Novel Point-of-Care Test for Simultaneous Detection of Nontreponemal and Treponemal Antibodies in Patients with Syphilis

Author:

Castro Arnold R.1,Esfandiari Javan2,Kumar Shailendra2,Ashton Matthew2,Kikkert Susan E.1,Park Mahin M.3,Ballard Ronald C.1

Affiliation:

1. Centers for Disease Control and Prevention, Division of STD Prevention, Atlanta, Georgia

2. Chembio Diagnostic Systems Inc., Medford, New York

3. Georgia Public Health Laboratory, Atlanta, Georgia

Abstract

ABSTRACT We describe a point-of-care immunochromatographic test for the simultaneous detection of both nontreponemal and treponemal antibodies in the sera of patients with syphilis that acts as both a screening and a confirmatory test. A total of 1,601 banked serum samples were examined by the dual test, and the results were compared to those obtained using a quantitative rapid plasma reagin (RPR) test and the Treponema pallidum passive particle agglutination (TP-PA) assay. Compared to the RPR test, the reactive concordance of the dual test nontreponemal line was 98.4% when the RPR titers of sera were ≥1:2 and the nonreactive concordance was 98.6%. Compared to the TP-PA assay, the reactive and nonreactive concordances of the treponemal line were 96.5% and 95.5%, respectively. These results indicate that the dual test could be used for the serological diagnosis of syphilis in primary health care clinics or resource-poor settings and therefore improve rates of treatment where patients may fail to return for their laboratory results.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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