Evaluation of the analytical performance of lifotronic H9 glycated hemoglobin analyzer and its effect on clinical decision making
Küçük Resim Yok
Tarih
2020
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Clin Lab Publ
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Background: We aimed to analyze the analytical performance of Lifotronic H9 glycated hemoglobin analyzer (Li-fotronic H9) with Arkray Adams HA-8160 glycated hemoglobin analyzer (Arkray HA8160), which is currently used for measurement of HbA1c test in our laboratory. Methods: The verification studies of the Lifotronic H9 were performed by comparison with the Arkray HA8160, which has been verified and is already used in our laboratory, and in accordance with the CLSI EP5-A3 and CLSI 15-A3 guidelines. The method comparison study was performed with 316 subjects. Results: Both instruments demonstrated perfect repeatability (within-run) CVs (0.8% - 1.6%), between-run CVs (0.2% - 1.0%), within-day CVs (0.8% - 1.7%), between-day CVs (0.3% - 0.6%), and within laboratory (total imprecision) CVs (0.8% - 1.8%) with two levels of quality control materials. Very good linearity was observed in the method-comparison studies based on Passing-Bablok regression analysis (y = -0.03 + 1.02 x, CUSUM test p = 0.07). Intraclass correlation coefficient (ICC = 0.995) for results and Kappa value (kappa = 0.86) for classification of results according to the American Diabetes Association recommendations showed almost perfect agreement. Conclusions: The Lifotronic H9 analyzer shows good precision with lower than recommended total CV 2% and linearity with Arkray HA8160. The Lifotronic H9 is a suitable analyzer for the diagnosis of diabetes and monitoring diabetic control.
Açıklama
Anahtar Kelimeler
Glycated Hemoglobin, HbA1c, Analytical Performance, Diabetes Mellitus
Kaynak
Clinical Laboratory
WoS Q Değeri
Q4
Scopus Q Değeri
Q3
Cilt
66
Sayı
9
