MANILA — The Department of Health (DOH) on Tuesday announced that the country is already allowing the use of saliva samples for Polymerase Chain Reaction (PCR) tests for COVID-19.
In a statement, the DOH said it issued Department Memorandum (DM) No. 2021-0161 “in pursuit of expanding the country’s testing capacity and ensuring immediate and efficient implementation of PDITR (Prevent-Detect-Isolate-Treat-Reintegrate) strategies.”
The DOH said only licensed COVID-19 laboratories, certified by the Research Institute for Tropical Medicine (RITM), can perform saliva-based PCR tests.
“Furthermore, point-of-care clinics, specimen collecting facilities, and disease reporting units can perform saliva specimen collection, provided that the specimen collectors have undergone training from the referral licensed COVID-19 laboratory certified to perform saliva testing,” it added.
Only RITM-validated test kits or those evaluated by RITM-recognized laboratories can be used for saliva tests. The kits should also have a special certification from the Food and Drug Administration.
Only test kits with 95% sensitivity and 99% specificity can be used. Sensitivity refers to a test’s ability to detect SARS-CoV-2 or the true positive rate while specificity refers to the test’s ability to identify those without the virus or the true negative rate. High sensitivity and specificity rates would ensure that the test won’t result in too many false positives and false negatives.
Laboratories will also have to conduct in-house verification of the new method before doing actual testing.
The DOH is also requiring “only trained saliva specimen collectors” to administer the test with medical doctors interpreting the results.
“Results need to be correlated with the overall clinical and epidemiological context of the patient,” the statement read.
Even as saliva tests are now being allowed, the DOH said the traditional swab test is still the gold standard for COVID-19 testing.
It explained that saliva tests “should only be done on certain conditions and are deemed valid when such conditions are met.”
The DOH said the best time to get saliva samples is in the morning due to higher viral load but that the test can still be done any other time. Those who need to give saliva samples are also not allowed to eat, drink, smoke, brush their teeth or use mouthwash for at least 30 minutes before sample collection.
On Monday, the Philippine Red Cross (PRC) welcomed the move of the DOH to allow PhilHealth coverage for saliva tests.
Before Department Memorandum (DM) No. 2021-0161, which was signed on March 31 but released to media on Tuesday, only the Red Cross was allowed to conduct saliva testing in the country. This was after the Red Cross conducted its own study.
The memorandum instructs PhilHealth to “develop the appropriate payment and provider engagement mechanisms for saliva-based PCR testing,” with no additional payments beyond the PhilHealth coverage to be charged to the patients.
Red Cross laboratories charge only P2,000 for saliva tests, half the price of swab tests. According to PRC, saliva tests minimizes the risk of exposure and transmission of the virus to healthcare workers.
Under the department memorandum, saliva samples are only allowed for PCR tests and not for antigen or antibody tests.