The use of saliva samples for polymerase chain-reaction (PCR) Covid19 testing has been approved by the Department of Health (DOH), under strict and specific guidelines and conditions.
Previously, only the Philippine Red Cross (PRC) had authorization to utilize saliva samples for PCR tests, after they had conducted their own research.
Department Memorandum (DM) No. 2021-0161 was issued “in pursuit of expanding the country’s testing capacity and ensuring immediate and efficient implementation of PDITR (Prevent-Detect-Isolate-Treat-Reintegrate) strategies”.
The DM explicitly states that saliva-based PCR tests may only be conducted by laboratories that have been certified by the Research Institute for Tropical Medicine (RITM).
Only test kits validated by the RITM or laboratories that are RITM certified, with special authorization from the Food and Drug Administration (FDA), and with 95% sensitivity and 99% specificity, shall be utilized.
Sensitivity refers to the kit’s ability to detect the SARS-CoV-2 virus, while specificity indicates its ability to identify the absence of the virus.
Furthermore, only trained individuals may administer the tests, with medical doctors interpreting the results, taking into consideration the individual’s “clinical and epidemiological context…”.
Sample collection is best done in the morning according to the DOH, with no eating, drinking, smoking or brushing done 30 minutes prior.
The DOH further stated that saliva testing must only be done for PCR testing, under specific conditions, while regular swab testing remains the gold standard.
Under the memorandum, PhilHealth is mandated to “develop the appropriate payment and provider engagement mechanisms for saliva-based PCR testing” and not charge patients beyond their coverage.
The new directive comes as the country faces a rapid surge in Covid19 infections in the past weeks, with total cases in the country now surpassing 800,000.