FDA Authorizes D.C. Health Department’s Pooled COVID-19 Test

A pooled COVID-19 test developed in Washington, D.C.’s local health department has received the FDA’s Emergency Use Authorization.

The test is intended for qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples using a matrix pooling strategy, containing up to five individual nasal swab specimens per pool and 25 specimens per matrix.

The test is authorized for collection of anterior nasal swab specimens at home for pooled analysis with Labcorp’s COVID-19 real-time polymerase chain-reaction equipment. Adults age 18 and up can collect the swabs from themselves, while teenagers aged 14 to 17 can do so under adult supervision and younger children must have adult assistance.