Krintus Magdalena, Kozinski Marek, Fabiszak Tomasz, Kubica Jacek, Panteghini Mauro, Sypniewska Grazyna
Department of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland.
Department of Principles of Clinical Medicine, Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland.
Clin Biochem. 2017 Jul;50(10-11):599-604. doi: 10.1016/j.clinbiochem.2017.03.015. Epub 2017 Mar 18.
Appropriately established reference intervals for laboratory biomarkers may help the interpretation of their results and facilitate clinical utilization.
i) To determine reference intervals for serum galectin-3 measured using the Architect STAT immunoassay, and ii) to identify factors affecting galectin-3 concentrations.
We recruited 533 questionnaire-identified apparently healthy individuals, in which laboratory biomarkers were used to detect asymptomatic myocardial injury and dysfunction, ongoing inflammation, hyperglycemia, dyslipidemia, and renal dysfunction. A final reference group of 180 subjects was selected.
2.5th and 97.5th percentiles of distribution of galectin-3 concentrations in the reference group (90% confidence interval) were 5.9 (5.0-6.8) and 18.1 (17.2-19.0) μg/L, respectively. Older age contributed to higher galectin-3 concentrations, but influenced derived reference intervals to a lesser extent. Other major determinants of galectin-3 concentrations observed in the questionnaire-screened population were not linked to galectin-3 in reference individuals. In aiming to decide if reference limits should be partitioned by age, we compared galectin-3 concentrations in subjects <40 (n=124) and ≥40years (n=56). Higher galectin-3 concentrations were found in older people (median, 12.4μg/L vs. 11.5μg/L, p=0.016). Accounting for manufacturer's declared imprecision at galectin-3 physiological concentrations of <10% (as CV) and the estimated URL for subjects ≥40 (18.8μg/L) and <40 (17.9μg/L), we recommend the adoption of a single URL for the overall adult population.
We established reference intervals for galectin-3 in which the effects of biological determinants were irrelevant. Although in healthy subjects age may affect galectin-3 release, this does not appear to necessitate age-related reference limits.
为实验室生物标志物建立合适的参考区间有助于对其结果进行解读，并促进临床应用。
i）确定使用Architect STAT免疫测定法测定血清半乳糖凝集素-3的参考区间，ii）识别影响半乳糖凝集素-3浓度的因素。
我们招募了533名经问卷筛选出的表面健康个体，使用实验室生物标志物检测无症状心肌损伤和功能障碍、持续性炎症、高血糖、血脂异常和肾功能障碍。最终选定了180名受试者作为参考组。
参考组中半乳糖凝集素-3浓度分布的第2.5百分位数和第97.5百分位数（90%置信区间）分别为5.9（5.0 - 6.8）μg/L和18.1（17.2 - 19.0）μg/L。年龄较大导致半乳糖凝集素-3浓度较高，但对得出的参考区间影响较小。在问卷筛选人群中观察到的半乳糖凝集素-3浓度的其他主要决定因素与参考个体中的半乳糖凝集素-3无关。为了决定参考限值是否应按年龄划分，我们比较了年龄<40岁（n = 124）和≥40岁（n = 56）受试者的半乳糖凝集素-3浓度。老年人的半乳糖凝集素-3浓度较高（中位数，12.4μg/L对11.5μg/L，p = 0.016）。考虑到制造商声明在半乳糖凝集素-3生理浓度<10%（作为CV）时的不精密度，以及≥40岁（18.8μg/L）和<40岁（17.9μg/L）受试者的估计URL，我们建议对所有成年人群采用单一URL。
我们建立了半乳糖凝集素-3的参考区间，其中生物学决定因素的影响不相关。虽然在健康受试者中年龄可能影响半乳糖凝集素-3的释放，但这似乎并不需要与年龄相关的参考限值。
