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Journal of Medical Biochemistry
2019, vol. 38, br. 1, str. 33-37
Procena analitičke izvodljivosti Variant II Turbo HbA1c analizatora primenom SIGMA metriks
Bozkaya Giray, Uzuncan Nuriye, Bilgili Sibel, Demirezen Ozlem
Izmir Bozyaka Egitim ve Arastirma Hastanesi, Izmir, Turkey
Ključne reči: HbA1c; SIGMA; ukupno dozvoljiva greska
Sažetak
Uvod: Hemoglobin A1c (HbA1c) koji je glavni sastojak glikoziliranog hemoglobina koristi se za procenu glikemije godinama kao i za dijagnostikovanje dijabetes mellitusa danas. S obzirom da anlitička izvodljivost HbA1c mora da bude jako visoka kao i kod drugih analitičkih testova, za procenu se koriste različite vrste kontrolnih procedura. SIGMA metriks je jedna od takvih mera i kombinuje se sa odstupanjem, preciznosću i ukupno dozvoljivom greskom sto osigurava visok analitički kvalitet. Svrha ovog rada je bila da se proceni analitička izvodljivost Bio-Rad Variant Turbo II HbA1c analizatora prema SIGMA metriks. Metode: Vrednosti SIGMA su računate korisćenjem podataka dobijenih iz dva nivoa internih i 12 eksternih kontrola kvaliteta (Bio-Rad) za Variant II Turbo Analizator HbA1c prema formuli a = (TEa% -Bias%)/CV%. Rezultati: Glavni SIGMA nivoi za niski i visoki kontrolni materijal su bili 3,0, odnosno 4,1. Zaključak: Nađeno je da je godisnja analitička izvodljivost Variant Turbo HbA1c analizatora bila prihvatljiva shodno SIGMA matriksu. Da bi bili sigurni da razlike u rezultatima HbA1c potiču od propusta u tretmanu pacijenta, a ne od analitičkih varijacija potrebno je spovoditi intenzivnu kontrolu kvaliteta kako bi se postigli visoki SIGMA nivoi.
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