title: A lateral flow paper microarray for rapid allergy point of care diagnostics.
abstract: There is a growing need for multiplexed specific IgE tests that can accurately evaluate patient sensitization profiles. However, currently available commercial tests are either single/low-plexed or require sophisticated instrumentation at considerable cost per assay. Here, we present a novel convenient lateral flow microarray-based device that employs a novel dual labelled gold nanoparticle-strategy for rapid and sensitive detection of a panel of 15 specific IgE responses in 35 clinical serum samples. Each gold nanoparticle was conjugated to an optimized ratio of HRP and anti-IgE, allowing significant enzymatic amplification to improve the sensitivity of the assay as compared to commercially available detection reagents. The mean inter-assay variability of the developed LFM assay was 12% CV, and analysis of a cohort of clinical samples (n = 35) revealed good general agreement with ImmunoCAP, yet with a varying performance among allergens (AUC = [0.54-0.88], threshold 1 kU). Due to the rapid and simple procedure, inexpensive materials and read-out by means of a consumer flatbed scanner, the presented assay may provide an interesting low-cost alternative to existing multiplexed methods when thresholds >1 kU are acceptable.
authors.affiliation: Division of Proteomics and Nanobiotechnology, Science for Life Laboratory, KTH-Royal Institute of Technology, P-Box 1031, 171 21 Solna, Stockholm, Sweden. helene.andersson.svahn@scilifelab.se.
authors.forename: Thiruppathiraja
authors.initials: T
authors.lastname: Chinnasamy
authors.forename: Loes I
authors.initials: LI
authors.lastname: Segerink
authors.forename: Mats
authors.initials: M
authors.lastname: Nystrand
authors.forename: Jesper
authors.initials: J
authors.lastname: Gantelius
authors.forename: Helene Andersson
authors.initials: HA
authors.lastname: Svahn
mesh_terms: D000485:Allergens / Q000032:analysis; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis*; D007073:Immunoglobulin E / Q000032:analysis; D053768:Metal Nanoparticles; D046529:Microscopy, Electron, Transmission; D010209:Paper; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000485:Allergens; D007073:Immunoglobulin E