Hemostasis testing has experienced a dramatic change over the last 50 years. From the 1950s through the early 1990s, coagulation tests were performed manually by many laboratories.
Reagents were manufactured by the laboratory staff at larger hospitals by processing animal or human brains in a batch-wise fashion. These reagents were then used in coagulation tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), and other global coagulation tests. Equipped with a centrifuge, stopwatch, pipette, water bath, and test tube, laboratory staff used these “in-house” reagents to determine the clotting capability of a patient sample.1
Through the 1990s to the early 2000s, semi-automated and fully-automated instrumentation arrived in the hemostasis laboratory, allowing for testing improvements through standardized processes like aspiration and dispensing of samples and reagents, mixing regimens, and measurement determination.
During this time, analyzers using optical endpoint clot detection for clot-based tests were improved upon, and colorimetric and immunoturbidimetric testing could be supported on the same platform, enabling increased productivity and workflow from automated coagulation analyzers. By the early 2000s, reagent quality (and therefore test results) also improved through increased standardization in reagent manufacturing.
The Sysmex CN-Series
In 2025, Sysmex America Inc, a diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry, and informatics solutions, received US Food and Drug Administration clearance for the Sysmex CN-Series automated blood coagulation analyzers.
The CN-Series includes two models, the Sysmex CN-3000 and CN-6000, designed to accommodate laboratories with different throughput requirements and size constraints. Both systems, identical in size and shape, have a smaller footprint than the Sysmex CS-5100 analyzer.
For low to mid-volume laboratories, the CN-3000 provides a throughput of 225 PT or 215 PT/APTT tests per hour. For medium- to high-volume laboratories, the CN-6000 provides a throughput of 450 PT or 401 PT/APTT tests per hour. Features such as closed-tube sampling, Preanalytical Sample Integrity (PSI™) checks, and hemolysis, icterus, and lipemia checks are performed to minimize manual handling, reduce error risk, and boost overall productivity.
The CN-Series systems also include gain switching analysis to help reduce assay interference by automatically switching the wavelength for detection, minimizing the effect of interference from samples with high intralipid concentrations.2
Sysmex CN-9000: Workflow and Automation
Sysmex has continued to expand its product portfolio across hematology, hemostasis, and urinalysis. The CN-Series introduces new hardware, improved software, and automation features to the hemostasis laboratory. Drawing on the “automated line” concept introduced by Sysmex hematology systems, the CN-9000 gives laboratories new options for maximizing workflow and resource utilization.
The CN-9000 streamlines the hemostasis laboratory with continuous sample loading and automated rerun and reflex testing, with a throughput of up to 1,000 samples per hour. Labs can operate the CN-9000 as a standalone automation solution or connect it to a compatible total laboratory automation line. The modular system supports up to three CN-3000 or CN-6000 blood coagulation analyzers, as well as the optional Sysmex TS-10 integrated tube sorter and archiver. The line can be configured with up to two turn unit modules, allowing 90° directional changes to help accommodate laboratory space constraints.
The Sysmex CN-9000 provides increased walkaway time with intelligent sample routing that knows which tests are available on each connected CN-Series analyzer, helping each system operate to maximum capacity and minimizing turnaround times. The reliability of Sysmex track automation, together with components like turn units, means that “island” automation is a realistic option for laboratories of all sizes and not just reserved for large workload sites.
Testing Capabilities
The CN-series works on the optical detection principle used by over 80% of the global hemostasis market. Sysmex refined this technology by providing a multi-wavelength detection system using transmitted light to allow simultaneous analysis of clotting, chromogenic, and immunoassays.
Turnaround times for clotting assays are improved over previous-generation systems. Time interval endpoint checking improves the time to result by approximately two minutes per test, while maintaining the pre-sample warming before analysis feature. In 2021, Nguyen et al demonstrated that the Sysmex CN-6000 provided a 30% higher throughput compared to the Stago STA-R Max2 analyzer (258 vs 185 tests per hour for a panel of tests including PT, APTT, Fibrinogen, Factor V, anti-Xa, and D-Dimer).3
“Sysmex’s hemostasis solutions bring together advanced technology, trusted reagents, and award-winning service to provide laboratories with reliable results for diagnosing patients suffering from bleeding or clotting disorders.”
Dan Zortman, ceo of sysmex america
Hardware and software improvements on the CN-Series are designed to reduce hands-on time and support system reliability.
- A light-emitting diode (LED) light source reduces operator maintenance and increases system reliability.
- Reduced sample volume requirements support automated rerun, reflex, and specialty testing.
- Enhanced cooling systems allow increased onboard stability for reagents, quality control (QC), and calibration materials.
- Workload prediction software estimates reagent needs based on historical system data.
Quality Control
Enhanced quality control options allow users to specify automated QC analysis at designated times or time intervals, test counts, or when new reagent vials are being accessed. The CN-Series also allows QC analysis for both current and new lots to be performed concurrently.
Enhanced QC charts improve navigation and access to QC information through simple viewing and export capabilities, including user comments linked to individual data points. Reagent lot information is integrated and displayed within the QC charts. These same enhancements have been applied to calibration displays, enabling easier comparison of up to 100 calibration curves within an assay and across assays.
Clotting factor assay testing on the CN-Series uses multi-dilution analysis (MDA) to help maximize the measurement range of the eight extrinsic and intrinsic one-stage factor assays, without extrapolation of the calibration curve. In addition, reflex and re-analysis rules on the CN-Series provide automation to MDA assays using the appropriate dilution set.
“Sysmex America’s hemostasis solutions help labs keep up with growing testing demands. With the CN-9000, we’re giving labs a reliable, high-throughput, walkaway solution that makes daily operations easier and more efficient,” says Dan Zortman, CEO of Sysmex America.
Photo caption: The Sysmex CN-Series hemostasis testing solutions offer modular and scalable workflow options for laboratories.
Photo credit: Sysmex
References
- Huber AR, Méndez A, Brunner-Agten S. Automation in haemostasis. Hamostaseologie. 2013;33(4):295-8.
- Gardiner C, Lane P, Langley K, et al. A comparative evaluation of the CN-6000 haemostasis analyser using coagulation, amidolytic, immuno-turbidometric and light transmission aggregometry assays. Int J Lab Hematol. 2020;42(5):643-9.
- Nguyen G, Lejeune M, Gaaloul M, et al. Performance evaluation of the fully automated random-access multiparameter Sysmex CN-6000 hemostasis analyzer at a core laboratory with a high sample throughput. Int J Lab Hematol. 2022 Apr;44(2):385-92.
