Rapid test kits can produce false negatives: DOH

FILE: DOH Undersecretary , Dr. Maria Rosario Vergeire (PIA Photo)

MANILA – The Department of Health (DOH) does not recommend the use of rapid test kits for coronavirus disease 2019 (Covid-2019), a health official said Monday.

During the Laging Handa public briefing, DOH Undersecretary Maria Rosario Vergeire said such test kits measure the immunoglobulin, an antibody, which tells if the person had acute and past infection.

“Ito pong mga rapid test kits maaari magbigay ng false negative results na maaari tayo magkaroon ng problema na pauuwiin natin ang mga pasiyente tapos magta-transmit sila ng infection sa community. Kasi itong mine-measure nating antibody ay hindi naman po agad lumalabas sa isang tao kapag naguumpisa ang impeksiyon (These rapid test kits may produce false negative results which could give us problems when we let the patients go home and they will transmit infection to the community. The antibody they measure doesn’t come out in a person when the infection is just starting),” Vergeire said.

Citing that the Food and Drug Administration (FDA) has released an initial list of eight commercially available test kits, Vergeire clarified that these test kits are used in laboratories with Reverse Transcription-Polymerase Chain Reaction machines as they are not rapid or point-of-care test kits.

“Hindi na po kailangan i-validate ng Research Institute for Tropical Medicine (RITM) ang FDA-approved test kits, maaari nang bilhinh yan ng mga hospital na may (The RITM need not validate the FDA-approved test kits, they can be bought by hospitals with) laboratory capacities,” she said.

Vergeire also reported that the 100,000 test kits donated by the Chinese Embassy have already been allocated to the RITM and the sub-national testing laboratories in the country.

“Ang allocation po ng bawat laboratoryo ay base sa pangangailangan at kapasidad nila kung ilan po ang puwedeng magawa nila sa isang araw. Mostly, po ay nandito sa RITM na may pinakamataas ang capacity para magsagawa ng test dahil marami silang makina (The allocation of the test kits in every laboratory is based on its needs and capacity on the number of tests they can perform in a day. Most of the test kits went to RITM because it has the highest capacity to test as they have numerous machines),” she said.

Vergeire added that similar protocol on Covid-19 testing, such as the patients must be tested or sent home for self-monitoring depending on their symptoms, will be observed.

Donated test kits to be validated

While the DOH is open to receiving donated test kits, Vergeire explained that the FDA performs a “parallel process” for the donated test kits to ensure that they are of quality.

“Unang-una, dapat (First of all, they must be) compatible with the machines we’re using here in the Philippines,” she said.

Vergeire also said the test kits must be recognized by reputable national regulatory agencies like Japan, United States of America, South Korea, and other countries listed in the FDA circular, or are prequalified by the World Health Organization Emergency Use List.