Daly S, Freeman K P, Graham P A
Veterinary Pathology Group, Cork, Ireland.
School of Veterinary Medicine and Science, University of Nottingham, Leicestershire, UK.
Vet Clin Pathol. 2025 Jun;54(2):95-105. doi: 10.1111/vcp.70023. Epub 2025 Jul 17.
Previous studies have shown that veterinary in-clinic hematology analyzers may have analytical errors, but few studies have been found that attempt bias correction and look at the effect of this on the achievement of several quality goals and evaluation of analytical performance specifications.
To design a comparative testing program for use by in-clinic laboratories with a variety of point-of-care (POC) analyzers and to evaluate the performance of in-clinic hematology analyzers compared to a reference analyzer. To determine whether the removal of bias from the in-clinic result can be used in preparation for the harmonization of the results with those of the reference laboratory. To determine the analytical performance specifications/quality goals that can be achieved with the removal of bias from the in-clinic results. To determine whether clinic-based clinicians and technicians found the information provided valuable for ongoing in-clinic hematology quality management.
Fresh EDTA whole blood canine samples with results that were within reference limits were processed five times by in-clinic staff using their in-clinic analyzer before sending the sample to the reference laboratory for comparison. Results were assessed using quality goals, including total allowable error (TE) or expert opinion and sigma metrics. The quality goal index (QGI) was calculated for measurands whose performance was < 4 sigma. The potential impact of any difference in results on clinical interpretation was also reviewed.
In comparison to the reference analyzer, in-clinic hematology analyzers often had analytical error and failed to meet quality goals for TE and sigma metrics. This error was often undetected by the in-clinic laboratory. Sigma metric < 4 was a useful performance indicator of poor performance, and only 54% of measurands had sigma metrics > 4. Of these poor-performing instances, 90% were attributed to bias. Performance improved for in-clinic analyzers by adjusting results to correct for bias in preparation for harmonization.
A comparative testing program was successfully designed and implemented to evaluate performance and harmonize in-clinic hematology analyzers to a reference analyzer using samples that are within reference intervals.
先前的研究表明，兽医临床血液分析仪可能存在分析误差，但很少有研究尝试进行偏差校正并观察其对实现多个质量目标以及分析性能规范评估的影响。
设计一个供临床实验室使用的比较测试程序，用于多种即时检验（POC）分析仪，并评估临床血液分析仪与参考分析仪相比的性能。确定从临床结果中消除偏差是否可用于使结果与参考实验室的结果协调一致。确定通过消除临床结果中的偏差可实现的分析性能规范/质量目标。确定基于临床的临床医生和技术人员是否认为所提供的信息对持续的临床血液学质量管理有价值。
临床工作人员使用其临床分析仪对新鲜的EDTA抗凝犬全血样本进行五次检测，这些样本的结果在参考范围内，然后将样本送至参考实验室进行比较。使用质量目标评估结果，包括总允许误差（TE）或专家意见以及西格玛度量。为性能<4西格玛的被测量计算质量目标指数（QGI）。还审查了结果差异对临床解释的潜在影响。
与参考分析仪相比，临床血液分析仪经常存在分析误差，并且未达到TE和西格玛度量的质量目标。这种误差在临床实验室中常常未被检测到。西格玛度量<4是性能不佳的有用指标，只有54%的被测量具有>4的西格玛度量。在这些性能不佳的情况中，90%归因于偏差。通过调整结果以校正偏差，为协调做准备，临床分析仪的性能得到了改善。
成功设计并实施了一个比较测试程序以评估性能，并使用参考区间内的样本使临床血液分析仪与参考分析仪协调一致。
