Abstract
Treponema pallidum infections can have severe complications if not diagnosed and treated at an early stage. Screening and diagnosis of syphilis require assays with high specificity and sensitivity. The Elecsys Syphilis assay is an automated treponemal immunoassay for the detection of antibodies against T. pallidum. The performance of this assay was investigated previously in a multicenter study. The current study expands on that evaluation in a variety of diagnostic settings and patient populations, at seven independent laboratories. The samples included routine diagnostic samples, blood donation samples, samples from patients with confirmed HIV infections, samples from living organ or bone marrow donors, and banked samples, including samples previously confirmed as syphilis positive. This study also investigated the seroconversion sensitivity of the assay. With a total of 1,965 syphilis-negative routine diagnostic samples and 5,792 syphilis-negative samples collected from blood donations, the Elecsys Syphilis assay had specificity values of 99.85% and 99.86%, respectively. With 333 samples previously identified as syphilis positive, the sensitivity was 100% regardless of disease stage. The assay also showed 100% sensitivity and specificity with samples from 69 patients coinfected with HIV. The Elecsys Syphilis assay detected infection in the same bleed or earlier, compared with comparator assays, in a set of sequential samples from a patient with primary syphilis. In archived serial blood samples collected from 14 patients with direct diagnoses of primary syphilis, the Elecsys Syphilis assay detected T. pallidum antibodies for 3 patients for whom antibodies were not detected with the Architect Syphilis TP assay, indicating a trend for earlier detection of infection, which may have the potential to shorten the time between infection and reactive screening test results.
Highlights
Syphilis is a curable sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subsp. pallidum [1]
In the case of the Mediace T. pallidum latex agglutination (TPLA) assay, the results were expressed as titer units; for the Serodia T. pallidum particle agglutination (TPPA) assay, the agglutination patterns were inspected and the results expressed as titers
11 blood donor samples that were found to be reactive with the Architect and/or Elecsys Syphilis assays showed indeterminate confirmation results
Summary
Syphilis is a curable sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subsp. pallidum [1]. Syphilis is a curable sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subsp. It can be transmitted from mother to child in utero or during birth or, rarely, by transfusion of blood, blood components, or organs from donors with active syphilis [1,2,3,4,5]. The primary and secondary stages of the disease are characterized by initial skin manifestations, such as painless sores and macules, and symptoms such as tiredness and headaches, which may be mistaken for other conditions. Syphilis enters a lengthy latent period, defined as having serological proof of infection without symptoms of disease. Early diagnosis is crucial to prevent transmission and to avoid delays in treatment [1]
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