p24 revisited: a landscape review of antigen detection for early HIV diagnosis.
p24 revisited: a landscape review of antigen detection for early HIV diagnosis.
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DOI：
10.1097/qad.0000000000001982
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发表时间：
2018-09-24
期刊：
影响因子：
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通讯作者：
McKendry RA
中科院分区：
文献类型：
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作者：
Gray ER;Bain R;Varsaneux O;Peeling RW;Stevens MM;McKendry RA
尽管在艾滋病毒检测方面取得了重大进展，但在护理点早期发现感染仍然是一个关键挑战。虽然快速抗体检测和基于实验室的核酸扩增测试主导了诊断市场，但病毒衣壳蛋白p24被认为是感染的替代早期病毒学生物标志物。然而，在大肠杆菌中检测超低水平的p24已被证明具有挑战性。在这里，我们回顾了p24诊断的前景，以确定知识差距和障碍，并帮助塑造未来的研究议程。截至2018年5月，共有574篇研究论文提出或评估了p24的诊断方法。我们给出了诊断发展的简要历史，以及p24作为不同人群（如婴儿、新感染者、暴露前预防者和自我检测者）的生物标志物的效用。我们回顾了商业p24检测的性能，并考虑了免疫复合物破坏，资源匮乏的环境，患病率和检测抗体等因素。新兴的和超灵敏的检测方法进行了审查，并显示了一些有前途的方法，但进一步的翻译已受到限制。我们总结了使用抗原检测的卫生经济效益的研究。最后，我们推测未来使用的高性能p24检测，特别是如果在自我测试格式。
Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. While rapid antibody PoC and laboratory-based nucleic acid amplification tests dominate the diagnostics market, the viral capsid protein p24 is recognized as an alternative early virological biomarker of infection. However, the detection of ultra-low levels of p24 at the PoC has proven challenging. Here we review the landscape of p24-diagnostics to identify knowledge gaps and barriers and help shape future research agendas. 574 research papers to May 2018 that propose or evaluate diagnostic assays for p24 were identified and reviewed. We give a brief history of diagnostic development, and the utility of p24 as a biomarker in different populations such as infants, the newly infected, those on pre-exposure prophylaxis and self-testers. We review the performance of commercial p24 assays and consider elements such as immune complex disruption, resource-poor settings, prevalence, and assay antibodies. Emerging and ultrasensitive assays are reviewed and show a number of promising approaches but further translation has been limited. We summarize studies on the health economic benefits of using antigen testing. Finally, we speculate on the future uses of high performance p24 assays, particularly if available in self-test format.