title: Clinical evaluation of an automated enzyme-linked fluorescent assay for the detection of chlamydial antigen in specimens from high-risk patients.
abstract: A fully automated enzyme-linked fluorescent assay (ELFA) on the Vitek Immunodiagnostic Assay System (VIDAS CHL) was evaluated for the detection of chlamydial antigen in specimens from symptomatic and asymptomatic high-risk patients. The results were compared with those from McCoy cell culture and Chlamydiazyme with a blocking assay. False-positive VIDAS specimens were centrifuged and the pellet stained with direct fluorescent antibody (DFA). Of the 158 urine specimens, 52 (33%) were infected by Chlamydia trachomatis. The sensitivity and specificity of the VIDAS when compared with cell culture, DFA, and Chlamydiazyme were 75% and 96%, respectively, for urine specimens while the predictive value of a positive (PVP) and a negative (PVN) were 91% and 88%, respectively. Of the 245 urethral swabs, 75 (31%) were considered positive. The sensitivity and specificity were 71% and 92%, respectively, and the PVP and PVN were 80% and 87%, respectively. The sensitivity and specificity on the 108 cervical swabs, 22 of which were positive, were 95% and 95%, respectively, and PVP and PVN were 88% and 99%, respectively. Compared with Chlamydiazyme, the VIDAS was more sensitive on specimens from female patients and urine specimens, but less sensitive on urethral specimens from male patients.
authors.affiliation: Department of Microbiology, University of Iceland, Reykjavík.
authors.forename: O
authors.initials: O
authors.lastname: Steingrímsson
authors.forename: J H
authors.initials: JH
authors.lastname: Olafsson
authors.forename: E
authors.initials: E
authors.lastname: Sigvaldadóttir
authors.forename: R
authors.initials: R
authors.lastname: Pálsdóttir
mesh_terms: D000293:Adolescent; D000328:Adult; D000942:Antigens, Bacterial / Q000032:analysis*; D001331:Automation; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000276:immunology*; D005069:Evaluation Studies as Topic; D005260:Female; D005455:Fluorescent Antibody Technique; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
chemical_list: D000942:Antigens, Bacterial