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Elecsys® Syphilis

Elecsys Syphilis

Immunoassay for the qualitative determination of total antibodies against Treponema pallidum

Syphilis is caused by the intracellular Gram-negative spirochete bacterium Treponema pallidum subspecies pallidum. In 2012, approximately 12 million new cases of infection were reported.1

Most people with syphilis are asymptomatic, but if untreated the infection can cause significant complications.2 Although syphilis is usually transmitted sexually, it can also be transmitted from mother to fetus with an estimated 1.5 million pregnancies affected globally each year.3,4 However, if diagnosed in the early stages, syphilis can be successfully treated and congenital syphilis prevented.2,3

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.5

 

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)5 and Katz (2010)6

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References

 

  1. World Health Organisation (2012). Baseline report on global sexually transmitted infection surveillance 2012. Available from: https://apps.who.int/iris/handle/10665/85376?search-result=true&query=Baseline+report+on+global+sexually+transmitted+infection+surveillance&scope=&rpp=10&sort_by=score&order=desc (accessed January 2023).
  2. Workowski, K.A., Berman, S.; CDC. (2010). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep 59, 1-110.
  3. 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).
  4. 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).
  5. 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).
  6. Katz, K. (2010). Newer laboratory testing algorithms for syphilis begin with EIA. MLO Med Lab Obs. 42, 18-20.
  7. RPR2 Package Insert 2022-12, V3.0.
  8. TPLA2 Package Insert 2017-10, V3.0.
  9. Elecsys Syphilis Pack Insert for 09014977190 2021-01 v1.0, 09015035190 2021-02 v1.0, 9015051190 2022-11, V 2.0.

 

Elecsys® Syphilis

  • Systems

    cobas e 402 module
    cobas e 411 module
    cobas e 601 module
    cobas e 602 module
    cobas e 801 module

     

  • 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, K2‑EDTA, K3‑EDTA, CPDA and Na‑citrate plasma. 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 601 / 602 modules: CV 2.5 – 5.0%
    cobas e 411 module: CV 1.9 – 4.1%
    cobas e 402 / e 801 modules: CV 1.4 - 2.3%

     

  • Clinical sensitivity

    100 % (n = 924), including all stages

  • Clinical specificity

    100% pos. % agreement n = 228
    99.2% neg. % agreement n = 2,054

  • Analytical specificity

    >200 samples containing antibodies against different pathogens showed no cross re-activity