CAP认可要求下SYSMEX XN-9000血液分析仪测定网织红细胞及其参数的性能验证与干扰因素研究

doi:10.3969/j.issn.1673-8640.2018.05.014

摘要/Abstract

摘要：

目的评价SYSMEX XN-9000血液分析仪检测网织红细胞（RET）及其特异性参数的性能,进一步加强临床对贫血疾病的诊断和治疗。方法收集508例患者标本,采用新亚甲蓝（NMB）染色显微镜目视计数法与SYSMEX XN-9000血液分析仪的RET计数进行方法学比对和不同干扰因素分组研究;根据美国临床实验室标准化协会（CLSI）-国际血液学标准化委员会（ICSH）H44-A2文件要求对SYSMEX XN-9000血液分析仪计数RET的精密度、携带污染率、可比性、准确度、干扰因素等进行验证;采用直线回归和配对t检验进行相关性统计,用Bland-Altman检验进行一致性检验,采用t检验或Wilcoxon秩和检验对干扰因素进行分析。结果目视计数法与仪器法r²=0.97,一致性符合率为91.7 %;精密度、携带污染率、准确度、稳定性均在允许范围内,线性范围和正常参考区间均符合验证;红细胞、血小板增多,红细胞碎片、有核红细胞等干扰因素的存在均能导致网织红细胞计数百分比（RET%）结果的假性增高,荧光类药物和疟原虫等影响因素对RET结果会产生严重干扰。结论 SYSMEX XN-9000血液分析仪对RET及其参数的检测性能良好,但在临床应用中仍需及时发现和纠正可能存在的干扰。

关键词: 网织红细胞, 未成熟网织红细胞指数, 新亚甲蓝, 流式细胞术, 干扰因素

Abstract:

Objective To assess the performance of reticulocyte （RET） determination and its specific parameters by SYSMEX XN-9000 hematology analyzer,and to improve the diagnosis and treatment of anemia. Methods A total of 508 specimens were collected. New methylene blue （NMB） visual microscopy method and SYSMEX XN-9000 for the determination of RET count were compared,and the interference factors were analyzed. The precision,carry-over rate,comparability,accuracy and interference factors of RET determination by SYSMEX XN-9000 were evaluated according to the Clinical and Laboratory Standards Institute （CLSI）-the International Council for Standardization in Haematology （ICSH）document H44-A2. The correlation analysis was performed by linear regression analysis and paired t test. The consistency test was performed by Bland-Altman test,and the interference factors were assessed by t test or Wilcoxon rank sum test. Results The coefficient of determination （r²） between NMB visual microscopy method and SYSMEX XN-9000 was 0.97,and the consistency rate was 91.7%. The precision,carry-over rate,accuracy and stability were within allowable ranges. Linear range and normal reference interval met the requirements of verification. The main sources of spuriously high RET counts were erythrocytosis,thrombocytosis,erythrocyte fragments and nucleated erythrocytes,especially autofluorescence due to drugs and malaria. Conclusions SYSMEX XN-9000 for the determination of RET count has good performance. Potential interference may exist,which should be corrected in time.

Key words: Reticulocyte, Immature reticulocyte fraction, New methylene blue, Flow cytometry, Interference factor

中图分类号:

R446.1

蒋浩琴, 顾剑飞, 陈健, 王吉, 王凯俊, 吕元. CAP认可要求下SYSMEX XN-9000血液分析仪测定网织红细胞及其参数的性能验证与干扰因素研究[J]. 检验医学, 2018, 33(5): 431-436.

JIANG Haoqin, GU Jianfei, CHEN Jian, WANG Ji, WANG Kaijun, LÜ Yuan. Performance verification and interference factors of SYSMEX XN-9000 hematology analyzer for the determinations of reticulocyte count and parameters according to CAP accreditation requirements[J]. Laboratory Medicine, 2018, 33(5): 431-436.

图/表 4

参考文献 12

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RET %	P值	q值	Var_R	Var_FC	SE_p	允许下限（%）	允许上限（%）
0.1	0.001	0.999	0.000 000 25	0.000 000 03	0.000 53	-0.09^*	0.29
1.0	0.010	0.990	0.000 002 48	0.000 000 33	0.001 67	0.39	1.61
2.0	0.020	0.980	0.000 004 90	0.000 000 65	0.002 36	1.14	2.86
3.0	0.030	0.970	0.000 007 28	0.000 000 97	0.002 87	1.95	4.05
4.0	0.040	0.960	0.000 009 60	0.000 001 28	0.003 30	2.79	5.21
5.0	0.050	0.950	0.000 011 88	0.000 001 58	0.003 67	3.66	6.34
6.0	0.060	0.940	0.000 014 10	0.000 001 88	0.004 00	4.54	7.46
7.0	0.070	0.930	0.000 016 28	0.000 002 17	0.004 29	5.43	8.57
8.0	0.080	0.920	0.000 018 40	0.000 002 45	0.004 57	6.33	9.67
9.0	0.090	0.910	0.000 020 48	0.000 002 73	0.004 82	7.24	10.76
10.0	0.100	0.900	0.000 022 50	0.000 003 00	0.005 05	8.15	11.85

RET %	P值	q值	Var_R	Var_FC	SE_p	允许下限（%）	允许上限（%）
0.1	0.001	0.999	0.000 000 25	0.000 000 03	0.000 53	-0.09^*	0.29
1.0	0.010	0.990	0.000 002 48	0.000 000 33	0.001 67	0.39	1.61
2.0	0.020	0.980	0.000 004 90	0.000 000 65	0.002 36	1.14	2.86
3.0	0.030	0.970	0.000 007 28	0.000 000 97	0.002 87	1.95	4.05
4.0	0.040	0.960	0.000 009 60	0.000 001 28	0.003 30	2.79	5.21
5.0	0.050	0.950	0.000 011 88	0.000 001 58	0.003 67	3.66	6.34
6.0	0.060	0.940	0.000 014 10	0.000 001 88	0.004 00	4.54	7.46
7.0	0.070	0.930	0.000 016 28	0.000 002 17	0.004 29	5.43	8.57
8.0	0.080	0.920	0.000 018 40	0.000 002 45	0.004 57	6.33	9.67
9.0	0.090	0.910	0.000 020 48	0.000 002 73	0.004 82	7.24	10.76
10.0	0.100	0.900	0.000 022 50	0.000 003 00	0.005 05	8.15	11.85

项目	男性		女性
项目	参考区间	来源	参考区间	来源
RET%（%）	0.90~2.22	厂商	0.76~2.21	厂商
RET#（×10¹²/L）	0.046 4~0.121 2	厂商	0.033 1~0.101 5	厂商
IRF （%）	3.8~15.8	x±1.96s	4.7~15.40	P_2.5,P_97.5
LFR （%）	84.2~96.2	x±1.96s	84.6~95.3	P_2.5,P_97.5
MFR （%）	3.8~13.0	x±1.96s	4.4~13.0	P_2.5,P_97.5
HFR （%）	0.2~4.9	P_2.5,P_97.5	0.2~3.5	P_2.5,P_97.5

项目	男性		女性
项目	参考区间	来源	参考区间	来源
RET%（%）	0.90~2.22	厂商	0.76~2.21	厂商
RET#（×10¹²/L）	0.046 4~0.121 2	厂商	0.033 1~0.101 5	厂商
IRF （%）	3.8~15.8	x±1.96s	4.7~15.40	P_2.5,P_97.5
LFR （%）	84.2~96.2	x±1.96s	84.6~95.3	P_2.5,P_97.5
MFR （%）	3.8~13.0	x±1.96s	4.4~13.0	P_2.5,P_97.5
HFR （%）	0.2~4.9	P_2.5,P_97.5	0.2~3.5	P_2.5,P_97.5

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