摘要
目的:通过量值溯源和对测量不确定度估计来实现产前筛查实验室标准化。方法:针对大批量的筛查标本,测定实验中采用第三方质控物标明的可接受范围了解测定校准后的正确性,根据测定量来确定质控点数,并用长期室内质控的CV值来估计相对不确定度。结果:三年内采用两个批号的质控品,AFP和游离β-人绒毛膜促性腺激素(freeβ-HCG)设定的低中高各值的CV值小于3.8%。结论:通过改良测量流程和确定可执行的有效的质量控制管理体系,本产前筛查实验室的分析测定水平和室内质量控制能力已经达到卫生行业标准,具有标准化的执行能力。
Objective：To achieve the laboratory standardization in prenatal screening laboratories through measurement traceability and uncertainty estimation.Methods： In large quantities of screening samples,the correctness of the calibration measured by the third-party quality control substance in acceptable limits was determined.According to the numbers of samples,the control points were determined and CV values of long-term quality control in laboratory were used to estimate the relative uncertainty.Results： In three years,with two batches of quality control materials,CV values of AFP and free-β-human chorionic gonadotropin（free β-HCG） in low,medium or high level were less than 3.8%.Conclusion： The improvement of measurement process and the executable and effective internal quality control management have made the determination level and internal quality control ability of our prenatal screening laboratory reach the health industry standard and have standardized executive capacity.
出处
《中国卫生检验杂志》
CAS
2011年第12期2901-2902,共2页
Chinese Journal of Health Laboratory Technology
关键词
产前筛查
量值溯源
测量不确定度
质量控制
Prenatal screening
Measurement traceability
Measurement uncertainty
Quality control
