Biosens

bSens.SYPH

Syphilis

RoadmapTechnology readiness level 5 of 9

A point-of-care strip test with nanoparticles, in development for syphilis.

  • Intended use and result: not defined yet. The test is in development.

TRL, or technology readiness level, is a scale from 1 to 9 that shows a technology's stage of development. It does not indicate how a test performs.

Scientific context

What the studies say.

Data from scientific papers and books. They describe the condition, the field and the technology, not bSens products.

  • 6.3 million

    Global estimates indicate 6.3 million new syphilis cases among people aged 15 to 49 in 2016. In the same year, there were an estimated 661,000 cases of congenital syphilis, 355,000 of them with adverse birth outcomes: fetal loss or stillbirth, neonatal death, prematurity or low birth weight, or clinical signs of syphilis in the infant. 1,2

  • 9.6 per 1,000

    In Brazil, the reported rate of congenital syphilis rose from 1.9 to 9.6 cases per 1,000 live births between 2007 and 2023, with 297,062 cases reported in the period. WHO's target for eliminating mother-to-child transmission is 0.5 cases or fewer per 1,000 live births. 3

  • 4-fold

    Treponemal tests usually stay reactive for life, even after treatment. Treatment is followed with nontreponemal test titers (VDRL or RPR), and only a change of at least 4-fold (two dilutions) between results of the same test is considered clinically significant. 4,5

  • 66.5%

    In a meta-analysis of six case-control studies from 1917 to 2000, 66.5% of pregnancies in women with untreated syphilis had an adverse pregnancy or infant outcome. In women without syphilis the figure was 14.3%, and the authors report large heterogeneity between the studies. 6

  • The US Preventive Services Task Force (USPSTF) recommends screening all pregnant people for syphilis early in pregnancy, or at the first available opportunity if that did not happen (grade A recommendation, 2025). It concludes with high certainty that this screening has a substantial net benefit. 7

  • A 2014 Cochrane review found two cluster-randomized trials, at high or unclear risk of bias for most domains, that compared on-site syphilis testing at antenatal clinics with conventional testing. In Mongolia, on-site testing increased testing and treatment and reduced congenital syphilis. In rural South Africa, among women who tested positive, there was no clear evidence of an effect on adequate treatment or perinatal mortality. The authors call for more trials. 8

References

  1. 1.Rowley J, Vander Hoorn S, Korenromp E, et al. Chlamydia, gonorrhoea, trichomoniasis and syphilis: global prevalence and incidence estimates, 2016. Bull World Health Organ. 2019;97:548-562P. doi:10.2471/BLT.18.228486
  2. 2.Korenromp EL, Rowley J, Alonso M, et al. Global burden of maternal and congenital syphilis and associated adverse birth outcomes - Estimates for 2016 and progress since 2012. PLoS One. 2019;14:e0211720. doi:10.1371/journal.pone.0211720
  3. 3.Fernandes MD, Menezes RC, Almeida IBC, et al. The neglected role of partner treatment in congenital syphilis control in Brazil: nationwide evidence from 2007 to 2023. Lancet Reg Health Am. 2026;56:101434. doi:10.1016/j.lana.2026.101434
  4. 4.Workowski KA, Bachmann LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70:1-187. doi:10.15585/mmwr.rr7004a1
  5. 5.Peeling RW, Mabey D, Kamb ML, Chen XS, Radolf JD, Benzaken AS. Syphilis. Nat Rev Dis Primers. 2017;3:17073. doi:10.1038/nrdp.2017.73
  6. 6.Gomez GB, Kamb ML, Newman LM, et al. Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis. Bull World Health Organ. 2013;91:217-226. doi:10.2471/BLT.12.107623
  7. 7.US Preventive Services Task Force; Silverstein M, Wong JB, Davis EM, et al. Screening for Syphilis Infection During Pregnancy: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA. 2025;333:2006-2012. doi:10.1001/jama.2025.5009
  8. 8.Shahrook S, Mori R, Ochirbat T, Gomi H. Strategies of testing for syphilis during pregnancy. Cochrane Database Syst Rev. 2014;10:CD010385. doi:10.1002/14651858.CD010385.pub2

Contact

Results at the Point of Care

Get in touch to learn about the bSens system.

Please do not send health information by e-mail. Biosens does not interpret test results or guide treatment.

E-mail

contact@biosens.tech

Address

Av. Theodomiro Porto da Fonseca 3101, Building 3, Room 1, 93022-715, São Leopoldo, RS, Brazil