Westgard多规则质量控制法在HPLC筛查珠蛋白生成障碍性贫血中的应用  

Application of multiple Westgard QC rules on screening of thalassemia by high performance liquid chromatography

作　　者：夏超然[1,2] 王娟[1,2] 陈美珏[1,2] 任兆瑞[1,2] 黄英[1,2] 王伟[1,2] 

机构地区：[1]上海交通大学附属儿童医院/上海市儿童医院,上海200040 [2]上海交通大学医学遗传研究所,上海200040

出　　处：《检验医学与临床》2016年第1期1-3,共3页Laboratory Medicine and Clinic

基　　金：国家科技支撑计划资助项目(2012BAI09B04)

摘　　要：目的探讨Westgard多规则质量控制法在应用高效液相色谱(HPLC)技术对珠蛋白生成障碍性贫血进行分子检测和筛查中的应用价值。方法应用全自动HPLC分析系统对血红蛋白分子中胎儿血红蛋白(HbF)和血红蛋白A2(HbA_2)两个组分进行定量检测分析,对每一组分的低值和高值质量控制品与每批次样品进行同批检测,绘制Levey-Jennings质量控制图。应用Westgard多规则1_(2s)/1_(3s)2_(2s)R_(4s)对每批次检测结果进行室内质量控制。分析HbF和HbA_2的两个质量控制品在选用的质量控制警戒值1_(2s)出现前后的重测比对结果,验证质量控制规则在临床诊断中的适用性并探讨该规则在珠蛋白生成障碍性贫血筛查中的应用价值。珠蛋白生成障碍性贫血的基因诊断分别采用跨越断裂点聚合酶链反应(Gap-PCR)法检测缺失和反向点杂交技术检测常见的基因突变位点。结果 Westgard质量控制警戒值1_(2s)出现后,重测比对结果差异无统计学意义(P>0.05),与该批次的基因诊断符合率无明显差异。研究建立并验证Westgard多规则1_(2s)/1_(3s)2_(2s)R_(4s)在应用HPLC分析技术对HbF和HbA_2定量检测的质量控制作用,证实可以通过质控品检测出误差类型,降低假失控概率,可应用于定量检测珠蛋白生成障碍性贫血的临床诊断和筛查中。结论 Westgard多规则质量控制法在应用全自动HPLC定量分析珠蛋白生成障碍性贫血的筛查诊断中起到重要的室内质量监控作用,可以评价临床检测报告的可靠性,并且对导致结果不可靠的误差实时监控。Objective To investigate the application value of the Westgard quality control（QC） rules in the molecular detection and screening of thalassemia by using high-performance liquid chromatography （HPLC）. Methods The automatic HPLC analysis system was applied to quantitatively detect HbF and HbA2 in hemoglobin molecule. The low and high value quality control materials of each ingredient together with each batch of specimens were performed the same batch detection and the Levey-Jennings quality control chat was drawn. The obtained results of each batch were conducted the internal quality control by applying the Westgard multiple rules 12s/1s 22s R4s. Analysis of the data obtained before and after the appearance of the QC alert value 12s ,demonstrated multiple QC rules can be applied in the quantitative measurement of HbF and HbAz for the diagnosis and screening of thalassemia. The molecular diagnosis of thalassemia including Gap-PCR and reverse dot blot were used for the detection of deletion and common genetic mutations in Chinese population. Results After the appearance of the QC alert value 12s,the data showed no statistically significant difference（P〉0.05）. The corresponding results also showed no statistically significant difference with the gene diagnosis. The Westgard multiple quality control rules 12s/1s 22s R4s in the analysis of quantitative detection of HbF and HbA2 by using the HPLC technology established in this study was validated and could be further used in the other quantitative analysis in the clinical diagnosis of thalassemia. By monitoring the process of QC materials,the types of errors could be identified using these quality control rules, the probability for false rejection could also be reduced. Conclusion The use of multiple Westgard QC rules plays an important role in the internal quality control on quantitative analysis of HbF and HbA2 by automated HPLC for the screening and diagnosis of thalassemia. It is used to evaluate and inspect whether the clinical reports are reliable,an

关 键 词：WESTGARD多规则 高效液相色谱 珠蛋白生成障碍性贫血 血红蛋白 

分 类 号：R446.1[医药卫生—诊断学]