Analytical verification and quality assessment of the Tosoh HLC-723GX HbA1C analyzer
HbA1C assay has been established as the cornerstone of diabetes care for decades. Advances in methodology and global standardization of HbA1C assays have enabled an effective laboratory tool for global implementation of recommended clinical practice based on specific targets for diagnosis and monitoring of diabetes.
Verification of total imprecision of the Tosoh HLC-723GX analyzer was performed over five consecutive days using two levels of commercial control materials and two levels of pooled human whole blood samples.
Our results show that HbA1C results obtained by the Tosoh HLC-723GX are highly reproducible and comparable to the CE procedure. The results of our study clearly demonstrate that Tosoh HLC-723GX, with a very low bias at the recommended HbA1C clinical decision level (48 mmol/mol/6.5%) and excellent precision, meets the recently recommended sigma-based quality criteria for reliable clinical use of HbA1C in routine laboratories.
Thus, compliance to the quality targets, as evidenced in this study, together with a user-friendly interface, compact size and total automation, support the Tosoh HLC-723GX analyzer as a reliable analytical choice for HbA1C measurement in low-volume laboratories.
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Analytical verification and quality assessment of the Tosoh HLC-723GX HbA1c analyzer - PMC
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