COAGULATION
setup of key functions such as reflex testing rules, IQC management, and calibration routines. This structured approach helped ensure that the platform was evaluated in a manner consistent with intended use scenarios, while also allowing flexibility to test alternative workflows. Importantly, this support remained advisory, with all assessment decisions and performance interpretations independently determined by the laboratory team. Analytical performance was also central to the evaluation. Coefficients of variation between 1–2% were observed for routine PT and APTT assays, indicating strong repeatability. In a setting where clinical decisions are often guided by narrow decision limits, particularly in high-volume routine testing, this level of precision supported greater confidence in diagnostic interpretation.
The sthemO 201’s 2D barcoded inputs, pre-installed calibration data, and a fully traceable audit trail help reduce manual entry and minimise risk.
sthemO 201’s user interface was found to support this need. Features such as icon- driven navigation, clear reagent loading prompts, and straightforward access to calibration and quality control functions helped reduce the time needed to reach basic competency.
This contributed not only to workflow
continuity, but also to the resilience of the service during periods of leave, shift transitions, or operational peaks. And with very little technical maintenance required, analyser downtime was kept to an absolute minimum. The maintenance steps were handled entirely by the analyser without the need for staff to spend prolonged periods performing the maintenance.
This usability extended to reagent and consumable loading and calibration: 2D barcoded inputs, pre-installed calibration data, and a fully traceable audit trail helped reduce manual entry and minimise risk. The step-by-step instructions on the system allow guided performance of all activities.
“I’ve used a lot of machines over a lot of years. The user interface is sensible on the analyser software. It’s logical. You could walk up to that with very minimal training and still have an intuitive understanding of it,” said Stephen.
Assessing sthemO’s real-world potential “Although the sthemO 201 was evaluated outside of routine clinical workflows, the implementation support received was considered indicative of
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how such a system might be integrated into service,” Stephen noted. “Regular site visits from Stago’s technical and application teams went beyond initial setup, providing opportunities to explore workflow configuration, software functionality, and instrument performance under simulated use conditions,” he added. Effective implementation of a new analyser is rarely defined solely by the success of the initial installation. More often, the true value lies in how well the platform integrates into existing workflows, meets evolving service demands, and adapts to user feedback. “In this evaluation, engagement with the supplier focused not only on technical aspects, but also on understanding how the analyser might align with clinical and accreditation requirements in future deployment scenarios,” Stephen commented. This collaborative approach allowed the evaluation team to retain ownership of the process while drawing on expert insight to test and optimise analyser use. It also enabled rapid clarification of queries and provided a structured opportunity to assess the platform’s real- world potential before any commitment to routine adoption. Throughout the evaluation, Stago
provided detailed protocols and configuration guidance to support the assessment process. While the laboratory retained control over how the system was tested, input from technical specialists allowed for efficient
Evaluation summary The consensus among those involved in the evaluation was that the sthemO 201: “Provided a reliable platform for high-complexity haemostasis testing without the need for multiple instruments or manual workarounds. It met key requirements around flexibility, automation, and traceability while also supporting broader service objectives such as accreditation readiness and workforce efficiency.” In laboratories where diagnostic complexity intersects with clinical urgency and accreditation demands, the ability to consolidate testing, automate processes, and manage data intelligently is critical. The sthemO 201 platform, as evaluated in one such environment, demonstrated capabilities aligned with these needs: “its multi-method detection, walkaway operation, and integrated data tools supported robust haemostasis workflows without compromising analytical performance.”
Stephen concluded: “While long-term
performance monitoring will remain important, early experience suggests that such platforms can help laboratories enhance precision, improve efficiency, and ultimately support safer, more reliable clinical decision-making.”
For more information about the sthemO 201 analyser, and the sthemE eSolutions product suite, visit the Stago website.
www.sthemo.stago.com
Note: Reagents mentioned may still be under development at the time of writing. No financial sponsorship was received for this evaluation; instrumentation and reagents were provided for assessment purposes only.
SEPTEMBER 2025
WWW.PATHOLOGYINPRACTICE.COM
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