Kur Dår Kristian, Eriksson Boija Elisabet, Morken Christine, Sandberg Sverre, Stavelin Anne
Danish Institute for External Quality Assurance for Laboratories in the Health Sector (DEKS), Rigshospitalet Glostrup, Glostrup, Denmark.
Equalis AB, Uppsala, Sweden.
Diagnosis (Berl). 2025 May 23. doi: 10.1515/dx-2025-0023.
Scandinavian evaluation of laboratory equipment for point of care testing (SKUP) provides objective and supplier-independent information about analytical quality and user-friendliness of point-of-care (POC) measuring systems. The evaluation reports are freely available online and are valuable tools when selecting fit-for-purpose POC equipment. In this study, we present an overview of the performance of four POC measuring systems for monitoring prothrombin time international normalized ratio (INR) assessed against updated analytical performance specifications (APSs).
Primary healthcare centres (PHCCs) in Sweden and Norway did the practical work under real-life conditions. In each evaluation, 2-4 PHCCs participated with at least 40 patients on Warfarin treatment per site. Capillary samples were measured on the POC INR systems (qLabs Q3 Plus PT-INR Owren, Xprecia Stride, microINR or ProTime InRhythm), with venous samples analysed at hospital laboratories for comparison (STA-R Evolution or Sysmex CS5100). In the current study, APSs from SKUP, ISO 17593:2022, and CLSI POCT14-Ed2 were used. User-friendliness was assessed by addressing operational facilities, user-manual, time factors, and quality control.
Only microINR coagulometer met the APS for accuracy, while qLabs Q3 Plus PT-INR Owren and ProTime InRhythm met the repeatability criteria. Xprecia Stride scored highest on user-friendliness, whereas the other systems faced challenges with sample application and unclear error messages on the devices.
This study highlights the potential for improvements in POC INR measuring systems and underscores the importance of performing objective evaluations under real-life conditions.
斯堪的纳维亚即时检验实验室设备评估（SKUP）提供有关即时检验（POC）测量系统分析质量和用户友好性的客观且独立于供应商的信息。评估报告可在网上免费获取，是选择适用的POC设备时的宝贵工具。在本研究中，我们概述了四种用于监测凝血酶原时间国际标准化比值（INR）的POC测量系统根据更新后的分析性能规范（APS）进行评估的性能。
瑞典和挪威的初级医疗保健中心（PHCC）在实际条件下开展实际工作。每次评估有2 - 4个PHCC参与，每个地点至少有40名接受华法林治疗的患者。在POC INR系统（qLabs Q3 Plus PT - INR Owren、Xprecia Stride、microINR或ProTime InRhythm）上测量毛细血管样本，同时在医院实验室分析静脉样本以作比较（STA - R Evolution或Sysmex CS5100）。在本研究中，使用了来自SKUP、ISO 17593:2022和CLSI POCT14 - Ed2的APS。通过考察操作设施、用户手册、时间因素和质量控制来评估用户友好性。
只有microINR凝血仪符合APS的准确性要求，而qLabs Q3 Plus PT - INR Owren和ProTime InRhythm符合重复性标准。Xprecia Stride在用户友好性方面得分最高，而其他系统在样本应用和设备上不明确的错误信息方面面临挑战。
本研究突出了POC INR测量系统改进的潜力，并强调了在实际条件下进行客观评估的重要性。
