Abstract
We conducted a systematic review of relevant syphilis diagnostic literature to address the question, “What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis (by stage)?” There were 16 treponemal assays evaluated: 13 immunoassays and 3 manual assays (fluorescent treponemal antibody absorbed test [FTA-ABS], microhemagglutination assay for Treponema pallidum antibodies [MHA-TP], Treponema pallidum particle agglutination assay [TP-PA]). MHA-TP and FTA-ABS were less sensitive in primary and secondary syphilis than TP-PA; TP-PA is the most specific manual treponemal assay. There is insufficient evidence to recommend one particular treponemal immunoassay (eg, enzyme immunoassays, chemiluminescence immunoassays, microbead immunoassays) over another based on published performance data. For diagnosis of neurosyphilis, cerebrospinal fluid (CSF) TP-PA has similar performance to CSF FTA-ABS in studies with patients with definitive or presumptive neurosyphilis. However, CSF treponemal testing has limitations in its sensitivity and specificity and should be interpreted within the context of the clinical scenario, additional CSF test results and syphilis prevalence.
Highlights
Laboratory diagnosis of syphilis has traditionally involved an algorithm beginning with a nontreponemal test followed by a manual Treponema pallidum–specific assay for confirmation of reactive nontreponemal serology
Various treponemal-specific immunoassays are increasingly being used for syphilis screening and diagnosis, including enzyme immunoassays (EIAs), chemiluminescence immunoassays (CIAs), and microbead immunoassays (MBIAs), among others
Our review was based on a single key question: What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis? Our objective of this review was to inform the selection of the appropriate confirmatory treponemal test for laboratories using the traditional algorithm
Summary
Laboratory diagnosis of syphilis has traditionally involved an algorithm beginning with a nontreponemal test (eg, rapid plasma regain [RPR]) followed by a manual Treponema pallidum–specific assay (eg, T. pallidum particle agglutination assay [TP-PA]) for confirmation of reactive nontreponemal serology. Regardless of which algorithm is used, for laboratories to select the most appropriate treponemal test(s) it is important to consider the sensitivity and specificity of these assays in clinically characterized sera, stratified by stage of syphilis. Among the other 8 that had data stratified by stage of syphilis, 3 were manual treponemal assays and 5 were immunoassays (ADVIA Centaur, Bioplex 2200, Captia Syphilis, G, LIAISON, Trep-Sure).
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