This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results were compared against the BD FACSCalibur for enumerating AbsCD4 and CD4% and Sysmex XT-4000i hematology analyzer for determining Hb levels. Method comparison studies were performed using Deming regression and Bland-Altman plots. The Deming regression analyses comparing the accuracy of the BD FACSPresto system with the reference standard technologies demonstrated a significant linear correlation between the AbsCD4, CD4%, and Hb values generated by the two platforms. The 95% CI of the slopes for AbsCD4, CD4%, and Hb levels were 0.94-0.99, 0.99-1.01 and 0.86-0.93, respectively (P<0.001). Bland-Altman plots for AbsCD4, CD4%, and Hb levels demonstrated close agreement between the BD FACSPresto system and the reference standards for all study participants. The performance and accuracy of BD FACSPresto system was comparable to the reference standard technologies. The BD FACSPresto system can be used interchangeably with BD FACSCalibur platform for CD4 and Sysmex XT-4000i hematology analyzer for Hb concentrations in resource-limited settings thus, improving accessibility to point-of-care testing services.
基金：
BD Biosciences (San Jose, CA, USA); Emergency Research Project of Shanghai Science and Technology Commission [20411950502]; Major Special Project of National Ministry of Science and Technology of the 13th Five-year Plan [2018ZX10714002-001-005]
第一作者机构：[1]Capital Med Univ, Beijing Youan Hosp, Ctr Infect Dis, Beijing, Peoples R China[2]Beijing Key Lab HIV AIDS Res, Beijing, Peoples R China
共同第一作者：
通讯作者：
通讯机构：[1]Capital Med Univ, Beijing Youan Hosp, Ctr Infect Dis, Beijing, Peoples R China[2]Beijing Key Lab HIV AIDS Res, Beijing, Peoples R China
推荐引用方式(GB/T 7714)：
Lu Xiaofan,Sun Hanxiao,Li Haicong,et al.Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects[J].SCIENTIFIC REPORTS.2020,10(1):doi:10.1038/s41598-020-76549-6.
APA：
Lu, Xiaofan,Sun, Hanxiao,Li, Haicong,Xia, Wei,Wu, Hao...&Zhu, Zhaoqin.(2020).Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects.SCIENTIFIC REPORTS,10,(1)
MLA：
Lu, Xiaofan,et al."Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects".SCIENTIFIC REPORTS 10..1(2020)
