Evaluation of the Analytical Performance of NOVA StatStrip(R) Blood Glucometer in a Peritoneal Dialysis Setting / 임상검사와정도관리

ABSTRACT

BACKGROUND: The use of point of care glucometer is widely established. However, the reliability of glucometer can vary according to the type of patients tested. Chemical interference with some current glucometer has been observed in patients undergoing peritoneal dialysis. StatStrip(R) (Nova Biomedical, USA) has been designed to compensate for this interference effect. So we compared the analytic performance and interference response of StatStrip(R) to two conventional glucometers. And we also evaluated the interference response with samples in patients undergoing peritoneal dialysis. METHODS: StatStrip(R) and two other glucometers were compared for linearity, imprecision, correlations with Advia 2400(TM) (Bayer Diagnostics, USA). Interference by lactate, maltose, were evaluated. Interferences in 20 samples of patients undergoing peritoneal dialysis were also evaluated. RESULTS: The coefficients of variation (CVs) of within-run precision were 1.70-3.77% and CVs of total precision were 1.98-3.99%. The linearity was R2=0.9776-0.988 (P<0.001). High correlation was found in each glucometer and the Advia 2400(TM). But all the glucometers showed a variable positive or negative bias compared with reference method. Including samples of patients undergoing peritoneal dialysis, maltose did not significantly influence the glucose concentration in StatStrip(R) and one of the conventional glucometers within 20% difference range. Lactate and hematocrit did not significantly influence the glucose concentration in all glucometers. CONCLUSIONS: StatStrip(R) shows good linearity, precision, correlation with the reference method and shows minimal interference effects. Our results indicate that StatStrip(R) also has clinical reliability when used in a peritoneal dialysis setting.