14、18C、19F及23F型肺炎链球菌血清抗体定量检测方法验证

Validation of quantitative determination of serum antibodies for Streptococcs pneumoniae serotypes 14,18C,19F and 23F

目的验证14、18C、19F及23F型肺炎链球菌荚膜多糖血清Ig G抗体定量ELISA检测方法。方法以国际参考血清007sp为标准,测定4份国际质控血清的14、18C、19F及23F型Ig G抗体值,计算线性、检测限及定量限;同时计算准确度;连续测定15份质控血清,计算精密度。利用3份质控血清进行抑制试验,绘制抑制曲线,计算特异性。结果该方法的R2、检测限和定量限均可达到可接受标准,准确度较高,精密度良好,特异性较好。结论该定量检测方法经过验证可用于肺炎球菌疫苗临床血清检测。

Objective To validate the test of specific Ig G antibodies for Streptococcs pneumoniae serotypes 14,18 C,19F and23 F by quantitative ELISA method. Methods Ig G antibodies for Streptococcs pneumoniae serotypes 14,18 C,19F and 23 F in four international quality control sera were measured with international reference serum 007 sp as standard. The linear range,detection limit,quantitative limit and accuracy were determined. 15 quality control sera were tested consecutively for precision determination. Inhibition assay was tested in 3 quality control sera to determine the specificity. Results The R^2,detection limit and quantitative limit of the ELISA method all reached the acceptable criteria. The method showed high precision and accuracy as well as good specificity. Conclusions Validation results show that the ELISA method is appropriate for the assay of penumococcal clinical serum.