Department Biomedical Engineering, University of Houston, Houston, TX 77204, USA.
John Sealy School of Medicine, UT Medical Branch, Galveston, TX 77555, USA.
Biosensors (Basel). 2024 Feb 12;14(2):98. doi: 10.3390/bios14020098.
The goal of this study is to develop a rapid diagnostic test for rheumatic disease and systemic lupus erythematosus (SLE) screening. A novel rapid vertical flow assay (VFA) was engineered and used to assay anti-nuclear (ANA) and anti-dsDNA (αDNA) autoantibodies from systemic lupus erythematosus (SLE) patients and healthy controls (HCs). Observer scores and absolute signal intensities from the VFA were validated via ELISA. The rapid point-of-care VFA test that was engineered demonstrated a limit of detection of 0.5 IU/mL for ANA and αDNA autoantibodies in human plasma with an inter-operator CV of 19% for ANA and 12% for αDNA. Storage stability was verified over a three-month period. When testing anti-dsDNA and ANA levels in SLE and HC serum samples, the duplex VFA revealed 95% sensitivity, 72% specificity and an 84% ROC AUC value in discriminating disease groups, comparable to the gold standard, ELISA. The rapid αDNA/ANA duplex VFA can potentially be used in primary care clinics for evaluating patients or at-risk subjects for rheumatic diseases and for planning follow-up testing. Given its low cost, ease, and rapid turnaround, it can also be used to assess SLE prevalence estimates.
本研究旨在开发一种用于风湿性疾病和系统性红斑狼疮（SLE）筛查的快速诊断检测方法。设计了一种新型快速垂直流动分析（VFA），用于检测系统性红斑狼疮（SLE）患者和健康对照（HC）的抗核（ANA）和抗双链 DNA（αDNA）自身抗体。通过 ELISA 验证了 VFA 的观察者评分和绝对信号强度。设计的快速即时护理 VFA 测试在人血浆中对 ANA 和 αDNA 自身抗体的检测限为 0.5 IU/mL，ANA 的操作者间 CV 为 19%，αDNA 为 12%。在三个月的时间里验证了存储稳定性。在检测 SLE 和 HC 血清样本中的抗 dsDNA 和 ANA 水平时，双链 VFA 在区分疾病组方面显示出 95%的灵敏度、72%的特异性和 84%的 ROC AUC 值，与金标准 ELISA 相当。快速的 αDNA/ANA 双链 VFA 可潜在地用于初级保健诊所评估风湿性疾病患者或高危人群，并计划进行后续检测。鉴于其成本低、操作简单和快速周转，也可用于评估 SLE 的患病率估计。
