Syphilis Care

Diagnostic
Diagnostic
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Syphilis Care
    Representative Product

    Condition
    Syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum. In adults, the untreated disease can progress over the course of years or decades, causing a variety of health complications  and death. Overall risk of placental transmission is 60-80%, rising during the second half of pregnancy. According to one estimate, roughly 30% of infected fetuses are stillborn or suffer early neonatal deaths.

    Mechanism of Action
    Syphilis diagnosis presents opportunity for innovation. Dark field microscopy can be used to characterize fluid from open lesions. More commonly, serological tests are used. Treponemal tests check for the specific antibodies to T. pallidum. These antibodies can remain active even after syphilis is cured, so a positive test does not confirm active infection. Non-treponemal confirm an active infection, but not necessarily syphilis. The two tests, therefore, are best used in combination.  Syphilis treatment is relatively mature.  For mothers, a single dose of 2.4M units Penicillin G IM is recommended. Erythromycin and tetracycline (which can be effective for non-pregnant adults) are second line therapy. For neonates, 50K units/kg/day is used.  

    Current Use in High-Resource Settings
    Non-treponemal blood tests (RPR or VDRL) are typically a first screen for infection in a centralized laboratory setting where reagents, refrigeration, heating, and microscopes are available. If the patient’s non-treponemal test is reactive, then the more expensive treponemal blood test confirms the diagnosis. Several variations are used, but all require a microscope, centrifuge, water bath, plate shaker, and/or refrigerator.

    Application in Low-Resource Settings
    Antenatal syphilis screening is a national policy in many low-resource settings, but the majority of mothers do not have access to laboratory-based services. Rapid, point of care diagnostics performed on whole blood present a promising alternative. These tests  are typically performed using whole blood taken from the patient’s finger tip and placed on immunochromatographic strip housed in a plastic cartridge. No power is required, and results visible to the naked eye are available in 20 minutes or less. While treatment is inexpensive, benzathine penicillin G requires refrigeration and at least one injection.

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE
    TECH
    STATUS
    NOTES

    Fujirebio

    Espline TP
    $3.25
    Treponemal Dx
    Marketed
    98% sensitive, 94% specific

    Standard

    SD Bioline Syphilis 3.0
    $1.00
    Treponemal Dx
    Marketed
    95% sensitive, 95% specific

    Qualpro

    Syphicheck-WB
    $0.75
    Treponemal Dx
    Marketed
    85% sensitive, 98% specific

    ChemBio

    DPP Syphilis
    N/A
    Dual Dx
    Marketed
    Treponemal and treponemal

    Generic

    RPR Test Materials
    $0.25
    Non-treponemal
    Marketed
    Requires functioning lab

    Generic

    2.4M units penicillin G
    $0.25
    Treatment
    Marketed
    Incl materials for injection

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Nurse, technician
    Hours
    20 minutes

    As the only assay to easily detect both treponemal and non-treponemal markers at the point of care, this device has great advantages. Combining the visual indicator bars could further simplify use.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    Biohazard
    Sterile wipe, lancet, micropipette, buffer
    Room temperature
    None

    Compared with the conventional testing methods used in high-resource settings, the rapid diagnostic tests have made great progress.

    COST

    Device Cost (Approx)
    Cost/use (Approx)
    N/A
    N/A

    Cost data on this device is not readily available

    OTHER

    Portability
    Regulatory
    Efficacy
    <100g

    Additional devices required for impact: Intramuscular injection of 2.4M units benzathine penicillin G

Sources: BR Schackman et al. (2007) Cost-Effectiveness of Rapid Syphilis Screening in Prenatal HIV Testing Programs in Haiti. PLoS Med 4(5): e183. R W Peeling. Rapid tests for sexually transmitted infections (STIs): the way forward. ex Transm Infect 2006;82:v1-v6 PATH. RDT Info. Rapid tests for syphilis 2008. M Caserta. Congenital Syphilis. The Merck Manual. October 2009. R W Peeling. Laboratory-based evaluation of rapid syphilis diagnostics: Results from 8 SDI Sites. The Sexually Transmitted Diseases Diagnostics Initiative (SDI). UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)