采用静脉血和指血对床边 CD4(+) T 细胞计数仪进行多中心评估：PIMA CD4。
Multisite evaluation of a point-of-care instrument for CD4(+) T-cell enumeration using venous and finger-prick blood: the PIMA CD4.
机构信息
Laboratoire de Bactériologie-Virologie, CHU Aristide le Dantec, Université Cheikh Anta Diop, Dakar, Sénégal.
出版信息
J Acquir Immune Defic Syndr. 2011 Dec 1;58(4):e103-11. doi: 10.1097/QAI.0b013e318235b378.
BACKGROUND
CD4(+) T-cell enumeration (CD4 count) is used as a criterion to initiate antiretroviral therapy (ART) in HIV patients and to monitor treatment efficacy. However, simple, affordable, and reliable point-of-care (POC) instruments adapted to resource-limited settings are still lacking. The PIMA CD4 analyzer is a new POC instrument for CD4 counting that uses disposable cartridges and a battery-powered analyzer.
METHODS
Whole blood samples were taken by venipuncture or by finger prick from 300 subjects, including HIV-infected patients and HIV (-) controls. CD4 counts were measured by PIMA (using venous or capillary blood) and by FACSCount (using venous blood) considered as the reference.
RESULTS
Similar CD4 counts were obtained by PIMA and FACSCount using either HIV+ venous blood or HIV+ finger-prick blood samples. However, with a concordance coefficient of 0.88 and a Pearson correlation of 0.89, finger-prick blood performed not as good as venous blood (0.97 and 0.98, respectively). For a clinical decision to start ART at 200 CD4 cells per microliter, sensitivity of PIMA was 90%/91% and specificity 98%/96% for venous/finger-prick blood, respectively, and for a treatment threshold of 350 CD4 cells per microliter, the sensitivity was 98%/91% and the specificity was 79%/80% for venous/finger-prick blood, respectively. Repeatability (precision) on venous blood resulted in a coefficient of variation of 4%. Using finger-prick blood, the average instrument error frequency resulting in aborted analyses was 14%.
CONCLUSIONS
PIMA is a good POC instrument for screening adult HIV-infected patients in resource-limited settings for treatment eligibility. Its performance on finger-prick blood is not as good as on venous blood. Adequate training for correct use of finger-prick blood samples is mandatory.
背景
CD4(+) T 细胞计数（CD4 计数）被用作启动抗逆转录病毒疗法（ART）的标准，并用于监测治疗效果。然而，在资源有限的环境中，仍然缺乏简单、经济实惠且可靠的即时护理（POC）仪器。PIMA CD4 分析仪是一种新的用于 CD4 计数的 POC 仪器，它使用一次性卡盒和电池供电的分析仪。
方法
通过静脉穿刺或手指穿刺从 300 名受试者中采集全血样本，包括 HIV 感染者和 HIV（-）对照者。使用 PIMA（使用静脉或毛细血管血）和 FACSCount（使用静脉血）测量 CD4 计数，后者被认为是参考。
结果
使用 PIMA 和 FACSCount 分别使用 HIV+静脉血或 HIV+手指穿刺血样本，均可获得相似的 CD4 计数。然而，吻合系数为 0.88，皮尔逊相关系数为 0.89，手指穿刺血的表现不如静脉血（分别为 0.97 和 0.98）。为了以每微升 200 个 CD4 细胞的临床决策开始 ART，PIMA 的灵敏度为静脉/手指穿刺血分别为 90%/91%，特异性为 98%/96%，而对于每微升 350 个 CD4 细胞的治疗阈值，灵敏度为静脉/手指穿刺血分别为 98%/91%，特异性为 79%/80%。静脉血的重复性（精密度）导致变异系数为 4%。使用手指穿刺血，导致分析中止的仪器误差频率平均为 14%。
结论
PIMA 是一种在资源有限的环境中用于筛选成年 HIV 感染者是否符合治疗条件的良好 POC 仪器。其在手指穿刺血上的性能不如静脉血。必须对正确使用手指穿刺血样本进行充分培训。
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