MANILA - The Research Institute for Tropical Medicine (RITM) on Thursday urged local government units (LGUs) and private establishments to strictly comply with laboratory standards before facilities can perform diagnostic testing for the coronavirus disease 2019 (COVID-19).
“We greatly appreciate all parties who expressed their intention to establish their own COVID-19 testing centers. This is a step forward towards the achievement of our overall goal to create a large network of laboratories that can respond to public health emergencies," RITM director Celia Carlos said in a statement.
"However, in as much as we want to accelerate this effort, we should remain meticulous in observing good laboratory practices and biosafety protocols recommended by the World Health Organization (WHO). Not all laboratories can be COVID-19 testing centers," she added.
The state-run health research facility said laboratories dealing with coronavirus samples must be capable of performing molecular diagnostics in terms of infrastructure, personnel, apparatus and quality assurance.
Molecular diagnostics through polymerase chain reaction (PCR) test requires a biosafety level 2 facility, fully-trained staff on test procedures and specialized equipment, among others, it added.
Inadequacy of the prerequisites, the RITM stressed, may lead to inaccurate results, possible infection and contamination of collected samples.
“The virus we look for in all samples we receive is highly contagious, hence, COVID-19 testing is done in laboratories with complex systems and strict biosafety measures. It is not as simple as a fingerprick examination or a self-administered pregnancy test," Carlos said.
"Each sample goes through multiple testing phases by detecting DNA/RNA of specific viruses, bacteria, or other pathogens. In the case of COVID-19, we check for the presence of genes of the SARS-CoV-2 virus in order to determine beyond all doubt that the sample is positive or negative for the disease," she added.
Those interested of setting up COVID-19 testing centers should write a letter of intent to Health Undersecretary Myrna Cabotaje, the RITM said.
The Department of Health (DOH) will send a self-assessment tool for the requesting parties to accomplish.
A composite team made up of representatives from RITM, WHO and the Health Facilities and Services Bureau will evaluate the application based on the abovementioned prerequisites, and provide necessary recommendations to facilitate their application, the RITM added.
Once application deficiencies are addressed, technologists of the applicant laboratory must undergo a proficiency test.
Once they pass the said test, the laboratory will then be authorized to operate as a testing laboratory for COVID-19.
The newly-operational laboratory should submit to RITM the first 5 positive samples for confirmation. If there is good concordance between the newly-operational laboratory’s and RITM’s results, the newly-operational laboratory can commence COVID-19 testing independently of RITM.
Also on Thursday, the DOH rejected Marikina City's application for a COVID-19 testing center after it failed on standards for space and biosafety.