Field Evaluation of a Point-of-Care CD4 Analyzer for Monitoring HIV Patients in the Interior of the Amazon Region, Brazil.
Field Evaluation of a Point-of-Care CD4 Analyzer for Monitoring HIV Patients in the Interior of the Amazon Region, Brazil.
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DOI：
10.1371/journal.pone.0121400
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发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Benzaken AS
中科院分区：
文献类型：
--
作者：
Pinto IC;Sabidó M;Pereira AB;Mello MB;de Melo Xavier Shimizu A;Protti BL;Benzaken AS
评价PIMA床旁CD 4分析仪（PIMA）在现场条件下与当前CD 4计数系统（FACSCalibur）相比的准确性，并评价在亚马逊地区的卫生诊所中使用PIMA的卫生专业人员（HP）和HIV患者的操作适用性和可接受性。在现场由PIMA使用手指采血测量CD 4计数，在参考实验室由PIMA和FACSCalibur使用静脉血测量CD 4计数。我们使用Bland-Altman方法估计平均偏倚，并计算<200和<500 cell/μL阈值时的灵敏度和特异性。就PIMA的可接受性和操作适用性对患者（n = 404）和HP（n = 7）进行了访谈。使用手指采血（n = 337），PIMA显示一致性相关系数（Rc）为0.81，在<200和<500个细胞/μL阈值时的平均差异为-111.9个细胞/μL，灵敏度分别为93.1%/98.5%和89.2%/56.7%。静脉血（n = 340）显示Rc为0.89，平均差异为-83.4个细胞/μL，在<200和<500个细胞/μL阈值时，灵敏度分别为98.3%/97.5%，特异性分别为93.9%/66.0%。毛细血管PIMA被患者和HP广泛接受并发现操作适当。两种仪器之间的一致性较差，PIMA低估了CD 4细胞计数，这在CD 4计数≥500个细胞/μl时更为明显。PIMA对指尖血的检测结果不如对静脉血的检测结果可靠。在巴西，抗逆转录病毒治疗的启动与CD 4计数无关，PIMA对CD 4低估的系统性偏见可能会限制其监测艾滋病毒患者的作用。
To evaluate the accuracy of the PIMA point-of-care CD4 analyzer (PIMA) under field conditions in comparison to the current CD4 count system (FACSCalibur), and to evaluate the operational suitability and acceptability of health professionals (HP) and HIV-patients in using the PIMA in health clinics in the Amazon Region. CD4 counts were measured onsite by the PIMA using fingerprick blood and in the reference laboratory by both the PIMA and FACSCalibur using venous blood. We used the Bland–Altman method to estimate the mean bias, and calculated the sensitivity and specificity at <200 and <500 cell/μL thresholds. Patients (n = 404) and HP (n = 7) were interviewed on the acceptability and operational suitability of the PIMA. Using fingerprick blood (n = 337), the PIMA showed a concordance correlation coefficient (Rc) of 0.81, mean difference of -111.9 cell/μL, 93.1%/98.5% sensitivity, and 89.2%/56.7% specificity at <200 and <500 cell/μL thresholds, respectively. Venous blood (n = 340) showed an Rc of 0.89, mean difference of -83.4 cell/μL, 98.3%/97.5% sensitivity, and 93.9%/66.0% specificity at <200 and <500 cell/μL thresholds, respectively. The capillary PIMA was well accepted and found operationally appropriate by patients and HP. The agreement between both instruments was poor and the PIMA underestimated CD4 cell counts, which was more pronounced at CD4 counts ≥500 cell/μl. The PIMA’s performance with fingerprick blood was less reliable than its performance with venous blood. In Brazil, where antiretroviral treatment is initiated regardless of CD4 counts, the PIMA’s systematic bias towards CD4 underestimation may limit its role for monitoring HIV-patients.
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影响因子：
2.2
作者：
Shott JP;Galiwango RM;Reynolds SJ
通讯作者：
Reynolds SJ
影响因子：
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作者：
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影响因子：
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作者：
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Rosen, Sydney
DOI：
10.1097/qai.0b013e31822866a2
发表时间：
2011-10-01
影响因子：
3.6
作者：
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通讯作者：
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