Demirci Bio-Acoustic MEMS Laboratory, Center for Biomedical Engineering, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.
PLoS One. 2011;6(7):e21409. doi: 10.1371/journal.pone.0021409. Epub 2011 Jul 6.
CD4(+) T-lymphocyte count (CD4 count) is a standard method used to monitor HIV-infected patients during anti-retroviral therapy (ART). The World Health Organization (WHO) has pointed out or recommended that a handheld, point-of-care, reliable, and affordable CD4 count platform is urgently needed in resource-scarce settings.
HIV-infected patient blood samples were tested at the point-of-care using a portable and label-free microchip CD4 count platform that we have developed. A total of 130 HIV-infected patient samples were collected that included 16 de-identified left over blood samples from Brigham and Women's Hospital (BWH), and 114 left over samples from Muhimbili University of Health and Allied Sciences (MUHAS) enrolled in the HIV and AIDS care and treatment centers in the City of Dar es Salaam, Tanzania. The two data groups from BWH and MUHAS were analyzed and compared to the commonly accepted CD4 count reference method (FACSCalibur system).
The portable, battery operated and microscope-free microchip platform developed in our laboratory (BWH) showed significant correlation in CD4 counts compared with FACSCalibur system both at BWH (r = 0.94, p<0.01) and MUHAS (r = 0.49, p<0.01), which was supported by the Bland-Altman methods comparison analysis. The device rapidly produced CD4 count within 10 minutes using an in-house developed automated cell counting program.
We obtained CD4 counts of HIV-infected patients using a portable platform which is an inexpensive (<$1 material cost) and disposable microchip that uses whole blood sample (<10 µl) without any pre-processing. The system operates without the need for antibody-based fluorescent labeling and expensive fluorescent illumination and microscope setup. This portable CD4 count platform displays agreement with the FACSCalibur results and has the potential to expand access to HIV and AIDS monitoring using fingerprick volume of whole blood and helping people who suffer from HIV and AIDS in resource-limited settings.
CD4(+)T 淋巴细胞计数（CD4 计数）是监测接受抗逆转录病毒疗法（ART）的 HIV 感染者的标准方法。世界卫生组织（WHO）指出或建议，在资源匮乏的环境中迫切需要一种手持式、即时、可靠且负担得起的 CD4 计数平台。
我们开发了一种便携式、无标签的微芯片 CD4 计数平台，在即时护理点对 HIV 感染者的血液样本进行检测。共收集了 130 例 HIV 感染者的样本，其中包括 16 份来自布莱根妇女医院（BWH）的匿名剩余血液样本，以及来自坦桑尼亚达累斯萨拉姆市 HIV 和艾滋病护理治疗中心的 114 份来自穆希比利大学卫生和联合科学学院（MUHAS）的剩余样本。对 BWH 和 MUHAS 的两组数据进行了分析，并与公认的 CD4 计数参考方法（FACSCalibur 系统）进行了比较。
我们实验室（BWH）开发的便携式、电池供电且无显微镜的微芯片平台在与 FACSCalibur 系统的 CD4 计数比较中显示出显著相关性，在 BWH（r=0.94，p<0.01）和 MUHAS（r=0.49，p<0.01）均如此，这一结果得到了 Bland-Altman 方法比较分析的支持。该设备使用内部开发的自动细胞计数程序在 10 分钟内快速生成 CD4 计数。
我们使用一种便携式平台获得了 HIV 感染者的 CD4 计数，该平台使用廉价（<$1 材料成本）且一次性的微芯片，使用全血样本（<10μl），无需任何预处理。该系统无需基于抗体的荧光标记和昂贵的荧光照明以及显微镜设置即可运行。这种便携式 CD4 计数平台与 FACSCalibur 结果一致，有可能通过使用指尖血全血体积扩大 HIV 和 AIDS 监测的机会，并帮助资源有限环境中的 HIV 和 AIDS 感染者。
