Monitor J100+血沉仪的性能评价及武汉地区健康成人红细胞沉降率的参考区间调查

Performance evaluation of Monitor J100+ automated sedimentation analyzer and reference interval investigation of ESR in healthy adult in Wuhan

目的:对Monitor J100+血沉仪检测性能及准确性进行评价,同时使用其对武汉健康成人红细胞沉降率(erythrocyte sedimentation rate,ESR)参考区间进行调查。方法:以重复测定样本来检验其批内和日间精密度;选取90例样本,用魏氏手工法(标准方法)与Monitor J100+仪器法进行比较,以评价其准确度;标本存放24 h后重测,以评估延时检测对其结果稳定性的影响;通过对武汉地区21～70岁健康成人ESR检测,初步调查其参考区间。结果:Monitor J100+血沉仪检测ESR的批内精密度为4.10%～24.80%,日间精密度为6.17%～33.33%;仪器法与魏氏手工法比较,其结果差异的95%一致性范围为-15.3～14.7 mm/h,偏倚为-0.3 mm/h;标本存放24 h后检测的结果与即时检测的结果比较,其线性回归方程为Y=0.973X-1.301,r^2=0.985;调查ESR健康成人参考区间发现,女性ESR高于男性,且均随年龄增长而增高。结论:Monitor J100+血沉仪检测ESR的精密度好、准确度高、标本的稳定性合格,具有快速、简便、生物危害低,适合大批量样本检测等优点,且其参考区间的建立能为临床提供有效帮助。

Objective To evaluate the detection performance and accuracy of Monitor J100+and to apply it to investigating the ESR reference interval for healthy adult individuals in Wuhan.Methods Repeated samples were used to test the intra-assay precision and inter-day precision;90 samples were selected and compared with the Westergren method and instrument method to evaluate the accuracy of Monitor J100+;the samples were repeatedly tested for their time stability after 24-hour storage.Through the detection of healthy adult individuals aged 21 to 70 in Wuhan,a preliminary investigation of the reference range of ESR was conducted.Results The intra-assay precision of Monitor J100+ESR was 4.10%to 24.80%,and the inter-day precision was 6.17%to 33.33%.When the instrumental method compared with the Westergren method,the 95%consistency of the resulting difference ranged from-15.3 to 14.7 mm/h with a bias of-0.3 mm/h;the time stability of the specimen placed for 24 hours was Y=0.973X-1.301,r^2=0.985;after investigating ESR healthy adult individuals,it’s discovered that women were higher than men in reference intervals,and the reference intervals increased with age.Conclusion Monitor J100+ESR has a good precision,high accuracy and time stability of specimen placement.It has the advantages of rapidity,simplicity,low biological hazards and suitability for the detection of large quantities of samples,and the establishment of its reference interval provides effective support for clinicians’diagnosis and treatment.