Evaluating the consistency of prothrombin time results from two kinds of coagulation analyzers with EP9-A3
10.13602/j.cnki.jcls.2019.01.19
- VernacularTitle:用EP9-A3评价2种血凝分析仪凝血酶原时间检测结果的一致性
- Author:
Qiang ZHANG
1
;
Xiaolong ZONG
2
;
Dongming LI
3
;
Jing LIN
1
;
Peng LI
1
;
Jin WANG
1
Author Information
1. Department of Clinical Laboratory, Branch of Tianjin Third Central Hospital
2. Department of Clinical Laboratory, the Second Hospital of Tianjin Medical University
3. Department of Clinical Laboratory, Tianjin Third Central Hospital
- Publication Type:Journal Article
- Keywords:
coagulation analyzer;
prothrombin time;
EP9-A3;
method comparison;
bias
- From:
Chinese Journal of Clinical Laboratory Science
2019;37(1):71-74
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the consistency of plasma prothrombin time (PT) results detected by the STAGO STA-R Evolution and Mindray Precil C3510 automatic coagulation analyzers.
Methods:The PTs from 69 plasma samples were detected by the STA-R Evolution and Precil C3510 coagulation analyzers, respectively, and the obtained results were compared. Based on the CLSI EP9-A3 protocol, the ESD test was used to detect outliers, the scatter plot, difference plot, and frequency distribution plot were drawn, and the method comparison and bias evaluation were performed using the Passing-Bablok regression and Bland-Altman plot.
Results:The PTs (median \[P 25, P 75\]) detected by the STA-R Evolution and Precil C3510 analyzers were 19.00 (13.85, 25.65) s and 20.50 (13.83, 26.30) s, respectively, and there was no significant difference between them (P＞0.05). No outliers were detected by the ESD test, and the variation of PTs (CV) was constant. There were no systematic, random and proportional differences in PT results from two coagulation analyzers. The bias between two coagulation analyzers was within the acceptable range (1/2 CLIA′88 TEa). The predicted bias of PT at each medical decision point was also within the acceptable range.
Conclusion:The results of PT detected by the Precil C3510 and STA-R Evolution coagulation analyzers are comparable, and the bias is within the acceptable range, which can meet the needs of clinical diagnosis and treatment.
