Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum.

Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis there- fore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screen- ing. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal as- says used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr vi- rus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are in- cluded in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-posi- tive samples were identified.