Performance Evaluation of the Alere PIMA CD4 Test for Monitoring HIV-Infected Individuals in Resource-Constrained Settings
Performance Evaluation of the Alere PIMA CD4 Test for Monitoring HIV-Infected Individuals in Resource-Constrained Settings
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DOI：
10.1097/qai.0b013e31822866a2
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发表时间：
2011-10-01
影响因子：
3.6
通讯作者：
Pattanapanyasat, Kovit
中科院分区：
文献类型：
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作者：
Sukapirom, Kasama;Onlamoon, Nattawat;Pattanapanyasat, Kovit
背景：CD 4破竖条T淋巴细胞计数在HIV管理中具有重要意义。然而，基于流式细胞术的标准实验室系统是昂贵的、复杂的，并且因此不可用于需要低成本和全自动护理点CD 4测试系统的大多数资源有限的环境。为了解决这一问题，进行了一项研究，以验证Alere PIMA床旁CD 4检测。方法：将使用PIMA系统获得的203份HIV感染血液样本中的CD 4 + T淋巴细胞绝对数量的重复值与两种等同单平台FACSCount和双平台FACSCan进行比较结果：使用PIMA系统获得的总体绝对CD 4 + T淋巴细胞计数与FACSCount高度相关（r（2）= 0.957;平均偏差，-54.2个细胞/μ L;一致性限，-190.9至+82.5个细胞/μ L）和FACSCan（r（2）= 0.957;平均偏倚-44.0个细胞/μ L;一致性限，-179.7至+91.6个细胞/μ L）。对于CD 4 + T淋巴细胞计数范围为0 - 200和0 - 350个细胞/μ L的样本，也观察到良好的相关性和低偏倚。此外，有绝对CD 4 + T淋巴细胞计数之间的重复样本使用PIMA system.Conclusions没有显着差异：这种新的即时护理产品是一种简单可靠的系统，应有助于显着简化执行CD 4检测，从而增加资源有限的设置为患者的访问。无法获得CD 4 + T淋巴细胞计数的频率（%）值是PIMA系统的一个局限性，增加该值对于HIV感染的儿科患者的临床分期或监测具有价值。
Background: Enumeration of CD4 broken vertical bar T-lymphocytes is important in the management of HIV. However, standard laboratory systems based on flow cytometry are expensive, complicated, and thus unavailable to most resource-limited settings where a low-cost and fully automated point-of-care CD4 testing system is required. In attempts to address this issue, a study was conducted to validate the Alere PIMA point-of-care CD4 test.Method: Duplicate values of the absolute number of CD4+ T-lymphocytes in 203 HIV-infected blood samples obtained using the PIMA system were compared with the two predicate single-platform FACSCount and the dual-platform FACSCan (Becton Dickinson Biosciences).Results: The overall absolute CD4+ T-lymphocyte count obtained using the PIMA system correlated highly with the FACSCount (r(2) = 0.957; mean bias, -54.2 cells/mu L; limit of agreement, -190.9 to +82.5 cells/mu L) and the FACSCan (r(2) = 0.957; mean bias -44.0 cells/mu L; limit of agreement, -179.7 to +91.6 cells/mu L). Good correlation and low biases were also observed for samples with CD4+ T-lymphocyte count ranges of 0 to 200 and 0 to 350 cells/mu L. Additionally, there was no significant difference in absolute CD4+ T-lymphocyte counts noted between the duplicate samples using the PIMA system.Conclusions: This new point-of-care product is a simple and reliable system and should contribute significantly to the simplification of performing CD4 testing and thus increase access for patients in resource-limited settings. The inability to obtain values for the frequency (%) of CD4+ T-lymphocyte count is one limitation of the PIMA system, the addition of which would be of value for clinical staging or monitoring in HIV-infected pediatric patients.