探讨标记物分析前变异在产前筛查质量控制中的影响

目的探讨分析前变异在产前筛查中对测定结果的影响，建立标准的分析前质量管理程序。方法检测不同采血管的类型、处理温度和时间条件下血清甲胎蛋白（AFP）和游离β-人绒毛膜促性腺激素（free13-HCG）值，利用方差分析和t检验计算分析前变异。结果与真空促凝管相比，2～8℃条件下放置7d的分离胶管样本，AFP的测定值差异有统计学意义（P〈0．05），不同温度和延长水浴时间分离血清检测freeB—HCG值差异有统计学意义（P〈0．05）。结论分析前变异会影响AFP和free β—HCG的测定结果，采用分离胶管执行样本条码化测定可降低分析前处理的不合格率和差错率。

The impact of preanalytical variations of markers on the quality control of the prenatal screening

Objective To study the impact of preanalytical variation in the detecting results of prenatal screening,and to establish the standard preanalytical quality management procedures.Methods For the study of the preanalytical variations,to detect alpha-fetoprotein(AFP) and free β-human chorionic gonadotropin(free β-HCG) under the different type of blood collection,processing temperature and and storage conditions,and using ANOVA and t test to caculate the preanalytical variations.Results At 2-8 ℃ for 7 days in the separation gel tube samples,the difference of AFP value was significantly higher than vacuum coaqatant tubes(P <0.05);Free β-HCG value was statistically significant at different temperatures and storage conditions(P < 0.05).Conclusion The impact of preanalytical variation in the detecting will affect the AFP and freeβ-HCG of the determination results,and using of separate sample gel tube barcode implementation can reduce the analysis of measured pre-treatment failure rate and error rate.