Médecins sans Frontières, Paris, France.
Epicentre, Paris, France.
Trop Med Int Health. 2021 Feb;26(2):184-194. doi: 10.1111/tmi.13519. Epub 2020 Dec 3.
We monitored a large-scale implementation of the Simple Amplification-Based Assay semi-quantitative viral load test for HIV-1 version I (SAMBA I Viral Load = SAMBA I VL) within Médecins Sans Frontières' HIV programmes in Malawi and Uganda, to assess its performance and operational feasibility.
Descriptive analysis of routine programme data between August 2013 and December 2016. The dataset included samples collected for VL monitoring and tested using SAMBA I VL in five HIV clinics in Malawi (four peripheral health centres and one district hospital), and one HIV clinic in a regional referral hospital in Uganda. SAMBA I VL was used for VL testing in patients who had been receiving ART for between 6 months and ten years, to determine whether plasma VL was above or below 1000 copies/mL of HIV-1, reflecting ART failure or efficacy. Randomly selected samples were quantified with commercial VL assays. SAMBA I instruments and test performance, site throughput, and delays in communicating results to clinicians and patients were monitored.
Between August 2013 and December 2016 a total of 60 889 patient samples were analysed with SAMBA I VL. Overall, 0.23% of initial SAMBA I VL results were invalid; this was reduced to 0.04% after repeating the test once. Global test failure, including instrument failure, was 1.34%. Concordance with reference quantitative testing of VL was 2620/2727, 96.0% (1338/1382, 96.8% in Malawi; 1282/1345, 95.3% in Uganda). For Chiradzulu peripheral health centres and Arua Hospital HIV clinic, where testing was performed on-site, same-day results were communicated to clinicians for between 91% and 97% of samples. Same-day clinical review was obtained for 84.7% across the whole set of samples tested.
SAMBA I VL testing is feasible for monitoring cohorts of 1000 to 5000 ART-experienced patients. Same-day results can be used to inform rapid clinical decision-making at rural and remote health facilities, potentially reducing time available for development of resistance and conceivably helping to reduce morbidity and mortality.
我们监测了无国界医生组织在马拉维和乌干达的艾滋病毒规划中大规模实施的基于简单扩增的 HIV-1 版本 I 半定量病毒载量检测（SAMBA I 病毒载量=SAMBA I VL），以评估其性能和操作可行性。
对 2013 年 8 月至 2016 年 12 月期间的常规规划数据进行描述性分析。该数据集包括在马拉维五个艾滋病毒诊所（四个基层卫生中心和一个区医院）收集的用于病毒载量监测的样本，并在乌干达一个地区转诊医院的一个艾滋病毒诊所收集了用于测试 SAMBA I VL 的样本。SAMBA I VL 用于检测接受抗逆转录病毒治疗 6 个月至 10 年的患者的病毒载量，以确定血浆 HIV-1 病毒载量是否高于或低于 1000 拷贝/毫升，反映抗逆转录病毒治疗失败或疗效。随机选择的样本用商业 VL 检测进行定量分析。监测了 SAMBA I 仪器和测试性能、站点吞吐量以及向临床医生和患者传达结果的延迟。
2013 年 8 月至 2016 年 12 月期间，共有 60889 份患者样本用 SAMBA I VL 进行了分析。总体而言，初始 SAMBA I VL 结果无效的比例为 0.23%；重复测试一次后，这一比例降至 0.04%。包括仪器故障在内的全球测试失败率为 1.34%。与参考定量 VL 检测的一致性为 2620/2727，96.0%（马拉维 1338/1382，96.8%；乌干达 1282/1345，95.3%）。在 Chiradzulu 基层卫生中心和 Arua 医院艾滋病毒诊所，现场进行了检测，91%至 97%的样本当天将结果告知了临床医生。整个检测样本中，84.7%当天进行了临床审查。
SAMBA I VL 检测可用于监测 1000 至 5000 名接受过抗逆转录病毒治疗的患者队列。当天的结果可用于指导农村和偏远地区卫生设施的快速临床决策，有可能减少产生耐药性的时间，并可以帮助降低发病率和死亡率。
