Detection and analysis of blood donors seropositive for syphilis

Transfus Med. 2021 Apr;31(2):121-128. doi: 10.1111/tme.12761. Epub 2021 Jan 21.

Abstract

Background: The increasing incidence of syphilis worldwide has called attention to the risk of transmission by transfusion.

Aims: To determine the prevalence of active syphilis in blood donors and characterise the serological profile of syphilis-positive donors.

Methods: Samples positive for Treponema pallidum using the chemiluminescent microparticle immunoassay (CMIA) during blood donor screening from 2017 to 2018 were tested by the Venereal Disease Research Laboratory (VDRL) non-treponemal test and for anti-T. pallidum IgM by ELISA (Immunoassay Enzyme test for detection of IgM antibodies). The INNO-LIA Syphilis test (Line Immuno Assay solid test for confirmation antibodies to Treponema pallidum) was performed as a confirmatory test on samples that were positive on ELISA-IgM but negative on VDRL. ELISA-IgM (+) samples were also tested for T. pallidum DNA in sera by real-time polymerase chain reaction (PCR).

Results: Of 248 542 samples screened, 1679 (0.67%) were positive for syphilis by CMIA. Further analysis was performed on 1144 (68.1%) of these samples. Of those tested, 16% were ELISA IgM(+)/VDRL(+), 16.5% were ELISA IgM(-)/VDRL(+), 4.1% were ELISA IgM(+)/VDRL(-), and 63.4% were ELISA IgM (-)/VDRL(-). The INNO-LIA Syphilis test results were 33 (3%) positive, 2 (0.2%) undetermined and 12 (1%) negative. Of the 230 EIA-IgM(+) samples (20.1%), 5 (2.2%) were PCR positive. The prevalence of active syphilis in 2017 and 2018 was 0.1% and 0.07%, respectively, and overall prevalence of serologic markers for syphilis was highest among male, unmarried, 25-34-year-olds with a high school education and who were first-time donors.

Conclusion: There is a risk of transfusion-transmitted syphilis in blood banks that exclusively use the VDRL test for donor screening, as is currently the situation in some Brazilian blood centres, as well as in other blood centres around the world.

Keywords: IgM antibody; Treponema pallidum; VDRL; blood donors; syphilis.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Bacterial / blood*
  • Biomarkers / blood
  • Blood Donors*
  • Blood Safety*
  • Brazil / epidemiology
  • Cross-Sectional Studies
  • Donor Selection / methods*
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Immunoassay
  • Male
  • Middle Aged
  • Polymerase Chain Reaction
  • Prevalence
  • Reproducibility of Results
  • Retrospective Studies
  • Seroepidemiologic Studies
  • Syphilis / blood
  • Syphilis / diagnosis*
  • Syphilis / epidemiology
  • Syphilis / transmission
  • Syphilis Serodiagnosis* / methods
  • Treponema pallidum / immunology*
  • Young Adult

Substances

  • Antibodies, Bacterial
  • Biomarkers