酶联免疫吸附试验中HBsAg室内质控参考品的制备和应用

The preparation and application of the reference serum for internal quality control of HBsAg by ELISA

目的建立室内质控参考品以鉴别诊断试剂的质量和控制操作误差,提高乙型肝炎病毒表面抗原的检测准确度。方法以国家标准品为标准制备灵敏度系列参考品、特异性参考品及精密性参考品。检测其稳定性,并进行同厂家、不同批号试剂的比较及不同厂家、三批试剂的比较。结果制备的室内质控参考品在-20℃与4℃保存3～4周检测结果无统计学差异。采用同一厂家、不同批号的HBsAg诊断试剂检测室内质控参考品,结果无统计学差异。采用不同厂家、同一批号的HBsAg诊断试剂检测结果有统计学差异。结论我们建立的室内质控参考品适宜作HBsAg室内质控,提醒我们在更换试剂厂家时应特别注意室内质控参考品的变化。

Objective To establish internal quality control to distinguish the quality of diagnostic Kit and control operate error and improve the accuracy of HBsAg detection. Method The reference serum with sensitivity, specificity and accuracy for internal quality control was prepared as the national standard, and its stability was detected. The reagents of same factory variant batch number and variant factory three batch number, were tested using the reference sera. Results There was no difference as keep the reference serum in-20℃ and 4℃ for 3 ～ 4 weeks. The results of same manufactuare variant batch number has no difference using the reference serum. The results of using variant manufactuare three batch number had statistical difference. Conclusions The reference serum is suitable for the internal quality control for detection of HBsAg by ELISA. It must be notice to the variety as changing the HBsAg kits.