Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood).
Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood).
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DOI：
10.1128/jcm.02555-20
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发表时间：
2021-02-18
影响因子：
9.4
通讯作者：
Lee H
中科院分区：
文献类型：
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作者：
Brook G;Stepchenkova T;Ali IM;Chipuka S;Goel N;Lee H
许多低收入和中等收入 (LMI) 国家的偏远地区很难获得艾滋病毒病毒载量 (HIV VL) 检测。 SAMBA II（基于简单扩增的检测）Semi-Q 全血检测（英国剑桥的现实世界诊断 [DRW]）是一种即时检测检测，它使用白细胞去除技术来允许在远程环境中进行全血检测。许多低收入和中等收入 (LMI) 国家的偏远地区很难获得艾滋病毒病毒载量 (HIV VL) 检测。 SAMBA II（基于简单扩增的检测）Semi-Q 全血检测（英国剑桥的现实世界诊断 [DRW]）是一种即时检测检测，它使用白细胞去除技术来允许在远程环境中进行全血检测。喀麦隆（250 名）、英国（633 名）、乌克兰（412 名）和津巴布韦（245 名）总共 1,540 名连续的 HIV 阳性临床患者捐献了静脉血（所有国家）和指尖采血（除英国外的所有国家）用于 SAMBA II 测试。将 SAMBA II 结果与 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 ≥1,000 RNA 拷贝/ml。对于 SAMBA II 测试的 1,528 个静脉全血样本，与 HIV VL ≥1,000 拷贝/ml 截止值的参考测试的总体一致性百分比为 96.9%（1,480/1,528；95% 置信区间 [CI]，95.9% 至 97.7%），阴性一致性百分比为 97.7% （1,259/1,289；95% CI， 96.7% 至 98.4%），阳性一致性百分比为 92.5%（221/239；95% CI，88.4% 至 95.5%）。对于 854 个手指采血样本，总体一致性百分比为 95.0%（811/854；95% CI，93.3% 至 96.3%），阴性一致性百分比为 98.0%（625/638；95% CI，96.5% 至 98.9%），阴性一致性百分比为 86.1%（186/216；95% CI， 80.8% 到 90.4%）的正百分比一致。排除乌克兰中心的异常结果后，这一比例上升至 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 与基于实验室的测定之间高度一致。 SAMBA-II 的性能适合在远程环境中用作 VL 现场检测。
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. 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.