Performance verification of Hitachi 7600-210 automatic biochemical analyzer detection system to glucose detection
10.3969/j.issn.1673-4130.2019.02.017
- VernacularTitle:日立7600-210检测系统对血糖检测的性能验证
- Author:
Fan CHANG
1
;
Yongbin HOU
;
Lijun HUANG
;
Qizhi DIAO
Author Information
1. 重庆医科大学附属永川医院检验科
- Keywords:
automatic biochemical analyzer;
detection system;
glucose;
performance verification
- From:
International Journal of Laboratory Medicine
2019;40(2):192-195
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the analytical performance of Hitachi 7600-210automatic biochemical analyzer detection system.Methods The precision, accuracy, linearity and clinical reportable range, limit of quantitative detection and anti-interference capability were validated according to Clinical and Laboratory Standards Institute (CLSI) documents (EP15-A3and EP17-A2) and Clinical Laboratory Improvement Amendment 1988 (CLIA′88) standards.Results The within precisions of high and low two concentrations were both less than1/4CLIA′88TEa (laboratory permissible total error), the day precisions were less than 1/3CLIA′88TEa, the pass rates of three external quality assessments in 2017 were all not less than 80％and range from 0.02mmol/L to 401.80mmol/L.The clinical reportable was ranged from 0.02to 401.80mmol/L with a linear relationship.The LoB, LoD and LoQ of glucose (GLU) detection were 0.01 mmol/L, 0.03 mmol/L and 0.08mmol/L respectively.The anti-interference capability to hemoglobin (Hb), vitamin C (VitC), bilirubin (BIL) and triglyceride (TG) in the detection system to GLU measurement were in accordance with the manufacturer′s statement.Conclusion Performance verification of Hitachi 7600-210automatic biochemical analyzer detection system to GLU detection is consistent with the manufacturer statement also in accordance with CLIA′88standards, which can meet the expectant use of clinical test.
