SYSMEX XN-9000全自动血液分析仪有核红细胞镜检规则的建立与评价

doi:10.3969/j.issn.1673-8640.2017.06.019

检验医学 ›› 2017, Vol. 32 ›› Issue (6): 531-534.DOI: 10.3969/j.issn.1673-8640.2017.06.019

• 技术研究与评价_论著 • 上一篇下一篇

SYSMEX XN-9000全自动血液分析仪有核红细胞镜检规则的建立与评价

顾梅秀, 孟志民, 唐文佳, 罗磊, 王冲, 郭玮, 潘柏申, 王蓓丽

复旦大学附属中山医院检验科,上海 200032

收稿日期:2016-11-15 出版日期:2017-06-30 发布日期:2017-07-04
作者简介:null
作者简介：顾梅秀,女,1968年生,学士,主管技师,主要从事临床血液学及体液学检验工作。
基金资助:
国家自然科学基金面上项目（81572064）;上海市卫生计生系统重要薄弱学科建设项目（2015ZB0201）;上海市卫生系统先进适宜推广技术项目（2013SY065）;上海申康医院发展中心课题（SHDC22014017）

Establishment and evaluation on the microscopy rule for nucleated red blood cell by SYSMEX XN-9000 automatic hematology analyzer

GU Meixiu, MENG Zhimin, TANG Wenjia, LUO Lei, WANG Chong, GUO Wei, PAN Baishen, WANG Beili

Department of Clinical Laboratory,Zhongshan Hospital,Fudan University,Shanghai 200032,China

Received:2016-11-15 Online:2017-06-30 Published:2017-07-04

摘要/Abstract

摘要：

目的探讨SYSMEX XN-9000 全自动血液分析仪（简称XN-9000）有核红细胞（NRBC）镜检规则以及白细胞（WBC）计数校正的方法。方法收集716例XN-9000检出>0个NRBC/100个WBC的标本,所有标本经瑞氏染色后在显微镜下进行外周血NRBC计数。以镜检法为金标准,评估仪器法计数NRBC的准确性并制定相应的镜检规则及WBC计数的校正公式。结果仪器法与镜检法NRBC计数结果呈明显正相关（r²=0.981）。Bland-Altman分析显示仪器法与镜检法差异的95%一致性界限为（-0.59±2.73）个NRBC/100个WBC,共有23例（3.21%）标本在一致性界限范围外,二者具有良好的一致性。以人工镜检NRBC计数作为金标准绘制受试者工作特征（ROC）曲线,当设定仪器计数结果≥1.1个NRBC/100个WBC作为镜检规则时,敏感性（87.3%）和特异性（76.5%）最佳,ROC曲线下面积为0.88,但NRBC检出的假阳性率为12.7%,假阴性率为23.5%,不符合ISO 15189的要求（假阴性率≤5%）;当设定仪器计数结果≥0.3个NRBC/100个WBC为镜检规则时,假阳性率为49.6%,假阴性率为2.3%,符合要求。当仪器自动校正的WBC计数结果与镜检法校正后的WBC计数结果间偏差>5%[1/3允许总误差（TEa）]时,结果应以镜检法为准,仪器计数结果需重新校正,校正公式为WBC=（100×WBC_仪器+NRBC_仪器×WBC_仪器）/（100+NRBC_镜检）。结论 XN-9000能快速、准确、有效地自动计数外周血NRBC。当镜检结果与仪器检测结果差异较大时,需重新校正WBC计数。

关键词: 有核红细胞, 镜检规则, SYSMEX XN-9000全自动血液分析仪

Abstract:

Objective To investigate the microscopy rule for nucleated red blood cell （NRBC） by SYSMEX XN-9000 automatic hematology analyzer,and to evaluate the correction formula for white blood cell （WBC） count and NRBC. Methods Samples were determined by SYSMEX XN-9000. The results must be >0 NRBC/100 WBC. Totally,716 samples were collected. Every sample was observed by microscopy after Wright-Giemsa staining. The accuracy of SYSMEX XN-9000 was evaluated,and the results were compared with those of microscopy （gold standard）. The correction formula was investigated. Results The correlation coefficient （r²）between SYSMEX XN-9000 and microscopy was 0.981. Bland-Altman plot showed a good consistency between the 2 methods. The 95% agreement limit of difference between the 2 methods was（-0.59±2.73） NRBC/100 WBC,and 23 samples （3.21%） was beyond the 95% agreement limit of difference. Receiver operating characteristic （ROC）curves were used to identify the optimal smear threshold value. The sensitivity was 87.3%,and the specificity was 76.5% at ≥1.1 NRBC/100 WBC,while the area under ROC curve was 0.88. However,the false negative rate was 23.5%,which was against the criterion of ISO 15189 （≤5%）. At ≥0.3 NRBC/100 WBC,the false positive rate was 49.6%,and the false negative rate was 2.3%. If WBC count error between SYSMEX XN-9000 and microscopy was >5% [1/3 allowable total error （TEa）],the results of SYSMEX XN-9000 should be recalculated according to those of microscopy. The correction formula was WBC=（100×WBC_{SYSMEX XN-9000}+NRBC_{SYSMEX XN-9000}×WBC_{SYSMEX XN-9000}）/（100+NRBC_microscopy）. Conclusions SYSMEX XN-9000 could determine NRBC in peripheral blood rapidly,accurately and effectively. WBC count should be recalculated,when there is difference between SYSMEX XN-9000 and microscopy.

Key words: Nucleated red blood cell, Microscopy rule, SYSMEX XN-9000 automatic hematology analyzer

中图分类号:

R446.1

顾梅秀, 孟志民, 唐文佳, 罗磊, 王冲, 郭玮, 潘柏申, 王蓓丽. SYSMEX XN-9000全自动血液分析仪有核红细胞镜检规则的建立与评价[J]. 检验医学, 2017, 32(6): 531-534.

GU Meixiu, MENG Zhimin, TANG Wenjia, LUO Lei, WANG Chong, GUO Wei, PAN Baishen, WANG Beili. Establishment and evaluation on the microscopy rule for nucleated red blood cell by SYSMEX XN-9000 automatic hematology analyzer[J]. Laboratory Medicine, 2017, 32(6): 531-534.

图/表 5

参考文献 10

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镜检规则（个NRBC/100个WBC）	敏感性	特异性	假阳性率	假阴性率
≥0.2	30.4	97.7	69.6	2.3
≥0.3	50.4	97.7	49.6	2.3
≥0.4	63.7	88.2	36.3	11.8
≥0.5	71.8	84.7	28.2	15.3
≥0.6	78.3	84.7	21.7	15.3
≥0.7	80.4	81.2	19.7	18.8
≥0.8	82.3	78.8	17.8	21.2
≥0.9	83.7	77.7	16.3	22.4
≥1.0	86.2	76.5	13.8	23.5
≥1.1	87.3	76.5	12.7	23.5
≥1.2	89.1	72.9	10.9	27.1
≥1.3	89.9	69.4	10.1	30.6
≥1.4	90.8	69.4	9.2	30.6
≥1.5	91.6	65.9	8.4	34.1

镜检规则（个NRBC/100个WBC）	敏感性	特异性	假阳性率	假阴性率
≥0.2	30.4	97.7	69.6	2.3
≥0.3	50.4	97.7	49.6	2.3
≥0.4	63.7	88.2	36.3	11.8
≥0.5	71.8	84.7	28.2	15.3
≥0.6	78.3	84.7	21.7	15.3
≥0.7	80.4	81.2	19.7	18.8
≥0.8	82.3	78.8	17.8	21.2
≥0.9	83.7	77.7	16.3	22.4
≥1.0	86.2	76.5	13.8	23.5
≥1.1	87.3	76.5	12.7	23.5
≥1.2	89.1	72.9	10.9	27.1
≥1.3	89.9	69.4	10.1	30.6
≥1.4	90.8	69.4	9.2	30.6
≥1.5	91.6	65.9	8.4	34.1

SYSMEX XN-9000全自动血液分析仪有核红细胞镜检规则的建立与评价

Establishment and evaluation on the microscopy rule for nucleated red blood cell by SYSMEX XN-9000 automatic hematology analyzer

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