Recommendation for the review of biological reference intervals in medical laboratories

Abstract

(ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Quantifying atherogenic lipoproteins for lipid-lowering strategies: consensus-based recommendations from EAS and EFLM

“…Countries are encouraged to establish reference intervals in their local populations, to account for differences in lifestyle and risk factors in different European regions. Ideally, these reference intervals should be regularly updated because significant changes in population lipid concentrations occur mainly related to the substantial increase in unhealthy lifestyle and obesity and changes of analytical methods over time [95][96][97]. In the adoption of published reference concentrations with known biological or analytical sources of variation, the clinical laboratory should verify the reference interval with its own analytical method on 20 samples drawn from its local population under similar pre-analytical conditions [96,97].…”

“…Ideally, these reference intervals should be regularly updated because significant changes in population lipid concentrations occur mainly related to the substantial increase in unhealthy lifestyle and obesity and changes of analytical methods over time [95][96][97]. In the adoption of published reference concentrations with known biological or analytical sources of variation, the clinical laboratory should verify the reference interval with its own analytical method on 20 samples drawn from its local population under similar pre-analytical conditions [96,97]. If ≤2 of 20 values (≤10%) fall outside the reference interval, then the interval can be adopted [96,97].…”

“…In the adoption of published reference concentrations with known biological or analytical sources of variation, the clinical laboratory should verify the reference interval with its own analytical method on 20 samples drawn from its local population under similar pre-analytical conditions [96,97]. If ≤2 of 20 values (≤10%) fall outside the reference interval, then the interval can be adopted [96,97]. For decision thresholds it is unnecessary to validate them in the laboratory [97].…”

“…If ≤2 of 20 values (≤10%) fall outside the reference interval, then the interval can be adopted [96,97]. For decision thresholds it is unnecessary to validate them in the laboratory [97].…”

Tracking Macroprolactin: Use of an Optimized Polyethylene Glycol Precipitation Method More Compatible with the Requirements and Processes of Automated Core Laboratories

“…The next scope of this study is to confirm those data with our own post-PEG PRL reference values that represent the best approach. For this purpose, the recent publication of Henny et al (20) could be useful.…”