Discordant syphilis immunoassays in pregnancy: perinatal outcomes and implications for clinical management.
Open accessAbstract
BACKGROUND: The reverse sequence algorithm is often used for prenatal syphilis screening by high-volume laboratories, beginning with a treponemal test such as the chemiluminescence immunoassay (CIA), followed by testing of CIA-positive (CIA(+)) specimens with the rapid plasma reagin test (RPR). The clinical significance of discordant serology (CIA(+)/RPR(-)) for maternal and neonatal outcomes is unknown. METHODS: From August 2007 to August 2010, all pregnant women at Kaiser Permanente Northern California with discordant treponemal serology underwent reflexive testing with Treponema pallidum particle agglutination assay (TP-PA) and were categorized as "TP-PA confirmed" (CIA(+)/RPR(-)/TP-PA(+)) or "isolated CIA positive" (CIA(+)/RPR(-)/TP-PA(-)). Demographic variables and clinical data were abstracted from the medical record and compared by TP-PA status. RESULTS: Of 194 pregnant women, 156 (80%) were CIA(+)/RPR(-)/TP-PA(-) and 38 (20%) were CIA(+)/RPR(-)/TP-PA(+). Among the 77 (49%) CIA(+)/RPR(-)/TP-PA(-) women who were retested, 53% became CIA(-). CIA(+)/RPR(-)/TP-PA(+) (n = 38) women were more likely to be older, have a prior history of sexually transmitted infections, and receive treatment for syphilis during pregnancy than women who were CIA(+)/RPR(-)/TP-PA(-) (all P < .005). Most pregnancies (189/194 [97.5%]) resulted in a live birth; there was no difference in birth outcomes according to TP-PA status and no stillbirths attributable to syphilis. CONCLUSIONS: Most pregnant women with discordant serology were CIA(+)/RPR(-)/TP-PA(-); more than half who were retested became CIA(-). CIA(+)/RPR(-)/TP-PA(-) serology in pregnancy is likely to be falsely positive. Reflexive testing of discordant specimens with TP-PA is important to stratify risk given the likelihood of false-positive results in this population.
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If the second treponemal test is negative, the positive EIA or CIA is more likely to represent a false-positive test result for women who are living in communities with low rates of syphilis, have a partner who is uninfected, and have no history of treated syphilis.
“If the second treponemal test is negative (e.g., EIA positive, RPR negative, or TP-PA negative), the positive EIA or CIA is more likely to represent a false-positive test result for women who are living in communities with low rates of syphilis, have a partner who is uninfected, and have no history of treated syphilis (637,638).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [638]
The Discussion reports a high likelihood of false-positive CIA results in pregnant women with CIA-positive, RPR-negative, TP-PA-negative serology and notes that syphilis prevalence in the study population was low. It does not establish the claim's specific conditions concerning an uninfected partner or no history of treated syphilis; the authors say sexual-history data were largely incomplete. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAmong low-prevalence populations, isolated reactive maternal treponemal serology results are likely false-positive results and might become nonreactive with repeat testing.
“Among low-prevalence populations, these are likely false-positive results and might become nonreactive with repeat testing (638).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [638]
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Diagnostic accuracy of a point-of-care syphilis test when used among pregnant women in Bolivia
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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
Self-citation
- Authors
- Mmeje, O., Chow, J. M., Davidson, L., Shieh, J., Schapiro, J. M., & Park, I. U.
- Affiliations
- University of Michigan (US)
- California Department of Public Health (US)
- Kaiser Permanente (US)
- Corresponding author
- Mmeje, Okeoma
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-06-10
- Volume
- 61
- Issue
- 7
- Pages
- 1049-1053
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC4560902
- OpenAlex
- W2148947758
- Cited by
- 46
- References
- 13
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 4 · 2023: 3 · 2022: 5 · 2021: 4 · 2020: 7 · 2019: 3 · 2018: 6 · 2017: 4 · 2016: 3
- FWCI
- 3.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Infectious Diseases (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- the University of California, San Francisco
- NIH (T32AI065388)
- the National Institute of Allergy and Infectious Diseases
- the CDC (H25PS001379-01))
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Neonatal and Maternal Infections
- Keywords
- syphilis, pregnancy, chemiluminescence immunoassay, RPR, Treponema pallidum particle agglutination assay, false positives, prenatal screening, perinatal outcomes, live birth, sexually transmitted infections
- MeSH terms
- Adult, Female, Humans, Immunoassay, Pregnancy, Pregnancy Complications, Infectious, Pregnancy Outcome, Retrospective Studies, Syphilis, Syphilis Serodiagnosis
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