Calibration verification for blood glucose test in automatic biochemistry analyzers / 中华检验医学杂志

ABSTRACT

Objective To perform calibration verification for the blood glucose test in Hitachi and Olympus automatic biochemistry analyzers and present a method of calibration verification and evaluate the results.Methods The glucose test results were divided into two groupsHitachi and Olympus groups according to the different analytical instruments.The calibration verification was performed following the current College of American Pathologists strategies.The slope and intercept of the calibration line were tested by one-sample t test and the percentage differences were calculated.The percentage differences were compared with allowable errors.If the slope and intercept had no statistically significant difference from 1 and 0 respectively and the percentage differences were within the limits of allowable errors,the calibration line was evaluated as verified 1 ; if the slope and intercept had no statistically significant difference from 1 and 0 respectively and at least one of the percentage differences exceeded the limits of allowable errors,the calibration line was evaluated as different 1 ; if the slope or intercept had statistically significant difference from 1 and 0 respectively and the percentage differences were within the limits of allowable errors,the calibration line was evaluated as verified 2; if the slope or intercept had statistically significant difference from 1 and 0 respectively and at least one of the percentage differences exceeded the limits of allowable errors,the calibration line was evaluated as different 2.Results In Hitachi group,verified 1,different 1,verified 2 and different 2 were 5.4％ ( 4/74 ),0.0％ ( 0/74 ),68.9％ ( 51/74 ) and 25.7％ ( 19/74 ),respectively.In Olympus group,verified 1,different 1,verified 2 and different 2 were 16.4％ (12/73),0.0％ (0/73),58.9％ (43/73) and 24.7％ ( 18/73 ),respectively.Conclusions The current College of American Pathologist strategies could be performed as a reasonable and feasible method for calibration verification.Most of participating laboratories ( 74.8％,110/147 passed the assessment of calibration verification.