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Updated: Jul 21, 2026

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
Published on: August 17, 2015
Clinically useful limits (CUL) criteria as a basis for quality control including minimal and optimal goals for
I Schoen1, G A Graham, E Custer
1Department of Pathology, University of Texas Medical Branch, Galveston 77550.
Abstract:
Quality control goals for quantitative clinical chemistry assays are reviewed. Recommendations for clinically useful limits (CUL) criteria as minimally acceptable +/- 2 SD for run-to-run and/or day-to-day technical reliability are presented in terms of biologic variations for different levels and clinical applications. A review of the literature and the questionnaire response of a medical school staff presented in this study reveal striking agreement of acceptable analytic goals based on physicians' opinions, biologic variation, and practical analytic feasibility. The current state-of-the-art in clinical laboratories can approach excellence because actual within-laboratory 2-SD variability estimates are somewhere between acceptable CUL criteria and twice as good. Assessing the reliability of laboratory reports based on accuracy and precision or total analytic error is also discussed.
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