Implementation of a reformulated Roche® bilirubin Gen.3 reagent did not affect the relationship between BiliChek transcutaneous and Roche total serum bilirubin.

Objective: Determine whether introduction of a reformulated bilirubin reagent, the Roche bilirubin Gen.3 assay, changed the relationship between BiliChek transcutaneous bilirubin (TcB) and total serum bilirubin (TSB).

Design And Methods: TcB results from term infants in the level 1 nursery obtained within one hour of a TSB were reviewed over two periods, six months before and after the conversion from the previous generation Roche bilirubin reagent to the new Roche Gen.

Local verification and assignment of mean normal prothrombin time and International Sensitivity Index values across various instruments: recent experience and outcome from North America.

Warfarin dosing relies on accurate measurements of international normalized ratio (INR), which is calculated from the prothrombin time (PT), International Sensitivity Index international sensitivity index (ISI) of the thromboplastin, and the geometric mean of normal PT (MNPT). However, ISI assignments of certain reagent/instrument combinations are frequently unavailable, especially when the reagent and instrument are not from the same manufacturer. The effort to be in compliance with widely endorsed Clinical and Laboratory Standards Institute (CLSI) guidelines by locally verifying or assigning an ISI to an unsupported reagent/instrument combination is further hindered by the lack of US Food and Drug Administration (FDA)-approved certified plasmas designated for a particular reagent/instrument combination.