The CLSI has published recommendations for appropriate medical decision level concentrations for interference testing for common analytes (4).
This is of concern because hemolysis interference is not always independent of analyte concentration, and significant interference may be missed if testing is performed at only 1 medical decision level (3).
A]) was determined as fifteen percent of the medical decision level
(MDL) of G6PD deficiency, 10.
0) at each medical decision level is represented by [?
An adequate regression procedure must provide (a) statistically unbiased estimates of slope and intercept to compute unbiased point estimates of systematic bias at each medical decision level, and (b) an estimated confidence coefficient ([?
In these cases, clinical significance was evaluated by comparing the total error estimate provided by the regression data at the medical decision level for each analyte [6,8,91 with the allowable error ([E.
Total precision was determined for each analyte with two controls representing high and low medical decision levels , and compared with manufacturer claims per NCCLS guidelines .
We also enter the manufacturer's claims for reproducibility, recovery, and other performance characteristics and the allowable error (Ea) at the medical decision level.
From the computed statistics, total error at the medical decision level is evaluated and tested for acceptability.
Depending on the testing performed, the recommended materials used for this verification include covering the lower and upper limits of the reportable range, the midpoint of the reference range, and medical decision levels
Critical limits reflect medical decision levels for emergency patient evaluation and optimization points for critical care.
Clinicians can assess the merits of critical limits as medical decision levels for crisis intervention in conjunction with the laboratorians, who can use the national survey results to improve resource allocation and communication systems.