ADVIA Centaur Syphilis Assay Now Available in the United States

The Diagnostics Division of Siemens Healthcare has announced the U.S. availability of its ADVIA Centaur Syphilis assay to be used as an aid in the disease’s diagnosis.

The assay, which allows for sensitive and specific detection of antibodies to the proteins of Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, sodium citrate), is available on the company’s ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP immunoassay systems. It is not intended for blood and tissue donor screening.

Use of a treponemal assay as the initial assay followed by a non-treponemal test (a reverse testing algorithm) has been shown to increase detection of both early primary and late-latent infections that would have been missed using a traditional testing approach (using a non-treponemal, e.g., RPR, as the initial assay).¹ Also, unlike manual syphilis testing methods, the automated Siemens assay helps improve laboratory workflow efficiency and testing accuracy and reliability.

The ADVIA Centaur Syphilis assay reduces testing turn-around time, even when compared to the other automated syphilis assays currently available in the U.S. market.^2,3 Results are delivered in approximately 29 minutes on the ADVIA Centaur and ADVIA Centaur XP systems and approximately 26 minutes on the ADVIA Centaur CP systems, compared to turnaround times of 40 minutes or more for the two other FDA-cleared automated tests currently on the market.

Syphilis is primarily acquired by sexual contact, but can also be transmitted from mother to fetus. Vertical transmission results in the significant potential for birth defects and fetal death. Early identification of syphilis infection in pregnant women can significantly reduce risk of transmission to the fetus through treatment with antibiotic. Syphilis can represent a diagnostic challenge due to diverse signs and symptoms which can mimic other disease states, or through lack of any clinical manifestations. Before the advent of serological testing, precise diagnosis was very difficult. If untreated, syphilis can cause serious effects such as damage of the heart, aorta, brain, eyes, and bones. In some cases these effects can be fatal.⁴

1. Singh, A.E., T. Wong, and P. De. 2008. Characteristics of primary and late latent syphilis cases which were initially non-reactive with the rapid plasma regain as the screening test. Int. J. STD AIDS 19:464-468.
2. www.accessdata.fda.gov/cdrh_docs/reviews/K063866.pdf
3. www.accessdata.fda.gov/cdrh_docs/reviews/K061247.pdf
4. The Merck Manual Professional Edition. Syphilis. Available at http://www.merckmanuals.com/professional/infectious_diseases/sexually_transmitted_diseases_std/syphilis.html. Accessed 1/29/15.