title: A rapid lateral flow immunoassay for the detection of tyrosine phosphatase-like protein IA-2 autoantibodies in human serum.
abstract: Type 1 diabetes (T1D) results from the destruction of pancreatic insulin-producing beta cells and is strongly associated with the presence of islet autoantibodies. Autoantibodies to tyrosine phosphatase-like protein IA-2 (IA-2As) are considered to be highly predictive markers of T1D. We developed a novel lateral flow immunoassay (LFIA) based on a bridging format for the rapid detection of IA-2As in human serum samples. In this assay, one site of the IA-2As is bound to HA-tagged-IA-2, which is subsequently captured on the anti-HA-Tag antibody-coated test line on the strip. The other site of the IA-2As is bound to biotinylated IA-2, allowing the complex to be visualized using colloidal gold nanoparticle-conjugated streptavidin. For this study, 35 serum samples from T1D patients and 44 control sera from non-diabetic individuals were analyzed with our novel assay and the results were correlated with two IA-2A ELISAs. Among the 35 serum samples from T1D patients, the IA-2A LFIA, the in-house IA-2A ELISA and the commercial IA-2A ELISA identified as positive 21, 29 and 30 IA-2A-positive sera, respectively. The major advantages of the IA-2A LFIA are its rapidity and simplicity.
authors.affiliation: CEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, Laboratoire d'Etudes et de Recherches en Immunoanalyse, Gif sur Yvette, France.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kikkas
authors.affiliation: INSERM, U1016, Cochin Institute, DeAR Lab, Paris, France; Paris Descartes University, Sorbonne Paris Cité, Faculté de Médecine, Paris, France; Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Service de Diabétologie, Paris, France.
authors.forename: Roberto
authors.initials: R
authors.lastname: Mallone
authors.affiliation: Paris Descartes University, Sorbonne Paris Cité, Faculté de Médecine, Paris, France; Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Service de Diabétologie, Paris, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Larger
authors.affiliation: CEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, Laboratoire d'Etudes et de Recherches en Immunoanalyse, Gif sur Yvette, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Volland
authors.affiliation: CEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, Laboratoire d'Etudes et de Recherches en Immunoanalyse, Gif sur Yvette, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Morel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001323:Autoantibodies / Q000097:blood*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008875:Middle Aged; D054635:Receptor-Like Protein Tyrosine Phosphatases, Class 8 / Q000276:immunology*; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D001323:Autoantibodies; C096322:ICA512 autoantibody; C516862:PTPRN protein, human; D054635:Receptor-Like Protein Tyrosine Phosphatases, Class 8