Evaluation of PIMA Point-of-care CD4 Analyzer in Yunnan, China  

作　　者：Jun Liang Song Duan Yan-Ling Ma Ji-Bao Wang Ying-Zhen Su Hui Zhang Chin-Yih Ou Ling Hao Ming-Shan Qi Marc Bulterys Larry Westerman Yan Jiang Yao Xiao 

机构地区：[1]Department of AIDS/STD Prevention, National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China [2]Department of Laboratory, Tongzhou Blood Center, Beijing 101100, China [3]Department of AIDS/STD Prevention, Dehong Prefecture Center for Disease Control and Prevention, Dehong, Yunnan 678400, China [4]Department of AIDS/STD Prevention, Yunnan Provincial Center for Disease Control and Prevention, Kunming, Yunnan 650022, China [5]Global AIDS Program-China Office, US Center for Disease Control and Prevention, Beijing 100600, China [6]International Laboratory Branch, Division of Global HIV/AIDS, Center for Global Health, U.S. Centers for Disease Control and Prevention, Atlanta, GA 30329, USA

出　　处：《Chinese Medical Journal》2015年第7期890-895,共6页中华医学杂志（英文版）

摘　　要：Background： CD4 count is used to determine antiretroviral therapy （ART） eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance ofAlere PIMA point-of-care CD4 analyzer. Methods： Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results： Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of- 47.0 cells/μl （limit of agreement, [LOA]： -204-110 cells/μl） for venous blood and -71.0 cells/μl （LOA： -295-153 cells/μl） for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value （PPV） of PIMA was 84.2% and 75.7% and the negative predictive value （NPV） was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions： CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.Background： CD4 count is used to determine antiretroviral therapy （ART） eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance ofAlere PIMA point-of-care CD4 analyzer. Methods： Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results： Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of- 47.0 cells/μl （limit of agreement, [LOA]： -204-110 cells/μl） for venous blood and -71.0 cells/μl （LOA： -295-153 cells/μl） for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value （PPV） of PIMA was 84.2% and 75.7% and the negative predictive value （NPV） was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions： CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.

关 键 词：CD4 Counts Finger-prick HIV POINT-OF-CARE Venous Blood 

分 类 号：Q2-33[生物学—细胞生物学] TH776.2[机械工程—仪器科学与技术]