上海地区血清丙氨酸转氨酶测定结果一致性和参考范围调查

A study for harmonization and reference range of serum ALT measurement in Shanghai

目的探索上海地区血清丙氨酸转氨酶(ALT)临床检测结果的一致性,并进行表面健康人群的参考范围调查.方法每次实验前将c.f.a.s.中含有的根据国际临床化学家联合会(IFCC)推荐方法要求测得的ALT值传递到1份新鲜人混合血清,以此校准各参加医院检验科的ALT检测系统.32家医院检验科先后进行了9次实验,并在检测结果基本一致后分别进行了7 598例和21 970例年龄为17～78岁的表面健康人员ALT测定值调查.结果校准前各参加医院检验科之间的ALT检测值变异系数(CV)为17.1%～20.5%,校准后各医院之间检测值具有良好的一致性,CV降至1.42%～5.97%.2次ALT参考范围调查中男性和女性的第95百分位值分别为58和45 U/L,约相当于30或23赖氏法单位;第97.5百分位值分别为67和55 U/L,约相当于35或29赖氏法单位;第99百分位值分别为75和67 U/L,约相当于39或35赖氏法单位.结论采用统一的校准血清,可以使不同医院(不同检测系统)之间ALT检测值差异明显减小,一致性显著增加.

Objective To observe the possibility of harmonization of ALT results in 32 different laboratories in Shanghai area and investigate the reference range in apparently healthy people. Methods A pooled patients＇ serum, which was given IFCC＇s ALT level from e. f. a. s. , was used as calibrator and sent to the 32 participated laboratories together with 2 to 5 fresh patients＇ serum and studied for 9 times. The reference range in 7 598 （4 000 males and 3 598 females） and 21 970 （ 12 856 males and 9 114 females） apparently healthy people, respectively, ages from 17 to 78 years, was investigated after harmonization of ALT results. Results Before harmonization, the inter-laboratories CV of ALT results varied from 17.1% to 20.5% , and after harmonization, CV decreased to 1.42% to 5.97%. The reference range after harmonization of ALT results in the 95 th, 97.5 th, and for women 45, 55 and 67 U/L, respectively. Conclusions for harmonizing of ALT results among the laboratories. and 99 th percentiles for men was 58, 67 and 75 U/L, The pooled patients＇ serum could be used as calibrator