92例梅毒检验的假阴性与假阳性研究

Analysis of false negative and false positiveamong 92 cases of syphilis

目的分析92例梅毒检验假阴性与假阳性原因,为提高梅毒检验的准确性提供参考。方法选取2015年1月至2016年1月在榆林市第二医院行梅毒筛查的患者临床资料进行回顾性分析,按照是否出现假阴性与假阳性,将患者分为三组,假阴性组、假阳性组和真阳性真阴性组,其中真阳性真阴性组为对照组,比较三组受检者的临床病理生理资料,按照分组统计执行检验的人员、检验所用的设备、设施、试剂、试液、质控品等,分析三组患者上述指标之间存在的差异,探讨导致梅毒检验假阴性和假阳性的原因。结果假阳性组患者恶性肿瘤、免疫系统疾病、肺结核、血液病的几率显著高于对照组和假阴性组,差异具有统计学意义(P<0.05);假阳性组患者标本溶血、离心转速和时间不够、标本污染细菌率明显高于对照组和假阴性组,差异具有统计学意义(P<0.05)。人员操作误差率、设备设施故障率、试剂试液偏差率明显高于对照组,但与假阴性组比较差异无统计学意义(P>0.05),假阴性组患者检查前1个月抗菌药物使用频率明显高于对照组和假阳性组患者(P<0.05);检验操作人员误差和仪器设备质控品等系统误差率明显高于对照组和假阳性组,差异具有统计学意义(P<0.05)。结论梅毒检验结果的准确性受到受试者因素、检验系统因素等多方面影响,临床应根据受检者实际情况,制定个性化的检验方案,同时加强检验人员和设备设施、试剂试药质控品的管理,降低系统误差,提高检验结果的准确性。

Objective To analyze the causes of false negative and false positive in 92 cases of syphilis,in order to provide reference for improving the accuracy of syphilis test.Methods A retrospective analysis on the clinical data of patients in our center for syphilis screening from January 2015 to January 2016 was conducted.The patients,according to whether the occurrence of false negative and false positive,were divided into three groups,false negative group,false positive group and true positive and true negative group(control group).The clinical pathological data was compared between the three groups.Differences in inspection personnel,inspection equipment,facilities,reagents,test solution and equipment quality control were studied between the three groups to explore the causes of false negative and false positive.Results The probability of malignant tumor,immune system disease,tuberculosis and blood disease in false positive group was higher than that of control group and false negative group(P<0.05).The probability of specimen hemolysis,insufficient centrifugal speed and time,and sample contaminated with bacteria in the false positive group was significantly higher than that of control group and false negative group(P<0.05).The incidence of operator error,equipment failure and reagent deviation was significantly higher in the false positive group than that of the control group,but without statistically significant difference with that in the false negative group(P<0.05).The antimicrobial drug use frequency in the false negative group a month before test was much higher than the other two groups(P>0.05),and the inspection personnel and equipment quality control error was significantly higher than that in the control group and false positive group(P<0.05).Conclusions The accuracy of syphilis test results is affected by test subject factors,system factors and other aspects,so personalized test plan should be formulated based on the actual situation of patients,and the quality control management over test personnel,equipment and reagents should be conducted to reduce system error and improve the accuracy of test results.