目的 建立3种破伤风抗体体外检测方法并比较。 方法 分别构建间接法、双抗原法和毒素结合抑制试验体外测定破伤风抗体，对方法进行线性与范围、中间精密度、准确度、检测限的初步验证。 结果 间接法在浓度范围0.007 8~1.000 0毫国际单位（mili-international unit，mIU）/mL之间呈现良好的线性关系（决定系数= 0.998 6）；双抗原法在浓度范围0.078~10.000 mIU/mL之间呈现良好的线性关系（决定系数=0.998 7）；毒素结合抑制试验在浓度范围1.95~31.25 mIU/mL之间呈现良好的线性关系（相关系数＞0.98）。方法学验证结果表明3种方法在精密度、准确度、特异性等方面均符合分析方法验证的指导原则。比较3种方法的阳性检出率，差异无统计学意义（χ²=1.34，P=0.513）。 结论 成功建立间接法、双抗原法和毒素结合抑制试验3种体外破伤风抗体检测法，为体外法替代体内毒素中和试验奠定研究基础。

Objective To establish and compare 3 tetanus antibody detection methods in vitro. Methods The indirect method, double antigen assay and toxin binding inhibition (ToBI) test were established. The developed methods were validated for linearity and range, intermediate precision, accuracy and detection limit. Results The linear range of indirect method was 0.007 8-1.000 0 mili-international unit (mIU)/mL [coefficient of determination (R²) = 0.998 6], of double antigen assay was 0.078-10.000 mIU/mL (R²=0.998 7) and of ToBI test was 1.95-31.25 mIU/mL (correlation coefficient > 0.98). The validation results indicated that three methods meet the guiding principles of analytical method validation in terms of precision, accuracy, and specificity. Comparing the positive detection rates of these methods, there was no statistically significant difference (χ²=1.34，P=0.513). Conclusion Three detection methods for tetanus antibody in vitro, namely indirect method, double antigen assay and ToBI test, are successfully established, laying research foundation for in vitro method to replace in vivo neutralizing assay.