Performance verification of Hitachi 7600-210 automatic biochemical analyzer detection system to glucose detection / 国际检验医学杂志

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.