We need to talk about the analytical performance of our laboratory developed clinical LC-MS/MS tests, and start separating the wheat from the chaff

With the upcoming EU regulation on use of in-vitro diagnostic devices, a critical evaluation current status our in-house developed LC-MS/MS methods is timely and great relevance. Recently, much attention has been devoted to need for better specification analytical clinical performance. Appropriate reporting actual achieved performance an important determinant subsequent effectiveness test. We advocate application CLSI C62-A guidelines method validation suggest some adaptations endogenous substances. Additionally, we underline importance well-equipped reviewers standardized description, including presentation figural evidence obtained Achieving this ensures future quality methods.