Denny T N, Jensen B D, Gavin E I, Louzao A G, Vella F A, Oleske J M, Wong W
Department of Pediatrics and Pathology, New Jersey Medical School, Newark 07013, USA.
Clin Diagn Lab Immunol. 1995 May;2(3):330-6. doi: 10.1128/cdli.2.3.330-336.1995.
The purpose of this study was to evaluate a new alternative fluorescence immunoassay method (Zymmune CD4/CD8 Cell Monitoring Kit; Zynaxis, Inc., Malvern, Pa.) for determining the absolute CD4+ and CD8+ T-lymphocyte concentrations in whole blood. The investigation was performed as a two-site comparison of the reference whole blood flow cytometric method with the Zymmune method. In this investigation, a total of 166 patient samples were evaluated of which approximately 20% were from human immunodeficiency virus-positive individuals. The mean value for samples performed by the Zymmune CD4 assay was 1,094 (range, 74 to 2,586) cells per microliters, while the reference method yielded a mean of 890 (range, 35 to 2,033) cells per microliter. The correlation coefficient for regression analysis was 0.940. The mean value for samples performed by the Zymmune CD8 assay was 700 (range, 212 to 1,813) cells per microliter, while the reference method yielded a mean of 546 (range, 82 to 2,158) cells per microliter. The correlation coefficient for regression analysis was 0.921. No site-specific differences or trends in CD4 or CD8 values were seen when the data were analyzed by site of collection. The average precision of the CD4 assay varied from 6 to 14%, corresponding to the high and low concentration ranges. For CD8, the average precision varied from 8.3 to 16% over the respective high to low concentration ranges. We conclude that the Zymmune CD4/CD8 Cell Monitoring Kit method provides absolute CD4+ and CD8+ T-lymphocyte concentrations which are equivalent to those given by the reference flow cytometric method.
本研究的目的是评估一种新的替代荧光免疫测定方法（Zymmune CD4/CD8细胞监测试剂盒；Zynaxis公司，宾夕法尼亚州马尔文）用于测定全血中CD4+和CD8+T淋巴细胞的绝对浓度。该研究作为参考全血流式细胞术方法与Zymmune方法的两点比较进行。在本研究中，共评估了166份患者样本，其中约20%来自人类免疫缺陷病毒阳性个体。Zymmune CD4测定法检测的样本平均值为每微升1094个细胞（范围为74至2586个细胞），而参考方法得出的平均值为每微升890个细胞（范围为35至2033个细胞）。回归分析的相关系数为0.940。Zymmune CD8测定法检测的样本平均值为每微升700个细胞（范围为212至1813个细胞），而参考方法得出的平均值为每微升546个细胞（范围为82至2158个细胞）。回归分析的相关系数为0.921。当按采集地点分析数据时，未发现CD4或CD8值存在特定地点差异或趋势。CD4测定的平均精密度在6%至14%之间，对应于高浓度和低浓度范围。对于CD8，在各自的高浓度到低浓度范围内，平均精密度在8.3%至16%之间变化。我们得出结论，Zymmune CD4/CD8细胞监测试剂盒方法提供的CD4+和CD8+T淋巴细胞绝对浓度与参考流式细胞术方法相当。
