FDA Clears Siemens Fully Automated ADVIA Centaur Syphilis Assay
Siemens Healthcare Diagnostics has received FDA clearance for its ADVIA Centaur® Syphilis Assay¹ for the detection of antibodies against Treponema pallidum, a bacterium known to cause the sexually-transmitted disease, syphilis. Now, laboratories in the United States can further automate testing for this serious condition and drive additional workflow and efficiency gains by combining it with other infectious disease testing on the Siemens ADVIA Centaur family of high-throughput, random-access immunoassay systems.
Syphilis has been called the “great imposter” because its symptoms can mimic other infections in advanced stages.² When left untreated, syphilis can lead to serious neurological and cardiovascular complications, and cause stillbirth in pregnant women. Fortunately, detection of the presence of syphilis antibodies in patients may be used to support decisions for an antibiotic therapy, detect persons at risk to spread the infection and identify those that are not aware of their infection to prevent late complications. Recently, a meta-analysis of 10 studies involving 41,049 women found that screening and treatment of the infection in pregnant women could reduce the number of stillbirths and perinatal deaths resulting from maternal transmission of syphilis by more than half.³
As part of the company’s ongoing educational initiatives, Siemens is offering “Syphilis Testing and the Reverse Algorithm Approach,” a complimentary webinar to review the clinical aspects of syphilis and laboratory testing’s role in diagnosing the disease. To register, please visit: www.meetme.net/syphilistesting.
For more on Siemens’ extensive portfolio of infectious disease assays compatible with laboratory automation, including syphilis testing for the ADVIA Centaur systems, please visit: www.siemens.com/infectious-disease.
Launched in November 2011, Agenda 2013 is a global initiative to further strengthen the innovative power and competitiveness of the Siemens Healthcare Sector. Specific measures will be implemented in four fields of action: Innovation, Competitiveness, Regional Footprint, and People Development.
The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: www.siemens.com/healthcare.
1Method availability is subject to local regulatory requirements and therefore varies by country. In the U.S. the assay is not intended for blood or tissue donor screening.
2Medscape. Available at http://emedicine.medscape.com/article/229461-overview#a0101. Accessed 6/10/11
3Hawkes, S, Matin, M, Broutet, N, Low, N. Effectiveness of interventions to improve screening for syphilis in pregnancy: a systematic review and meta-analysis. The Lancet Infectious Diseases, Early Online Publication, 16 June 2011 doi:10.1016/S1473-3099(11)70104-9