Performance verification and interference factors of SYSMEX XN-9000 hematology analyzer for the determinations of reticulocyte count and parameters according to CAP accreditation requirements

doi:10.3969/j.issn.1673-8640.2018.05.014

Abstract

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

CLC Number:

R446.1

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.

Figures/Tables 4

References 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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