Evaluation on the performance of Sysmex CS 5100 automatic blood coagulation analyzer

doi:10.3969/j.issn.1673-8640.2015.02.018

Abstract

Abstract: Objective

To evaluate the performance of Sysmex CS 5100 automatic blood coagulation analyzer.

Methods

PT, PT(INR), APTT, Fbg, TT, AT, D-dimer (DD) and FDP were measured by Sysmex CS 5100 automatic blood coagulation analyzer. The accuracy, imprecision, Fg linearity (reportable range), reference range, carry-over rate were evaluated, and the correlation with Sysmex CA 7000 automatic blood coagulation analyzer was analyzed.

Results

The accuracy was in the range provided by quality control instructions. The maximum within-run and inter-day coefficients of variation met the requirements of Clia'88. Fbg linear validation test showed that the linearity of Fbg was from 1.071 to 5.355, and the correlation coefficient (r) was 0.9950, which met the specified requirements (r≥0.975).The reference range verification tests showed that the R values of all the tests were >0.9, which proved that the laboratory preset reference range can be applied to the analyzer. The r for several items between CS 5100 and CA 7000 were >0.95, which showed good correlation between the 2 analyzers.

Conclusions

CS 5100 has an excellent accuracy, a good precision, a wide range of Fbg detection as well as a strong anti-interference ability. CS 5100 can totally meet the requirements of clinical laboratories.

Key words: CS 5100, Automatic blood coagulation analyzer, Performance evaluation

CLC Number:

R446.11

WANG Fang, ZHANG Jun, XU Weijie, YUE Jun, CHEN Xiaoyan, CHEN Jin.. Evaluation on the performance of Sysmex CS 5100 automatic blood coagulation analyzer[J]. Laboratory Medicine, 2015, 30(2): 177-180.

项目	正常值			异常值
项目	均值	靶值	允许范围	均值	靶值	允许范围
PT(s)	11.9	11.5	9.8~13.2	21.0	21.1	16.9~25.3
APTT(s)	2.7	25.1	21.3~28.9	76.2	71.8	57.4~86.2
TT(s)	18.9	18.3	14.6~22.0
Fbg(g/L)	2.39	2.32	1.86~2.78	0.86	0.85	0.45~1.25
AT(%)	63.8	100.0	80.0~120.0	32.8	35.0	26.0~44.0
DD(mg/L)	0.32	0.33	0.26~0.40	2.9	3.16	2.53~3.79
FDP(μg/mL)	10.7	10.6	7.6~13.6	30.0	31.1	25.1~37.1

项目	正常值			异常值
项目	均值	靶值	允许范围	均值	靶值	允许范围
PT(s)	11.9	11.5	9.8~13.2	21.0	21.1	16.9~25.3
APTT(s)	2.7	25.1	21.3~28.9	76.2	71.8	57.4~86.2
TT(s)	18.9	18.3	14.6~22.0
Fbg(g/L)	2.39	2.32	1.86~2.78	0.86	0.85	0.45~1.25
AT(%)	63.8	100.0	80.0~120.0	32.8	35.0	26.0~44.0
DD(mg/L)	0.32	0.33	0.26~0.40	2.9	3.16	2.53~3.79
FDP(μg/mL)	10.7	10.6	7.6~13.6	30.0	31.1	25.1~37.1

项目	批内	天间
	正常	异常		正常	异常
	Mean	规定CV%		CV%		Mean	规定CV%	CV%	Mean	规定CV%	CV%		Mean	规定CV%	CV%
PT(s)	11.44	3.75	0.45	21.72	3.75	1.42	11.84	5.00	0.63	20.64	5.00	1.38
APTT(s)	26.17	3.75	0.36	83.10	3.75	0.81	23.52	5.00	1.02	81.32	5.00	0.48
TT(s)	16.25	7.50	1.43				18.41	10.00	1.14
Fbg(g/L)	2.20	5.00	1.39	0.72	5.00	2.64	2.43	6.67	1.38	0.75	6.67	2.66
DD(mg/L)	0.33	5.00	3.62	2.99	5.00	1.42	0.33	6.67	4.03	2.96	6.67	1.50
AT(%)	88.36	7.50	0.83	31.76	7.50	5.35	95.50	10.00	2.30	34.45	10.00	3.94

项目	批内	天间
	正常	异常		正常	异常
	Mean	规定CV%		CV%		Mean	规定CV%	CV%	Mean	规定CV%	CV%		Mean	规定CV%	CV%
PT(s)	11.44	3.75	0.45	21.72	3.75	1.42	11.84	5.00	0.63	20.64	5.00	1.38
APTT(s)	26.17	3.75	0.36	83.10	3.75	0.81	23.52	5.00	1.02	81.32	5.00	0.48
TT(s)	16.25	7.50	1.43				18.41	10.00	1.14
Fbg(g/L)	2.20	5.00	1.39	0.72	5.00	2.64	2.43	6.67	1.38	0.75	6.67	2.66
DD(mg/L)	0.33	5.00	3.62	2.99	5.00	1.42	0.33	6.67	4.03	2.96	6.67	1.50
AT(%)	88.36	7.50	0.83	31.76	7.50	5.35	95.50	10.00	2.30	34.45	10.00	3.94

稀释度(%)	Mean	理论值
100	5.355	5.355
80	4.294	4.284
60	3.203	3.213
40	2.056	2.142
20	1.077	1.071

Evaluation on the performance of Sysmex CS 5100 automatic blood coagulation analyzer

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Metrics

项目	Mean	R值(%)	实验室范围
PT (s)	11.5	100	9.8~12.8
PT INR	0.9	100	0.8~1.1
APTT (s)	29.0	100	20.0~35.0
Fbg (g/L)	2.6	100	1.8~3.8
TT (s)	18.3	95	16.0~20.0
AT (%)	91.6	100	75.0~125
DD (mg/L)	0.3	95	0.0~0.55
FDP (ug/mL)	1.6	100	0.0~5.0

项目	高值对低值	低值对高值
PT	1.02	0.45
APTT	0.30	0.31
Fbg	2.98	0.00
DD	0.00	0.28
FDP	4.00	0.83
AT	1.19	0.03

项目	r值	回归斜率a	偏倚符合率(%)
PT	0.999 9	0.997 1	100
PT(INR)	0.999 9	1.002 6	100
APTT	0.999 1	1.035 1	100
Fbg	0.999 6	1.031 1	95
TT	0.949 4	0.990 3	100
AT	0.995 0	0.966 1	100
DD	0.999 4	0.981 7	95
FDP	0.999 8	1.010 2	95

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