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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 application of immunoturbidimetry in the detection of Treponema pallidum specific antibodies. Methods The turbidimetric method was used to determine the negative and positive syphilis serum samples on an automatic biochemical analyzer. The precision, linearity range and common interference factors of the method were determined. A total of 1 286 serum samples were tested and compared This method is consistent with the results of gelatin particle agglutination test (TPPA). Results The coefficient of variation (CV) was 2.95% ~ 5.43% in the batch assay and the coefficient of variation was 4.55% ~ 7.06% in the batch assay. The linearity ranged from 0 to 350 U / ml. The level of bilirubin and hemolysis had no significant effect on the test results, Chylous blood on the test results greater impact. Immunoturbidimetry and TPPA method has a good consistency (Kappa = 0.994), the test results with a total compliance rate of 99.8%. Conclusion Immunoturbidimetric method has good precision, wide linear range and certain anti-interference ability. It also has the advantages of automatic analysis, simple and rapid quantification, and is suitable for large sample screening of Treponema pallidum antibody.