Manufacture of FDA-Approved Local COVID19 Test Kits in Full Blast

Manufacture of the recently approved local COVID19 (coronavirus) test kits is now in full blast. After receiving the certificate from the Food and Drug Administration (FDA) allowing the use of test kits developed by local scientists at the University of the Philippines-National Institute of Health (UP-­NIH), they will immediately manufacture more kits to help the Department of Health (DOH) facilitate faster detection of local cases of COVID19.

The kit called SARS CoV-2 PCR Detection Kit was developed by local scientists led by Dr. Raul V. Destura from UP-NIH and funded by the Department of Science and Technology (DOST) through its Philippine Council for Health Research and Development (DOST-PCHRD). The DOST also helped Dr. Destura in forming his spin-off company Manila Health Tek. Dr. Destura’s team developed the coronavirus detection kit in January the whole genome sequence of the virus was released. It will be used for field testing coupled with gene sequencing at the Philippine Genome Center.

COVID19 Test Kit

The test kits have been developed as early as January when the complete genome sequence of coronavirus was released. It was approved for use by FDA on March 10. Besides being cheaper, it can be manufactured at 200 kits per week, local availability is thus guaranteed (photo from Manila HealthTek Facebook page)

According to DOST Secretary Fortunato “Boy de la Peña, the COVID-19 kit costs Php28,000 per 25 tests and the RNA extraction kit costs Php10,000 per 50 reactions. The RNA extraction kit is for extracting the virus from the specimen. So, cost of each test is Php1,120+200 = Php1,320. Current costing from foreign counterpart is Php8,500.

Besides being cheaper, the locally developed test kits will help solve the shortage in the country, which has caused the unintentional under-reporting of local cases of COVID19, which DOH Secretary Francisco Duque III admitted in a recent presscon. He said there is a possibility of unintentional under-reporting because of limited testing supplies. “As soon as we get more, then we will be able to expand the coverage of who will be tested,” Duque said.

At present, the government’s testing capacity is at 2,000 individual tests only, clearly not enough for the country’s population of about 100 million. The recently approved test kits by UPNIH can be manufactured at a rate of 200 kits per week. Supply of raw materials are a major factor, but they said they have enough in stock for 6,000 tests now and they ordered 20,000 more last week. Expected arrival date is two weeks. They will start  manufacturing in full blast upon receiving the FDA certificate. They will deploy 1,000 tests this week by Friday (March 13), then 2,000 next week and 3,000 the week after.

According to FDA head DG Domingo, “The increasing number of reported COVID 19 cases will require immediate diagnosis and monitoring. This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases. Furthermore, this will provide greater access to a less costly diagnostic procedure.”

As of Tuesday (March 10), there are already 24 confirmed COVID19 cases in the Philippines who are being treated in various hospitals in Metro Manila. This prompted the Department of Health (DOH) to raise to CODE RED the alert status for COVID19 and for President Rodrigo Duterte to declare a state of Public Health Emergency. Classes in Metro Manila have also been suspended until March 14.

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