供多年使用、多厂家试剂共用的HIV抗体干血棉球质控品应用研究

[目的]研究设计一种供多年使用,多厂家ELISA检测HIV抗体试剂盒共用的干血棉球质控品。[方法]用HIV抗体阴性血清稀释HIV抗体强阳性血清,制备成较高S/CO值的干血棉球质控品。根据不同厂家ELISA检测HIV抗体试剂盒敏感性的差异,标定出不同试剂盒检测干血棉球质控品S/CO值2～3时溶解液的各自用量。实验时,不同厂家试剂盒用不同用量的溶解液溶解干血棉球质控品,使之成为该厂家试剂盒S/CO值2～3的弱阳性质控血清,用于室内质量控制。[结果]干血棉球质控品置-20℃历时3年,经多个厂家的ELISA检测HIV抗体试剂盒对干血棉球质控品20次检测结果,其S/CO值的变异系数(cv)均﹤20%。[结论]使用干血棉球质控品大大减少了制备频次,简化了操作程序,为各级艾滋病检测实验室ELISA检测HIV抗体的室内质量控制提供了极大的方便。

APPLICATION RESEACH OF QUALITY-CONTROL SPECIMEN OF DRIED-BLOOD TAMPON FOR DETECTING HIV ANTIBODY USED BY DIFFERENT ELISA KIT FOR YEARS

[Objective]To design a quality-control specimen of dried-blood tampon for detecting HIV(Human Immunodeficiency Virus)which could be used by different ELISA Kit for years.[Methods]Diluted strong positive serum of HIV antibody by negative serum of HIV antibody to made quality-control specimen of dried-blood tampon of high S/CO.On the basis of different sensitivities of different ELISA Kits detecting HIV,marked their dosages respectively with their S/CO values of 2-3 of different quality-control specimen of dried-blood tampon.Different ELISA Kits using different amounts of solution to dissolve quality-control specimen of dried-blood tampon to make them as the weak positive quality control serum which S/CO of 2-3 to control the quality.[Results]The quality-control specimen of dried-blood tampon was kept in the temperature of-20℃ for 3 years,and were detected by many different HIV ELISA Kits for 20 times,the results of S/CO cv were all ﹤20%.[Conclusion]Quality-control product of dried-blood tampon can reduce the frequency of preparation heavily,simplify the operating procedure and give facilities for quality-control of ELISA detecting HIV.