What would a CAP inspector do if a lab were not following the manufacturer’s SOP/recommendations for molecular SARS-CoV-2 methods with FDA EUAs? Even in the case of tests with EUAs, the lab must follow the method’s IFU. If the lab chooses to make any kind of modification, the test is now considered an LDT and the lab must then follow all standards for an LDT. If the lab doesn’t, the CAP inspector will likely cite multiple deficiencies. However, if the only modification a lab makes is adding or changing a specimen type, then the lab can simply do a bridging study.