Evaluation of the analytical performance of lifotronic H9 glycated hemoglobin analyzer and its effect on clinical decision making

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dc.authorid0000-0002-7006-3125
dc.contributor.authorYis, Özgür Mehmet
dc.date.accessioned2021-06-23T19:54:43Z
dc.date.available2021-06-23T19:54:43Z
dc.date.issued2020
dc.departmentBAİBÜ, Tıp Fakültesi, Temel Tıp Bilimleri Bölümüen_US
dc.description.abstractBackground: 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.en_US
dc.identifier.doi10.7754/Clin.Lab.2020.200205
dc.identifier.endpage1841en_US
dc.identifier.issn1433-6510
dc.identifier.issue9en_US
dc.identifier.pmid32902215en_US
dc.identifier.scopus2-s2.0-85090732226en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage1835en_US
dc.identifier.urihttps://doi.org/10.7754/Clin.Lab.2020.200205
dc.identifier.urihttps://hdl.handle.net/20.500.12491/10627
dc.identifier.volume66en_US
dc.identifier.wosWOS:000581034500023en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.institutionauthorYis, Özgür Mehmet
dc.language.isoenen_US
dc.publisherClin Lab Publen_US
dc.relation.ispartofClinical Laboratoryen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectGlycated Hemoglobinen_US
dc.subjectHbA1cen_US
dc.subjectAnalytical Performanceen_US
dc.subjectDiabetes Mellitusen_US
dc.titleEvaluation of the analytical performance of lifotronic H9 glycated hemoglobin analyzer and its effect on clinical decision makingen_US
dc.typeArticleen_US

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