摘要
目的评价免疫比浊法在梅毒螺旋体特异性抗体检测中的临床应用效果。方法在自动生化分析仪上利用免疫比浊法测定梅毒阴性和阳性血清样本,确定该方法的精密度、线性范围和常见干扰因素对检测结果的影响,并对1 286份血清样本进行检测,比较该方法与明胶颗粒凝集试验(TPPA)检测结果的一致性。结果免疫比浊法批内变异系数为2.95%~5.43%,批间变异系数为4.55%~7.06%;检测线性为0~350U/ml;一定程度胆红素和溶血对检测结果无明显影响,乳糜血对检测结果影响较大。免疫比浊法与TPPA法具有良好的一致性(Kappa=0.994),检测结果总符合率为99.8%。结论免疫比浊法精密度好、线性范围宽,具有一定的抗干扰性,同时具有自动化分析、简便快速可定量的优势,适用于梅毒螺旋体抗体的大批量样本筛查。
Objective To evaluate the clinical performance of immunoturbidimetry assay in Treponema Pallidum（TP） antibody detecting. Methods Immunoturbidimetry assay was used to measure TP antibody in serum on automatic biochemical analyzer. The assay precision,linearity and interference factors were assessed. A total of 1 286 samples were tested to compare the coincidence of immunoturbidimetry assay with TPPA. Results The within-run coefficient of variation （CV） of immunoturbidimetry assay was 2.95%-5.43%,and the between-run CV was 4.55%-7.06%,the linear range was 0-350 U/ml. Some degree of hemolysis and icterus had no significant interference on the test, whereas lipidemia influence the results remarkably. The results had good consistency with TPPA,the overall coincidence of the two methods was 99.8%. Conclusion Immunoturbidimetry assay showed good preeision,linearity and some degree of anti-interference ability. The assay had some advantages including high automation and fast speed detection which were suited for clinical application in screening TP antibody.
出处
《中国国境卫生检疫杂志》
CAS
2017年第1期18-20,共3页
Chinese Journal of Frontier Health and Quarantine
基金
国家质检总局科技计划项目(2015IK273)
