Rickman W J, Waxdal M J, Monical C, Damato J D, Burke D S
Division of Retrovirology, Walter Reed Army Institute of Research, Rockville, Maryland 20850.
Clin Immunol Immunopathol. 1989 Jul;52(1):85-95. doi: 10.1016/0090-1229(89)90195-5.
With the emergence of the human immunodeficiency virus (HIV) epidemic, lymphocyte immunophenotyping has become the single most important laboratory test for clinical management of HIV-infected subjects. To meet this challenge, the department of Army instituted a multicenter lymphocyte immunophenotyping quality assurance (QA) program in March 1986. An integral part of the QA program has been the development of a monthly proficiency testing program to survey the degree of precision and reproducibility of lymphocyte subset determinations within the Army. After 15 months of proficiency testing, the multicenter cumulative average standard deviation for the percentage of positive CD2 was 3.3, CD3 was 4.4, CD4 was 3.3, CD8 was 3.6, CD8CD3 was 2.8, CD19/20 was 2.9, and 3.0 for natural killer (NK) cells. The cumulative average coefficient of variation for the percentage of positive CD2 was 3.9%, CD3 was 4.9%, CD4 was 6.6%, CD8 was 11.4%, CD8CD3 was 9.4%, CD19/20 was 18.8%, and 26.5% for NK. Five survey shipments were also shipped to an additional 49 laboratories outside the Department of Army. The difference of the mean Army percentage positive values from the mean overall percentage positive values ranged from zero to 9.6, with an average difference of 1.6. The interlaboratory variability of flow cytometrically-derived percentage values presented in this report are almost half that cited by other multicenter lymphocyte comparative studies.
随着人类免疫缺陷病毒（HIV）疫情的出现，淋巴细胞免疫表型分析已成为HIV感染患者临床管理中最重要的单项实验室检测。为应对这一挑战，陆军部于1986年3月启动了一项多中心淋巴细胞免疫表型分析质量保证（QA）计划。QA计划的一个重要组成部分是制定每月能力验证计划，以调查陆军内部淋巴细胞亚群测定的精密度和可重复性程度。经过15个月的能力验证，多中心CD2阳性百分比的累积平均标准差为3.3，CD3为4.4，CD4为3.3，CD8为3.6，CD8CD3为2.8，CD19/20为2.9，自然杀伤（NK）细胞为3.0。CD2阳性百分比的累积平均变异系数为3.9%，CD3为4.9%，CD4为6.6%，CD8为11.4%，CD8CD3为9.4%，CD19/20为18.8%，NK为26.5%。另外还向陆军部以外的49个实验室发送了5批调查样本。陆军阳性百分比平均值与总体阳性百分比平均值的差异范围为0至9.6，平均差异为1.6。本报告中流式细胞仪得出的百分比值的实验室间变异性几乎是其他多中心淋巴细胞比较研究引用值的一半。
