The comparability verification for the results of different automated hematology analyzers

doi:10.3969/j.issn.1673-8640.2015.03.009

Abstract

Abstract: Objective

To analyze comparatively for white blood cell (WBC), red blood cell (RBC) and platelet (PLT) results of different automated hematology analyzers, to evaluate the consistency, in order to provide reliable results for clinic.

Methods

According to THE Guideline for Comparability Verification of Quantitative Results within One Health Care System, the WBC, PLT, RBC, HGB, HCT, MCV, MCH and MCHC were detected by different automated hematology analyzers, and their relative bias (R) was calculated. As the standard of 1/3 allowed total error (TEa) of Clinical Laboratory Improvement Amendments (CLIA)'88, the comparability among different analyzers was analyzed.

Results

The R of WBC, PLT, RBC, HGB, HCT, MCV, MCH and MCHC by different automated hematology analyzers were <1/3 CLIA'88 TEa, which were all acceptable.

Conclusions

The results of WBC, PLT, RBC, HGB, HCT, MCV, MCH and MCHC by different analyzers have good consistency and comparability which is suitable for clinic.

Key words: Hematology analyzer, Imprecision, Comparability, Verification

CLC Number:

R446.11

ZHU Xiang, HAN Lingfei, XIE Ping, ZHAO Weisong. The comparability verification for the results of different automated hematology analyzers[J]. Laboratory Medicine, 2015, 30(3): 240-242.

Figures/Tables 4

项目		LJZX-LJ-XQY-01 (CV)	LJZX-LJ-XQY-02 (CV)	LJZX-LJ-XQY-03 (CV)	CV合并	CLIA'88的 1/3TEa	重复次数
WBC	高值	1.63	1.32	1.25	1.41	±7.5%	2
	中值	1.60	1.38	1.48	1.47
PLT	高值	2.22	1.83	2.10	2.06	±12.5%	2
	中值	3.33	2.50	2.83	2.91
RBC	高值	0.77	0.58	0.77	0.71	±3.0%	3
	中值	0.46	0.46	0.92	0.65
Hb	高值	0.75	0.75	0.87	0.79	±3.5%	2
	中值	0.59	0.59	0.90	0.71
HCT	高值	0.79	0.59	0.44	0.66	±3.0%	3
	中值	0.50	0.50	0.75	0.60
MCV	高值	0.35	0.35	0.34	0.35	±3.5%	2
	中值	0.29	0.33	0.52	0.39
MCH	高值	0.81	0.63	0.82	0.76	±3.5%	2
	中值	0.71	0.64	0.58	0.65
MCHC	高值	1.01	0.80	0.74	0.86	±3.5%	2
	中值	0.73	0.60	0.71	0.68

项目		LJZX-LJ-XQY-01 (m)	LJZX-LJ-XQY-02 (m)	LJZX-LJ-XQY-03 (m)	$x ? 总$	$x ? 总$ 的样本浓度选择范围(±20%)
WBC	高值	23.84	23.34	24.13	23.77	19.02~	28.52
(×10⁹/L)	中值	10.64	10.42	10.33	1.47	8.37~	12.55
PLT	高值	481	454	500	478	382~	574
(×10⁹/L)	中值	213	203	224	213	170~	256
RBC	高值	5.43	5.38	5.45	5.42	4.34~	6.50
(×10⁹/L)	中值	4.45	4.44	4.43	4.44	3.55~	5.33
Hb	高值	181	181	180	181	145~	217
(g/L)	中值	139	140	138	139	111~	167
HCT	高值	0.523	0.523	0.527	0.524	0.419~	0.629
(%)	中值	0.406	0.407	0.410	0.408	0.326~	0.490
MCV	高值	96.2	97.1	96.7	96.7	77.4~	116.0
(fL)	中值	91.2	91.5	92.7	91.8	73.4~	110.2
MCH	高值	33.3	33.7	33.1	33.4	26.7~	40.1
(Pg)	中值	31.3	31.5	31.1	31.3	25.0~	37.6
MCHC	高值	346	347	342	345	276~	414
(g/L)	中值	343	343	335	340	272~	408

项目		LJZX-LJ-XQY-01 (m)	LJZX-LJ-XQY-02 (m)	LJZX-LJ-XQY-03 (m)	$x ? 总$	$x ? 总$ 的样本浓度选择范围(±20%)
WBC	高值	23.84	23.34	24.13	23.77	19.02~	28.52
(×10⁹/L)	中值	10.64	10.42	10.33	1.47	8.37~	12.55
PLT	高值	481	454	500	478	382~	574
(×10⁹/L)	中值	213	203	224	213	170~	256
RBC	高值	5.43	5.38	5.45	5.42	4.34~	6.50
(×10⁹/L)	中值	4.45	4.44	4.43	4.44	3.55~	5.33
Hb	高值	181	181	180	181	145~	217
(g/L)	中值	139	140	138	139	111~	167
HCT	高值	0.523	0.523	0.527	0.524	0.419~	0.629
(%)	中值	0.406	0.407	0.410	0.408	0.326~	0.490
MCV	高值	96.2	97.1	96.7	96.7	77.4~	116.0
(fL)	中值	91.2	91.5	92.7	91.8	73.4~	110.2
MCH	高值	33.3	33.7	33.1	33.4	26.7~	40.1
(Pg)	中值	31.3	31.5	31.1	31.3	25.0~	37.6
MCHC	高值	346	347	342	345	276~	414
(g/L)	中值	343	343	335	340	272~	408

检测系统数量	检测次数	CV_合并
检测系统数量	检测次数	1%	2%	3%	4%
3	2	4.18	8.36	12.54	16.72
3	3	2.51	5.01	7.52	10.02

项目		$x ? 总$	极差	R (%)	CLIA'88 的1/3 TEa	结论
WBC	高值	21.13	0.64	3.03	±7.5%	通过
(×10⁹/L)	中值	9.41	0.30	3.19
PLT	高值	436	34	7.80	±12.5%	通过
(×10⁹/L)	中值	211	7	3.32
RBC	高值	5.26	0.05	0.95	±3.0%	通过
(×10¹²/L)	中值	3.93	0.03	0.76
Hb	高值	174	0	0	±3.5%	通过
(g/L)	中值	119	1.00	0.84
HCT	高值	50.3	0.70	1.39	±3.0%	通过
(%)	中值	35.1	0.8	2.28
MCV	高值	95.8	2.2	2.30	±3.5%	通过
(fL)	中值	89.3	1.2	1.34
MCH	高值	33.0	0.4	1.21	±3.5%	通过
(pg)	中值	30.3	0.30	0.99
MCHC	高值	345	4	1.16	±3.5%	通过
(g/L)	中值	340	4	1.18

项目		$x ? 总$	极差	R (%)	CLIA'88 的1/3 TEa	结论
WBC	高值	21.13	0.64	3.03	±7.5%	通过
(×10⁹/L)	中值	9.41	0.30	3.19
PLT	高值	436	34	7.80	±12.5%	通过
(×10⁹/L)	中值	211	7	3.32
RBC	高值	5.26	0.05	0.95	±3.0%	通过
(×10¹²/L)	中值	3.93	0.03	0.76
Hb	高值	174	0	0	±3.5%	通过
(g/L)	中值	119	1.00	0.84
HCT	高值	50.3	0.70	1.39	±3.0%	通过
(%)	中值	35.1	0.8	2.28
MCV	高值	95.8	2.2	2.30	±3.5%	通过
(fL)	中值	89.3	1.2	1.34
MCH	高值	33.0	0.4	1.21	±3.5%	通过
(pg)	中值	30.3	0.30	0.99
MCHC	高值	345	4	1.16	±3.5%	通过
(g/L)	中值	340	4	1.18

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