Siemens Healthcare, Erlangen, Germany, has received FDA premarket notification (510(k)) clearance of the Sysmex CS-5100 hemostasis system.
The first analyzer in the Sysmex CS family of hemostasis systems to be available in the United States, the system enables automated, standardized sample management, as well as automated detection of unsuitable samples. It is equipped with simultaneous multiwavelength preanalytical sample integrity technology, enabling high-volume laboratories to achieve first-run accuracy.
Preanalytical errors and unsuitable samples account for up to 70% of mistakes in laboratory diagnostics.1 In coagulation testing, for example, underfilling of sample tubes may cause significant sample dilution and provide falsely prolonged clotting times.2 The effect of laboratory diagnostic errors on patient care is potentially significant, since information provided by clinical laboratories affects up to 70% of clinical decisions.3
The Sysmex CS-5100 system enables laboratories to automate and standardize sample management and detect unsuitable samples prior to analysis, enhancing the reliability of results while improving efficiency by minimizing the need for manual sample inspections. The system connects to Siemens’ automation and data-management offerings, including the track-based Aptio automation and Advia LabCell automation systems.
“This new technology provides a strong operational advantage to customers, as they no longer need to manually inspect patient samples to ensure the correct volume prior to analysis,” says Franz Walt, president of laboratory diagnostics at Siemens Healthcare. “Available both as a standalone or complete workflow solution with connectivity to automation, the Sysmex CS-5100 system has the flexibility to meet varying testing volume requirements.”
The system features third-generation cap-piercing technology, which contributes to reduced sample-processing time and maintains the analyzer’s high-throughput capability, and a wide optical spectrum, which allows clotting, chromogenic, immunologic, and aggregation testing capabilities on a single platform. It also supports an onboard capacity of up to 3,000 tests and up to 40 reagents.
“US healthcare providers have experienced seismic shifts due to the implementation of the Affordable Care Act and reimbursement cuts. In response, laboratories must be more cost-effective in delivering timely, accurate results for a steadily increasing volume of patient tests,” says Jack Kenny, senior vice president of laboratory diagnostics at Siemens Healthcare, North America. “The Sysmex CS-5100 system enables customers to confidently achieve higher throughput while improving accuracy.”
To better ensure consistency of results and simplify testing in multisite labs, test results from the Sysmex CS-5100 system correlate with all other Sysmex CS and CA hemostasis systems. Additionally, the Sysmex CS-5100 system uses the same reagents, controls, and calibrators as other coagulation analyzers offered by Siemens.
For more information, visit Siemens Healthcare.
- Lippi G, Banfi G, Buttarello M, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728–736.
- Favaloro E, Lippi G, Adcock D. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis? Semin Thromb Hemost. 2008;34:612–634.
- LLopis MA, Alvarez V, Martínez-Brú C, et al. Quality assurance in the preanalytical phase. In Applications and experiences of quality control. Ed. Ivanov O. Rijeka, Croatia: InTech, 2011. Available at: www.intechopen.com/books/applications-and-experiences-of-qualitycontrol/quality-assurance-in-the-preanalytical-phase. Accessed 12 January 2016.