Duplex Vertical-Flow Rapid Tests for Point-of-Care Detection of Anti-dsDNA and Anti-Nuclear Autoantibodies

dc.contributor.authorLei, Rongwei
dc.contributor.authorArain, Hufsa
dc.contributor.authorWang, David
dc.contributor.authorArunachalam, Janani
dc.contributor.authorSaxena, Ramesh
dc.contributor.authorMohan, Chandra
dc.date.accessioned2024-02-23T15:03:54Z
dc.date.available2024-02-23T15:03:54Z
dc.date.issued2024-02-12
dc.date.updated2024-02-23T15:03:54Z
dc.description.abstractThe 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.
dc.identifierdoi: 10.3390/bios14020098
dc.identifier.citationBiosensors 14 (2): 98 (2024)
dc.identifier.urihttps://hdl.handle.net/10657/16296
dc.titleDuplex Vertical-Flow Rapid Tests for Point-of-Care Detection of Anti-dsDNA and Anti-Nuclear Autoantibodies

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