Kagan Jonathan M, Sanchez Ana M, Landay Alan, Denny Thomas N
Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, United States Department of Health and Human Services, Rockville, MD.
Duke Human Vaccine Institute and Center for HIV/AIDS, Duke University, Durham, NC.
For Immunopathol Dis Therap. 2015;6(1-2):55-64. doi: 10.1615/ForumImmunDisTher.2016014169.
Foundational cellular immunology research of the 1960s and 1970s, together with the advent of monoclonal antibodies and flow cytometry, provided the knowledge base and the technological capability that enabled the elucidation of the role of CD4 T cells in HIV infection. Research identifying the sources and magnitude of variation in CD4 measurements, standardized reagents and protocols, and the development of clinical flow cytometers all contributed to the feasibility of widespread CD4 testing. Cohort studies and clinical trials provided the context for establishing the utility of CD4 for prognosis in HIV-infected persons, initial assessment of antiretroviral drug activity, and as a surrogate marker for clinical outcome in antiretroviral therapeutic trials. Even with sensitive HIV viral load measurement, CD4 cell counting is still utilized in determining antiretroviral therapy eligibility and time to initiate therapy. New point of care technologies are helping both to lower the cost of CD4 testing and enable its use in HIV test and treat programs around the world.
20世纪60年代和70年代的基础细胞免疫学研究，以及单克隆抗体和流式细胞术的出现，提供了知识库和技术能力，使得阐明CD4 T细胞在HIV感染中的作用成为可能。确定CD4测量值变化来源和幅度的研究、标准化试剂和方案，以及临床流式细胞仪的开发，都有助于广泛开展CD4检测的可行性。队列研究和临床试验为确立CD4在HIV感染者预后评估、抗逆转录病毒药物活性初步评估以及抗逆转录病毒治疗试验临床结局替代标志物方面的效用提供了背景。即使有了灵敏的HIV病毒载量检测，CD4细胞计数仍被用于确定抗逆转录病毒治疗的资格和开始治疗的时机。新的即时检测技术有助于降低CD4检测成本，并使其能够在全球的HIV检测和治疗项目中使用。
