Elecsys® Syphilis

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> Syphilis

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Immunoassay for the qualitative determination of total antibodies against Treponema pallidum

 

Intended to aid in the diagnosis of syphilis infection in conjunction with nontreponemal tests and clinical signs and symptoms

 

Syphilis is caused by the intracellular Gram-negative spirochete bacterium Treponema pallidum subspecies pallidum.1 In 2023, over 200,000 new cases were reported in the US, the greatest number of cases since 1950.2

Most people with syphilis are asymptomatic, but if untreated the infection can cause significant complications.3 Although syphilis is usually transmitted sexually, it can also be transmitted from mother to fetus with over 3,700 pregnancies affected in the US each year.4 However, if diagnosed in the early stages, syphilis can be successfully treated and congenital syphilis prevented.5,6

Serologic tests like the Elecsys® Syphilis assay are the method of choice for the reliable detection of total antibodies against Treponema pallidum in clinical routine samples.7

Elecsys® Syphilis specifications

  • Systems

    cobas® e 411 module, cobas® e 601 / cobas® e 602 modules, cobas® e 402/ cobas® e 801 modules

  • Material numbers

    e 411/601/602: 09014977190
    e 402/801: 09015051190
    PreciControl: 06923364190

  • Testing time

    18 minutes

  • Test principle

    One-step double-antigen sandwich assay
    Assay detects total IgG and IgM against bacterial TpN15, TpN17 and TpN47

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, Na-heparin, K2-EDTA, K3-EDTA, CPDA, and Na-citrate plasma and Li-heparin plasma tubes. K2‑EDTA plasma tubes containing separating gel can be used.

     

     

     

     

     

  • Sample volume

    cobas e 411 analyzer, cobas e 601 / 602 modules: 10 μL
    cobas e 402 / e 801 modules: 6 μL

  • Intermediate precision in positive samples

    cobas e 411 module: CV 5.7 – 6.3%
    cobas e 601 / 602 modules: CV 4.4 – 6.3%
    cobas e 402 / e 801 modules: CV 2.4 – 3.6%

  • Clinical sensitivity

    Positive percent agreement —

    Total: 100% (n = 228), including all stages and in pregnant women

  • Clinical specificity

    Negative percent agreement —

    99.2% (n = 2054)

Would you like to know more about the Elecsys® Syphilis assay?

Please submit your information in the following form to be contacted by a Roche representative with more details.

General representation of the reverse and traditional syphilis testing algorithms

Elecsys Syphilis

ECLIA, electrochemiluminescence immunoassay; EIA, enyzme immunoassay; RPR, rapid plasma reagin; TPLA, Treponema pallidum latex agglutination; VDRL, Veneral Disease Reasearch Laboratory test, Adapted from Binnicker (2012)7 and Katz (2010)8

References

  1. Seña AC, White BL, Sparling PF. Novel Treponema pallidum serologic tests: a paradigm shift in syphilis screening for the 21st century. Clin Infect Dis 2010:51(6);700-708..
  2. CDC.gov. STI statistics. https://www.cdc.gov/sti-statistics/annual/summary.html
  3. CDC.gov. Syphilis in babies reflects health system failures. https://www.cdc.gov/vitalsigns/newborn-syphilis/index.html
  4. Workowski, K.A., Berman, S.; CDC. (2010). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep 59, 1-110.
  5. World Health Organisation (2012). Investment case for eliminating mother-to-child transmission of syphilis. Available from: https://apps.who.int/iris/handle/10665/75480?search-result=true&query=Investment+case+for+eliminating+mother-to-child+transmission+of+syphilis&scope=&rpp=10&sort_by=score&order=desc (accessed January 2023).
  6. World Health Organisation (2010). Screening donated blood for transfusion-transmissible infections: recommendations. Available from: https://apps.who.int/iris/handle/10665/44202?search-result=true&query=Screening+donated+blood+for+transfusion-transmissible+infections&scope=&rpp=10&sort_by=score&order=desc (accessed January 2023).
  7. Binnicker MJ. Which algorithm should be used to screen for syphilis? Curr Opin Infect Dis. 2012 Feb;25(1):79-85. doi: 10.1097/QCO.0b013e32834e9a3c. (accessed January 2021).
  8. Katz, K. (2010). Newer laboratory testing algorithms for syphilis begin with EIA. MLO Med Lab Obs. 42, 18-20.
  9. Elecsys syphilis method sheet. MN 09014977190 2024-12 V2.0; MN 09015051190 2024-06 V3.0

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