MANILA — The Department of Health on Friday warned hospitals about unregistered COVID-19 test kits that are reportedly being offered to the public.
“Meron tayong naririnig na mga ospital sa ating mga karatig-pook na gumagamit ng unregistered test kits,” said Health Undersecretary Maria Rosario Vergeire in a televised DOH briefing.
(We have heard that some hospitals in nearby places are using unregistered test kits.)
“Kayo po ay binabalaan namin na ito po ay masama at hindi dapat ginagawa dahil maaaring magbunga yan ng false negative or false positive at maaari yang makaapekto sa inyong kalusugan at sa kalusugan ng ating komunidad,” she added.
(We are warning you because you should not using these kits, because they might result in false negative or false positive and that will have an effect on your health and the health of your community.)
Vergeire pointed out that the Food and Drug Administration (FDA) has not approved any point-of-care or instant COVID-19 test kits.
“Sa mga taong nagbebenta nito kayo po ay lumalabag sa batas at ito ay may katapat na kaparusahan,” she said, also warning users of its inaccuracy.
(To those who are selling these, you are violating the law and there are penalties.)
The DOH earlier explained that it was only recommending real-time polymerase chain reaction (RT-PCR) based test kits because these are more reliable. These PCR test kits are used in laboratories to extract genetic material from patient samples. These are then matched to the COVID-19 virus. On the other hand, rapid test kits, which can be used at home, can only measure antibodies, which may not be easily detected at the onset of the disease.
The FDA said the sale of unregistered test kits is in violation of Republic Act 9711 or the FDA Act.
There are now 803 confirmed COVID-19 cases in the Philippines.