Being Rational about (Im)precision: A Statement from the Biochemistry Subcommittee of the Joint European Society of Cardiology/American College of Cardiology Foundation/American Heart Association/World Heart Federation Task Force for the Definition of Myocardial Infarction

摘要

[...] this policy would make the logistics of clinical trials increasingly complex because it would preclude certain centers from participation if they did not use an assay that met this particular metric, and it might preclude end points from being counted if a study patient's event occurred in a hospital where a "less precise" assay was being used. 6. In our view, to make these decisions transparent through uniform information disclosure, regulatory agencies should demand that manufacturers of in vitro diagnostic assays provide published information concerning their assays that includes the limit of the blank, limit of detection, limit of quantification, lowest concentration that has a 20%CV(also called the functional sensitivity), and percentage CV at the 99th percentile (16 ).