From Kelly Townsend, Tri-core Reference Laboratories, Albuquerque. Looking for opinions on what constitutes a “Laboratory Developed Test” in Coag. Obviously if the reagent kit is not FDA-cleared, it will be an LDT, but what about factor assays, etc where there is no real kit. What if you are using a kit with a different calibrator or control than the manufacturer sells/endorses? Having trouble coming up with a concise definition for LDT. Thanks, Kelly.
Kelly, thank you for a question on one of the more provocative issues facing laboratory directors in 2014. I’ve attached a document from an unidentified source, perhaps CLIAC, that attempts a definition, however the document doesn’t drill down to specifics. I’ll look to some of my American Society for Clinical Laboratory Science colleagues who have spent a lot of time on the issue for some meaningful discussion.
I work at IU Health in Indianapolis. We recently validated
I work at IU Health in Indianapolis. We recently validated rivaroxaban calibrators and controls that are RUO with our exising anti-Xa kit, which is FDA-approved. We called our assay LDT since we took an FDA-approved kit and modified it.