Instituto Nacional da Saúde, Marracuene, Mozambique.
CIH LMU Center for International Health, University Hospital, LMU Munich, Munich, Germany.
J Acquir Immune Defic Syndr. 2021 May 1;87(1):693-699. doi: 10.1097/QAI.0000000000002621.
Timely viral load (VL) results during pregnancy and the postpartum period are crucial for HIV disease management and for preventing mother-to-child transmission. Point-of-care (POC) VL testing could reduce turnaround times and streamline patient management. We evaluated the diagnostic performance of the novel m-PIMA HIV-1/2 VL assay (Abbott, Chicago, IL) in Mozambique.
The study was conducted in prenatal and postpartum consultation rooms in 2 primary health care clinics. Sample collection and testing on m-PIMA were performed by trained nurses.
HIV-infected pregnant and postpartum women on antiretroviral treatment (ART) or ART naive were tested using both on-site m-PIMA POC and referral laboratory-based real-time VL assays. Linear regression analysis and Bland-Altman plots were used to calculate the agreement between both.
Correlation between venous blood plasma POC and plasma laboratory-based VL was strong (r2 = 0.850, P < 0.01), with good agreement between the methods [overall bias 0.202 log copies/mL (95% CI: 0.366 to 0.772 log copies/mL)]. Using the threshold of 1000 copies/mL, which is used to determine ART failure, the sensitivity and specificity of the POC VL assay were 95.0% (95% CI: 91.6% to 97.3%) and 96.5% (95% CI: 94.2% to 98.0%), respectively. The correlation coefficient between the venous and capillary sample types was 0.983 (r2 = 0.966).
On-site, nurse-performed POC VL testing is feasible and accurate in resource-limited primary health care settings. The operational challenge of plasma separation within clinics for POC testing was successfully overcome using minicentrifuges. The use of capillary blood could simplify the execution of the assay in a clinical environment.
怀孕期间和产后及时获得病毒载量 (VL) 结果对于 HIV 疾病管理和预防母婴传播至关重要。即时检测 (POC) 技术可缩短周转时间，简化患者管理。我们评估了新型 m-PIMA HIV-1/2 VL 检测（雅培，芝加哥，伊利诺伊州）在莫桑比克的诊断性能。
该研究在 2 家初级保健诊所的产前和产后咨询室进行。经培训的护士在现场进行 m-PIMA 样本采集和检测。
对接受抗逆转录病毒治疗 (ART) 的 HIV 感染孕妇和产后妇女或接受 ART 治疗的 HIV 感染孕妇和产后妇女进行检测，分别使用现场 m-PIMA POC 和基于实验室的实时 VL 检测。采用线性回归分析和 Bland-Altman 图计算两种方法之间的一致性。
静脉血血浆 POC 和实验室基于血浆的 VL 之间具有很强的相关性（r2 = 0.850，P < 0.01），两种方法之间具有良好的一致性[总体偏差 0.202 log 拷贝/mL（95%CI：0.366 至 0.772 log 拷贝/mL）]。使用确定 ART 失败的 1000 拷贝/mL 阈值，POC VL 检测的灵敏度和特异性分别为 95.0%（95%CI：91.6%至 97.3%）和 96.5%（95%CI：94.2%至 98.0%）。静脉和毛细血管样本类型之间的相关系数为 0.983（r2 = 0.966）。
在资源有限的初级保健环境中，现场、护士执行的 POC VL 检测是可行且准确的。使用微型离心机成功克服了在诊所内进行 POC 检测时血浆分离的操作挑战。在临床环境中使用毛细血管血可简化检测的执行。
