Evaluation of recomWell Treponema, a novel recombinant antigen-based enzyme-linked immunosorbent assay for the diagnosis of syphilis

• Published in: Clinical microbiology and infection Vol. 7; no. 4; pp. 200 - 205
• Main Authors: Sambri, V., Marangoni, A., Simone, M.A., D'Antuono, A., Negosanti, M., Cevenini, R.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Elsevier Ltd 01.04.2001; Blackwell Science Ltd; Blackwell; Elsevier Limited
• Subjects: Antibodies, Bacterial - blood; Antigens, Bacterial - immunology; Bacterial diseases; Bacterial diseases of the genital system; Biological and medical sciences; ELISA; Enzyme-Linked Immunosorbent Assay - methods; Enzyme-Linked Immunosorbent Assay - standards; Human bacterial diseases; Humans; Immunoglobulin G - blood; Immunoglobulin M - blood; Infectious diseases; Medical sciences; Reagent Kits, Diagnostic; recombinant antigens; Recombinant Proteins - immunology; Sensitivity and Specificity; serology; syphilis; Syphilis - blood; Syphilis - diagnosis; Syphilis Serodiagnosis - methods; Syphilis Serodiagnosis - standards; Treponema; Treponema pallidum; Treponema pallidum - immunology; syphilis; recombinant antigens; serology; Treponema pallidum; ELISA; Performance evaluation; Human; Spirochaetales; Serology; Method; Treponematosis; Infection; Antigen; Sensitivity; Specificity; Sexually transmitted disease; Syphilis; Bacteriosis; Bacteria; Serum; Diagnosis; Treponemataceae; ELISA assay; Spirachaetosis
• DOI: 10.1046/j.1469-0691.2001.00232.x
• ISSN: 1198-743X

Objective To evaluate the diagnostic performance of an enzyme immunosorbent assay (recomWell Treponema) for the diagnosis of syphilis. The novel recombinant antigens Tpn47, TpN17 and TpN15 were utilized. Methods A total of 782 human serum specimens, belonging to four different categories (blood donors, n = 200; routine laboratory screening for syphilis, n = 400; syphilis patients, n = 122; potential cross-reactors, n = 60), were evaluated to compare the sensitivity and specificity of the recomWell Treponema kit with a standard whole Treponema pallidum cell lysate antigen-based ELISA (Syphilis Screening) and with micro-haemagglutination (MHA-TP). Results The overall specificity and sensitivity of the recomWell Treponema IgG was 98.9% and 98.3%, respectively. The specificity and sensitivity of Syphilis Screening ELISA was 98.7% and 98.3%, respectively. The agreement between recomWell Treponema and Syphilis Screening was 100%, 97.8%, 95.9% and 95% among the blood donor specimens, screening samples, syphilis specimens and the potential cross-reactors, respectively. Values of concordance varying from 96.7% to 98.3% were found in the different groups of sera between recomWell Treponema and MHA-TP. In addition, recomWell Treponema demonstrated a good diagnostic performance when used to detect the IgM to T pallidum. No false-positive sera were identified and, in 17/19 samples from primary infection, an IgM immune response was found. Conclusions recomWell Treponema was shown to be a highly specific and sensitive method in all stages of syphilis screening and it can be considered as alternative to other ELISA tests based on native antigen preparations.