常规体检生物化学项目波动性参考区间的建立与验证

摘要

目的 建立常规体检生物化学(生化)项目个性化参考区间并验证.方法 随机选取2014、2015、2016连续3年总蛋白(TP)、清蛋白(Alb)、总胆红素(T-Bil)、丙氨酸氨基转移酶(ALT)、葡萄糖(Glu)、尿素(Urea)、肌酐(Cr)、尿酸(UA)、三酰甘油(TG)、总胆固醇(TC)检测结果均在参考区间内的体检者,共2 089例,收集检测结果.计算2015年结果与2014年的比值(λ1),对λ1进行统计学分析并建立波动性参考区间(CIλ);计算2016年结果与2015年的比值(λ2),用λ2验证CIλ,将体检者2015年结果分别与CIλ的上、下限相乘,即为个性化参考区间(CIP),用2016年结果验证CIP;计算CIP和传统参考区间的上、下限比值.结果 CIλ:TP(0.91～1.08)、Alb(0.91～1.08)、T-Bil(0.58～1.74)、ALT(0.49～1.99)、Glu(0.84～1.20)、Urea(0.67～1.50)、Cr(0.82～1.22)、UA(0.77～1.32)、TG(0.51～1.98)、TC(0.80～1.26).与传统参考区间相比,CIP的上、下限比值更小.结论 建立并验证了CIP,CIP可提高传统参考区间灵敏度.%Objective To establish and verify the fluctuation of reference intervals for biochestry parameters in routine physical exami-nation. Methods The results of biochemistry parameters,i.e., total protein (TP), albumin (Alb), total bilirubin (T-Bil), alanine aminotransferase (ALT), glucose (Glu), urea (Urea), creatinine (Cr), uric acid (UA), triacylglycerol (TG) and total cholesterol ( TC) from 2 089 healthy subjects in routine physical examination during consecutive 2014, 2015 and 2016 were randomly collected, in which all the results were within the reference range. The ratio (λ1) of the results of 2015 to those of 2014, and ratio (λ2) of the re-sults of 2016 to those of 2015 were calculated. λ1was analyzed statistically to establish the fluctuation of reference interval (CIλ). CIλ was verified by λ2.The personalized reference interval (CIp) was established by multiplying each result of 2015 and the upper and low-er limits of CIλ. The CIpwas verified by the results of 2016. The ratios of CIpto the upper and lower limits of conventional reference in-terval were calculated. Results The values of CIλwere as follows: TP: 0.91 to 1.08, Alb: 0.91 to 1.08, T-Bil: 0.58 to 1.74, ALT:0.49 to 1.99, Glu: 0.84 to 1.20, Urea: 0.67 to 1.50, Cr: 0.82 to 1.22, UA: 0.77 to 1.32, TG: 0.51 to 1.98 and TC: 0.80 to 1.26. Compared with conventional reference interval, the ratio of the upper and lower limits of CIp was lessened. Conclusion The personal-ized reference interval (CIp) which may increase the sensitivity of conventional reference intervals was established and verified.