Thorn R M, Braman V, Stella M, Yi A
Cambridge BioScience Corporation, Worcester, MA 01605.
Transfusion. 1989 Jan;29(1):78-80. doi: 10.1046/j.1537-2995.1989.29189101171.x.
Three FDA licensed HIV-1 viral lysate and two nonlicensed recombinant antigen assays were used to evaluate six serially diluted plasma samples and 2 highly characterized seroconversion series. The sensitivity as measured by serial dilution did not necessarily correlate with the sensitivity as measured by seroconversion performance with the lysate and the recombinant assays. It is concluded that national licensing agencies should arrange to share seroconversion panels to evaluate accurately the sensitivity of new HIV-1 screening tests.
使用三种获得美国食品药品监督管理局（FDA）许可的HIV-1病毒裂解物检测法和两种未经许可的重组抗原检测法，对6份系列稀释的血浆样本和2个高度特征化的血清转化系列进行评估。通过系列稀释测得的灵敏度不一定与通过病毒裂解物和重组检测法的血清转化性能测得的灵敏度相关。得出的结论是，国家许可机构应安排共享血清转化样本组，以准确评估新型HIV-1筛查检测的灵敏度。
