Evaluation of Analytical Performance of Variant II Turbo HbA1c Analyzer According to Sigma Metrics
| Autor: | Ozlem Demirezen, Giray Bozkaya, Sibel Bilgili, Nuriye Uzuncan |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
030213 general clinical medicine
Spectrum analyzer HbA1c endocrine system diseases Turbo sigma 030209 endocrinology & metabolism total allowable error Sigma Metrics lcsh:Biochemistry 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Statistics lcsh:QD415-436 Mathematics Original Paper biology nutritional and metabolic diseases Quality control Sigma biology.organism_classification Hemoglobin A chemistry ukupno dozvoljiva greška Glycated hemoglobin |
| Zdroj: | Journal of Medical Biochemistry, Vol 38, Iss 1, Pp 33-37 (2019) Journal of Medical Biochemistry |
| ISSN: | 1452-8266 |
| DOI: | 10.2478/jomb-2018-0014 |
| Popis: | Hemoglobin A1c, (HbA1c) which is the major constituent of glycated hemoglobin, has been used in the follow-up of retrospective glycemia for years and in the diagnosis of diabetes mellitus nowadays. Since the analytical performance of HbA1c should be high likewise all laboratory tests, various quality control measures are used. Sigma metrics is one of these measures and it is the combination of bias, precision and total allowable error that ensures a general evaluation of analytical quality. The aim of our study was to evaluate the analytical performance of Bio-Rad's Variant Turbo II HbA1c analyzer according to sigma metrics.Sigma levels were calculated using the data obtained from two levels of internal and 12 external quality control materials (Bio-Rad) of Variant II Turbo HbA1c analyzer according to σ = (TEa% - Bias%) / CV% formula.The mean sigma levels for low and high quality control materials were found to be 3.0 and 4.1, respectively.The annual mean analytical performance of Variant II Turbo HbA1c analyzer was found to be acceptable according to sigma metrics. In order to be sure of the difference in HbA1c results indicating the success or failure in treatment but not arise from analytical variation, it is thought that more stringent quality control measures should be applied to reach higher sigma levels.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, preciznošću i ukupno dozvoljivom greškom što osigurava visok analitički kvalitet. Svrha ovog rada je bila da se proceni analitička izvodljivost Bio-Rad Variant Turbo II HbA1c analizatora prema Sigma metriks.Vrednosti Sigma su računate korišćenjem podataka dobijenih iz dva nivoa internih i 12 eksternih kontrola kvaliteta (Bio-Rad) za Variant II Turbo Analizator HbA1c prema for-muli σ = (TEa% -Bias%)/CV%.Glavni Sigma nivoi za niski i visoki kontrolni materijal su bili 3,0, odnosno 4,1.Nađeno je da je godišnja 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. |
| Databáze: | OpenAIRE |
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