Ana Sayfa | Amaç ve Kapsam | Dergi Hakkında | İçindekiler | Arşiv | Yayın Arama | Yazarlara Bilgi | İletişim  
2004, Cilt 2, Sayı 3, Sayfa(lar) 105-112
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Evaluation of Glucometer Performance
Hale Aral, Pınar Tonbaklar, Alper Tunga Özdemir, Güvenç Güvenen
SSK İstanbul Eğitim Hastanesi Klinik Biyokimya Laboratuvarı, İstanbul
Keywords: Glucometer, QC, EGA

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, (value 2: 120 mg/dl) -4.5 mg/dl, (value 3: 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.

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