柳州地区成人血清和尿中淀粉酶生物参考区间的建立

Liuzhou Region to Establish Adult Serum and Urine Amylase Biological Reference Intervals

目的:以本实验室血清淀粉酶(AMY)和尿淀粉酶生化项目为例,探讨建立适合本实验室的生物参考区间的方法。方法应用美国临床实验室标准化研究院(CLSI)C28-A2文件推荐方法,结合IS015189:2003(E)《医学实验室--质量和能力的专用要求》条款要求,同时参考试剂生产厂家的说明书、权威书籍期刊或转移其他医院实验室的生物参考区间,进行验证,验证不通过的项目。收集本地区120例健康成人参考个体建立适用于本实验室的生物参考区间,定期进行临床评审。结果血清以及尿AMY现用生物参考区间验证未通过验证,须自行建立生物参考区间。血清AMY自建生物参考区间为39-152U/L,尿AMY自建参考区间:男性56~897 U/L,女性34~758 U/L。结论采用本研究方法建立实验室生物参考区间能确保生物参考区间符合临床要求,结果可靠、准确。方法科学、实用。

Objective To explore a suitable method for our laboratory to establish the biological reference interval,taking serum amylase(AMY)and urine amylase as examples.Methods According to the items of ISO15189:2003(E)'the medical laboratory-The quality and the ability of special-purpose'and the methods recommended by(CLSI)C28-A2,a reference reagent manufacturers instructions,or transfer authority books,other hospital laboratories biological reference interval,then experimental verification,when validation project is not passed,collected 120 healthy adult individuals in the region establish reference applicable to the biological laboratory reference intervals,regular clinical assessment.Results Serum AMY and urinary AMY active biology reference interval validation does not pass,must establish a new biology reference.The new serum AMY interval was 39-152U/L,the urine AMY interval was:male 56-897 U/L,female 34-758 U/L.Conclusion The study established clinical laboratory methods can effectively guarantee the biological reference interval test indicators of biological reference intervals reliable,accurate,scientific,practical,biological reference intervals to ensure compliance with clinical requirements.