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  5. Quality assurance of hematological research on the example of validation methods for determining concentration of hemoglobin in biological fluids by gemoglobintsianid

Quality assurance of hematological research on the example of validation methods for determining concentration of hemoglobin in biological fluids by gemoglobintsianid

V.E. Dobrova, K.O. Zupanets, S.V. Misyurova, N.S. Mazur
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For assurance of the quality of clinical and laboratory research in the laboratory of clinical diagnostics of Clinical and Diagnostics Center of the National University of Pharmacy the features, approaches and requirements for assessing the suitability of laboratory methods were defined, validation procedure and conducted validation of methods «Determination of hemoglobin concentration in biological fluids by gemoglobintsianid when working on automatic hematological system ADVIA 60 CT and spectrophotometer UNICO 2800UV / VIS» were developed. It is approved that performance characteristics correspond to the regimented, satisfy the criteria.
Keywords: validation, clinical laboratory diagnostics, hemohlobintsianid method, indicators repeatability and reproducibility, the expanded uncertainty of measurement