Test kits for novel coronavirus need WHO validation before use – DOH

MANILA, Philippines – Rapid test kits that could expedite the process of confirming 2019 novel coronavirus cases in the Philippines need to be validated first by the World Health Organization (WHO) before use, the Department of Health (DOH) said.

As of Wednesday, February 5, the WHO has not validated a single rapid test kit for use of laboratories, according to Health Undersecretary Eric Domingo. This effectively means that no test kit has yet been approved by the Philippines' Food and Drug Administration (FDA). 

"There are actually test kits available, you can probably buy them online, but the WHO has not yet validated any test kit," Domingo said.

Right now, the WHO-approved protocol is "still the long laboratory test" done by the Research Institute for Tropical Medicine (RITM), according to the health official. 

Currently, the RITM is running tests with primers from a referral laboratory in Japan, of which it has a limited supply. The DOH had initially sent samples to a referral laboratory in Australia to confirm the presence of the novel coronavirus – a process that took more than 48 hours.

With testing capacities in place locally, results can be expected within 24 to 48 hours. Rapid test kits would expedite the process of confirming novel coronavirus cases, making it more efficient for the government to perform disease detection.

"WHO told us that they're validating a test kit right now, and it might take one to two weeks before they come up with the recommendation," Domingo added. 

Scientists at the University of the Philippines' (UP) National Institutes of Health said on Tuesday, February 4, that they had developed test kits for the novel coronavirus and would release them next week to the RITM for validation. 

Domingo said that WHO also told the UP institute to send them the kits for validation. "Once it's validated and it is very clear that it is accurate, then it can be used," Domingo said. 

While there are no commercial test kits cleared by the FDA for use as of Wednesday, infectious disease expert Edsel Salvana said that the FDA can fast-track the verification of such products in times of health emergencies.

Salvana also stressed that it is important for the RITM to test the validity of such kits first to ensure their efficacy.

"We don't want false positive and false negative results," he said. 

More persons in the Philippines are expected to be probed for the novel coronavirus after the DOH expanded its criteria for monitoring. 

It had initially screened only people coming from Wuhan, China, the epicenter of the outbreak, but has since expanded it to cover the rest of China. The DOH is now monitoring even asymptomatic people traveling from China.  

As of Wednesday noon, February 5, there are 133 patients under investigation for the novel coronavirus, 3 of whom tested positive. The virus has killed 492 and infected 23,939 across China and 24 other countries. (READ: First nCoV-related death outside China as patient dies in PH)

MEDICAL EXPERTS. Medical experts speak to media at a Kapihan sa Manila Bay about the 2019 novel coronavirus. Photo by Janella Paris/Rappler

MEDICAL EXPERTS. Medical experts speak to media at a Kapihan sa Manila Bay about the 2019 novel coronavirus.

Photo by Janella Paris/Rappler

Free kits  

The Pharmaceutical and Healthcare Association of the Philippines (PHAP) said it would be willing to assist the government in acquiring more test kits for confirmation of novel coronavirus cases.

PHAP medical adviser Diana Edralin told reporters on Wednesday that the pharma group would coordinate with its member companies and counterparts abroad to acquire sought-after test kits in case the the country's demand for testing increases. (READ: 'Novel coronavirus' or 2019 nCoV: What we know so far)

Edralin said PHAP would be willing to offer commercial test kits to the DOH for free.

"This is the partnership we are offering the government. For these kits, we'll give them for free," Edralin said.  

She added that a number of PHAP partner companies in Southeast Asia have commercially available test kits that have passed regulations in their own countries, though she did not reveal what these companies were and how many. 

She said, however, that PHAP would make sure that prospective test kits go through proper FDA screenings before being used locally. 

As testing capacities are being improved, medical experts like Edralin and Salvana echoed advisories from the DOH and WHO to remain calm and practice proper hygiene.

"We should not underestimate proper hygiene. As a doctor, that's my number one advice," Edralin said. – Rappler.com