两种血小板抗体试剂在儿童患者应用的一致性评价

The consistency of two kind of reagents in detection of platelet antibody for pediatric patients

目的评价两种血小板抗体检测试剂在儿童患者应用的一致性。方法选择2016年12月至2017年5月首都医科大学附属北京儿童医院的患儿血液标本1 409例,分别使用血小板抗体检测试剂A和试剂B,通过固相凝集法对血小板抗体进行平行检测,分析其差异性与一致性,并计算试剂B的灵敏度、特异度、阳性预测值与阴性预测值。结果1 409例样本中,试剂A和试剂B检出患儿血小板抗体强阳性、弱阳性和阴性例数分别为114、62、1 233例和113、60、1236例,差异无统计学意义(Zu=4.000,P=0.900)。两种试剂检测血小板抗体的配对Bowker分析亦显示,差异无统计学意义(t=1.911,P=0.385),且具有高度一致性(Kappa=0.956;U=45.032,P<0.001)。同时,试剂B可能具有较高检测效能:灵敏度为97.72%、特异度为99.92%、阳性预测值为99.42%、阴性预测值为99.68%。结论试剂B可替代试剂A进行患儿血小板抗体检测。

Objective To assess the consistency of two kind of reagents in the detection of platelet antibodies from pediatric patients.Methods A total of 1 409 cases from December 20 th,2016 to March 5 th,2017 were selected randomly in Beijing Children’s Hospital.The platelet antibody was parallel checked by solid phase agglutination using platelet antibody detection reagents A and B.The difference and consistency of the results were analyzed.Simultaneously,the sensitivity,specificity,positive predictive value and negative predictive value of reagent B values were calculated.Results Among 1 409 samples,114,62,1 233 and 113,60 and 1 236 cases were strongly positive,weakly positive and negative for platelet antibodies detected by reagent A and B,respectively,with no significant difference(Zu=4.000,P=0.900).Paired Bowker analysis of platelet antibody results for both two kind of reagents showed no statistically significant difference(t=1.911,P=0.385),and that a high degree of agreement(Kappa=0.956;U=45.032,P<0.001).Furthermore,compared to A reagent,B reagent was extremely efficient,the sensitivity,specificity,positive predictive value and negative predictive value were 97.72%,99.92%,99.42%and 99.68%,respectively.Conclusions The A reagent could replace by B reagent in the platelet antibody detection.