RITM studying 2 other antigen test kits after first one failed local validation

Kristine Sabillo, ABS-CBN News

Posted at Sep 30 2020 03:14 PM

A health worker puts a sample into a coronavirus disease (COVID-19) antigen rapid test device at an antigen test station, in Vienna, Austria, September 23, 2020. Lisi Niesner, Reuters

MANILA — The Department of Health (DOH) on Wednesday confirmed that the antigen test kit from South Korea-based SD Biosensor did not pass the requirement of the government, although there are other kits still being studied by the Research Institute for Tropical Medicine (RITM).

“This is the first antigen test kit that has been validated by RITM. And yes, it’s true, hindi s'ya umabot doon sa diagnostic performance na ating itinatala base sa rekomendasyon ng WHO na dapat lahat ng antigen test kits may 80% sensitivity and meron syang 97% specificity,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing.

(It did not reach the diagnostic performance based on the recommendation of WHO that all antigen test kits must have 80% sensitivity and 97% specificity.)

The kit showed only 71% sensitivity, which refers to a kit’s ability to accurately detect the COVID-19 virus.

However, Vergeire said they are still consulting the World Health Organization because SD Biosensor is already included in the latter’s emergency use listing.

The DOH said the RITM is currentlly evaluating 2 other antigen test kits from the United States: LumiQuick Diagnostic Inc.’s QuickProfile COVID-19 Antigen Test, and Quidel Corp.’s Sofia 2 SARS Antigen FIA.

Antigen testing is another way to detect the COVID-19 virus. It is quicker to use than the gold standard that is polymerase chain reaction (PCR) tests, but not as accurate.

OMNIBUS GUIDELINES

Meanwhile, Vergeire said the release of the country's omnibus guidelines for COVID-19 response, which includes when to use antigen tests, is still stalled.

She said it was supposed to be out before Sept. 11, but they are still studying how antigen tests can be used after the WHO advised member countries not to use it for border screening. The Philippine government was planning to use it for airport screening and for locally stranded individuals.

Vergeire said the pilot test in Baguio City is still ongoing.

“Nakapagbigay na sila sa atin ng initial results. But of course these are still not conclusive,” she said.

(They already gave us initial results. But of course, these are still not conclusive.)

Vergeire said they will have to finish the pilot test and determine the guidelines for antigen testing before releasing the whole omnibus guidelines document.

“Kailangan kasi kumpleto ang choices namin ng testing methods kung ano ang appropriate na gamitin,” she explained.

(It’s because the choices should be complete to know which testing method is appropriate.)

PCR PRICE CAP

PCR tests, which range from a few thousand pesos to more than P10,000 pesos, may have a price cap once President Rodrigo Duterte approves the DOH proposal for an executive order regulating tests.

Vergeire said they are already preparing for a market survey to determine the price range of tests once the Office of the President gives them a go signal.

Other testing methods being studied are ones on saliva testing. Instead of using specimen from the nose and the throat, the government is now studying the effectivity of saliva samples.

“Ang Philippine Red Cross, nagsasagawa ng independent trial. Pinag-aaralan ang gamit ng saliva testing. Ang RITM, ginagawa din nila ngayon. So, dalawang institution ang gumagawa ngayon ng pag-aaral sa saliva specimen,” Vergeire said.

(The Philippine Red Cross is doing an independent trial. They are studying the use of saliva testing. The RITM is doing that as well. So there are 2 institutions studying saliva specimen.)

More than 3.6 million samples in the country so far have been tested for the new coronavirus, according to the latest COVID-19 situationer report of the government. In terms of individuals, the number of those tested is already more than 3.4 million.

There are 104 RT-PCR and 32 genexpert laboratories accredited by the DOH for COVID-19 testing, with 97 others still in the process of application. 

The confirmed COVID-19 cases in the country climbed to 309,303 on Tuesday, of which, 50,925 are active infections. Total recoveries are 252,930, while the death toll is 5,448.

The country logged its first confirmed COVID-19 case on Jan. 30 in a Chinese woman who arrived from Wuhan City, China where the disease is believed to have first emerged late last year.