Evaluation of LIAISON Treponema Screen, a Novel Recombinant Antigen-Based Chemiluminescence Immunoassay for Laboratory Diagnosis of Syphilis

ABSTRACT The purpose of this study was to evaluate the diagnostic performance of LIAISON Treponema Screen (DiaSorin, Saluggia, Italy), a new automated chemiluminescence immunoassay (CLIA), in comparison with that of rapid plasma reagin (RPR) and the following currently used treponemal tests: hemagglutination test (TPHA), immunoenzymatic assay (EIA), and Western blot (WB). First, a retrospective study was performed with a panel of 2,494 blood donor sera, a panel of 131 clinical and serologically characterized syphilitic sera, and 96 samples obtained from subjects with potentially interfering diseases or conditions. A prospective study was also performed by testing 1,800 unselected samples submitted to the Microbiology Laboratory of the St. Orsola Hospital in Bologna, Italy, for routine screening for syphilis. As expected, RPR was the least specific method, especially when potentially cross-reacting sera were tested. On the contrary, all of the treponemal tests proved to be very specific (99.9%) and they performed with the following sensitivities: 100% (WB), 99.2% (CLIA), 95.4% (EIA), and 94.7% (TPHA).

[1]  L. Helsel,et al.  Four-step enzyme-linked immunosorbent assay for detection of Treponema pallidum antibody , 1985, Journal of clinical microbiology.

[2]  U. K. Laemmli,et al.  Cleavage of Structural Proteins during the Assembly of the Head of Bacteriophage T4 , 1970, Nature.

[3]  M. Ashton,et al.  An outbreak no longer: factors contributing to the return of syphilis in Greater Manchester , 2003, Sexually transmitted infections.

[4]  G. Burstein,et al.  Sexually transmitted diseases treatment guidelines , 2003, Current opinion in pediatrics.

[5]  S. Larsen,et al.  Laboratory diagnosis and interpretation of tests for syphilis , 1995, Clinical microbiology reviews.

[6]  J. Rosenblatt,et al.  Clinical Comparison of the Treponema pallidum CAPTIA Syphilis-G Enzyme Immunoassay with the Fluorescent Treponemal Antibody Absorption Immunoglobulin G Assay for Syphilis Testing , 1999, Journal of Clinical Microbiology.

[7]  E. Salakhov,et al.  Congenital syphilis in the Russian Federation: magnitude, determinants, and consequences , 2003, Sexually transmitted infections.

[8]  V. Sambri,et al.  Evaluation of recomWell Treponema, a novel recombinant antigen-based enzyme-linked immunosorbent assay for the diagnosis of syphilis. , 2001, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[9]  J. Azevedo,et al.  Evaluation of an Enzyme Immunoassay Technique for Detection of Antibodies against Treponema pallidum , 2003, Journal of Clinical Microbiology.

[10]  A. Luger,et al.  Comparative Evaluation of Nine Different Enzyme-Linked Immunosorbent Assays for Determination of Antibodies againstTreponema pallidum in Patients with Primary Syphilis , 2000, Journal of Clinical Microbiology.

[11]  Yoshinori Iwatani,et al.  Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay. , 2004, Journal of virological methods.

[12]  H. Young,et al.  Screening for treponemal infection by a new enzyme immunoassay. , 1989, Genitourinary medicine.

[13]  H. Towbin,et al.  Electrophoretic transfer of proteins from polyacrylamide gels to nitrocellulose sheets: procedure and some applications. , 1979, Proceedings of the National Academy of Sciences of the United States of America.

[14]  E. Soutschek,et al.  Western Immunoblotting with Five Treponema pallidum Recombinant Antigens for Serologic Diagnosis of Syphilis , 2001, Clinical Diagnostic Laboratory Immunology.

[15]  I. Mushahwar,et al.  Immunoassay detection of hepatitis B surface antigen mutants , 1999, Journal of medical virology.

[16]  V. Sambri,et al.  IgG western blot as a confirmatory test in early syphilis. , 1999, Zentralblatt fur Bakteriologie : international journal of medical microbiology.

[17]  L. Soufflet,et al.  Recombinant antigen-based enzyme immunoassay for screening of Treponema pallidum antibodies in blood bank routine , 1995, Journal of clinical microbiology.

[18]  Ellen Jo Baron,et al.  Manual of clinical microbiology , 1975 .

[19]  B. Romanowski,et al.  Syphilis: Review with Emphasis on Clinical, Epidemiologic, and Some Biologic Features , 1999, Clinical Microbiology Reviews.