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Clinical and Vaccine Immunology, June 2007, p. 710-713, Vol. 14, No. 6
1071-412X/07/$08.00+0     doi:10.1128/CVI.00068-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Evaluation of the LIAISON Chemiluminescence Immunoassay for Diagnosis of Syphilis{triangledown}

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

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

Received 30 January 2007/ Returned for modification 21 March 2007/ Accepted 11 April 2007

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.

* Corresponding author. Mailing address: Department of Pathology, P230 West Pavilion, University of Alabama at Birmingham, 619 South 19th St., Birmingham, AL 35233. Phone: (205) 934-9925. Fax: (205) 975-9927. E-mail: hardy{at}path.uab.edu

{triangledown} Published ahead of print on 25 April 2007.

Clinical and Vaccine Immunology, June 2007, p. 710-713, Vol. 14, No. 6
1071-412X/07/$08.00+0     doi:10.1128/CVI.00068-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Kingston, M, French, P, Goh, B, Goold, P, Higgins, S, Sukthankar, A, Stott, C, Turner, A, Tyler, C, Young, H (2008). UK National Guidelines on the Management of Syphilis 2008. Int J STD AIDS 19: 729-740 [Full Text]  


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