Journal of Turkish Clinical Biochemistry

The official publication of Turkish Society of Clinical Biochemistry

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Original Research
December 01, 2004
JTCB. 2004 Dec 1; 2 (3) : 105-112

Evaluation of Glucometer Performance

1 SSK İstanbul Eğitim Hastanesi Klinik Biyokimya Laboratuvarı, İstanbul

Abstract

There is no a standart pr ocedure to assess instrument quality on technical and analytical performance of glucometers yet. We made up our protocole considering NCCLS EP9-A2 (National Commitee for Clinical Laboratory Standarts EP9-A2) and ISO 15197 (International Organization for Standardization 15197). Technically (deviation from the given value, precision, agreement, correlation, lineer regression, sigma-metrics)and clinically (error grid analysis) evaluations were done. The study was achieved by an expert medical laboratory technician. Patients having hematocrit levels within 30-45% were included. Venous plasma was used in our laboratory method, glucose oxidase-peroxidase by means of Olympus AU 5223. Deviation from the given value in control materials was found as follows, (value1: 40 mg/dl) -2.5 mg/dl, (value2: 120 mg/dl) -4.5 mg/dl, (value3: 350 mg/dl) +19.5 mg/dl. With the same control materials precision was calculated as, respectively, CV1:4.6% , CV2: 5.2%, CV3: 4% (<10%). In whole blood samples taken from three different patients (mean values: 77.1; 92.9; 156.3 mg/dl) imprecision was calculated as CV1: 2.9%; CV2: 3.7%; CV3: 3.4 (<10%). In agreement, 97% of capillary measurements (n=36) reached the ISO standart quality goal (<±20%), correlation (r=0.969) was calculated. Using the 120 mg/dl as critical medical decision level, it was calculated as sigma = 4.63 (sigma>3), it was considered acceptable. In error grid analysis data were in zone A, B. The instrument met the required quality specifications.

Citation

Aral, Hale, Pınar Tonbaklar, Alper Tunga Özdemir, and Güvenç Güvenen. 2004. “Evaluation of Glucometer Performance”. Journal of Turkish Clinical Biochemistry 2 (3):105-12. https://turkclinbiochem.org/index.php/pub/article/view/38.

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