Abstract：
Globally, hepatitis B virus (HBV) affects over 250 million people, whereas hepatitis C virus (HCV) affects approximately 70 million people, posing major public health challenges. Despite the availability of vaccines and treatments, a lack of comprehensive diagnostic coverage has left many cases undiagnosed and untreated. To address the need for sensitive, specific, and accessible diagnostics, this study introduced a multiplex loop-mediated isothermal amplification assay with lateral flow detection for simultaneous HBV and HCV testing. This assay achieved exceptional sensitivity and was capable of detecting HBV and HCV concurrently in a single tube and on a single strip within 25 min, achieving the required clinical sensitivity (10 and 103 genomic copies/reaction for HBV and HCV, respectively). The method was validated in clinical samples of various viral genotypes, achieving an equivalent limit of detection. Additionally, a custom portable heating device was developed for field use. The assay developed here, capable of direct viral detection on the strip, shows promise in supplanting current methods that solely identify antibodies and necessitate additional qPCR for viral activity assessment. This economical and rapid assay aligns with point-of-care testing needs, offering significant advancements in enhancing viral hepatitis diagnostics in settings with limited resources.
摘要：
全球范围内,乙型肝炎病毒（HBV）影响超过250万人，而丙型肝炎病毒（HCV）影响大约7000万人，构成重大公共卫生挑战。尽管有疫苗和治疗方法，缺乏全面的诊断覆盖导致许多病例未得到诊断和治疗。为了解决对敏感的需求，具体,和可访问的诊断，这项研究引入了一种多重环介导等温扩增测定法，该测定法具有侧流检测，可同时进行HBV和HCV检测。该测定实现了卓越的灵敏度，并能够在25分钟内同时在单管和单条上检测HBV和HCV，实现所需的临床敏感性（10和103基因组拷贝/反应为HBV和HCV，分别)。该方法在各种病毒基因型的临床样本中得到了验证，实现等效的检测限。此外,一种定制的便携式加热装置被开发用于现场使用。这里开发的检测方法，能够在带上直接检测病毒，显示了替代仅鉴定抗体并需要额外的qPCR进行病毒活性评估的当前方法的希望。这种经济、快速的检测方法符合即时检测需求，在资源有限的环境中增强病毒性肝炎诊断方面提供了重大进展。
