NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for saliva collection devices used for SARS-CoV-2 testing that was developed by DNA Genotek.
The ORAcollect RNA ORE-100 and ORAcollect RNA OR-100 devices are designed for the collection, stabilization, transport of saliva specimens suspected of containing SARS-CoV-2 RNA. They are intended for use as a component of a third-party SAR-CoV-2 test or home/self-collection kit and are not intended for sale directly to patients.
Both devices are identical except for model numbers and labeling, according to the FDA.
DNA Genotek is a subsidiary of Bethlehem, Pennsylvania-based OraSure Technologies.
Authorized SARS-CoV-2 tests that use the OraCollect devices include Quadrant Biosciences' Clarifi COVID-19 Test Kit.