基于全血的莱姆病单级检测即时检验方法
Whole Blood-Based Point-of-Care Assay for Single-Tier Lyme Disease Testing
AI总结：
本研究开发了WB-xVFA全血多重垂直流检测法，结合智能手机成像与机器学习，可20分钟内从全血实现莱姆病单级检测，在62份样本中灵敏度和特异性约97%，验证了床旁应用的可行性。
AI中文摘要：
直接对全血进行检测的快速即时诊断技术可绕过复杂的样本前处理和中心化实验室基础设施，加快临床决策，但多数血清学检测仍需血清或血浆，限制了床旁应用，莱姆病的诊断尤其依赖中心化的两级血清学检测。本文提出一种全血多重垂直流检测法（WB-xVFA），可直接从50微升全血中进行莱姆病单级血清学检测。该检测结合多层血液过滤与肽图案化硝酸纤维素膜，分离细胞成分并在 cartridge 上检测莱姆病相关的IgM/IgG应答，搭配智能手机成像和机器学习分析，20分钟即可出结果。该检测在血细胞比容高达60%、样本体积25至100微升的范围内均保持稳定，对62份全血样本的盲法测试显示其灵敏度和特异性约为97%，证明了快速床旁全血莱姆病血清学检测的可行性。
英文摘要：
Rapid point-of-care diagnostics that operate directly on whole blood can accelerate clinical decision-making by bypassing complex sample preprocessing and centralized laboratory infrastructure. However, most serologic assays still require serum or plasma, limiting near-patient deployment. This challenge is particularly evident for Lyme disease, whose diagnosis relies on centralized two-tier serology. Here, we present a whole-blood multiplexed vertical flow assay (WB-xVFA) that performs single-tier Lyme serology directly from 50 microliter of whole blood. The assay combines multilayer blood filtration with a peptide-patterned nitrocellulose membrane to separate cellular components and detect Lyme-associated IgM/IgG responses on a cartridge. Coupled with smartphone-based imaging and machine-learning analysis, the WB-xVFA provides results in 20 min. The assay remained robust across hematocrits up to 60% and sample volumes ranging from 25 to 100 microliter. In blinded testing of 62 whole-blood measurements, it achieved ~97% sensitivity and specificity, demonstrating the feasibility of rapid, near-patient whole-blood Lyme serology.
