ALIFAX TEST1血沉仪性能评价及桂北地区健康人群血沉参考区间的探索

Performance Evaluation of ALIFAX TEST1 and Establishment of Erythrocyte Sedimentation Rate Reference Intervals Among Healthy Population in Northern Guangxi

目的评价ALIFAX TEST1血沉仪的性能,探索桂北地区健康人群红细胞沉降率(Erythrocyte Sedimentation Rate,ESR)的参考区间。方法采用准确性、重复性和稳定性3个指标来评价TEST1血沉仪的性能;检测1719名健康人群的EDTA-K2抗凝血,按年龄和性别分组来统计、建立ESR参考区间。结果TEST1血沉仪的准确性、重复性变异系数(Coefficient of Variation,CV)均小于10%,与采集后立即检测(0 h)的样本相比,ESR水平在室温下4 h内结果保持稳定(P=0.022);ESR整体水平女性高于男性,并具有随年龄增长而增高的趋势。最终的ESR的参考区间,男性:21~30岁为0~24.25mm/h,31~50岁为0~31.00mm/h,51~60岁为0~33.55mm/h,60岁以上为0~37.00mm/h;女性:21~30岁为0~33mm/h,31~60岁为0~37.35 mm/h,60岁以上为0~41.20 mm/h。结论ALIFAX TEST1血沉仪的准确性和重复性均表现良好,标本应在采集后4 h内完成检测。桂北地区健康人群ESR水平与其他地区已发表数据略有不同,建立本地区人群参考区间具有临床参考意义。

Objective To evaluate the performance of ALIFAX TEST1 automated sedimentation analyzer and to establish the reference intervals of erythrocyte sedimentation rate(ESR)for healthy population in northern Guangxi.Methods Accuracy,repeatability and stability were used to evaluate the performance of TEST1.A total of 1719 EDTA-K2 anticoagulation of healthy subjects were detected by TEST1,and the reference intervals were established according to age and gender.Results The accuracy and repeatability coefficient of variation(CV)of TEST1 were both less than 10%.Compared with the samples tested immediately after collection(0 h),the ESR levels remained stable within 4 h at room temperature(P=0.022).The ESR values in females were higher than males,and the values were increased with ages.The ESR reference intervals of males were 0-24.25 mm/h for 21-30-yearold,0-31.00 mm/h for 31-50-year-old,0-33.55 mm/h for 51-60-year-old,and 0-37.00 mm/h for over 60-year-old;and the ESR reference intervals of females were 0-33 mm/h for 21-30-year-old,0-37.35 mm/h for 31-60-year-old,0-41.20 mm/h for over 60-yearold.Conclusion TEST1 showed satisfactory accuracy and repeatability,and the specimens should be tested within 4 h after collection.ESR values of healthy population in northern Guangxi were slightly different from the published data in other regions,so the establishment of targeted reference intervals for the population in this region has clinical reference significance.