MUNTINLUPA CITY—Given the complexity of conducting polymerase chain reaction (PCR) testing of suspected COVID-19 cases, the Department of Health-Research Institute for Tropical Medicine (DOH–RITM) reiterates that molecular diagnostics laboratories to be established by local government units (LGUs) and other interested parties must first undergo proper evaluation and proficiency tests.
RITM Director Celia Carlos highlighted that conforming to biosafety principles is a precondition to avoiding inaccuracies and the occurrence of laboratory-acquired infections. “Assuring results accuracy and preventing possible infection of laboratory personnel are the fundamental principles behind the evaluation of COVID-19 testing center candidates. The virus we look for in every sample we receive is highly contagious, thus, it necessitates a Biosafety Level 2 facility, laboratory technologists trained on biosafety and PCR procedures, regularly calibrated equipment and instruments, and a well-established protocol on the quality assurance of test results,” she explained.
The biosafety measures and PCR testing procedures to detect genetic sequences of SARS- CoV-2—the virus that causes COVID-19—are recommendations made by the World Health Organization (WHO) long before the disease was declared a pandemic. This virus is new and the world has yet to develop a vaccine, hence, the mishandling of samples presents a high risk of producing inaccurate results, the possible infection of laboratory technologists, and the contamination of collected samples and the immediate testing environment.
As more and more groups are expressing their intention to establish their own testing centers, the DOH calls on all interested parties to observe the proper laboratory application protocol. Currently, facilities and groups are advised to write a letter of intent addressed to OIC Undersecretary Maria Rosario Singh-Vergiere of the Health Regulation 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 (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.
As the National Reference Laboratory for emerging and re-emerging infectious diseases, RITM will regularly conduct proficiency tests to ensure and maintain the high-quality performance of independent laboratories.