Elecsys® Syphilis immunoassayConfidence in all stages of treponemal infection

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References1. World Health Organisation (2012). Baseline report on global sexually transmitted

infection surveillance 2012. Available from: http://apps.who.int/iris/bitstream/10665/85376/1/9789241505895_eng.pdf (accessed December 2013).

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: http://apps.who.int/iris/bitstream/10665/75480/1/9789241504348_eng.pdf (accessed October 2013).

4. World Health Organisation (2010). Screening donated blood for transfusion-transmissible infections: recommendations. Available from: http://www.who.int/bloodsafety/ScreeningDonatedBloodforTransfusion.pdf (accessed October 2013).

5. Binnicker, M.J. (2012). Which algorithm should be used to screen for syphilis? Curr Opin Infect Dis 25, 79–85.

6. Eccleston, K., Collins, L., Higgins, S.P. (2008). Primary syphilis. Int J STD AIDS 19, 145–151.

7. Larsen, S.A., Steiner, B.M., Rudolph, A.H. (1995). Laboratory diagnosis and interpretation of tests for syphilis. Clin Microbiol Rev 8, 1–21.

8. Peeling, R.W., Ye, H. (2004). Diagnostic tools for preventing and managing maternal and congenital syphilis: an overview. Bull World Health Organ 82, 439–446.

Elecsys® Syphilis immunoassayConfidence in all stages of treponemal infection

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 and through blood transfusion.4 However, if diagnosed in the early stages, syphilis can be successfully treated and congenital syphilis prevented.2,3

Patterns of serologic responseSerological tests remain the method of choice for diagnosing syphilis. Two to 3 weeks after infection, IgM antibodies are usually detectable, followed by the appearance of IgG approximately 2 weeks later.6 Treponemal tests (such as Elecsys® Syphilis test from Roche Diagnostics) are utilized to detect the presence of anti-T. pallidum specific antibodies in serum.8 The Elecsys® Syphilis test can be used for screening, diagnosis and confirmation of the infection.5 Positivity of treponemal tests usually can be observed 2 to 5 weeks after the initial infection and remain reactive for years, if not a lifetime.6,7

Figure adapted from Peeling et al. (2004).8

T O R C HToxo IgG Syphilis ECLIA Rubella IgG CMV IgG HSV-1 IgGToxo IgM Rubella IgM CMV IgM HSV-2 IgGToxo Avidity CMV Avidity

Tests are compatible with the Elecsys® 2010 analyzer, MODULAR® ANALYTICS E170, cobas e 411 analyzer and cobas e 601/602 modules.

Completing the Roche TORCH portfolioThe comprehensive Elecsys® assay menu for consolidated pregnancy testing.

Time of infection Weeks Time post-infection Years

IgM

Non-treponemalTests

TreponemalTests

Untreated

Treated

Primary stage

Primarylesion

Secondarylesion

Secondary stage Latent (asymptomatic) stage Tertiary stage

IgG Cardiolipins

2 4 6 8 10 12 2 10 20

Non-treponemalTests

Assay type

Patterns of serologic response to T. pallidum

Elecsys® Syphilis immunoassay, higher standard in syphilis testing

Overall sensitivity Primary Syphilis Secondary SyphilisLatent SyphilisUnknown stage

100%100%100%100%100%

n=924n=101n=124n=470n=229

Overall specificityRoutine samples (general diagnosis)Blood donors (Blood Safety Solutions)

99.88% 99.80% 99.93%

n=8079n=3500n=4579

Reliable identification of syphilis infection• Fully automated and integrated with other tests in the STD

and TORCH portfolios• Efficient and safe testing of Blood donors

Your benefitsDetection of total antibodies to T. pallidum• Detection of IgG and IgM antibodies against TpN15,

TpN17 and TpN47Designed for high sensitivity and specificity• High sensitivity and specificity minimizes the probability

of missing true positives in all stages of infectionCost efficiency• High specificity reduces the need for retestingClear interpretation of results• Clear cut-off separation of positive and negative resultsEfficient use of sample volume and time• Only 10 µL testing volume to perform all tests using the

same sample • Result obtained in only 18 minutes

Higher standard in syphilis testing