Performance evaluation of Mindray CX-9000 automatic coagulation analyzer
10.19745/j.1003-8868.2024030
- VernacularTitle:迈瑞CX-9000全自动凝血分析仪性能评估
- Author:
Jia-Quan GUO
1
;
Jiong WEI
;
Miao LI
;
Ke-Ke LI
;
Ming LIU
Author Information
1. 海南省人民医院检验科,海口 570311
- Keywords:
Mindray CX-9000 automatic coagulation analyzer;
precision;
accuracy;
carry-over;
linear range;
reference interval;
performance evaluation
- From:
Chinese Medical Equipment Journal
2024;45(2):58-61
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify and evaluate the performance of Mindray CX-9000 automatic coagulation analyzer.Methods Myriad CX-9000 automatic coagulation analyzer had its performance validated and evaluated by five routine coagulation tests with reference to the industry including standard prothrombin time(PT),activated partial thromboplastin time(APTT),fibrino-gen(FIB),thrombin time(TT)and D-dimer,so as to clarity whether the analyzer meets the clinical requirements in terms of precision,accuracy,linear range,carry-over and reference interval.Results The five routine coagulation tests had the intra-batch precision CVs lower than 3％,the inter-day precision CVs lower than 5％and the relative deviations of the accuracies within±10％.The slope k of the linear regression equation was 1.006 0 for FIB and 1.013 2 for D-dimer,and the correlation coefficient r was 0.999 3 for FIB and 0.997 5 for D-dimer,which showed high linearity.The carry-over rate of sample concen-tration(CR1)was 4.6％,and the carry-over rate between test items(CR2)was lower than 2％;the R value of the reference interval was 100％;the requirements of industrial standards were met.Conclusion Mindray CX-9000 automatic coagulation analyzer gains advantages in precision,accuracy,linear range and carry-over,and is worthy promoting clinically.[Chinese Medical Equipment Journal,2024,45(2):58-61]
