XU Si-hong, SONG Ai-jing, LI Xiu-hua and WANG You-chun*. Studies on National Reference of HIV-1 P24 Antigen[J]. Virologica Sinica, 2006, 21(2): 102-105.
Citation: XU Si-hong, SONG Ai-jing, LI Xiu-hua, WANG You-chun*. Studies on National Reference of HIV-1 P24 Antigen .VIROLOGICA SINICA, 2006, 21(2) : 102-105.

HIV-1 P24抗原国家参考品的研制

  • 收集正常人、HIV感染者和疑似感染者血浆以及HIV-1病毒培养裂解液,对其进行HIV抗体、HIV P24抗原、HCV抗体和HBsAg检测,对HIVP24抗原阳性者进行HIV RNA检测,并对部分样品进行基因分型。以NIBSCP24抗原标准品的系列稀释样品作为线性灵敏度参考品。经过实验筛选出20份阴性参考品,10份阳性参考品,10份线性灵敏度参考品,2份精密性参考品,共同组成HIV-1P24抗原国家参考品,经多家不同的试剂进行标定,制定了相应的标准。稳定性研究结果表明,反复冻融三次对该参考品的稳定性没有影响。由此,初步建立了HIV-1P24抗原国家参考品,该参考品将对HIV-1P24抗原、HIV抗体/P24抗原联合检测试剂的质量控制提供重要依据。

Studies on National Reference of HIV-1 P24 Antigen

  • To develop national reference of HIV-1 P24 antigen and establish the corresponding standard, specimens collected from normal population, HIV cultivated cell lysates and patients infected with HIV or suspected infection, were detected for HIV antibody, HIV P24 antigen, HCV antibody and HBsAg. 21 specimens positive for HIV P24 antigen, from patients infected with HIV or suspected infection, were detected for HIV RNA and, at the same time, HIV genotypes of these samples positive for HIV RNA were analyzed. The national references of HIV P24 consisted of 20 negative samples, 10 positive samples, 10 sensitivity samples and 2 precision samples, were developed. After analysed the p24 references with the P24-detecting reagents from different manufactures, the corresponding standards were established. It also showed that 3 times freeze-thawing did not affect the stability of the references. The national references of HIV-1 P24 antigen would provide important guides on quality control of HIV P24-detecting reagents.

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    Studies on National Reference of HIV-1 P24 Antigen

    • 1. National Institute for the control of Pharmaceutical and Biological Products, Beijing 100050, China

    Abstract: To develop national reference of HIV-1 P24 antigen and establish the corresponding standard, specimens collected from normal population, HIV cultivated cell lysates and patients infected with HIV or suspected infection, were detected for HIV antibody, HIV P24 antigen, HCV antibody and HBsAg. 21 specimens positive for HIV P24 antigen, from patients infected with HIV or suspected infection, were detected for HIV RNA and, at the same time, HIV genotypes of these samples positive for HIV RNA were analyzed. The national references of HIV P24 consisted of 20 negative samples, 10 positive samples, 10 sensitivity samples and 2 precision samples, were developed. After analysed the p24 references with the P24-detecting reagents from different manufactures, the corresponding standards were established. It also showed that 3 times freeze-thawing did not affect the stability of the references. The national references of HIV-1 P24 antigen would provide important guides on quality control of HIV P24-detecting reagents.

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