Evaluation of FlaB1, FlaB2, FlaB3, and Tp0463 of Treponema pallidum for serodiagnosis of syphilis

We report an assessment of Syphilis Fast, a new latex test that uses a pool of 3 recombinant Treponema pallidum antigens (TpN15, TpN17, and TpN47) for the serodiagnosis of syphilis. Specificity was evaluated by screening 1518 unselected blood specimens in parallel with Syphilis Fast, the Captia SelectSyphG EIA and the Venereal Disease Research Laboratory (VDRL) cardiolipin antigen test while sensitivity was tested using a panel of 99 treponemal sera (treated and untreated) representing various stages of infection and 15 treponemal sera detected on screening. The specificity of Syphilis Fast on initial testing (99.8%) was significantly higher (P 0.02) than that of Captia SelectSyph-G (99.2%) and the VDRL (99.1%): the specificity of Syphilis Fast remained significantly higher (P 0.02) after repeat testing (respective values 99.9%, 99.5% and 99.4%). There was no difference in the sensitivity of Syphilis Fast and Captia SelectSyph-G on initial (93% vs 92.1%) or repeat (95.6% vs 94.7%) testing: both were significantly more sensitive (P 0.001) than the VDRL (46.5% on initial and 43.9% on repeat testing). The sensitivities of the Treponema pallidum haemagglutination test (TPHA) and FTA-abs were 98.2% and 95.6% respectively. Negative reactions in Syphilis Fast and SelectSyph-G were associated with treated infections and correlated with low TPHA titres (80). We conclude that Syphilis Fast is a highly specific, simple and fast screening test with a sensitivity comparable to native antigen treponemal tests and that it merits consideration as a front-line screening test.

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Novel Recombinant-Antigen Enzyme Immunoassay for Serological Diagnosis of Syphilis

Journal of Clinical Microbiology ◽

10.1128/jcm.36.4.913-917.1998 ◽

1998 ◽

Vol 36 (4) ◽

pp. 913-917 ◽

Cited By ~ 51

Author(s):

H. Young ◽

A. Moyes ◽

L. Seagar ◽

A. McMillan

Keyword(s):

Enzyme Immunoassay ◽

Treponema Pallidum ◽

High Sensitivity ◽

Hemagglutination Assay ◽

Large Numbers ◽

Immunodeficiency Virus ◽

Treponemal Infection ◽

Serodiagnosis Of Syphilis ◽

Ideal Method ◽

Test Serum

Enzyme immunoassay (EIA) is an ideal method for screening large numbers of patients for syphilis. We evaluated a novel immune-capture EIA (ICE Syphilis; Murex Diagnostics) that uses three recombinantTreponema pallidum antigens (TpN15, TpN17, and TpN47) and compared the results with those obtained by the native T. pallidum antigen EIA (Captia SelectSyph-G; Centocor) that we currently use for the serodiagnosis of syphilis. Specificity was evaluated by screening 1,184 unselected serum specimens in parallel by the ICE Syphilis and SelectSyph-G assays, while sensitivity was tested with a panel of 101 serum specimens containing antitreponemal antibodies (treated and untreated) from patients with various stages of infection. The specificity of the ICE Syphilis EIA (99.8%) on screening was significantly higher (P < 0.02) than that of the SelectSyph-G EIA (99.2%). The sensitivity of the ICE Syphilis EIA was significantly higher (P < 0.01) than that of the SelectSyph-G EIA on both initial (99 versus 91.4%) and repeat (100 versus 92.4%) testing. The ICE Syphilis EIA was also significantly more sensitive (P < 0.01) than the fluorescent treponemal antibody-abs (92.4%) but not the T. pallidum hemagglutination assay (97.1%). Sera containing antitreponemal antibodies gave a much higher antibody index (absorbance of test serum/kit cutoff) by the ICE Syphilis EIA than by the SelectSyph-G EIA. This combined with the overall high sensitivity makes the ICE Syphilis EIA an ideal test for excluding or detecting treponemal infection in human immunodeficiency virus (HIV)-infected patients. The ICE Syphilis EIA was positive with sera from all 15 HIV-infected patients in the study, whereas sera from 3 HIV-infected patients were negative by the SelectSyph-G EIA. We conclude that the high sensitivity and specificity of the ICE Syphilis EIA and its suitability for automation make it an ideal screening test.

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Serodiagnosis of Syphilis by Enzyme-Linked Immunosorbent Assay with Purified Recombinant Treponema pallidum Antigen 4D

The Journal of Infectious Diseases ◽

10.1093/infdis/153.6.1023 ◽

1986 ◽

Vol 153 (6) ◽

pp. 1023-1027 ◽

Cited By ~ 23

Author(s):

J. D. Radolf ◽

E. B. Lernhardt ◽

T. E. Fehniger ◽

M. A. Lovett

Keyword(s):

Immunosorbent Assay ◽

Treponema Pallidum ◽

Enzyme Linked Immunosorbent Assay ◽

Serodiagnosis Of Syphilis

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Evaluation of the Recombinant Protein TpF1 of Treponema pallidum for Serodiagnosis of Syphilis

Clinical and Vaccine Immunology ◽

10.1128/cvi.00122-13 ◽

2013 ◽

Vol 20 (10) ◽

pp. 1563-1568 ◽

Cited By ~ 13

Author(s):

Chuanhao Jiang ◽

Feijun Zhao ◽

Jinhong Xiao ◽

Tiebing Zeng ◽

Jian Yu ◽

...

Keyword(s):

Recombinant Protein ◽

Western Blot ◽

Western Blotting ◽

Congenital Syphilis ◽

Treponema Pallidum ◽

Enzyme Linked Immunosorbent Assay ◽

Western Blot Assay ◽

Content Type ◽

Human Sera ◽

Serodiagnosis Of Syphilis

ABSTRACTSyphilis is a chronic infection caused byTreponema pallidumsubsp.pallidum, and diagnosis with sensitive and specific methods is a challenging process that is important for its prevention and treatment. In the present study, we established a recombinant protein TpF1-based indirect immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and a Western blot assay for human and rabbit sera. The 20-kDa recombinant protein TpF1 was detected by Western blotting performed with sera from rabbits immunized with recombinant TpF1 and infected with theT. pallidumNichols strain andT. pallidumclinical isolates but was not detected by Western blotting with sera from uninfected rabbits. The sensitivity of the recombinant protein was determined by screening sera from individuals with primary, secondary, latent, and congenital syphilis (n= 82). The specificity of the recombinant protein was determined by screening sera from uninfected controls (n= 30) and individuals with potentially cross-reactive infections, including Lyme disease (n= 30) and leptospirosis (n= 5). The sensitivities of TpF1-based ELISAs were 93.3%, 100%, 100%, and 100% for primary, secondary, latent, and congenital syphilis, respectively, and the specificities were all 100% for sera from uninfected controls and individuals with potentially cross-reactive infections. In Western blot assays, the sensitivities and specificities of TpF1 for human sera were all 100%. The reactivities of TpF1 with syphilitic sera were proportional to the titers of theT. pallidumparticle agglutination (TPPA) assay. These data indicate that the recombinant protein TpF1 is a highly immunogenic protein in human and rabbit infections and a promising marker for the screening of syphilis.

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