Evaluation of Automated Architect Syphilis TP as a Diagnostic Laboratory Screening Test for Syphilis

Abstract

Background : The aim of the study was to establish a new syphilis test algorithm using Architect Syphilis TP (Abbott Japan, Japan: AST), a fully automated treponemal antibody test, as a screening test in a university hospital laboratory. We evaluated performance characteristics of AST in various patient groups.Methods : A total of 1,357 serum samples obtained from patients at a university hospital from June to August, 2008 were categorized into checkup, preoperative, other diseases, diagnosis (clinically suspected of syphilis), and follow up groups. We compared the results of AST with those of RPR (N=1,276) or Treponema pallidum hemagglutination assay (TPHA, N=81). Samples with discrepant results between RPR or TPHA and AST were retested by fluorescent treponemal antibody absorption test (FTA-ABS) and all patients' clinical records were thoroughly reviewed.Results : The positive rate of AST was significantly higher than that of RPR in preoperative and other diseases groups and was the same as that of RPR in diagnosis group. There were no significant differences in check up and follow up groups. The results of AST showed 97.4% (1,243/1,276) and 97.5% (79/81) concordance rates with those of RPR and TPHA, respectively. Among 26 RPR-AST discrepant and FTA-ABS confirmed cases, there were 20 RPR false-negatives, 4 RPR falsepositives, 1 AST false-negative, and 1 AST false-positive.Conclusions : Based on the results and literature review, we established a new syphilis test algorithm using AST as a screening test, which would be helpful for detection of more syphilis patients including latent infections. (Korean J Lab Med 2008;28:475-82)

Clinical Evaluation of Fully Automated Elecsys® Syphilis Assay for the Detection of Antibodies of Treponema pallidum

“…In conclusion, the Elecsys syphilis assay displays better sensitivity (100%), specificity (99.8%), PPV (98.7%), and NPV (100%) in 2,124 samples enrolled, compared with the InTec assay. The Elecsys ® Syphilis assay perfectly agreed with the InTec ELISA test kit and was also compared favorably with or better than other CLIAs reported in the literature . Besides, the Elecsys ® Syphilis assay demonstrates more priority in the terms of ease of use, high sensitivity in early syphilis, and less sera.…”

Characterization of Sera with Discordant Results from Reverse Sequence Screening for Syphilis

“…Architect syphilis TP assay has been known to have an excellent sensitivity and specificity [11, 12]. In our study, from the RSSS using the Architect Syphilis TP CIA as a screening assay, the positive rate of CIA was 1.7% in our low-prevalence population, and the proportion of TP-PA-negative sera among 153 CIA-reactive sera was 10.5% (16/153).…”

Secondary Syphilis with Nodular Vasculitis Mimicking Behçet's Disease

“…This may be related to increased incidence of HIV infection: cases of coinfection with syphilis and HIV have been reported in Korea. Therefore, syphilis may become a more common clinical challenge [10]. …”