摘要
目的 通过BD FACSCalibur与EasyCellAuto206B1检测系统检测CD3+T淋巴细胞(简称CD3细胞)、CD4细胞、CD8细胞的临床对比研究,以评估流式细胞检测系统在艾滋病领域国产化替代的可行性.方法 对于临床收集的211例患者的血液样本,分别用BD FACSCalibur(简称BD仪器)与其配套BD试剂(试验1)、国产EasyCellAuto206B1流式细胞仪(简称国产仪器)与其配套国产试剂(试验2)、国产仪器与BD试剂(试验3)、BD仪器与国产试剂(试验4)检测.通过Excel和Analyse-it 5.92软件分析定量结果.结果 通过对211例(包含确诊的HIV/AIDS患者113例,正常职业体检人群98例)样本CD3细胞、CD4细胞、CD8细胞检测以及CD4/CD8细胞比值,试验1与2、试验1与3、试验1与4、试验2与3、试验2与4、试验3与4,均具有良好的相关性,并在CD3细胞试验1与2、试验1与3、试验1与4、试验2与3、试验2与4;CD4细胞试验1与3、试验2与3;CD8细胞试验1与2、试验1与3、试验1与4、试验2与3、试验2与4;CD4/CD8细胞比值试验1与2、试验1与3、试验1与4上具有良好的一致性(P＜0.05).结论 在HIV检测中使用BD FACSCalibur、EasyCellAuto206B1国产流式细胞仪与BD试剂、EasyCellAuto206B1配套国产试剂具有显著相关性与较好的一致性,互为替代性较强.
Abstract
Objective The study aimed to evaluate the feasibility of replacing imported flow cytometry systems with domestically produced alternatives in the field of AIDS diagnosis.The performance of BD FACSCalibur(referred to as the BD instrument)and the EasyCell Auto 206B1(referred to as the domestic instrument)for detecting CD3+(referred to as CD3),CD4,and CD8 T lymphocytes were compared in a clinical setting.Methods Blood samples from 211 patients were collected.Each sample was analyzed by four different combinations of instruments and reagents:BD FACSCalibur(referred to as referred BD instrument)and its corresponding referred to as the domestic reagent(test 1),the EasyCell Auto 206B1 flow cytometer(referred to as the domestic instrument)and its corresponding domestic reagent(test 2),the domestic instrument and BD reagent(test 3),and the BD instrument and domestic reagent(test 4).Quantitative results were analyzed using Excel and Analyse-it 5.92 software.Results The study included 211 patients,comprising 113 diagnosed with HIV/AIDS and 98 individuals undergoing routine occupational health checks.The CD3,CD4,and CD8 T lymphocyte counts were measured and the CD4/CD8 cell ratio was calculated for each sample.Significant correlations(P＜0.05)were observed between the results obtained from all four experiment groups for all measured parameters(between tests 1 and 2,tests 1 and 3,tests 1 and 4,tests 2 and 3,tests 2 and 4,tests 3 and 4).CD3 T lymphocyte detection showed good correlations between tests 1 and 2,tests 1 and 3,tests 1 and 4,tests 2 and 3,tests 2 and 4.CD4 T cell identification results from tests 1 and 3,as well as 2 and 3,exhibited strong correlations.CD8 T cell detection findings were highly correlated between tests 1 and 2,tests 1 and 3,tests 1 and 4,tests 2 and 3,tests 2 and 4.The CD4/CD8 cell ratio results displayed significant correlations between tests 1 and 2,tests 1 and 3,and tests 1 and 4.Conclusions BD FACSCalibur,EasyCell Auto 206B1 domestic flow cytometer with BD reagents,and EasyCell Auto 206B1 with domestic reagents all produce highly correlated results in HIV testing.These findings suggest that domestically produced flow cytometers and reagents offer a viable alternative to imported systems for diagnosing AIDS.
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