Performance evaluation on the rapid determination of thrombus 4 items by magnetic particle chemiluminescence assay

doi:10.3969/j.issn.1673-8640.2019.06.017

Abstract

Abstract:

Objective To evaluate the role of magnetic particle chemiluminescence assay for thrombus 4 items,including thrombomodulin（TM）,thrombin-antithrombin（TAT） complex,plasmin-α2 plasmin inhibitor complex（PIC） and tissue plasminogen activator-plasminogen activator inhibitor complex（t-PAIC）. Methods TM,TAT,PIC and t-PAIC were determined. Precision,carry-over rate,accuracy,linear range,clinical reportable range and biological reference interval were analyzed. According to the EP guidelines of the Clinical and Laboratory Standards Institute（CLSI）,the performance of magnetic particle chemiluminescence assay for determining thrombus 4 items was evaluated. Results The within-run and between-run precisions [coefficient of variation（CV）] were <10%. The carry-over rate was <1.0%. Linear range analysis showed that a value was 1.00±0.05,and r2 was ≥0.950 0. The clinical reportable range,accuracy and biological reference interval were all qualified. Conclusions Magnetic particle chemiluminescence assay can be used clinically to determine thrombus 4 items.

Key words: Magnetic particle chemiluminescence assay, Thrombus 4 items, Early molecular marker of thrombus

CLC Number:

R446.1

LIU Yanhong, LI Yan, XIE Dongping, DONG Xiaoyu. Performance evaluation on the rapid determination of thrombus 4 items by magnetic particle chemiluminescence assay[J]. Laboratory Medicine, 2019, 34(6): 551-554.

Figures/Tables 4

References 8

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项目	水平1CV（%）	水平2CV（%）	厂家标准（%）	结论
TM	3.12	1.32	<10	合格
TAT	3.00	2.58	<10	合格
t-PAIC	3.06	1.02	<10	合格
PIC	2.17	2.73	<10	合格

项目	水平1CV（%）	水平2CV（%）	厂家标准（%）	结论
TM	3.12	1.32	<10	合格
TAT	3.00	2.58	<10	合格
t-PAIC	3.06	1.02	<10	合格
PIC	2.17	2.73	<10	合格

项目	水平1CV（%）	水平2CV（%）	厂家标准（%）	结论
TM	2.58	1.79	<10	合格
TAT	4.21	3.58	<10	合格
t-PAIC	5.72	1.88	<10	合格
PIC	3.08	2.06	<10	合格

项目	水平1CV（%）	水平2CV（%）	厂家标准（%）	结论
TM	2.58	1.79	<10	合格
TAT	4.21	3.58	<10	合格
t-PAIC	5.72	1.88	<10	合格
PIC	3.08	2.06	<10	合格

项目	携带污染率（%）	厂家标准（%）	结论
TM	0.10	<1.00	合格
TAT	0.09	<1.00	合格
t-PAIC	0.00	<1.00	合格
PIC	0.02	<1.00	合格