PH Red Cross expects Covid-19 saliva test approval within this week
MANILA, Philippines — The Philippine Red Cross (PRC) expects the laboratory experts panel of the Department of Health (DOH) and the Food and Drug Administration (FDA) to approve its Covid-19 saliva test within this week.
“Ang inaasahan po namin, within this week ay makuha po namin ‘yung two approval from FDA and DOH,” PRC biomolecular laboratories chief Paulyn Ubial said over ABS-CBN’s Teleradyo on Wednesday.
Ubial explained that there are two requirements required by the DOH for the saliva test to be conducted by the PRC: the test on 1,000 saliva samples, and the FDA’s approval of test kits to be used in the saliva test.
The DOH earlier said the PRC has already completed the study on saliva testing. Ubial said the PRC has also submitted before the FDA an application for the approval of the test kits.
According to Ubial, the PRC found the Covid-19 saliva test to be 98.11 percent accurate as compared to polymerase chain reaction (PCR) swab tests.
She said the PRC is set to present its findings on its study on Covid-19 saliva testing before the DOH this Wednesday afternoon.
“Sa calculation po namin, although nagtatalo pa ang mga statistician at mga doctor at this point—mamayang hapon namin ipepresent sa Covid lab expert panel ng Department of Health—meron pong accuracy ang saliva versus the swab of 98.11 percent,” said Ubial.
(Based on our calculation, although it is still being debated by statisticians and doctors at this point, the accuracy of saliva test versus swab test is 98.11 percent. We will present these findings to the Covid lab expert panel of the DOH later in the afternoon.)
The saliva testing, she said, can be performed by other laboratories as it is meant for the “public domain.”
“It can be done by any laboratory but the problem there is they must be using the same reagent as [the one] we are using. If they are using a different reagent, they have to do the same validation study that we did,” she added.
But even if the PRC’s saliva testing will be approved by the DOH, Ubial said the PCR swab test remains the gold standard for testing for Covid-19.
“The swab test is the gold standard. Pero ibig sabihin meron na tayong cheaper, faster, more convenient alternative which is just as accurate as the swab test or the gold standard,” she added, noting that Covid-19 rapid and antigen tests sometimes generate false negative or false-positive test results.
(The swab test is the gold standard. But with saliva tests, we can have a cheaper, faster, and more convenient alternative that is just as accurate as the swab test.)
/MUF
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