【摘要】 目的　对间接酶联免疫吸附法 (EL ISA)法检测人弓形虫 (TOXO) - Ig M的试剂进行优化改良。方法　以自制原材料采用间接 EL ISA法研制 TOXO- Ig M检测试剂 ,对试剂的特异性、精密性、灵敏度以及稳定性进行鉴定。结果　质量检定结果表明 ,该试剂特异性强、本底低 ,能有效消除类风湿因子等干扰因素的影响 ;灵敏度>1∶ 16 0 ;精密性好 ,变异系数 (C.V )均 <15 % ;试剂稳定 ,37℃存放 6天 ,各项指标的变化率不超过 15 %。结论　本试剂盒有较好的特异性、敏感性和稳定性 ,可广泛应用于临床优生优育检测更多还原

【Abstract】 Objective To promote the efficiency of the reagent which was used to diagnose TOXO IgM by indirect ELISA.Methods The TOXO-IgM was improved with materials of our lab by indirect ELISA. The reagent’s quality including specificity, sensitivity,precision and stability was tested.Results The reagent had high specificity and low background. The sensitivity is up to 1∶160, the precision was high and the coefficient of variation ( C.V) was lower than 15%. The reagent was stable (stored at 37 ℃ for 4 days, the change range of each target is no more than 15%).Conclusion The quality of the new reagent is as good as predicted. It may be used in clinic test of prepotency for its good quality in specificity and sensitivity.更多还原