The COVID-19 at-home collection test from our partner lab Molecular Testing Labs was validated in accordance with FDA’s Emergency Use Authorization (EUA) per the FDA’s February 29, 2020 guidance. Further, Molecular is conforming to the regulatory requirements of its home state of Washington, as required by the FDA, in validating their at-home collection COVID-19 test for use.
The majority of COVID-19 tests are Laboratory Developed Tests (LDTs). This includes COVID-19 tests provided at a hospital or clinic, as well as the Molecular Testing Lab COVID-19 home collection test. These tests are available for use under the Emergency Use Authorization by the February 29 FDA guidance.
Molecular is CAP-accredited and CLIA-licensed, with extensive experience in infectious diseases and home testing validation.