Kenya Medical Research Institute, Nairobi, Kenya.
Hologic, Inc., San Diego, CA, United States of America.
PLoS One. 2021 Apr 2;16(4):e0249376. doi: 10.1371/journal.pone.0249376. eCollection 2021.
Quantification of HIV-1 RNA is essential for clinical management of HIV patients. The limited throughput and significant hands-on time required by most HIV Viral load (VL) tests makes it challenging for laboratories with high test volume, to turn around patient results quickly. The Hologic Aptima HIV-1 Quant Dx Assay (Aptima), has the potential to alleviate this burden as it is high throughput and fully automated. This assay is validated for both plasma and dried blood spots (DBS), which are commonly used in resource limited settings. The objective of this study was to compare the performance of Aptima to Abbott RealTime HIV-1 Assay (Abbott RT), which was used as reference. This was a cross-sectional prospective study where HIV VL in finger stick (FS) DBS, venous blood (VB) DBS and plasma, collected from 258 consenting adults visiting 5 medical facilities in Kenya, Africa were tested in Aptima. The results were compared to plasma VL in Abbott RT at the medical decision point (MDP) of 1000 copies/mL and across Aptima assay range. The total agreement at MDP between plasma HIV VL in Abbott RT and plasma, FS and VB DBS tested in Aptima were 97.7%, 92.2% and 95.3% respectively with kappa statistic of 0.95, 0.84 and 0.90. The positive and negative agreement for all 3 sample types were >92%. Regression analysis between VL in Abbott RT plasma and various sample types tested in Aptima had a Pearson's correlation coefficient ≥0.91 with systematic bias of < 0.20 log copies/mL on Bland-Altman analysis. The high level of agreement in Aptima HIV VL results for all 3 sample types with Abbott RT plasma VL along with the high throughput, complete automation, and ease of use of the Panther platform makes Aptima a good option for HIV VL monitoring for busy laboratories with high volume of testing.
定量检测 HIV-1 RNA 对于 HIV 患者的临床管理至关重要。大多数 HIV 病毒载量（VL）检测的通量有限，且需要大量人工操作，这使得检测量大的实验室难以快速获得患者的检测结果。Hologic Aptima HIV-1 Quant Dx 检测（Aptima）具有高通量和全自动的特点，有潜力缓解这一负担。该检测已在血浆和干血斑（DBS）上得到验证，而这两种标本在资源有限的环境中通常都有使用。本研究旨在比较 Aptima 与 Abbott RealTime HIV-1 检测（Abbott RT）的性能，Abbott RT 作为参考方法。这是一项横断面前瞻性研究，在肯尼亚的 5 家医疗机构中，对 258 名同意参与的成年人进行了手指刺血（FS）DBS、静脉血（VB）DBS 和血浆样本采集，并用 Aptima 检测这些样本中的 HIV VL。结果与 Abbott RT 在 1000 拷贝/mL 医学决策点（MDP）和 Aptima 检测范围内的血浆 VL 进行比较。Abbott RT 血浆 HIV VL 与 Aptima 检测的血浆、FS 和 VB DBS 在 MDP 处的总符合率分别为 97.7%、92.2%和 95.3%，kappa 统计值分别为 0.95、0.84 和 0.90。所有 3 种样本类型的阳性和阴性符合率均>92%。Abbott RT 血浆与 Aptima 检测各种样本类型之间的 VL 进行回归分析，Pearson 相关系数≥0.91，Bland-Altman 分析显示系统偏差<0.20 log 拷贝/mL。Aptima 检测所有 3 种样本类型的 HIV VL 结果与 Abbott RT 血浆 VL 高度一致，加上 Panther 平台高通量、完全自动化和易于使用的特点，使 Aptima 成为检测量大的繁忙实验室 HIV VL 监测的一个不错选择。
