4 newly approved COVID-19 test kits not for home use – FDA

The Food and Drug Administration (FDA) approved four test kits for the coronavirus disease 2019 (COVID-19), FDA Director-General Eric Domingo said Friday.

In an interview on a 24 Oras Breaking News bulletin, Domingo said that two kinds of the test kits were from Korea and two were from China.

"Meron na po tayong apat na test kit ngayon na approve dito sa Pilipinas. Meron po'ng dalawa galing Korea at dalawang galing China," he said.

In an advisory, the FDA said the following approved products complied with the requirements of FDA Memorandum No. 2020-006:

• Nucleic acid detection kit for 2019 ncov
• Novel coronavirus 2019-ncov nucleic acid detection kit (flourescenece PCR method)
• AllplexTM 2019-nCoV Assay
• SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit

The director general however stressed that the four approved test kits were for laboratory testing and not for home use.

According to Domingo, only hospitals allowed by the Department of Health (DOH) to test for COVID-19 could use the products.

Domingo said that the DOH had also sent equipment to sub-national labs in Davao, Cebu, and Baguio for testing.

"[T]oday naman po meron silang team na ikkot sa mga private hospital para matignan kung sino po ang capable at papayagan na rin po nilang mag gawa ng testing," he said.

Domingo had previously warned the public against buying any kits sold in the local market for COVID-19 as none of these were registered for commercial distribution.

Meanwhile, confirmed cases of the virus in the country rose to 217 on Thursday while fatalities remained at 17. — Joahna Lei Casilao/DVM, GMA News