MICA: Performance evaluation of a point-of-care whole blood viral load test (SAMBA) to optimize HIV treatment in resource-limited settings

MICA：对床旁全血病毒载量测试 (SAMBA) 进行性能评估，以优化资源有限环境中的 HIV 治疗

• 批准号: MR/N027922/1
• 负责人: Helen Lee
• 金额: $ 133.68万
• 依托单位: University of Cambridge
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2016
• 资助国家: 英国
• 起止时间: 2016 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FN027922%2F1
• 关键词: MICA; Performance; evaluation; point; care

As of 2012, 9.7 million individuals were receiving antiretroviral therapy (ART) for treatment of HIV-1 infection in low- and middle-income countries. However, among patients receiving first-line ART, 20-30% will have a detectable viral load after 12 months. The long-term success of ART programmes is heavily dependent on accurate, available and timely viral load monitoring to document viral suppression or indicate the need for second line ART switch. Existing HIV viral load assays require significant infrastructure and highly trained personnel to perform, thus only a few centralised laboratories are capable of viral load testing in most developing countries. Centralised testing leads to poor access to those in need, long turn-around times, delay of results and subsequent loss of patients, all of which lead to sub-optimal ART treatment outcomes, which can cause significant morbidity and mortality.The University of Cambridge, in partnership with Diagnostics for the Real World, has developed an innovative point-of-care nucleic acid amplification test for the diagnosis monitoring the efficacy of HIV treatment by determining of the amount of circulating virus is above or below the threshold for treatment failure. The SAMBA HIV-1 Semi-Q Test allows the patient to be tested and treated in the same visit, thus improving access and treatment outcomes. The plasma-based semi-automated (SAMBA I) assay has received product approval in Malawi, Kenya, Zimbabwe and Uganda and has been used for testing of over 35,500 patients at Médecins sans Frontières (MSF) sites in Malawi and Uganda to date. The SAMBA HIV-1 Semi-Q Test has recently been improved to enable the use of small volume whole blood, using a patented method of filtration. This removes the need for plasma separation, thus increasing utility at lower cadre health clinics and reduces the time to result. In addition a fully automated SAMBA instrument system has been developed, called SAMBA II. The key aims of this proposal are: 1) integrate the whole blood SAMBA HIV-1 Semi-Q Test onto the fully automated SAMBA II instrument, 2) perform an evaluation in house, in Africa and in Europe to evaluate its perforce compared to another CE-marked test and 3) submit for CE-mark. Although the SAMBA test will most likely be used in Africa, a CE-mark is required to allow it to be procured by NGO's.

截至2012年，在低收入和中等收入国家，有970万人正在接受抗逆转录病毒疗法治疗艾滋病毒-1感染。然而，在接受一线抗逆转录病毒治疗的患者中，20-30%的患者在12个月后会有可检测到的病毒载量。抗逆转录病毒治疗方案的长期成功在很大程度上取决于准确、可用和及时的病毒载量监测，以记录病毒抑制或表明需要进行二线抗逆转录病毒治疗切换。现有的艾滋病毒病毒载量检测需要大量的基础设施和训练有素的人员才能进行，因此在大多数发展中国家，只有少数几个中央实验室能够进行病毒载量检测。集中式检测导致难以接触到有需要的人，周转时间长，结果延迟，继而失去患者，所有这些都导致次优的ART治疗结果，这可能会导致显著的发病率和死亡率。剑桥大学与现实世界诊断公司合作，开发了一种创新的医疗点核酸扩增测试，用于通过确定循环病毒量高于或低于治疗失败的阈值来监测艾滋病毒治疗的有效性。Samba HIV-1半Q检测使患者能够在同一次就诊中接受检测和治疗，从而改善了获得机会和治疗结果。基于血浆的半自动(Samba I)检测已经在马拉维、肯尼亚、津巴布韦和乌干达获得了产品批准，迄今已在马拉维和乌干达的无国界医生组织(MSF)地点对超过35,500名患者进行了检测。Samba HIV-1 Semi-Q检测最近得到了改进，使用了一种专利的过滤方法，可以使用小容量全血。这消除了血浆分离的需要，从而增加了低级别干部保健诊所的效用，并缩短了结果的时间。此外，还开发了一个名为Samba II的全自动Samba仪器系统。这项建议的主要目标是：1)将全血Samba HIV-1半定量检测整合到全自动Samba II仪器上，2)在内部、非洲和欧洲进行评估，以评估其与另一种CE标志测试相比的性能，以及3)提交CE标志。虽然Samba测试很可能在非洲使用，但需要CE标志才能由非政府组织采购。

项目成果

Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood).

• DOI: 10.1128/jcm.02555-20
• 发表时间: 2021-02-18
• 期刊: Journal of clinical microbiology
• 影响因子: 9.4
• 作者: Brook G;Stepchenkova T;Ali IM;Chipuka S;Goel N;Lee H
• 通讯作者: Lee H