In this revision, the hierarchy is simplified and represented by three different models to set analytical performance specifications. There is general agreement that some of these are better suited for certain measurands than for others. Model 1. Based on the effect of analytical performance on clinical outcomesThis can, in principle, be done using different types of studies:1. Direct outcome studies -investigating the impact of analytical performance of the test on clinical outcomes; 2. Indirect outcome studies -investigating the impact of analytical performance of the test on clinical classifications or decisions and thereby on the probability of patient outcomes, e.g., by simulation or decision analysis.Brought to you by | MIT Libraries Authenticated Download Date | 5/11/18 4:25 AM

No abstract

No abstract

No abstract

This paper is the fourth in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and the certification of reference preparations. Other parts deal with: Part 1. The Concept of Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes; Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase; Part 3. Reference Procedure for the Measurement of Catalytic Concentration of Lactate Dehydrogenase; Part 5. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase; Part 6. Reference Procedure for the Measurement of Catalytic Concentration of Gamma-Glutamyltransferase; Part 7. Certification of Four Reference Materials for the Determination of Enzymatic Activity of Gamma-Glutamyltransferase, Lactate Dehydrogenase, Alanine Aminotransferase and Creatine Kinase at 37 degrees C. A document describing the determination of preliminary upper reference limits is also in preparation. The procedure described here is deduced from the previously described 30 degrees C IFCC reference method. Differences are tabulated and commented on in Appendix 2.