Mitchai Manthana, Susaengrat Wattanachai, Krissadarak Kamoltip, Mitchai Jumphol, Leeratanapetch Niramol
Clinical Pathology Department, Khon Kaen Hospital, Ministry of Public Health, Khon Kaen, Thailand.
J Med Assoc Thai. 2008 Oct;91(10):1495-8.
The aim of the present study was to evaluate a manual CD4+ count kit assay (CD4+: cytospheres) for CD4+ T-lymphocyte count compared with flow cytometric method in HIV infected patients.
One hundred thirty three HIV infected patients were recruited from the out patient department of Khon Kaen Hospital. Blood samples were done by a manual CD4+ count kit assay (CD4+: cytospheres) and flow cytometry for CD4+ T-lymphocyte count. The data were analyzed for diagnostic test and correlation coefficient.
The data of cytospheres assay and flow cytomeric method showed good correlation (r = 0.88) for the total group. At the absolute CD4+ T-lymphocyte 200 cells/cu.mm, the cytospheres assay demonstrated sensitivity 83.10% (76.73-89.47%), specificity 93.55% (89.37-97.72%), PPV 93.65% (89.51-97.79%), NPV 82.86% (76.45-89.26%). In the case of CD4+ T-lymphocyte count were lower than 200 cells/cu.mm, the cytospheres assay displayed progressive decrease in sensitivity successive increase in specificity.
The cytospheres technique is an alternative noncytofluorometric assay for CD4+ T-lymphocyte count. This test may be useful for screening in HIV infected adult patients in community hospitals where flow cytometry technique is not available. But the assay is limited in determination only absolute CD4+ T-lymphocyte count with higher than 30 cells/cu.mm. This technique is not benefit in pediatric HIV/AIDS patient due to percentage CD4+ value did not obtained. The quality control should be concern technical skill and proficiency testing for laboratory setting.
本研究旨在评估一种手动CD4+计数试剂盒检测法（CD4+：细胞球）在HIV感染患者中用于CD4+ T淋巴细胞计数的情况，并与流式细胞术方法进行比较。
从孔敬医院门诊部招募了133例HIV感染患者。通过手动CD4+计数试剂盒检测法（CD4+：细胞球）和流式细胞术对血液样本进行CD4+ T淋巴细胞计数。对数据进行诊断试验和相关系数分析。
细胞球检测法和流式细胞术方法的数据在总体组中显示出良好的相关性（r = 0.88）。在绝对CD4+ T淋巴细胞为200个细胞/立方毫米时，细胞球检测法显示敏感性为83.10%（76.73 - 89.47%），特异性为93.55%（89.37 - 97.72%），阳性预测值为93.65%（89.51 - 97.79%），阴性预测值为82.86%（76.45 - 89.26%）。在CD4+ T淋巴细胞计数低于200个细胞/立方毫米的情况下，细胞球检测法的敏感性逐渐降低，特异性逐渐升高。
细胞球技术是一种用于CD4+ T淋巴细胞计数的非细胞荧光检测替代方法。该检测方法对于社区医院中无法使用流式细胞术技术的HIV感染成年患者的筛查可能有用。但该检测仅在测定高于30个细胞/立方毫米的绝对CD4+ T淋巴细胞计数时有效。由于无法获得CD4+百分比值，该技术对儿科HIV/AIDS患者无益。实验室应关注技术技能和能力验证方面的质量控制。
