ELISA一步法和二步法对HBsAg的检测结果比较

目的：为了提高临床实验诊断的可信性和准确性，尽可能减少或避免出现假阳性和假阴性。质控要求必需对HBsAg酶免疫测定的方法进行比对。方法：采用ELISA 一步法和二步法对体检人群样本进行 HBsAg平行测定，结果不一致样本用 CLIA 重新检测。结果：一步法阳性检出率为10．12％；二步法阳性检出率为12．19％。一步法检测的阴性样本中，有20例二步法检测为阳性。结论：阳性检出率一步法相对较低，二步法较高；方法学比较亦显示二步法优于一步法，建议临床采用二步法检测HBsAg。

Detection Result Comparison of One-step and Two-step Method of ELISA to HBsAg

Objective：To enhance reliability and accuracy of clinical laboratory diagnosis to avoid false positive and false negative as much as possible. Comparison of HBsAg enzyme immunoassay method should be finished. Methods：The HBsAg parallel determination was made by means of one-step and two-step method of ELISA. For the specimens with different results,CLIA method to retest was adopted. Results：Based on the one-step method,the positive rate was 10. 12%;as to two-step method,the positive rate was 12. 19%. 20 cases of two-step method test were positive in the negative specimens of one-step method. Conclusions：The detection rate of one-step method is lower than two-step method test. Methodology comparison shows that two-step method is superior to one-step method. HBsAg two-step method is properly proposed in the clinical detection.