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目的评价免疫比浊法测定梅毒螺旋体(TP)抗体的方法学性能。方法按照美国临床和实验室标准协会评价方案等,于2013年1~4月对免疫比浊法测定TP抗体的不精密度、线性范围、正确度、抗干扰性和参考范围等进行评价。结果免疫比浊法测定TP抗体低值和高值质控品的重复性估计值分别为2.10%和1.65%,低值和高值质控品的实验室内不精密度分别为3.06%和2.49%;TP检测值在0~310 U/ml范围内线性良好;血红蛋白≤4.5 g/L,胆红素≤342μmol/L时,对本方法无显著性干扰。测定2011-2013年的卫生部室间质量评价标本并与卫生部室间质量评价结果比较,检测正确度为95.6%;550例表观健康人血清TP检测值的95%置信区间为0.8~9.5 U/ml。结论免疫比浊法检测TP的不精密度符合要求,线性范围宽,可以实现自动化分析、检测速度快。
Objective To evaluate the methodological properties of the immunoturbidimetric method for the determination of antibodies against Treponema pallidum (TP). Methods The inaccuracies, linear ranges, accuracy, anti-interference and reference range of TP antibody were determined by immunoturbidimetry in accordance with the evaluation criteria of the American Society of Clinical and Laboratory Standards et al. Results The estimated reproducibility of the low and high-quality control antibody for TP antibody by immunoturbidimetry was 2.10% and 1.65% respectively. The intra-laboratory inaccuracies of low and high quality controls were 3.06% and 2.49, respectively %; TP linearity was good in the range of 0-310 U / ml; hemoglobin ≤4.5 g / L and bilirubin ≤342 μmol / L had no significant interference with this method. The interim laboratory quality assessment of Ministry of Health in 2011-2013 was compared with that of inter-laboratory quality assessment of Ministry of Health, and the 95% confidence interval was 95.6%. The 95% confidence interval (TP) of serum TP of the 550 healthy subjects was 0.8-9.5 U / ml. Conclusion Immunoturbidimetric method can be used to detect the inaccuracies of TP. The linear range is wide and can be automated. The detection speed is fast.