National HIV Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
Biomed Environ Sci. 2021 Apr 20;34(4):257-264. doi: 10.3967/bes2021.034.
The aim of the present study was to evaluate the performance of the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA using one dried blood spot (DBS) as an alternative sample to plasma.
A total of 571 paired DBS/plasma samples were collected from men who have sex with men (MSM) and injection drug users (IDUs), and serological and molecular assays were performed. Using plasma results as the reference standard, the performance of DBS tests for HIV-1 RNA, HIV-1 DNA, and HCV RNA was evaluated. Pearson's correlation coefficients and Bland-Altman analysis were performed to assess the correlation and concordance between DBS and plasma.
Among paired plasma/DBS samples with detectable HIV-1 RNA and HCV RNA, five samples (5/32) were not detectable in DBS, while measurable HIV-1 RNA levels were present in plasma (1.44 to 3.99 log copies/mL). There were two samples (2/94) with undetectable HCV RNA in DBS, while measurable HCV RNA levels were present in plasma (-5 to 5.99 log copies/mL). The correlation between HIV-1 RNA light chain variable region (VL) values obtained from plasma and DBS showed that = 0.683 ( < 0.01), = 27 and = 0.612 ( < 0.01), = 89 in HCV RNA. Bland-Altman analysis revealed that in HIV-1 RNA, the mean (± SD) difference between HIV-1 RNA in plasma and DBS was 1.00 ± 1.01 log copies/mL, and all samples were within ± 1.96 SD (-0.97 to 2.97 log copies/mL) for DBS. The mean difference (± SD) in HCV RNA was 0.15 ± 1.08 log copies/mL, and 94.38% (84/89) were within ± 1.96 SD (-1.96 to 2.67 log copies/mL). Overall, HIV-1 RNA and HCV RNA levels obtained from a DBS were lower than those obtained from plasma. HIV-1 DNA in a DBS showed concordant results with HIV-1 RNA in plasma. HIV-1 DNA RT-PCR using a DBS showed acceptable performance.
The performance of the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA using one DBS was acceptable. DBS, as an alternative sample to plasma, may be a viable option for the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA in resource-limited settings or for individuals living in areas that are difficult to access.
本研究旨在评估使用一份干血斑（DBS）替代血浆同时检测 HIV-1 RNA、HIV-1 DNA 和 HCV RNA 的性能。
共收集了 571 对来自男男性行为者（MSM）和注射吸毒者（IDU）的 DBS/血浆样本，并进行了血清学和分子学检测。以血浆结果为参考标准，评估了 DBS 检测 HIV-1 RNA、HIV-1 DNA 和 HCV RNA 的性能。采用 Pearson 相关系数和 Bland-Altman 分析评估 DBS 与血浆之间的相关性和一致性。
在可检测到 HIV-1 RNA 和 HCV RNA 的配对血浆/DBS 样本中，有 5 份样本（5/32）在 DBS 中不可检测，而在血浆中存在可检测到的 HIV-1 RNA 水平（1.44 至 3.99 log 拷贝/mL）。有 2 份样本（2/94）在 DBS 中不可检测到 HCV RNA，而在血浆中存在可检测到的 HCV RNA 水平（-5 至 5.99 log 拷贝/mL）。从血浆和 DBS 获得的 HIV-1 RNA 轻链可变区（VL）值之间的相关性表明， = 0.683（ < 0.01）， = 27， = 0.612（ < 0.01）， = 89 用于 HCV RNA。Bland-Altman 分析显示，在 HIV-1 RNA 中，血浆和 DBS 中 HIV-1 RNA 的平均（± SD）差值为 1.00 ± 1.01 log 拷贝/mL，所有样本均在 ± 1.96 SD（-0.97 至 2.97 log 拷贝/mL）范围内（DBS）。HCV RNA 的平均差值（± SD）为 0.15 ± 1.08 log 拷贝/mL，94.38%（84/89）在 ± 1.96 SD 范围内（-1.96 至 2.67 log 拷贝/mL）。总体而言，DBS 中 HIV-1 RNA 和 HCV RNA 水平低于血浆中 HIV-1 RNA 和 HCV RNA 水平。DBS 中的 HIV-1 DNA 与血浆中的 HIV-1 RNA 结果一致。使用 DBS 进行 HIV-1 DNA RT-PCR 显示出可接受的性能。
使用一份 DBS 同时检测 HIV-1 RNA、HIV-1 DNA 和 HCV RNA 的性能是可以接受的。DBS 作为血浆的替代样本，在资源有限的环境中或在难以到达的地区，可能是同时检测 HIV-1 RNA、HIV-1 DNA 和 HCV RNA 的可行选择。
