title: Development and validation of a radioligand binding assay to measure insulin specific IgG subclass antibodies in human serum.
abstract: The objective was to develop and validate a radioligand binding assay for insulin antibodies (IABs) of the IgG1, IgG2, IgG3, and IgG4 subclasses in human serum. The validation studies focused on determining specificity, capacity, linearity, sensitivity, and precision of each assay. It was seen that our assay for IAB IgG subclasses is specific and has sufficient capacity to measure each of the subclasses in human serum. Moreover, the linear region and limits of detection and quantitation for each assay are clearly determined.
authors.affiliation: Pfizer Incorporated, Groton, Connecticut 06340, USA. deborah_finco-kent@groton.pfizer.com
authors.forename: D
authors.initials: D
authors.lastname: Finco-Kent
authors.forename: A
authors.initials: A
authors.lastname: Morrone
authors.forename: M
authors.initials: M
authors.lastname: Moxness
authors.forename: V
authors.initials: V
authors.lastname: Bedian
authors.forename: A
authors.initials: A
authors.lastname: Krasner
authors.forename: J
authors.initials: J
authors.lastname: Foley
authors.forename: M
authors.initials: M
authors.lastname: Stene
authors.forename: T
authors.initials: T
authors.lastname: Kawabata
mesh_terms: D000918:Antibody Specificity; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood* / Q000276:immunology; D007328:Insulin / Q000276:immunology*; D011869:Radioligand Assay; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D007074:Immunoglobulin G; D007328:Insulin