人类免疫缺陷病毒1型RNA定量参考品的研制  

Establishment of the reference panel for HIV RNA

作　　者：张春涛[1] 宋爱京[1] 李秀华[1] 李娟[1] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所细胞室,北京100050

出　　处：《中华实验和临床病毒学杂志》2004年第4期321-324,共4页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的　研制人类免疫缺陷病毒 1型 (HIV 1)RNA核酸国家参考品及制定相应标准。方法　收集各地HIV感染者阳性血浆和HIV非感染者血浆 ,应用HIV、HCV抗体和HBsAg检测试剂进行筛选 ,对HIV抗体筛查阳性者用新加坡Genelabs公司的HIVBLOT 2 2确证试剂进行确证。以世界卫生组织 (WHO)推荐的HIVRNA标准品对国家HIV核酸参考品中定量样品进行标定 ,并对其稳定性进行研究。结果　经过筛选 ,选出 8份样品为阴性参考品 ,8份样品为阳性参考品 ,3份为定量参考品 ,6份为灵敏度参考品 ,5份为线性参考品。几次独立标定 ,得到定量参考品HIVRNA的国际单位(IU) ,其中b1～b3的国际单位的对数值在 x±s以内 ,表明结果可靠。稳定性实验数据表明 ,该核酸参考品在 4℃以下可存放 4d。结论　初步建立了HIV核酸参考品 。Objective To establish a national reference panel for HIV RNA diagnostic reagents. Methods Sera from patients with HIV infection and healthy blood donors were collected and tested for HIV and HCV antibodies and HBsAg by using ELISA. The HIV antibody positive samples with ELISA were confirmed with HIV Blot 2.2 (Genelabs). The quantitative samples for HIV RNA were calibrated with the WHO HIV RNA standard. The stability of the panel was evaluated with acceleration method. Results After screening and calibration, 8 negative samples, 8 positive samples, 3 quantitative samples, 6 sensitivity samples and 5 samples for linear analysis were composed of the national reference panel for HIV RNA. The convinced international units(IU) for the quantitative samples were obtained by seven independent calibration and the logarithm of international units for the quantitative samples (b1-b3) were less than ±s .The results showed that this panel may stabilize for 4 days at 4℃. Conclusion A national reference panel for HIV RNA reagents has been established. It may provide the basis for evaluating HIV RNA diagnostic reagents.

关 键 词：参考品 HIV 阳性 RNA 人类免疫缺陷病毒1型 核酸 定量 国际 结论 对数 

分 类 号：R392[医药卫生—免疫学]