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

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治疗，以治疗艾滋病毒-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个月后仍可检测到病毒载量。抗逆转录病毒疗法规划的长期成功在很大程度上取决于准确、可获得和及时的病毒载量监测，以记录病毒抑制或提示是否需要切换二线抗逆转录病毒疗法。现有的艾滋病毒载量检测需要大量的基础设施和训练有素的人员来执行，因此在大多数发展中国家只有少数集中实验室能够进行病毒载量检测。集中检测导致难以获得有需要的人，周转时间长，结果延迟以及随后的患者损失，所有这些都导致抗逆转录病毒治疗结果不理想，这可能导致严重的发病率和死亡率。剑桥大学与“真实世界诊断”合作，开发了一种创新的即时护理核酸扩增检测，通过确定循环病毒的数量高于或低于治疗失败的阈值，用于诊断监测艾滋病毒治疗的效果。SAMBA HIV-1半q测试允许患者在同一次就诊中进行检测和治疗，从而改善了可及性和治疗效果。基于血浆的半自动（SAMBA I）化验已在马拉维、肯尼亚、津巴布韦和乌干达获得产品批准，迄今已在马拉维和乌干达的无国界医生组织（MSF）站点用于检测35,500多名患者。SAMBA HIV-1半q测试最近得到了改进，可以使用小容量全血，使用专利过滤方法。这消除了对血浆分离的需要，从而增加了基层卫生诊所的效用，并缩短了获得结果的时间。此外，还开发了一个完全自动化的SAMBA仪器系统，称为SAMBA II。该提案的主要目标是：1)将全血SAMBA HIV-1半q测试整合到全自动SAMBA II仪器上；2)在国内、非洲和欧洲进行评估，以评估其与另一种ce标志测试相比的效果；3)提交ce标志。尽管SAMBA测试很可能在非洲使用，但非政府组织需要ce标志才能获得。

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.