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Cited by 124Syphilis Diagnosis and TreatmentHistorical Medical Research and TreatmentsVector-borne infectious diseases

The DOI matches its Crossref record; 142 of the 142 references it cites were found in a registry or an index.

Syphilis laboratory guidelines: performance characteristics of nontreponemal antibody tests.

Open access
Tuddenham, Susan, Katz, Samantha S, Ghanem, Khalil G·2020·Clinical Infectious Diseases
DOI 10.1093/cid/ciaa306PMC PMC7312285
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Abstract

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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Crossref · 10.1093/cid/ciaa306

Cites

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  • A presumptive diagnosis of syphilis requires use of two laboratory serologic tests: a nontreponemal test and a treponemal test.

    “A presumptive diagnosis of syphilis requires use of two laboratory serologic tests: a nontreponemal test (i.e., Venereal Disease Research Laboratory [VDRL] or rapid plasma reagin [RPR] test) and a treponemal test”

    From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [566]

    The Abstract (page not provided) says nontreponemal and treponemal antibodies are used in combination to help diagnose syphilis, and identifies VDRL and RPR as the primary nontreponemal tests. It does not state that a presumptive diagnosis requires both tests in every case; it also notes that diagnosis depends on clinical evaluation and interpretation of laboratory tests. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • The sensitivity of CSF VDRL is less than 50% in ocular syphilis and less than 10% in otosyphilis.

    “The sensitivity of CSF VDRL is <50% in ocular syphilis and <10% in otosyphilis.72”

    From BASHH UK guidelines for the management of syphilis 2024 (2024) · cites this paper as [72]

    The Ocular Syphilis conclusions state that CSF VDRL sensitivity is <50%. The Otic Syphilis conclusions give <10% for otosyphilis, but qualify it with “Limited data suggest”; the citing sentence presents that estimate without the qualification. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

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Citations

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Research works printed but not linked: 6

  1. Gibowski, 1998, Detection of specific IgM-CLASS antitreponemal antibodies in blood serum of patients with syphilis with the use of CAPTIA syphilis-M reaction and comparing it with VDRL, FTA-ABS and TPHA reactions, Med Sci Monit, 4, 882
  2. Harrison, 1976, An evaluation of the C.S.L. rapid plasma reagin (R.P.R.) test for syphilis, Aust J Med Technol, 7, 30
  3. United States Food and Drug Administration (Administration UFaD), 2015, 510k substantial equivalence determination decision summary (K150358)
  4. Administration UFaD, 2017, 510k substantial equivalence determination decision summary (K170413) Bioplex 2200 syphilis total and RPR kit
  5. Muic, 1997, Limitations and consequences of basing late syphilis seroassessments on VDRL test, Acta Dermatovenerologica Alpina Panonica et Adriatica, 6, 87
  6. Muic, 1998, Role of routine syphilis serotests in late neurosyphilis detection, Neurologia Croatica, 47, 229

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Metadata

Authors
Tuddenham, S., Katz, S. S., & Ghanem, K. G.
Affiliations
  • Johns Hopkins University (US)
  • Centers for Disease Control and Prevention (US)
Corresponding author
Tuddenham, Susan
ORCID
Venue
Clinical Infectious Diseases
Publisher
Oxford University Press (OUP)
Published
2020-06-24
Volume
71
Issue
Supplement_1
Pages
S21-S42
ISSN
  • 1058-4838 (ISSN-L)
  • 1537-6591
DOI
10.1093/cid/ciaa306
PMC
PMC7312285
OpenAlex
W3037357210
Cited by
124
References
142
Citations by year
2026: 15 · 2025: 27 · 2024: 18 · 2023: 31 · 2022: 24 · 2021: 8 · 2020: 1
FWCI
2.07
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Infectious Diseases (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Centers for Disease Control and Prevention
  • National Institutes of Health (K23AI125715)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Syphilis Diagnosis and Treatment
  • Health Sciences › Medicine › Pharmacology (medical) › Historical Medical Research and Treatments
  • Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
Keywords
syphilis, VDRL test, RPR, sensitivity and specificity, late latent syphilis, neurosyphilis, ocular syphilis, false-negative results, syphilis diagnosis
MeSH terms
Humans, Laboratories, Neurosyphilis, Syphilis, Syphilis Serodiagnosis, Treponema pallidum

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