The Food and Drug Administration has not yet approved the registration of saliva antigen test kits which involve putting tips of test strips directly in the mouth.
Deputy FDA secretary-general Surachok Tangwiwat said on Thursday his office had to date approved two main types of Covid-19 antigen test kits (ATKs) for home use — those testing from nasal swabs and those using saliva samples.
The latter type uses different ways of collecting saliva. Some instruct users to put saliva in a cup and then use a straw to add a few drops to a sample slot or test strip. Others tell users to use a wooden spatula to take a sample from the inside of a cheek, dip it in a supplied solution and then add a few drops of the mixture to a test strip.
The FDA stressed that the FDA has not approved the registration of any ATKs that instruct users to directly put the tip of a test strip in the mouth.
"Safety data involving the method have not been available or verified, especially on possible reactions and toxicity when a person conducts multiple tests," read the statement.
There is also no information on whether the chemicals coated on the tip would be transferred to the mouth while keeping it there. The collection method has also not been approved on children aged below 12 since there is no evidence toxic chemicals would not be released if a test strip is nipped or damaged while in the mouth.
Due to these reasons, the FDA deputy secretary-general urged people to use only the ATKs approved by it and followed the instructions of each brand for safety and testing efficiency.
