Usklađenost POCT metode sa potpuno automatizovanom metodom za određivanje HbA1c
Sažetak
Prethodna istraživanja sugerišu da je „point-of-care“ metoda (POCT) za određivanje glikoziliranog hemoglobina (HbA1c) dijagnostički test koji može biti adekvatna alternativa merenju HbA1c u laboratoriji. Glavni cilj ovog istraživanja bio je da se ispitaju analitičke karakteristike nove INCLIX POCT metode za određivanje HbA1c kako bi se testirale karakteristike izvođenja pre uvođenja ove metode u rutinsku upotrebu. HbA1c je meren u duplikatu u 44 uzorka EDTA krvi paralelno na INCLIX POCT uređaju (Sugitech, Inc.) i automatskim turbidimetrijskim imunoinhibicijskim testom na Olympus AU400 biohemijskom analizatoru (Beckman Coulter). Nepreciznost u seriji bila je 7,58%, nepreciznost između serija bila je 6,63% i 6,22%, a nepreciznost iz dana u dan bila je 8,80% i 7,51%. Ukupna laboratorijska nepreciznost bila je u slaganju sa podacima koje je naveo proizvođač. Izračunat je statistički značajan Pearsonov koeficijent korelacije (r = 0,871, P < 0,01; linearni R2 = 0,757). Demingovom regresionom analizom dobijena je sledeća jednačina: y = -1,80 + 1,304x. Naši rezultati ukazuju na statistički značajnu korelaciju, linearnu povezanost i značajan stepen kompatibilnosti između dve analizirane metode. Međutim, potvrđen je negativan bias vrednosti HbA1c određenih na POCT analizatoru u odnosu na Olympus AU400, što ističe potrebu za standardizacijom INCLIX metode.
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