of Tropical Medicine (WHO-RITM) na ginagamit sa kasalukuyan at ang na-develop na test kit ng University of the Philippines – National Institutes of Health (UP-NIH) at Department of Science and Technology (DOST) na isinabak sa field testing kahapon, 16 Marso, ang pinapayagan .

Ayon sa FDA, wala pang kompanyang nakapag-comply sa minimum set of requirements para sa diagnostic test ng coronavirus disease 2019 (COVID-19).

Requirements para sa imported test kits ang license to operate (LTO) bilang distributor at Certificate of Product Registration (CPR) mula sa reliable at mature national regulatory agency (NRA) tulad ng FDA counterparts sa Estados Unidos, Japan, Singapore, South Korea, Europe at iba pa o certificate of prequalification o  emergency use listing  mula sa WHO.

Ipinaliwanag ng FDA na walang delay sa pag-aaproba kung makapagsusumite rin agad ng kaukulang dokumento at maiisyuhan ng certification.

“We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without the proper regulatory certification from the country of origin and a reliable NRA. These kits may give false positive and false negative results which may affect the response to this pandemic. They may also be counterfeit products that will not test for the novel corona virus at all,” ayon kay Director General Eric Domingo. (JAJA GARCIA)