常规生化检验项目参考区间适用性验证
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摘要
目的验证新发布的卫生行业标准《临床常用生化检验项目参考区间》,判定其是否适用于长春地区。方法筛选20～<80岁汉族健康体检者,男女每10岁均入组30例以上。使用日立7600-210全自动生化分析仪进行生化项目检测。分析行业标准中8个生化检验项目性别及年龄的差异,判断其是否通过参考区间验证。结果男性血清清蛋白(ALB)水平随着年龄增长呈缓慢下降趋势,男性天门冬氨酸氨基转移酶(AST)、女性碱性磷酸酶(ALP)水平随着年龄增长逐渐上升。女性丙氨酸氨基转移酶(ALT),男性ALT及γ-谷氨酰基转移酶(GGT)水平在20～<60岁随年龄增长呈上升趋势,反之,在60～<80岁则随年龄增长逐渐下降,所有年龄段检测值均在推荐的参考区间内。常规生化检验项目男女12个亚组测定值94%以上均在参考区间内,均通过了参考区间验证。结论卫生行业标准《临床常用生化检验项目参考区间》适用于吉林地区汉族人群。
Objective To verify the Standards Reference Intervals for Common Clinical Biochemistry Tests and to determine if the standards are suitable for Jilin area.Methods Healthy Han reference individuals at 20-<80 years old were selected as reference individuals and there were more than 30 cases for each sex in every 10 years old group.The blood samples were detected by HITACHI 7600-210 automatic biochemical analyzer.Differences between sex and age for 8 clinical chemistry parameters were evaluated and distribution in range of reference individuals were analyzed.Results The levels of albumin among different age periods of male were shown a downward trend.The levels of AST in male,ALP and GGT in female were shown a upward trend with the growth of age.The levels of ALT in female,ALT and GGT in male were shown an upward trend at 20-<60 years old,while a downward trend was shown at 60-<80 years old.Nevertheless,the average levels of all the groups were within the recommended reference intervals.Over 94%of verification for eight common clinical biochemistry tests(6 subgroups for male and 6 subgroups for female)were in the reference range and all passed validation.Conclusion Standards Reference Intervals for Common Clinical Biochemistry Tests are applicable to Chinese Han population in Jilin area.
Objective To verify the Standards Reference Intervals for Common Clinical Biochemistry Tests and to determine if the standards are suitable for Jilin area.Methods Healthy Han reference individuals at 20-<80 years old were selected as reference individuals and there were more than 30 cases for each sex in every 10 years old group.The blood samples were detected by HITACHI 7600-210 automatic biochemical analyzer.Differences between sex and age for 8 clinical chemistry parameters were evaluated and distribution in range of reference individuals were analyzed.Results The levels of albumin among different age periods of male were shown a downward trend.The levels of AST in male,ALP and GGT in female were shown a upward trend with the growth of age.The levels of ALT in female,ALT and GGT in male were shown an upward trend at 20-<60 years old,while a downward trend was shown at 60-<80 years old.Nevertheless,the average levels of all the groups were within the recommended reference intervals.Over 94%of verification for eight common clinical biochemistry tests(6 subgroups for male and 6 subgroups for female)were in the reference range and all passed validation.Conclusion Standards Reference Intervals for Common Clinical Biochemistry Tests are applicable to Chinese Han population in Jilin area.
引文
[1]中华人民共和国卫生部.临床常用生化检验项目参考区间[S].北京:中国标准出版社,2012.
[2]中华人民共和国卫生部.临床实验室检验项目参考区间的制定[S].北京:中国标准出版社,2012.
[3] HOROWITZ G L,ALTAIE S,BOYD J C,et al.Defining,establishing,and verifying the reference intervals in a clinical laboratory;approved guideline-third edition:CLSI 28-A3[S].Wayne,PA,USA,2008.
[4]周涛,马润,王玉明,等.25个常规生化检验项目的参考区间验证[J].国际检验医学杂志,2017,38(9):1253-1255.
[5]李欣,王迪,杨春,等.长春市汉族儿童血清胆红素参考区间调查[J].检验医学,2016,31(8):640-646.
[6]王迪,杨春,张晓威,等.吉林省2~14岁汉族儿童血清碱性磷酸酶参考区间的建立[J].重庆医学,2015,44(26):3618-3621.
[7]王迪,杨春,周琪,等.长春市汉族儿童碱性磷酸酶参考区间的建立[J].中华临床医师杂志,2015,9(1):75-79.
[8]李欣,周琪,王迪,等.长春市不同年龄段汉族健康儿童血清总蛋白、清蛋白水平观察[J].山东医药,2016,56(23):61-64.
[9]杨俊英.多项生化项目参考区间验证分析[J].国际检验医学杂志,2015,36(10):1435-1436.
[10]吕礼应,杨九华,刘万利,等.常规化学参考区间行业标准(WS/T 404.1-2012、WS/T 404.1-2012)的临床适用性验证[J].中华检验医学杂志,2014,37(12):951-953.
[11]窦会东,李国江.北京房山区健康人群6项生化指标参考区间验证分析[J].国际检验医学杂志,2015,36(14):2115-2116.
[12]尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2015:337-451.
[2]中华人民共和国卫生部.临床实验室检验项目参考区间的制定[S].北京:中国标准出版社,2012.
[3] HOROWITZ G L,ALTAIE S,BOYD J C,et al.Defining,establishing,and verifying the reference intervals in a clinical laboratory;approved guideline-third edition:CLSI 28-A3[S].Wayne,PA,USA,2008.
[4]周涛,马润,王玉明,等.25个常规生化检验项目的参考区间验证[J].国际检验医学杂志,2017,38(9):1253-1255.
[5]李欣,王迪,杨春,等.长春市汉族儿童血清胆红素参考区间调查[J].检验医学,2016,31(8):640-646.
[6]王迪,杨春,张晓威,等.吉林省2~14岁汉族儿童血清碱性磷酸酶参考区间的建立[J].重庆医学,2015,44(26):3618-3621.
[7]王迪,杨春,周琪,等.长春市汉族儿童碱性磷酸酶参考区间的建立[J].中华临床医师杂志,2015,9(1):75-79.
[8]李欣,周琪,王迪,等.长春市不同年龄段汉族健康儿童血清总蛋白、清蛋白水平观察[J].山东医药,2016,56(23):61-64.
[9]杨俊英.多项生化项目参考区间验证分析[J].国际检验医学杂志,2015,36(10):1435-1436.
[10]吕礼应,杨九华,刘万利,等.常规化学参考区间行业标准(WS/T 404.1-2012、WS/T 404.1-2012)的临床适用性验证[J].中华检验医学杂志,2014,37(12):951-953.
[11]窦会东,李国江.北京房山区健康人群6项生化指标参考区间验证分析[J].国际检验医学杂志,2015,36(14):2115-2116.
[12]尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2015:337-451.