TEST1自动血沉仪的应用评估以及上海地区健康人群红细胞沉降率参考区间的建立

doi:10.3969/j.issn.1673-8640.2017.03.011

摘要/Abstract

摘要：

目的评价TEST1自动血沉仪（简称TEST1血沉仪）的主要性能指标,探讨其临床应用价值,同时建立上海地区健康人群红细胞沉降率（ESR）的参考区间。方法评价TEST1血沉仪的重复性和稳定性,比较TEST1血沉仪和用乙二胺四乙酸二钾（EDTA-K₂）抗凝的Westergren法（标准方法）检测ESR的结果差异。34份EDTA-K₂ 抗凝血标本采用TEST1血沉仪法和标准方法进行检测,同时评价TEST1血沉仪法的批内重复性和稳定性,并建立上海地区20~81岁成年人ESR的参考区间。结果 TEST1血沉仪法的准确性、重复性和稳定性比标准方法好。健康女性的ESR值比健康男性更高,并且随着年龄的增长而增加。结论 TEST1血沉仪具有安全、简便、快速以及标本处理的一致性等特点。TEST1血沉仪法参考区间的建立对检测大样本量的临床实验室较适宜。

关键词: 红细胞沉降率, Westergren 法, 参考方法, TEST1自动血沉仪, 参考区间

Abstract:

Objective To evaluate the performance of TEST1 automated sedimentation analyzer,and to establish the reference ranges of erythrocyte sedimentation rate（ESR）for healthy subjects in Shanghai. Methods The reproducibility and stability of TEST1 were evaluated. The result of ethylene diamine tetraacetic acid-K₂（EDTA-K₂） for ESR determination by Westergren method（standard method）was compared with that of TEST1. A total of 34 EDTA-K₂ samples were determined by TEST1 and standard method. The within-run reproducibility and stability of TEST1 were evaluated. The reference ranges of ESR for healthy subjects of 20-81 years old in Shanghai were determined. Results TEST1 showed satisfactory accuracy,reproducibility and stability. ESR was higher in healthy females than that in healthy males,and increased with ages. Conclusions TEST1 offers the advantages of safe,simple,rapid and uniform specimen handling. The reference ranges of ESR by TEST1 will be of use in clinical laboratories with large scale specimens.

Key words: Erythrocyte sedimentation rate, Westergren method, Reference method, TEST1 automated sedimentation analyzer, Reference range

中图分类号:

R446.5

徐黎明, 王志成, 蔡枫. TEST1自动血沉仪的应用评估以及上海地区健康人群红细胞沉降率参考区间的建立[J]. 检验医学, 2017, 32(3): 202-207.

XU Liming, WANG Zhicheng, CAI Feng. Evaluation of TEST1 automated sedimentation analyzer and establishment of the reference ranges of erythrocyte sedimentation rate for healthy subjects in Shanghai[J]. Laboratory Medicine, 2017, 32(3): 202-207.

图/表 8

图1 34例抗凝血标本标准方法与TEST1血沉仪法检测ERS的结果比较注：线性回归曲线分析差异无统计学意义（r2=0.951 2,P<0.001）,Y=0.993 9X+0.768 2

图2 13例抗凝血标本标准方法与TEST1血沉仪法检测ERS的结果比较注：13例标本ESR值<40 mm/h,该线性回归曲线分析差异无统计学意义（r2=0.088 379,P<0.001）,Y=1.202 9X-4.666 6

图3 15例ESR值在41~80 mm/h的抗凝血标本标准方法与TEST1血沉仪法的结果比较注：15例标本ESR值为41~80 mm/h,该线性回归曲线分析差异无统计学意义（r2=0.802 39,P<0.001）,Y=1.036 2X-4.754 4

图4 6例ESR值在81~120 mm/h的抗凝血标本标准方法与TEST1血沉仪法检测ERS的结果比较注：6例标本ESR值为81~120 mm/h,该线性回归曲线分析差异无统计学意义（r2=0.512 64,P<0.001）,Y=1.058 5X-5.430 6

表1 TEST1血沉仪法EDTA-K2抗凝标本批内精密度

标本	ESR（mm/h）	CV（%）
1	6.00±0.47	7.86
2	11.10±0.57	5.11
3	18.25±1.48	8.14
4	44.30±3.89	8.78
5	50.80±1.75	3.45
6	54.90±3.48	6.34
7	66.50±3.89	5.85
8	87.22±5.12	5.87

表2 TEST1血沉仪法ESR检测质量控制

标本	ESR（mm/h）	CV（%）
水平1	8.52±0.51	6.99
水平2	18.96±0.64	3.37
水平3	64.74±1.68	2.60

图5 TEST1血沉仪法2 d ESR检测结果的比较ESR（mm/h）注：横坐标代表4月9日检测的ESR值,纵坐标代表4月10日检测的ESR值;2个组线性回归曲线分析差异无统计学意义（r2=0.978 2,P<0.05）;Y=1.005 3X-0.878 7

表3 上海地区人群TEST1血沉仪法ESR的参考区间（mm/h,P2.5~P97.5）

年龄（岁）	男性		女性
年龄（岁）	例数	ESR	例数	ESR
≤50	392	2.00~12.00^*	346	2.00~24.00
20~30	110	2.00~11.28^*	135	2.00~23.00
31~50	282	2.00~12.00^*	211	2.00~24.00
>50	183	2.00~22.00	95	2.00~34.55

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