Gov't to reject importation, donation of COVID-19 test kits not approved by DOH, FDA
By Roy Mabasa
The Philippine government will reject the importation and donation of coronavirus disease 2019 (COVID-19) test kits that are not approved and recognized by the Food and Drug Administration (FDA) and the Department of Health (DOH).
Foreign Affairs Undersecretary for Civilian Security Brigido Dulay made this announcement in a tweet he posted on Tuesday, saying that only test kits that are real time-polymerase chain reaction (RT-PCR) will be accepted.
DFA Undersecretary for Civilian Security and Consular Concerns Brigido Dulay (Philippine Embassy / MANILA BULLETIN)
“For those who wish to import & donate COVID-19 test kits, please make sure it’s a real time-polymerase chain reaction (RT-PCR) based test kit. FDA already approved four types of RT-PCR test kits for commercial use. Other types not recognized by DOH will be rejected by (Bureau of) Customs,” Dulay said.
However, an FDA-approved list of COVID-19 test kits obtained by the Manila Bulletin showed that there are already eight test kit product brands that are authorized for commercial use in the Philippines as of March 20, 2020.
Two are from China, three from South Korea, one from Singapore, and one from Germany.
On Monday, the Chinese Embassy in Manila released a list of 20 COVID-19 test kit products that are approved by China’s National Medical Products Administration.
According to the Embassy, the National Medical Products Administration is the authority in China to supervise safety and regulate the registration of drugs, medical devices, and cosmetics.
Currently, the nucleic acid testing kit and antibody testing kit are the two main types of detection kits approved by the Chinese agency for commercial use.
Between the two, the nucleic acid testing remains the primary detection method for the novel coronavirus in China, it added.
The average detection time for the nucleic acid testing takes two to three hours with strong specificity and relatively high sensitivity.
DFA Undersecretary for Civilian Security and Consular Concerns Brigido Dulay (Philippine Embassy / MANILA BULLETIN)
“For those who wish to import & donate COVID-19 test kits, please make sure it’s a real time-polymerase chain reaction (RT-PCR) based test kit. FDA already approved four types of RT-PCR test kits for commercial use. Other types not recognized by DOH will be rejected by (Bureau of) Customs,” Dulay said.
However, an FDA-approved list of COVID-19 test kits obtained by the Manila Bulletin showed that there are already eight test kit product brands that are authorized for commercial use in the Philippines as of March 20, 2020.
Two are from China, three from South Korea, one from Singapore, and one from Germany.
On Monday, the Chinese Embassy in Manila released a list of 20 COVID-19 test kit products that are approved by China’s National Medical Products Administration.
According to the Embassy, the National Medical Products Administration is the authority in China to supervise safety and regulate the registration of drugs, medical devices, and cosmetics.
Currently, the nucleic acid testing kit and antibody testing kit are the two main types of detection kits approved by the Chinese agency for commercial use.
Between the two, the nucleic acid testing remains the primary detection method for the novel coronavirus in China, it added.
The average detection time for the nucleic acid testing takes two to three hours with strong specificity and relatively high sensitivity.