Clinical Evaluation of a New Screening Test for Syphilis

Dyckman, John D.; Gatenbein, Dorothea; Wende, Reuben D.; Williams, Robert P.

doi:10.1093/ajcp/70.6.918

Cited by 4 publications

(2 citation statements)

References 1 publication

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“…Comment and evidence summary. Sensitivity and specificity estimates of RPR and VDRL were similar but not exact in head-to-head studies and studies that used similar reference standards (95)(96)(97)(98)(99)(101)(102)(103)(104)(106)(107)(108)111,112,139). When assessing changes in antibody titers using nontreponemal (lipoidal antigen) tests, it is critical that the same test be used because titers are used by clinicians to classify the infection status of a patient and follow treatment response (55).…”

Section: Specificity Of Serologic Testsmentioning

confidence: 80%

“…gov/view/cdc/138288). VDRL had a similar sensitivity range (50.0%-78.4%) (95)(96)(97)(98)(99)(102)(103)(104)(105)(106)(107). One head-to-head comparison study of RPR and VDRL nontreponemal (lipoidal antigen) tests from 76 patients with primary syphilis confirmed by darkfield microscopy demonstrated a sensitivity of 48.7% and 50.0% for RPR and VDRL, respectively (101).…”

Section: Sensitivity Of Serologic Tests For Primary Syphilismentioning

confidence: 90%

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CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

Papp,

Park,

Fakile

et al. 2024

MMWR Recomm. Rep.

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Summary This report provides new CDC recommendations for tests that can support a diagnosis of syphilis, including serologic testing and methods for the identification of the causative agent Treponema pallidum . These comprehensive recommendations are the first published by CDC on laboratory testing for syphilis, which has traditionally been based on serologic algorithms to detect a humoral immune response to T. pallidum . These tests can be divided into nontreponemal and treponemal tests depending on whether they detect antibodies that are broadly reactive to lipoidal antigens shared by both host and T. pallidum or antibodies specific to T. pallidum , respectively. Both types of tests must be used in conjunction to help distinguish between an untreated infection or a past infection that has been successfully treated. Newer serologic tests allow for laboratory automation but must be used in an algorithm, which also can involve older manual serologic tests. Direct detection of T. pallidum continues to evolve from microscopic examination of material from lesions for visualization of T. pallidum to molecular detection of the organism. Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment. These recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science.

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Section: Specificity Of Serologic Testsmentioning

confidence: 80%

Section: Sensitivity Of Serologic Tests For Primary Syphilismentioning

confidence: 90%

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

Papp,

Park,

Fakile

et al. 2024

MMWR Recomm. Rep.

View full text Add to dashboard Cite

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Syphilis Laboratory Guidelines: Performance Characteristics of Nontreponemal Antibody Tests

Tuddenham

Katz

Ghanem

2020

Clinical Infectious Diseases

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We reviewed the relevant syphilis diagnostic literature to address the following question: what are the performance characteristics, stratified by the stage of syphilis, for nontreponemal serologic tests? The database search included key terms related to syphilis and nontreponemal tests from 1960–2017, and for data related to the venereal disease research laboratory test from 1940–1960. Based on this review, we report the sensitivity and specificity for each stage of syphilis (primary, secondary, early latent, late latent, or unknown duration; tertiary as well as neurosyphilis, ocular syphilis, and otic syphilis). We also report on reactive nontreponemal tests in conditions other than syphilis, false negatives, and automated nontreponemal tests. Overall, many studies were limited by their sample size, lack of clearly documented clinical staging, and lack of well-defined gold standards. There is a need to better define the performance characteristics of nontreponemal tests, particularly in the late stages of syphilis, with clinically well-characterized samples. Published data are needed on automated nontreponemal tests. Evidence-based guidelines are needed for optimal prozone titrations. Finally, improved criteria and diagnostics for neurosyphilis (as well as ocular and otic syphilis) are needed.

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Sensitivity and Specificity of Treponemal-specific Tests for the Diagnosis of Syphilis

Park

Tran

Pereira

et al. 2020

Clinical Infectious Diseases

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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.

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Clinical Evaluation of a New Screening Test for Syphilis

Cited by 4 publications

References 1 publication

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024

Syphilis Laboratory Guidelines: Performance Characteristics of Nontreponemal Antibody Tests

Sensitivity and Specificity of Treponemal-specific Tests for the Diagnosis of Syphilis

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