Lo Y C, Armbruster David A
Pamela Youde Nethersole Eastern Hospital , Hong Kong, China.
Global Scientific Affairs, Dept 09AA/Bldg CP1-5, Abbott Diagnostics , 100 Abbott Park Road.
EJIFCC. 2012 Apr 4;23(1):5-10. eCollection 2012 Apr.
Defining reference intervals is a major challenge because of the difficulty in recruiting volunteers to participate and testing samples from a significant number of healthy reference individuals. Historical literature citation intervals are often suboptimal because they're be based on obsolete methods and/or only a small number of poorly defined reference samples.
Blood donors in Hong Kong gave permission for additional blood to be collected for reference interval testing. The samples were tested for twenty-five routine analytes on the Abbott ARCHITECT clinical chemistry system. Results were analyzed using the Rhoads EP evaluator software program, which is based on the CLSI/IFCC C28-A guideline, and defines the reference interval as the 95% central range.
Method specific reference intervals were established for twenty-five common clinical chemistry analytes for a Chinese ethnic population. The intervals were defined for each gender separately and for genders combined. Gender specific or combined gender intervals were adapted as appropriate for each analyte.
A large number of healthy, apparently normal blood donors from a local ethnic population were tested to provide current reference intervals for a new clinical chemistry system. Intervals were determined following an accepted international guideline. Laboratories using the same or similar methodologies may adapt these intervals if deemed validated and deemed suitable for their patient population. Laboratories using different methodologies may be able to successfully adapt the intervals for their facilities using the reference interval transference technique based on a method comparison study.
由于招募志愿者参与以及检测大量健康参考个体的样本存在困难,定义参考区间是一项重大挑战。历史文献引用区间往往不尽人意,因为它们基于过时的方法和/或仅少量定义不明确的参考样本。
香港的献血者同意采集额外的血液用于参考区间检测。样本在雅培ARCHITECT临床化学系统上检测了25种常规分析物。使用基于CLSI/IFCC C28 - A指南的Rhoads EP评估软件程序分析结果,并将参考区间定义为95%的中心范围。
为中国人群的25种常见临床化学分析物建立了特定方法的参考区间。分别为每个性别以及综合两性定义了区间。针对每种分析物,适当采用了特定性别的区间或综合两性的区间。
对当地人群中大量健康、看似正常的献血者进行了检测,以提供新临床化学系统的当前参考区间。参考区间是按照公认的国际指南确定的。使用相同或类似方法的实验室如果认为经过验证且适合其患者群体,可采用这些区间。使用不同方法的实验室或许能够基于方法比较研究,通过参考区间转移技术成功为其机构调整区间。