The performance evaluation of emergency immunological parameters in Johnson Vitros 5600 fully automatic biochemical analyzer
10.3969/J.ISSN.1672-8270.2016.05.013
- VernacularTitle:强生Vitros 5600全自动生化免疫分析仪免疫急诊项目的性能评价
- Author:
Liyun LIN
;
Xiaojun LIU
;
Aisheng LIU
- Publication Type:Journal Article
- Keywords:
Biochemical immunity analyzer;
Emergency projects;
Immune;
Performance;
Evaluation
- From:
China Medical Equipment
2016;13(5):38-40,41
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To have the performance verification of Johnson Vitros 5600 fully automatic biochemical analyzer (hereinafter referred to as Vitros 5600 analyzer) emergency immunological parameter is to provide more accurate and more efficient service for the patients in emergency inspection items.Methods: According to the clinical laboratory standards institute (CLSI) evaluation criterion and Johnson validation plan, we verified the precision, accuracy, linear range, reference range, and carry pollution rate detection indexes of Myoglobin, Troponin I (TropI), N-terminal brain natriuretic titanium (NTproBNP) and total beta human chorionic gonadotropin (TβHCG) about the Vitros 5600 analyzer emergency projects evaluated the performance of the analyzer.Results: The batch precision CV of Myoglobin, TropI, NTproBNP and TβHCG tested by Vitros 5600 analyzer is 0.58~2.02%, < 2.5%, and the inter assay CV is 1.43~3.15%, < 5.0%. Accuracy relative bias is -3.52~4.21%. Linearity relationship is good within the scope of testing,r2 is 0.9836~0.9998, and the slope (a) is 0.9865~1.0207. Carry pollution rate is 0.096~0.180%. Reference range verification coincidence rate is R≥95%.Conclusion: The detection index performance of Vitros 5600 analyzer detecting immune emergency projects is good. It can meet the demand of emergency immune inspection work.
