title: Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis.
abstract: We report the results of an evaluation of the LIAISON Treponema pallidum-specific assay, a one-step sandwich chemiluminescence immunoassay (CLIA), as a screening test and as a confirmatory test for the diagnosis of syphilis. The assay was compared with the CAPTIA Syphilis-G enzyme immunoassay (EIA) and with a testing algorithm that also included the rapid plasma reagin (RPR) and T. pallidum particle agglutination (PA) assays. As a screening test, the CLIA showed levels of agreement with the EIA and with the algorithm, respectively, of 94.1 and 100% for 51 samples from patients with primary or secondary syphilis, 93.2 and 98.7% for 999 samples sent to the laboratory for routine syphilis testing, 84.5 and 94.0% for 200 samples from human immunodeficiency virus-positive patients, 98.0 and 100% for 200 samples from pregnant patients, and 94.3 and 98.3% for 992 samples from apparently healthy adults. As a confirmatory test, the CLIA showed 99% agreement with the EIA for 204 RPR-positive samples. After resolution with further T. pallidum PA testing and the discarding of one sample of insufficient quantity, there was 100% agreement for the remaining 203 samples. For the total group of 2,645 samples, the overall relative sensitivity was 95.8% and the relative specificity was 99.1%. We conclude that the LIAISON CLIA demonstrated excellent sensitivity and specificity when evaluated as a confirmatory test and as a screening test for syphilis among various patient populations, including specific populations with reportedly increased rates of false-positive nontreponemal test results.
authors: Department of Pathology, Division of Laboratory Medicine, P230 West Pavilion, University of Alabama at Birmingham, 619 South 19th St., Birmingham, AL 35233, USA.
authors: Carrie S
authors: CS
authors: Knight
authors: Mary A
authors: MA
authors: Crum
authors: Robert W
authors: RW
authors: Hardy
mesh_terms: D000328:Adult; D000372:Agglutination Tests; D000465:Algorithms; D016022:Case-Control Studies; D005189:False Positive Reactions; D005260:Female; D006679:HIV Seropositivity; D006801:Humans; D007124:Immunoenzyme Techniques; D049449:Luminescence; D008163:Luminescent Measurements; D008297:Male; D011247:Pregnancy; D011935:Reagins / Q000097:blood; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis* / Q000382:microbiology; D014210:Treponema pallidum / Q000276:immunology / Q000302:isolation & purification*
chemical_list: D011935:Reagins