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COVID-19 Molecular Methods and CAP Inspections

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.


Running on Empty

Clinical laboratorians can help patients avoid the complications of hypoglycemia by promoting smart glucose testing strategies.

About AACC

AACC is a global scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. Our leadership in education, advocacy and collaboration helps lab professionals adapt to change and do what they do best: provide vital insight and guidance so patients get the care they need.