title: Rapid, automated assay for progesterone on the Abbott AxSYM analyzer.
abstract: We describe an automated assay for progesterone (P4) in human serum and plasma with the Abbott AxSYM random-access immunoassay analyzer. In this one-step competitive assay, P4 immobilized onto latex microparticles competes with sample P4 for binding to a conjugate of alkaline phosphatase (AP) and anti-P4 antibody. Total CVs ranged from 3.4% to 8.2% in multiple precision studies conducted according to the 20-day NCCLS EP5-T protocol. The detection limit (zero calibrator + 2 SD) was 0.10 microg/L across 36 experiments. Values for diluted samples were 83-116% of expected. Recovery of P4 added to serum specimens was 92-115%. Cross-reactivities with 43 natural and synthetic steroids were 0-6.3%. No significant interference was detected from bilirubin, protein, erythrocytes, hemoglobin, triglycerides, or cholesterol. In a multisite correlation study, AxSYM P4 results compared well with results from a commercial RIA method (n = 1156; r = 0.976; slope = 1.03; y-intercept = 0.04). Assay throughput is >80 tests per hour in batch mode, 60 tests per hour with mixed load list configurations.
authors.affiliation: Department of Fertility, Pregnancy, and Neurodiagnostics, AxSYM R&D, Abbott Laboratories, Abbott Park, IL 60064, USA. wilson@apmac.abbott.com
authors.forename: D H
authors.initials: DH
authors.lastname: Wilson
authors.forename: W
authors.initials: W
authors.lastname: Groskopf
authors.forename: S
authors.initials: S
authors.lastname: Hsu
authors.forename: D
authors.initials: D
authors.lastname: Caplan
authors.forename: T
authors.initials: T
authors.lastname: Langner
authors.forename: M
authors.initials: M
authors.lastname: Baumann
authors.forename: D
authors.initials: D
authors.lastname: DeManno
authors.forename: G
authors.initials: G
authors.lastname: Williams
authors.forename: D
authors.initials: D
authors.lastname: Payette
authors.forename: C
authors.initials: C
authors.lastname: Dagel
authors.forename: D
authors.initials: D
authors.lastname: Lynch
authors.forename: G
authors.initials: G
authors.lastname: Manderino
mesh_terms: D001322:Autoanalysis / Q000295:instrumentation; D003429:Cross Reactions; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000295:instrumentation; D008297:Male; D008597:Menstrual Cycle / Q000097:blood; D017698:Postmenopause / Q000097:blood; D011247:Pregnancy; D011374:Progesterone / Q000097:blood*; D012680:Sensitivity and Specificity; D013050:Spectrometry, Fluorescence
chemical_list: D011374:Progesterone