胶乳凝集免疫比浊法快速检测血清梅毒抗体

Rapid detection of serum syphilis antibodies with latex agglutinate immunoturbidimetry assay

目的:对用于仪器快速测定血清梅毒抗体的胶乳凝集免疫比浊法试剂的性能进行初步评价。方法:在东芝7600型自动生化分析仪上应用日本A&T公司生产的改良型梅毒抗体测定试剂,对梅毒阴/阳性血清样本进行上机测定,检测该方法的精密度、检测线性、最低检出限、抗干扰能力、临界值确定以及和传统方法相关性。结果:本方法日内变异系数1.52%～5.40%,日间变异系数2.01%～6.29%,检测线性为4.12～350U。一定程度的溶血(血红蛋白<510g/L)、脂血(甘油三酯<13.78mmol/L)、黄疸(胆红素<357.4μmol/L)及类风湿因子<420U/ml对检测结果无明显干扰。临界值可确定为15.0U,检测灵敏度为96.6%,特异度为97.9%。结论:胶乳凝集免疫比浊法具有简便快速、敏感度高、抗干扰能力强、重复性好的特点,可用于血清梅毒抗体筛查检测。

Objective：To evaluate the latex agglutinate immunoturbidimetry assay in rapid detecting serum syphilis antibodies.Methods：Auto detected syphilis antibodies in serum samples by using immunoticles auto3TP reagent（made by Japan A＆T company） on Hitachi 7600 automatic biochemical analyzer.The latex agglutinate immunoturbidimetry assay was evaluated in precision,linear range,detection limit,anti-interference ability,cut-off value and relativity with routine methods.Results：The intraday coefficient of variation（CV）was 1.52%～5.40%,extraday CV was 2.01%～6.29%,the linear range of syphilis antibodies was 4.12～350U.Some degree of hemolyte（Hb〈510g/L）,lipidemia（TG〈13.78mmol/L）,icterus（TBil〈357.4μmol/L） and RF〈420U/ml didn＇t interfere with the result significantly.The cut-off value was 15.0U and showed 96.6% sensitivity,97.9% specificity.Conclusion：Some advantages were showed in latex agglutinate immunoturbidimetry assay,including easy to use and rapid,highly sensitivity and specificity,good anti-interference ability and repeatability.It can be used in screening serum syphilis antibodies.