Namuniina Annemarie, Lutwama Fredrick, Biribawa Victoria Menya, Kizza David, Kabuubi Brian Roy, Kitandwe Paul Kato, Mpendo Juliet, Nanvubya Annet, Ssempiira Julius, Nalutaaya Annet, Ssetaala Ali, Welsh Sabrina, Price Matt A, Kiwanuka Noah, Bagaya Bernard Ssentalo
1 UVRI-IAVI HIV Vaccine Program Limited, Entebbe, Uganda.
2 Department of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda.
AIDS Res Hum Retroviruses. 2019 Apr;35(4):382-387. doi: 10.1089/AID.2018.0223. Epub 2019 Feb 14.
Uganda is among the most HIV/AIDS-afflicted countries, and many HIV-infected persons live in remote areas with poor access to health care. The success of HIV care programs relies in part on patient monitoring using CD4 T cell counts. We conducted an evaluation of the point-of-care PIMA test using BD FACSCount as a gold standard. One hundred fifty-one participants were enrolled, provided venous blood and samples tested at the point of care with the Alere PIMA™ CD4 Analyzer and the BD FACSCount in the UVRI-IAVI main laboratory. Correlation between the methods was assessed, as was the ability of the Pima Analyzer to predict values <200, <350, and ≥500 CD4 cells/mm when compared with BD FACSCount as the gold standard. A near-perfect positive Pearson correlation coefficient (r = 0.948; p < .0001) between the two methods was observed. The Alere PIMA Analyzer had a mean bias of -32.5 cells/mm. The sensitivity and specificity, for PIMA to predict CD4 lymphocyte count less than 200 cells/mm, were 71.4% and 100%, respectively; less than 350 cells/mm were 84.6% and 94.6%, respectively; and at CD4 count less than 500 cells/mm were 94.4% and 100%. The Alere Pima Analyzer provides reliable CD4 cell count measurement and is suitable for monitoring and screening eligible HIV patients in hard-to-reach settings.
乌干达是受艾滋病毒/艾滋病影响最严重的国家之一，许多艾滋病毒感染者生活在偏远地区，难以获得医疗保健服务。艾滋病毒护理项目的成功部分依赖于使用CD4 T细胞计数进行患者监测。我们以BD FACSCount作为金标准，对即时检验PIMA检测进行了评估。招募了151名参与者，采集静脉血，并在乌干达病毒研究所-国际艾滋病疫苗倡议组织的主要实验室中，使用Alere PIMA™ CD4分析仪和BD FACSCount在即时检验点对样本进行检测。评估了两种方法之间的相关性，以及与作为金标准的BD FACSCount相比，Pima分析仪预测CD4细胞/mm<200、<350和≥500时的能力。观察到两种方法之间的Pearson正相关系数接近完美（r = 0.948；p <.0001）。Alere PIMA分析仪的平均偏差为-32.5细胞/mm。对于PIMA预测CD4淋巴细胞计数小于200细胞/mm，其敏感性和特异性分别为71.4%和100%；小于350细胞/mm时分别为84.6%和94.6%；CD4计数小于500细胞/mm时分别为94.4%和100%。Alere Pima分析仪可提供可靠的CD4细胞计数测量，适用于在难以到达的地区对符合条件 的艾滋病毒患者进行监测和筛查。
