A recent study of the automated immunoassay methods compared the major diagnostic instruments against a ID-LCMS reference method. When compared to the "true values", can any methods hit the most evidence-based biological variation-derived performance specifications? Can any methods hit the minimum performance specifications, for that matter?

A new study of biologic variation significantly reduce the desirable allowable imprecision and desirable allowable bias for hematology parameters. Using data from one of the latest generatation analyzers, the Sysmex XN, we try to see if the goals - or the instrument - are fit for purpose. What happens if we develop new goals that no one can achieve?  

The debate on performance specification (quality goal) models has been going for decades. What's the bottom line? If we used permissible uncertainty instead of allowable total error, would our judgments on method accepability be any different? 

 Continuing in our series of analytical goal comparisons, we evaluate the quality requirements and performance of alkaline phosphatase (ALP).