基于生物学变异建立老年人血清总蛋白和清蛋白水平个性化参考区间及应用

目的 基于实验室历史检测结果 (n)以及生物学变异 (biological variation，BV)数据，建立成都市郫都区中医医院医养中心老年人血清总蛋白（total protein，TP）和清蛋白（albumin，ALB）水平个性化参考区间（personalized reference interval，prRI）并进行验证，为医养中心老年人的健康管理提供评估帮助。方法 利用欧洲临床化学和实验医学联合会 (European Federation of Clinical Chemistry and Experimental Medicine ，flME）BV数据库中的个体内生物变异（within-subject variation, CVI）、个体间生物变异（between-subject biological variation，CVG）和实验室历史检测结果数据（n）、实验室内 TP和 ALB二质控水平的合并分析变异（analytical variation，CVA）估计值，估算 TP和 ALB的参考变化值（reference change value，RCV）和个体指数（individuality Index，II），计算稳态设定点（homeostatic set point，HSP）下老年人的 prRI，并与基于人群的参考区间 (population-based reference interval，popRI)进行比较 ,验证 prRI的应用价值。结果 医养中心老年人 TP 和 ALB的 RCV Increase/Decrease分别为 8.3（7.6～8.8）/-7.7(-7.0～-8.1)和 8.1（7.9～9.9）/-7.5(-7.3～-9.0)；TP，ALB的 prRI分别为 69.8～78.0 g/L, 41.0～48.4 g/L；参考区间指数（reference interval index，RRi）估算值分别为 0.57，0.51，均 <0.6。TP，ALB落在 prRI之外的比例分别为 8.97%，7.78%，均小于 10%。结论 基于 BV的 prRI对于医养中心老年人健康评估中的“个性化”诊断很有价值。在实验室报告中同时包括 popRIs和 prRIs，可帮助在老年健康管理随访中评估实验室检测结果，并为老年人健康评估提供个性化参考区间。

Establish Serum Total Protein and Albumin Levels in the Elderly Based on Biological Variation Personalized Reference Interval and Application

Objective Based on the laboratory historical test results data (n) and biological variation (BV) data, the serum total protein (TP) and albumin (ALB) levels personalized reference interval (prRI) of the elderly in medical care centers of Pidu District were established and verified to provide evaluation help for the health management of the elderly in medical care centers. Methods Used within-subject variation(CVI), between-subject biological variation (CVG) in European Federation of Clinical Chemistry and Experimental Medicine (EflM), and laboratory historical test result data (n)，combined analysis variant (CVA) estimate of the serum total protein and serum albumin 2 quality control level to estimate reference change value (RCV) and individual index (II) of detection items TP and ALB. Calculate personalized reference interval (prRI) for older people under steady state set point (HSP), and compare with population-based reference interval (popRI) and verified the application value of prRI. Results The RCV Increase / Decrease of TP and ALB in the elderly in medical care centers were 8.3 (7.6～8.8) / -7.7 (-7.0～-8.1) and 8.1 (7.9～9.9) / -7.5 (-7.3～-9.0). The personalized reference interval (prRI) of TP and ALB was 69.8~78.0 g/L and 41.0~48.4 g/L . Reference interval index（RRi）estimated value of TP and ALB was 0.57 and 0.51(all<0.6), and the proportion of TP and ALB falling outside of prRI was 8.97% and 7.78%, all less than 10%. Conclusion The prRI based on BV is valuable for “personalized” diagnosis in health assessment of elderly in medical care centers. Including both popRIs and prRIs in the laboratory reports, it can help evaluate laboratory test results in geriatric health management follow-up ，and provide personalized reference intervals for health assessment in the elderly.