Evaluation of a new chemiluminescence immunoassay for diagnosis of syphilis

European Journal of Medical Research

Weiming Gu¹  Weizhong Hu¹  Yang Yang¹  Yuelan Jin¹  Xiaohui Mo¹ 

[1] The Laboratory of Shanghai Skin Diseases and STD Hospital, Shanghai, China

关键词: Serology;    Chemiluminescence Immunoassay;    Treponema pallidum;    Syphilis;   

Others  :  1093343
DOI  :  10.1186/2047-783X-15-2-66

 received in 2008-11-24, accepted in 2009-05-08,  发布年份 2010

【 摘 要 】

Objective

To assess the sensitivity, specificity, and feasibility of a new chemiluminescence immunoassay (CLIA) in the diagnosis of syphilis.

Methods

At first, a retrospective study was conducted, using 135 documented cases of syphilis and 30 potentially interfering samples and 80 normal sera. A prospective study was also performed by testing 2, 071 unselected samples for routine screening for syphilis. CLIA was compared with a nontreponemal test (TRUST) and a treponemal test (TPPA).

Results

There was an agreement of 100% between CLIA and TPPA in the respective study. The percentage of agreement among the 245 sera tested was 100.0%. Compared with TPPA, the specificity of CLIA was 99.9% (1817/1819), the sensitivity of CLIA was 100.0% (244/244) in the prospective study. CLIA showed 99.5% agreement with TPPA by testing 2, 071 unselected samples. And CLIA seemed to be more sensitive than TPPA in detecting the samples of primary syphilis.

Conclusions

CLIA is easy to perform and the indicator results are objective and unequivocal. It may be suitable for large-scale screening as a treponemal test substituted for TPPA.

【 授权许可】

   
2010 I. Holzapfel Publishers

【 参考文献 】

• [1]Noh J, Ko HH, Yun Y: Evaluation of performance and false positivity of Mediace RPR test that uses a chemistry autoanalyzer. Korean J Lab Med 2008, 28(4):312-318.
• [2]de Larrañaga G, Trombetta L, Wingeyer SP, Remondino G: False positive reactions in confirmatory tests for syphilis in presence of antiphospholipid antibodies: misdiagnosis with prognostic and social consequences. Dermatol Online J 2006, 12(4):22.
• [3]Körber A, Dissemond J, Lehnen MS: Syphilis with HIV coinfection. J Dtsch Dermatol Ges 2004, 2(10):833-840.
• [4]Geusau A, Kittler H, Hein U: Biological false-positive tests comprise a high proportion of Venereal Disease Research Laboratory reactions in an analysis of 300,000 sera. Int J STD AIDS 2005, 16(11):722-726.
• [5]Marks R, Thomas-Kaskel AK, Schmidt D: Steroid refractory episcleritis as early manifestation of neurosyphilis. Eur J Med Res 2006, 11(7):309-312.
• [6]Ratnam S: The laboratory diagnosis of syphilis. Can J Infect Dis Med Microbiol 2005, 16(1):45-51.
• [7]Carrie SK, Mary AC, Robert WH: Evaluation of the LIAISON Chemiluminescence Immunoassay for Diagnosis of Syphils. Clin Vaccine Immunol 2007, 6:710-713.
• [8]Antonella M, Vittorio SA, Francesca C: Evaluation of LIAISON Treponema Screen, a Novel Recombinant Antigen-Based Chemmiluminesnce Immunoassay for Laboratory Diagnosis of Syphilis. Clin Diagn Lab Immunol 2005, 12:1231-1234.
• [9]Brinkman MB, McKevitt M, McLoughlin M, Perez C, Howell J, Weinstock GM, Norris SJ, Palzkill T: Reactivity of antibodies from syphilis patients to a protein array re presenting the treponema pallidum proteome. J Clin Microbiol 2006, 44(3):888-891.