弓形虫IgG亲和力诊断方法的验证与评价

Verification and assessment of avidity test for Toxoplasma gondii-specific IgG antibodies

目的对弓形虫IgG亲和力诊断试剂盒进行考核和验证。方法采用化学发光微粒子免疫检测法，用10份弓形虫IgG阳性血清及弓形虫IgG抗体检测血清国家参考品对三批弓形虫IgG亲和力测定试剂盒及质控品进行考核，计算符合率、精密度及加速稳定性等。结果试剂盒的符合率为100％，精密度变异系数（coefficient variation,CV）值均≤14％：经温度加速稳定性试验，其符合率与精密度无变化。结论经由化学发光微粒子免疫检测法制备的弓形虫IgG亲和力诊断试剂盒具有良好的符合率、精密度及稳定性．可用于临床检测。

Objective To verify and assess ARCHITECT Toxo IgG Avidity Reagent kit. Methods Ten human IgG antibodies positive serum and national reference serum for IgG against Toxoplasma were used for the evaluation on three batches of kits and controls by chemiluminescent microparticle immunoassay method, their coincidence rate, precision and accelerated stability were calculated. Results The coincidence rate of the kit was 100%, coefficient variation （CV） of precision was less than or equal to 14%. In accelerated stability test, coinci- dence rate and precision were no change. Conclusion ARCHITECT Toxo IgG Avidity Reagent kit shows good performance in coincidence rate, precision and accelerated stability test. It can be used for clinical detection.