Ready For 6,000 Tests: UP-developed Testing Kits For COVID-19 Cheaper

In January, the announcement of the Philippine Genome Center (PGC) that it had developed and was finalizing a kit to enable the country to conduct confirmatory tests locally on persons suspected to be infected with the new coronavirus strain did not generate much attention.

“We just need to coordinate all our activities with the DOH (Department of Health). We are already discussing with them as an office so that later on, we can be part of the rapid response in terms of diagnostic,” PGC deputy executive director Raul Destura told “The Chiefs” on Cignal TV’s One News channel on Jan. 28.

Concern had been raised on the long wait for the release of the test results of patients under investigation or PUIs in the country as their swab samples would still have to be sent abroad, particularly Australia.

The first coronavirus disease 2019 cases were confirmed by China in December 2019. In the Philippines, three Chinese nationals tested positive in January for what is now known as the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) – initially called novel coronavirus or nCoV – that is causing COVID-19.

After more than a month or on March 5, two cases involving Filipinos were confirmed by the Department of Health. The number of cases then began rising rapidly. DOH officials admitted in a Senate hearing on Monday that there were only 2,000 testing kits available for COVID-19 patients, further stoking public concern.

DOH Secretary Francisco Duque III admitted in a press briefing at Malacañang also on Monday that the coverage of the coronavirus tests in the country had been limited.

Acknowledging the observation of Sen. Panfilo Lacson that the DOH may have “underreported” COVID cases “albeit unintentionally,” Duque commented: “He said there is a possibility of underreporting, although unintentionally. This is largely because of our limited testing supplies. As soon as we get more, then we will be able to expand the coverage of who will be tested.”

Lack of supplies

During a hearing at the House of Representatives yesterday, March 11, Duque said the DOH received sufficient funds to respond to the COVID-19 outbreak, but the biggest challenge at the moment is the lack of available supplies of testing kits and personal protective equipment like surgical masks.

“We have the funds. That has not been our problem. The problem was the global shortage in supplies of testing kits as well as personal protective equipment,” Duque pointed out.

The DOH reiterated that only 2,000 testing kits from Japan are left and the government would need about 40,000 kits.

Duque welcomed the approval by the Food and Drug Administration (FDA) of the testing kits produced by the team led by Destura under the University of the Philippines-National Institutes of Health, but stressed that these are still in the testing stage.

“If we will be able to get 2,000 testing kit supplies every week, that might be good enough,” Duque noted.

Duque also disclosed that the DOH has a “problem in reporting system” that led to the delayed confirmation of COVID-19 cases in the country. They also had to comply with the laws on privacy when disclosing information about the patients.

“But I assure you… there was no deliberate intention on the part of the DOH to not disclose important pieces of information as can be legally allowed under the law,” he stressed.

 Much cheaper

The testing kit developed by scientists and researchers of the PGC would lower testing costs by over 80 percent, according to UP president Danilo Concepcion.

The testing kit will cost only around P1,320 per test, significantly lower than the current of P8,500.

Concepcion welcomed the certificate of exemption issued by the FDA for the SARS CoV-2 detection kit.

The development of  the testing kit was funded by the Department of Science and Technology through the Philippine Council for Health Research and Development.

It is currently being manufactured and stockpiled by Manila HealthTek Inc.

Concepcion said around 200 kits may be produced in a week, with the current stock enough for 6,000 tests, and more orders for around 20,000 tests are already expected.

The university official said the testing kit would greatly help in the early detection and effective treatment of COVID-19.

“The FDA’s issuance of a certificate of exemption for the kit will ensure that this locally produced technology will be made available to a greater number of Filipinos at much less cost,” Concepcion said.

He noted a possible problem: “With the increased availability of testing, we can expect that the number of confirmed cases of COVID-19 will likely grow in our country and perhaps in our university community. This might become a source of anxiety and concern, even fear.”

FDA director general Eric Domingo said they issued a certificate of exemption for the use of the local SARS CoV-2 detection kit because “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,” Domingo said.

He assured the public that the testing kits were validated and found to be accurate.       

“The next step would be to have them validated by the World Health Organization (WHO).  But since this will take months, the FDA has allowed them to be used coupled with gene sequencing at the Philippine Genome Center,” Domingo said.

Gene sequencing is conducted to determine the make-up of a virus – whether it is COVID-19 or not. Subjected to testing are the swab samples taken from a patient’s throat.

The exemption supports the Code Red Sub-Level 1 status raised by the DOH and the recent declaration of a state of public health emergency by President Duterte, the FDA said in a statement on March 9. 

This time, news about the local testing kit became viral. – With Sheila Crisostomo