Scott Lesley E, Campbell Jennifer, Westerman Larry, Kestens Luc, Vojnov Lara, Kohastsu Luciana, Nkengasong John, Peter Trevor, Stevens Wendy
Department of Molecular Medicine and Haematology, Faculty of Health Science, School of Pathology, University of the Witwatersrand, 7 York Road Parktown, Johannesburg, South Africa.
Clinton Health Access Initiative, Boston, MA, USA.
BMC Med. 2015 Jul 25;13:168. doi: 10.1186/s12916-015-0396-2.
The Alere point-of-care (POC) Pima™ CD4 analyzer allows for decentralized testing and expansion to testing antiretroviral therapy (ART) eligibility. A consortium conducted a pooled multi-data technical performance analysis of the Pima CD4.
Primary data (11,803 paired observations) comprised 22 independent studies between 2009-2012 from the Caribbean, Asia, Sub-Saharan Africa, USA and Europe, using 6 laboratory-based reference technologies. Data were analyzed as categorical (including binary) and numerical (absolute) observations using a bivariate and/or univariate random effects model when appropriate.
At a median reference CD4 of 383 cells/μl the mean Pima CD4 bias is -23 cells/μl (average bias across all CD4 ranges is 10 % for venous and 15% for capillary testing). Sensitivity of the Pima CD4 is 93% (95% confidence interval [CI] 91.4% - 94.9%) at 350 cells/μl and 96% (CI 95.2% - 96.9%) at 500 cells/μl, with no significant difference between venous and capillary testing. Sensitivity reduced to 86% (CI 82% - 89%) at 100 cells/μl (for Cryptococcal antigen (CrAg) screening), with a significant difference between venous (88%, CI: 85% - 91%) and capillary (79%, CI: 73% - 84%) testing. Total CD4 misclassification is 2.3% cases at 100 cells/μl, 11.0% at 350 cells/μl and 9.5 % at 500 cells/μl, due to higher false positive rates which resulted in more patients identified for treatment. This increased by 1.2%, 2.8% and 1.8%, respectively, for capillary testing. There was no difference in Pima CD4 misclassification between the meta-analysis data and a population subset of HIV+ ART naïve individuals, nor in misclassification among operator cadres. The Pima CD4 was most similar to Beckman Coulter PanLeucogated CD4, Becton Dickinson FACSCalibur and FACSCount, and less similar to Partec CyFlow reference technologies.
The Pima CD4 may be recommended using venous-derived specimens for screening (100 cells/μl) for reflex CrAg screening and for HIV ART eligibility at 350 cells/μl and 500 cells/μl thresholds using both capillary and venous derived specimens. These meta-analysis findings add to the knowledge of acceptance criteria of the Pima CD4 and future POC tests, but implementation and impact will require full costing analysis.
Alere即时检验（POC）Pima™ CD4分析仪可实现分散式检测，并扩大到用于检测抗逆转录病毒疗法（ART）的资格。一个联盟对Pima CD4进行了汇总多数据技术性能分析。
主要数据（11,803对观察值）包括2009年至2012年间来自加勒比地区、亚洲、撒哈拉以南非洲、美国和欧洲的22项独立研究，使用了6种基于实验室的参考技术。在适当时，使用双变量和/或单变量随机效应模型将数据作为分类（包括二元）和数值（绝对）观察值进行分析。
在参考CD4中位数为383个细胞/微升时，Pima CD4的平均偏差为-23个细胞/微升（所有CD4范围的平均偏差，静脉检测为10%，毛细血管检测为15%）。Pima CD4在350个细胞/微升时的灵敏度为93%（95%置信区间[CI] 91.4% - 94.9%），在500个细胞/微升时为96%（CI 95.2% - 96.9%），静脉检测和毛细血管检测之间无显著差异。在100个细胞/微升（用于隐球菌抗原（CrAg）筛查）时，灵敏度降至86%（CI 82% - 89%），静脉检测（88%，CI：85% - 91%）和毛细血管检测（79%，CI：73% - 84%）之间存在显著差异。在100个细胞/微升时，总CD4错误分类为2.3%的病例，在350个细胞/微升时为11.0%，在500个细胞/微升时为9.5%，这是由于较高的假阳性率导致更多患者被确定为适合治疗。对于毛细血管检测，这分别增加了1.2%、2.8%和1.8%。荟萃分析数据与未接受过ART的HIV阳性个体的人群子集之间，以及不同操作人员群体之间，Pima CD4错误分类没有差异。Pima CD4与贝克曼库尔特全白细胞分类CD4、BD FACSCalibur和FACSCount最为相似，与帕泰克CyFlow参考技术不太相似。
对于用于反射性CrAg筛查的100个细胞/微升筛查以及使用毛细血管和静脉来源标本在350个细胞/微升和500个细胞/微升阈值下的HIV ART资格检测，可能推荐使用Pima CD4检测静脉来源标本。这些荟萃分析结果增加了对Pima CD4和未来即时检验的验收标准的认识，但实施和影响将需要进行全面成本分析。
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