MUNTINLUPA CITY—The Department of Health-Research Institute for Tropical Medicine (DOH–RITM) calls on the local government units (LGUs) and other private laboratories expressing their intention to establish COVID-19 testing centers to exercise the utmost diligence in complying with all laboratory standards for molecular diagnostics (MolDx) before being accredited to perform COVID-19 tests.
“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. 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,” asserts RITM Director Celia Carlos.
Laboratories handling COVID-19 samples must be capable of performing molecular diagnostics in terms of infrastructure, personnel, apparatus, and quality assurance. As one of the most evolving areas of diagnostics, MolDx through polymerase chain reaction (PCR) testing requires a Biosafety Level 2 facility, laboratory staff fully-trained on test procedures and biosafety, specialized equipment and instruments, and established quality assurance protocols that guarantee the accuracy of results. Inadequacy in any of these prerequisites might lead to inaccurate results, possible infection of laboratory personnel, and the contamination of collected samples and the immediate testing environment.
“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. 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 adds.
Currently, facilities and groups interested to set up COVID-19 testing centers are advised to write a letter of intent addressed to Dr. Myrna Cabotaje, DOH Undersecretary of Public Health Services Team. Upon receipt of the letter, the 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.
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 five 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.