2011Zhongguo shengwuzhipinxue zazhiRequires access

Comparison of Third Generation of Domestic and The Fourth Generation of Imported Detection Kits for HIV

Ting Chen

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Abstract

Objective To compare the difference in detection results by the third generation of domestic and the fourth generation of imported kits for HIV,and provide a reference for selection of reagents and establish the standard for discard of blood.Methods A total of 35 487 blood samples were tested by the third generation of domestic(A and B) and the fourth generation of imported(C) kits separately for HIV following the instructions.The kits before use were evaluated for qualities by National Institute for the Control of Pharmaceutical and Biological Products(NICPBP).Results All the three kits met the relevant requirements for quality.The detection results of s/co values of not less than 1.0 by kits A and B showed no significant difference,while those with s/co values of not less than 0.8 showed significant difference,with those by kit C.Conclusion Taking account for the safety of blood products,the standard for discard of blood is suggested as a s/co value of not less than 0.5 by the third generation of detection kit for HIV,or not less than 0.8 by the fourth generation of imported kit.

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Objective To compare the difference in detection results by the third generation of domestic and the fourth generation of imported kits for HIV,and provide a reference for selection of reagents and establish the standard for discard of blood.Methods A total of 35 487 blood samples were tested by the third generation of domestic(A and B) and the fourth generation of imported(C) kits separately for HIV following the instructions.The kits before use were evaluated for qualities by National Institute for the Control of Pharmaceutical and Biological Products(NICPBP).Results All the three kits met the relevant requirements for quality.The detection results of s/co values of not less than 1.0 by kits A and B showed no significant difference,while those with s/co values of not less than 0.8 showed significant difference,with those by kit C.Conclusion Taking account for the safety of blood products,the standard for discard of blood is suggested as a s/co value of not less than 0.5 by the third generation of detection kit for HIV,or not less than 0.8 by the fourth generation of imported kit.

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Available abstract

Objective To compare the difference in detection results by the third generation of domestic and the fourth generation of imported kits for HIV,and provide a reference for selection of reagents and establish the standard for discard of blood.Methods A total of 35 487 blood samples were tested by the third generation of domestic(A and B) and the fourth generation of imported(C) kits separately for HIV following the instructions.The kits before use were evaluated for qualities by National Institute for the Control of Pharmaceutical and Biological Products(NICPBP).Results All the three kits met the relevant requirements for quality.The detection results of s/co values of not less than 1.0 by kits A and B showed no significant difference,while those with s/co values of not less than 0.8 showed significant difference,with those by kit C.Conclusion Taking account for the safety of blood products,the standard for discard of blood is suggested as a s/co value of not less than 0.5 by the third generation of detection kit for HIV,or not less than 0.8 by the fourth generation of imported kit.

Key concepts: Third generation, Fourth generation, Human immunodeficiency virus (HIV), First generation, Significant difference, Medicine, Virology, Internal medicine

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