摘要目的 本研究旨在评价便携式CD4细胞计数分析仪(PIMA)的应用价值.方法 样品采自2012年5-8月在云南省CDC的自愿咨询检测点(voluntary counseling and testing,VCT)门诊进行CD4细胞检测的HIV感染者,共196例,采集其25μl末梢血及5ml静脉血.使用PIMA分析仪检测同一HIV感染者末梢血及静脉血CD4细胞计数,同时采用Calibur分析仪进行静脉血检测,以其检测结果作为参比,采用Wilcoxon配对检验及Spearman秩相关分析两种仪器检测CD4细胞计数的差异及相关性,采用Bland-Altman法评价两种分析仪检测结果的一致性.结果 PIMA与Calibur分析仪检测静脉血(196份)CD4细胞计数的中位数(四分位数)分别为268(169 ～ 403)个/μl和302(181 ～ 474)个/μl,差异有统计学意义(Z=-7.31,P＜0.01)；PIMA分析仪检测188份末梢血与相应Calibur分析仪检测静脉血CD4细胞计数的中位数(四分位数)分别为271(165 ～450)个/μl和304(188 ～ 476)个/μl,差异有统计学意义(Z=-7.60,P＜0.01).PIMA分析仪检测静脉血及末梢血CD4细胞计数与Calibur分析仪的检测结果均呈正相关(r值分别为0.94、0.92,P值均＜0.01)；平均偏倚分别为-38.7(-210.9 ～133.5)个/μl和-45.4(-221.8 ～ 131.0)个/μl.以CD4细胞计数350个/μl为抗病毒治疗阈值时,PIMA分析仪检测静脉血的灵敏度和特异度分别为99.1％及79.3％,检测末梢血的灵敏度和特异度分别为97.2％及78.5％.结论 PIMA CD4细胞分析仪的检测值较Calibur偏低,但灵敏度较高.

abstractsObjective This study is aimed at evaluating the utility of the portable CD4 analyzersb (PIMA).Methods The paired finger prick blood (25 μl) and 5 ml venous blood samples were collected from 196 HIV infected patients,who came to Yunnan CDC voluntary counseling and testing(VCT) clinic for CD4 test services,from May to August,2012.The absolute CD4 cell counts were measured by PIMA (using venous and finger-prick blood) and by Calibur (using venous blood) as the reference.The PIMA and Calibur CD4 results were compared using the Wilcoxon matched-pairs test,and the Spearman's rank correlation coefficients were estimated.The Bland-Altman plots were used to assess the consistency of the two methods.Results The median absolute CD4 counts of 196 venous blood samples obtained by PIMA and by Calibur were 268 (range:169-403) cells/μl and 302 (range:181-474) cells/μl respectively,which showed significant difference (Z =-7.31,P ＜ 0.01).The median absolute CD4 counts measured by PIMA and by Calibur (using 188 finger-prick and venous blood samples respectively) were 271 (range:165-450)cells/μl and 304 (range:188-476) cells/μl,which also showed significant difference (Z =-7.60,P ＜0.01).The CD4 counts obtained by PIMA CD4 analyzer (using venous and finger-prick blood) showed strong positive correlation with the CD4 counts obtained by the reference method (using venous blood),and the r values were 0.94 and 0.92 respectively (P ＜ 0.01).The mean biases (limit of agreement) were -38.7 (-210.9-133.5) cells/μl and-45.4 (-221.8-131.0) cells/μl,respectively.Using 350 CD4 counts as the threshold for ART treatment initiation,the sensitivity and specificity of PIMA were 99.1％ and 79.3％ for venous blood samples,and 97.2％ and 78.5％ for finger-prick blood samples,respectively.Conclusion The CD4 counts obtained by PIMA are lower than that obtained by Calibur,while the sensitivity is high.