临床医学实验室生物参考区间的建立

目的以血清总胆固醇（TC）、高密度脂蛋白胆固醇（HDL—C）2个生化项目为例，探讨适合本实验室建立生物参考区间的方法。方法结合ISO15189：2003（E）《医学实验室——质量和能力的专用要求》条款要求和美国临床实验室标准化委员会（NCCLS）C28-A2文件推荐方法，先引用权威书刊、厂家试剂说明书或转移其他医院实验室的生物参考区间，然后进行实验验证，验证不通过的项目，收集120例健康参考个体自建适用于本实验室的生物参考区间，定期进行临床评审。结果TC现用生物参考区间验证通过，可以继续使用；HDL—C验证不通过，不适用，须自建生物参考区间，自建区间为男性0．82～1．82mmol／L、女性0．89～1．97mmol／L。结论采用本研究方法确立临床医学实验室生物参考区间从多途径保证检验指标的生物参考区间可靠、准确、科学、实用，能确保生物参考区间符合临床要求，值得推广应用。

Establishment of biology reference interval in clinical medicine laboratory

Objective To explore a suitable method for our laboratory to establish the biological reference interval, taking total cholesterol（TC ） and high-density lipoproteins-cholesterol （HDL-C） as examples. Methods According to the items of ISO15189：2003 （E） ＂ the medicine laboratory ——The quality and the ability of special-purpose ＂ and the methods recommended by （ NCCLS ） C28-A2 ,we verified TC and HDL-C through tests by means of intervals either quo- ted from periodicals or the manufactory instructions, or transferred from other medicine laboratories. A proper biology reference interval will be established again by collecting 120 healthy persons as reference. Results TC passed the test and remains valid, while HDL-C failed the verification and need to establish a new biology reference. The new interval of HDL-C was 0.82-1.82 mmol/L for male and 0.89-1.97 mmol/L for female. Conclusions The method of establishing biological reference interval used in our study can guarantee the intervals of testing items in many ways reliable, accurate, scientific and practical. It can satisfy the clinical requirement and is worth to be used in other medicine laboratory.