Remote areas of many low and middle income (LMI) countries have poor access to HIV viral load (HIV VL) testing. The SAMBA II (simple amplification-based assay) Semi-Q whole-blood test (Diagnostics for the Real World [DRW], Cambridge, UK) is a point-of-care assay, which uses leucodepletion technology to allow whole-blood testing in remote settings. A total of 1,540 consecutive HIV-positive clinic patients in Cameroon (250), United Kingdom (633), Ukraine (412), and Zimbabwe (245) donated venous blood (all countries) and finger prick blood (all except UK) for testing on SAMBA II. SAMBA II results were compared with simultaneous plasma results on the Abbott RealTime HIV-1 (Abbott Molecular, Des Plaines, IL) viral load assay and interpreted as either <1,000 RNA copies/ml or ≥1,000 RNA copies/ml. For 1,528 venous whole-blood samples tested on SAMBA II, overall percent agreement with the reference test at a cutoff HIV VL of ≥1,000 copies/ml was 96.9% (1,480/1,528; 95% confidence interval [CI], 95.9% to 97.7%), negative percent agreement was 97.7% (1,259/1,289; 95% CI, 96.7% to 98.4%), and positive percent agreement was 92.5% (221/239; 95% CI, 88.4% to 95.5%). For 854 finger prick samples, there was 95.0% (811/854; 95% CI, 93.3% to 96.3%) overall percent agreement, 98.0% (625/638; 95% CI, 96.5% to 98.9%) negative percent agreement, and 86.1% (186/216; 95% CI, 80.8% to 90.4%) positive percent agreement. These rose to 93.5% (82.1% to 98.6%), 97.6% (95.6% to 98.8%), and 95.6% (93.3% to 97.3%) after exclusion of aberrant results from the Ukraine center. These results show a high level of agreement between SAMBA-II and a laboratory-based assay. SAMBA-II has a performance that is suitable to use as a VL point-of-care assay in remote settings.

中文翻译：

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评价现场护理全血HIV病毒载量测试（SAMBA II HIV-1 Semi-Q全血）的性能的研究

许多中低收入国家（LMI）的偏远地区无法获得HIV病毒载量（HIV VL）检测。SAMBA II（基于简单扩增的测定）Semi-Q全血测试（诊断为“现实世界” [DRW]，英国剑桥）是一种即时护理测定，它使用leucodepletion技术进行全血测试在远程设置中。喀麦隆（250），英国（633），乌克兰（412）和津巴布韦（245）的1,540名连续HIV阳性临床患者捐赠了静脉血（所有国家）和手指刺血（所有英国除外）进行测试在SAMBA II上。将SAMBA II结果与通过Abbott RealTime HIV-1（Abbott Molecular，Des Plaines，IL）病毒载量测定的同时血浆结果进行比较，并解释为<1,000 RNA拷贝/ ml或≥1,000RNA拷贝/ ml。对于1 在SAMBA II上测试的528份静脉全血样品，在≥1,000拷贝/ ml的HIV VL临界值下与参考测试的总体百分率为96.9％（1,480 / 1,528； 95％的置信区间[CI]从95.9％至97.7％ ），负百分比一致性为97.7％（1,259 / 1,289; 95％CI，96.7％至98.4％），正百分比一致性为92.5％（221/239; 95％CI，88.4％至95.5％）。对于854个手指点刺样品，总体百分比一致性为95.0％（811/854； 95％CI为93.3％至96.3％），负百分比一致性为98.0％（625/638; 95％CI为96.5％至98.9％），和86.1％（186/216; 95％CI，80.8％至90.4％）的肯定百分比。从乌克兰中心排除异常结果后，这些数字上升至93.5％（82.1％至98.6％），97.6％（95.6％至98.8％）和95.6％（93.3％至97.3％）。这些结果表明，SAMBA-II和基于实验室的测定法之间的一致性很高。