The Food and Drug Administration has authorized the first diagnostic test with a home collection option for COVID-19, which would be available to consumers in most states with a doctor’s order.    It re-issued an emergency use authorization for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

The patient would collect a sample from their nose, using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.

The FDA notes that their authorization only applies to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit.   They say it is not a general authorization for any other at-home collection of patient samples.

It’s not clear when this test might be available through physicians in Hawaii.  On LabCorp’s web site, it says that initially, test kits will be limited and it will prioritize tests for health workers and first responders.

It also contains the disclaimer:  “Pixel by LabCorp offers this test and collection kit with an FDA Emergency Use Authorization. This means that while the laboratory performing this test has validation data to support offering this test and the collection kit, neither have been approved or cleared by the FDA.  This test has only been authorized by FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen.  It is only authorized during the duration of the COVID-19 emergency declaration by federal regulators. LabCorp may modify or cease to offer the test and the test kit upon direction of state or federal regulators in its sole discretion.  Please see the Patient Fact Sheet for additional information.”