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DOH clarifies commercially sold COVID19 test kits

#PHinfo: DOH clarifies commercially sold COVID19 test kits

DAVAO CITY, March 20 (PIA) – Health undersecretary Abdullah Dumama Jr. in a virtual press conference held at the Department of Health in Davao City in partnership with the Philippine Information Agency XI, urged local government executives (LCEs) to be aware on several aspects of these commercially available COVID-19 testing kits.

“There are kits being sold commercially but they need to understand that this kit is not like a pregnancy test that you easily get the result,” Dumama said.

The DOH clarified that to determine the result of this test kit, it must come along with these two: a real-time PCR machine; and Biosafety Level 2 (BSL 2) Cabinets in order to ensure accuracy in testing the sample from the patient.

Dumama said these PCR machines are available at the Department of Health-Research Institute for Tropical Medicine (DOH-RITM) and the five sub national laboratories namely: Baguio General Hospital and Medical Center (BGHMC); San Lazaro Hospital (SLH); Lung Center of the Philippines (LCP); Vicente Sotto Memorial Medical Center (VSMMC); and the Southern Philippines Medical Center (SPMC).

The official shared that some suppliers of these kits have already been selling to local government executives. But the DOH reminded officials that these kits would still be needing confirmatory procedures.

The Food and Drug Administration (FDA) – Philippines issued yesterday (March 19) an initial list of approved COVID-19 Test Kits for commercial use. The kits have complied with the requirements as per FDA Memorandum No. 2020-006 entitled, “Issuance of Special Certification for Imported Test Kits of COVID-19.” These are PCR based kits used in laboratories, and not point-of-care kits.

FDA-approved manufacturers of test kits are the following: Shanghai GenoeDx Biotech Co., LTD- Shanghai, China.; Beijing Applied Biological Technologies Co., Ltd- Changping District 102206 Beijing P.R; Seegene Inc. -Seoul, Republic of Korea; Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea.

Dumama, however, assured the public that 100 test kits from the RITM have arrived at the SPMC and are currently being used to test qualified Persons Under Investigation (PUI).

He stressed that not all PUIs would be allowed to take the COVID 19 test. Instead, it has revised its algorithm as of March 18 to strictly come up with the criteria as to who are allowed to be tested.

Those with mild symptoms would have to wait and standby while only those experiencing severe symptoms will undergo the test.

Meanwhile, health officials are also optimistic that more testing kits will arrive in the region soon. The SPMC is considered the only sub national laboratory in the entire Mindanao.

DOH Assistant secretary for Visayas and Mindanao Dr. Roy Ferrer asked local government units to allot a special lane for the entry and exit of test kits to and from Davao City.

The SPMC is expected to cater increase number of testing in the coming days given the availability of the kits and the high demand for testing from regions within Mindanao.

The DOH XI reported as of March 19 (6PM) a total of 96 PUI (59 are admitted while 34 are discharged) while 3 identified PUI have died. The DOH XI is still waiting for the results from the RITM. Persons Under Monitoring have increased to 5,403 (584 are cleared while 4,818 are under observation.

There is one confirmed case in Davao Region. P130 is currently admitted but in a stable condition. (PIA XI/Frances Mae Macapagat)

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References:

* Philippine Information Agency. "DOH clarifies commercially sold COVID19 test kits." Philippine Information Agency. https://pia.gov.ph/news/articles/1036771 (accessed March 21, 2020 at 07:17AM UTC+08).

* Philippine Infornation Agency. "DOH clarifies commercially sold COVID19 test kits." Archive Today. https://archive.ph/?run=1&url=https://pia.gov.ph/news/articles/1036771 (archived).