Clinical test performance of a rapid point-of-care syphilis treponemal antibody test: a systematic review and meta-analysis.
Open accessAbstract
We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, "What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum." The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1-100%), while pooled specificity was 95.9% (81.5-100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8-97.2%), while pooled specificity was 96.7% (91.9-99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8-98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.
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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 [568]
The Abstract says treponemal rapid tests cannot determine whether infection is current and that nontreponemal testing is recommended in some settings. The Results describe diagnostic algorithms using both RPR and a treponemal test. Neither passage establishes a universal requirement for two laboratory tests for a presumptive diagnosis; the paper also discusses treponemal testing outside laboratory settings. (LLM, conf=0.88)
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Cites
Sexually transmitted diseases treatment guidelines (2015)
Workowski, K., & BOLAN, G. A. (2015) · The Scientific Issues of Ternopil Volodymyr Hnatiuk National Pedagogical University Series pedagogy · doi:10.18370/2309-4117.2015.24.51-56 · Cited by 2,684 · see citing works
Sexually Transmitted Diseases Treatment Guidelines 2002
(2002) · PsycEXTRA Dataset · doi:10.1037/e548482006-001 · Cited by 1,229 · see citing works
Diagnostics for the developing world
Mabey, D., Peeling, R. W., Ustianowski, A., & Perkins, M. D. (2004) · Nature Reviews Microbiology · doi:10.1038/nrmicro841 · Cited by 1,054 · see citing works
Boily, M., Baggaley, R. F., Wang, L., Mâsse, B. R., White, R. G., Hayes, R., & Alary, M. (2009) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(09)70021-0 · Cited by 910 · see citing works
Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis
Gomez, G. B., Kamb, M. L., Newman, L. M., Mark, J., Broutet, N., & Hawkes, S. J. (2013) · Bulletin of the World Health Organization · doi:10.2471/blt.12.107623 · Cited by 634 · see citing works
Newman, L., Kamb, M., Hawkes, S., Gomez, G., Say, L., Seuc, A., & Broutet, N. (2013) · PLoS Medicine · doi:10.1371/journal.pmed.1001396 · Cited by 448 · see citing works
Point-of-care testing for sexually transmitted infections
Tucker, J. D., Bien, C. H., & Peeling, R. W. W. (2012) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0b013e32835c21b0 · Cited by 139 · see citing works
Accelerating worldwide syphilis screening through rapid testing: a systematic review
Tucker, J. D., Bu, J., Brown, L. B., Yin, Y.-P., Chen, X., & Cohen, M. S. (2010) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(10)70092-x · Cited by 137 · see citing works
Sellati, T. J., Wilkinson, D. A., Sheffield, J. S., et al. (2000) · The Journal of Infectious Diseases · doi:10.1086/315209 · Cited by 93 · see citing works
Kuznik, A., Lamorde, M., Nyabigambo, A., & Manabe, Y. C. (2013) · PLoS Medicine · doi:10.1371/journal.pmed.1001545 · Cited by 84 · see citing works
Rapid Syphilis Tests as Catalysts for Health Systems Strengthening: A Case Study from Peru
Garcia, P. J., Cárcamo, C., Chiappe, M., Valderrama, M., Rosa, S. L., Holmes, K. K., Mabey, D. C. W., & Peeling, R. W. W. (2013) · PLoS ONE · doi:10.1371/journal.pone.0066905 · Cited by 81 · see citing works
Sánchez, J., Lama, J. R., Peinado, J., Paredes, A. L., Lucchetti, A., Russell, K. L., Kochel, T. J., & Sebastian, J. L. (2009) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e3181a2671d · Cited by 73 · see citing works
Matthias, J., Dwiggins, P., Totten, Y. R., Blackmore, C., Wilson, C., & Peterman, T. A. (2016) · MMWR Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm6542a5 · Cited by 27 · see citing works
Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis
Nakku-Joloba, E., Kiragga, A. N., Kimeze, J., Kambugu, F., Jett‐Goheen, M., Parkes-Ratanshi, R. M., Gaydos, C. A., & Manabe, Y. C. (2016) · Sexually Transmitted Diseases · doi:10.1097/olq.0000000000000498 · Cited by 19 · see citing works
Laboratory Evaluation of a Commercially Available Rapid Syphilis Test
Pereira, L., McCormick, J., Dorji, T., et al. (2018) · Journal of Clinical Microbiology · doi:10.1128/jcm.00832-18 · Cited by 19 · see citing works
Evaluation of a Rapid Syphilis Test in an Emergency Department Setting in Detroit, Michigan
Fakile, Y. F., Markowitz, N. P., Zhu, W., et al. (2019) · Sexually Transmitted Diseases · doi:10.1097/olq.0000000000000993 · Cited by 19 · see citing works
Menke, J. (2013) · Medical Decision Making · doi:10.1177/0272989x13475719 · Cited by 16 · see citing works
Performance of the Syphilis Health Check in Clinic and Laboratory-Based Settings
Fakile, Y. F., Brinson, M., Mobley, V., et al. (2019) · Sexually Transmitted Diseases · doi:10.1097/olq.0000000000000974 · Cited by 16 · see citing works
Menke, J. (2014) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.12173 · Cited by 11 · see citing works
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Sexually Transmitted Infections Treatment Guidelines, 2021
Workowski, K. A., Bachmann, L. H., Chan, P. A., Johnston, C. M., Muzny, C. A., Park, I., Reno, H., Zenilman, J. M., & Bolan, G. A. (2021) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr7004a1 · Cited by 2,759 · see citing works
- Authors
- Bristow, C. C., Klausner, J. D., & Tran, A.
- Affiliations
- University of California San Diego (US)
- University of California, Los Angeles (US)
- District of Columbia Department of Forensic Sciences (US)
- Corresponding author
- Bristow, Claire C
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-06-24
- Volume
- 71
- Issue
- Supplement_1
- Pages
- S52-S57
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC7312211
- OpenAlex
- W3037173893
- Cited by
- 40
- References
- 19
- Citations by year
- 2026: 7 · 2025: 5 · 2024: 9 · 2023: 4 · 2022: 4 · 2021: 7 · 2020: 3 · 2019: 1
- FWCI
- 0.57
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Infectious Diseases (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (K01 AI136725, T32 AI007384, P30 AI028697, P30 MH058107)
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
- Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
- Keywords
- syphilis, Treponema pallidum, treponemal antibodies, point-of-care testing, rapid diagnostic tests, diagnostic sensitivity, diagnostic specificity, FDA clearance
- MeSH terms
- Antibodies, Bacterial, Bayes Theorem, Humans, Prospective Studies, Sensitivity and Specificity, Syphilis, Syphilis Serodiagnosis, Treponema pallidum, Point-of-Care Systems
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