4.1. Pancreatic iso-amylase in serum as a diagnostic test in different clinical situations. A simulation study

Abstract

The potential use of a pancreatic iso-amylase test has been studied by computer simulation. This simulation was performed to assess the quality requirements on the test in different clinical situations.

It was shown that, in most situations studied, an optimal discriminating level and an optimal analytical quality (imprecision and bias) could be established. In one situation studied in more detail, it was found that the influence of pre-analytical variation. duplicate determinations, reclassification of borderline cases and size of reference sample groups were of minor importance. The weighting ratio of false negatives: false positives was found to be critical for the results.

It is concluded that a simulation study of this type can be recommended prior to entering the phases of analytical refinement and clinical testing on patients.

Key Words:

• analytical quality specifications
• clinical chemical data
• medical decision-making
• pancreatic insufficiency