vWF:Ag国产试剂盒的性能验证研究  

The Performance Verification of vWF:Ag Domestic Kit

作　　者：杨伟民 马立艳[1] YANG Weimin;MA Liyan(Clinical Laboratory Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院临床检验中心,北京100050

出　　处：《标记免疫分析与临床》2024年第5期917-921,977,共6页Labeled Immunoassays and Clinical Medicine

基　　金：国产凝血产品vWF:Ag和抗Xa试剂盒产学协同研发项目(编号:22097010274456)。

摘　　要：目的评价国产vWF:Ag(胶乳免疫比浊法)试剂盒在进口血凝检测系统上的检测性能。方法共收集2023年4月至7月北京友谊医院西城院区157例住院患者和40例表观健康人员的枸橼酸钠抗凝血浆样本。vWF:Ag试剂检测质控在靶值宣称的范围内,再进行试剂的性能验证。选取vWF:Ag国产试剂质控品进行精密度评价;选取北京九强公司的工作校准品进行正确度验证;选取高、低值临床样本进行线性范围评价;选取表观健康人群样本进行参考区间验证;选取50例高、中、低值均匀分布临床样本,将国产试剂和进口试剂的结果进行比对,并计算两者相关性和相对偏差;对国产试剂盒对干扰物质(直接胆红素、间接胆红素、血红蛋白、脂肪乳)的抗干扰性能进行验证。结果vWF:Ag国产试剂高、中、低3个质控浓度的批内精密度CV、批间精密度CV和总精密度CV均<10%。正确度两个水平的工作校准品与靶值的偏倚分别为-2.0%和3.3%,均<±10%。线性范围相关系数大于0.995,偏差<±15%,验证的线性范围为10%~253%。O型血人群参考范围为47.8%~138.5%、非O型血人群参考范围为76.5%~163.0%,验证通过。干扰物质胆红素≤40mg/dL,血红蛋白≤150mg/dL,脂肪乳≤600mg/dL,回收率在90%~110%之间,相对偏差<±10%,满足试剂要求。结论在沃芬全自动血凝分析仪ACL TOP500检测系统上,vWF:Ag(胶乳免疫比浊法)国产试剂盒性能良好,符合实验室检测质量要求,满足临床检测需求。Objective To evaluate the detection performance of domestic vWF:Ag(latex immunoturbidimetry)kit on imported coagulation detection system.Methods From April to July,2023,serum samples of 157 inpatients and 40 apparently healthy individuals were collected from Beijing Friendship Hospital Xicheng Campus to evaluate the precision and correctness of the vWF:Ag domestic reagent.The results between domestic reagents and imported reagents were compared,and the correlation and bias between them were calculated.The anti-interference performance of the domestic kit against interfering substances(direct bilirubin,indirect bilirubin,hemoglobin,and fat emulsion)was also verified.Results The intra-assay precision CV,inter-assay precision CV and total precision CV of the three quality control concentrations of high-,medium-and low-domestic vWF:Ag reagents were below 10%.The bias of the two levels of correctness were-2.0%and 3.3%,and both were<±10%.The correlation coefficient of the linear range was greater than 0.995,while the deviation was<±15%,and the linear range of the validation was 10%-253%.The reference range for people with blood type O was 47.8%-138.5%,and the reference range for people with non-blood type O was 76.5%-163.0%,which passed the validation test.The interfering substance bilirubin was≤40mg/dL,hemoglobin was≤150mg/dL,fat emulsion was≤600mg/dL,while the recovery rate was between 90%and 110%,and the relative deviation was<±10%,which all met reagent requirements.Conclusion On the detection system of Werfen automatic coagulation analyzer ACL TOP500,the domestic vWF:Ag(latex immunoturbidimetry)kit shows a good performance,which can meet the quality requirements of both laboratory testing and clinical testing.

关 键 词：VWF:AG 国产体外诊断试剂 性能验证 

分 类 号：R-331[医药卫生]