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Analytical Imprecision and Reference Change Values for Longitudinal Monitoring of NCD-Related Biochemical Analytes

Year: 2026

Type: article

Abstract: Background: Internal quality control (IQC) data offers continuous insight into analytical performance under routine conditions. This study evaluated IQC practices and long-term analytical imprecision (CVa) across primary healthcare laboratories to derive analyte-specific reference change values (RCVs) for non-communicable disease (NCD) monitoring. Methods: A 22-month retrospective analysis of IQC data was conducted across 29 primary healthcare laboratories using 32 analytical units (Beckman Coulter AU480) in Malaysian primary healthcare. Six analytes were assessed: glucose, creatinine, total cholesterol, triglycerides, HDL cholesterol, and ALT. CVa was estimated using median and 90th percentile (P90) coefficients of variation across two concentration levels. RCVs were calculated at 95% probability (Z = 1.96) by integrating observed CVa with within-subject biological variation (CVi) from EFLM databases. Results: IQC testing was highly standardized (median: 20 measurements/month). Long-term data showed stable, concentration-dependent imprecision. Median CVa was lowest for glucose and lipids (1.7–1.9%) but higher for ALT (3.79%) and creatinine (3.52%) at Level 1. Derived RCV ranged from 14% (glucose) to 55.1% (triglycerides), with CVi being the dominant contributor to RCV magnitude for most analytes. Conclusions: Long-term routine IQC data provide an analytically realistic foundation for deriving RCV in primary healthcare by reflecting real-world performance. Applying these RCV supports evidence-based interpretation of serial results, enhancing NCD monitoring by distinguishing true physiological change from analytical and biological noise.

Source: Diagnostics

DOI: 10.3390/diagnostics16101532

Authors: Siti Nurwani Ahmad Ridzuan, Muhammad Nursyazwan Zamre, Fadzlyasraf Shaari, Ahmad Asyraff Iqbal Anuar, Noor Hafizah Hassan, Nurul Izzati Hamzan

Institutions: Institute for Medical Research, National Institutes of Health

Language: English

Topic: Clinical Laboratory Practices and Quality Control

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,137