Performance verification and evaluation of ACL-TOP700 automatic coagulation analyzer
10.7687/j.issn1003-8868.2017.11.086
- VernacularTitle:ACL-TOP700全自动血凝分析仪性能验证与评价
- Author:
xiang Ju ZHANG
1
;
hui Xiao ZHAO
Author Information
1. 北京中医医院顺义医院检验科
- Keywords:
automatic coagulation analyzer;
performance verification;
detection result;
verification;
evaluation
- From:
Chinese Medical Equipment Journal
2017;38(11):86-89
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the performances and evaluate the reliability of ACL-TOP700 automatic coagulation analyzer. Methods The analyzer had its precision, accuracy, carryover, linear range, reference interval and etc analyzed and verified according to the requirements of Clinical and Laboratory Standards Institute (CLSI) for PT, APTT, FIB, TT, DDHS, FDP and etc. Results The within-and between-array precision was both lower than 5%, which met the requirements of medical laboratory ISO 15189 requirements;the accuracy satisfied the requirements of external quality assessment by Beijing Center for Clinical Laboratory; linear analysis found high linearity (r≥0.975 or r2>0.95) in FIB, DDHS; the carryovers of FIB and DDHS were-0.34%and-0.10%respectively;more than 90%test results were restrained in the reference interval according to normal distribution principle. Conclusion ACL-TOP700 automatic coagulation analyzer has high performances and reliable results, and thus is worthy promoting clinically.
