CVI Accepts, published online ahead of print on 25 April 2007

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Clin. Vaccine Immunol. doi:10.1128/CVI.00068-07
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Evaluation of the LIAISON Treponema Assay, a Chemiluminescent Immunoassay for the Diagnosis of Syphilis

Carrie S. Knight, Mary A. Crum, and Robert W. Hardy^*

Department of Pathology, Division of Laboratory Medicine, University of Alabama at Birmingham, Birmingham, AL 35233

^* To whom correspondence should be addressed. Email: hardy{at}path.uab.edu.

We report the results of an evaluation of the LIAISON Treponema Assay, a one-step sandwich chemiluminescent immunoassay (CLIA), with evaluation of its performance as a screening test and as a confirmatory test for 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 Treponema pallidum particle agglutination (TP-PA) assays. As a screening test, the CLIA showed agreement with the EIA and with the algorithm, respectively, of 94.1% and 100% in 51 samples from patients with primary and secondary syphilis, of 93.2% and 98.7% in 999 samples sent to the laboratory for routine syphilis testing, of 84.5% and 94.0% in 200 samples from HIV-positive patients, of 98.0% and 100% in 200 samples from pregnant patients, and of 94.3% and 98.3% in 992 samples from apparently healthy adults. As a confirmatory test, the CLIA showed 99% agreement with the EIA in testing 204 RPR-positive samples. After resolution with further TP-PA testing and discarding one sample of insufficient quantity, there was 100% agreement in the remaining 203 samples. For the total group of 2645 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, including in specific populations with reportedly increased rates of false positive non-treponemal test results.

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