Quality assurance of biochemical studies using validation procedures in the laboratory of clinical diagnostics of the clinical diagnostic center of the national university of pharmacy on the example of the method of determining the level of general and di





validation, methods of determination, general and direct bilirubin, convergence and reproducibility, accuracy and uncertainty of measurements


The main principles of the quality system creating in modern laboratory diagnostics are: standardization of laboratory processes by developing standard operating procedures; general quality management of clinical laboratory researches based on the development and implementation of the requirements of international standards; quality control at all stages of the laboratory process through the introduction of the validation procedure.

Aim. Investigation of quality assurance aspects in the Laboratory of Clinical Diagnostics of the Clinical and Diagnostic Center of the NUPh by carrying out the validation procedures for evaluating the intra-laboratory reproducibility of biochemical techniques.

Materials and methods. The objects of the study were standardized biochemical methods for determining the levels of total and direct bilirubin in samples of biological liquids. As a control serum was used “Chemical control. Reagent kit”, produced by High Technology, Inc. (USA) with a known concentration of analytes. The measurements were carried out on the automatic biochemical analyzer Express Plus, Bayer (Germany). When processing the results of the research, descriptive statistics indicators were used and a number of statistical estimates were made.

Results. The procedure for validating the method consists of several stages. First of all, a validation scenario was compiled: features of methods for determining total and direct bilirubin in biological liquids were established; the parameters to be evaluated were analyzed. Secondly, protocols have been developed for assessing the suitability of these techniques and validating characteristics.

Evaluation of intralaboratory convergence and reproducibility of methods for determining the concentration of total and direct bilirubin by photometric method when working with the biochemical analyzer Еxpress Рlus, which was carried out by two operators-technicians of the same qualification, indicates the absence of gross errors in the analyzer operation and statistically significant differences in the measurement. Evaluation of the correctness of the methods carried out with the help of the control serum has proved that the systematic error is insignificant (according to the specified eligibility criterion). Thus, these methods, which have been certified, ensure the correctness of measurements within the laboratory. The increased uncertainty, which was calculated as a metrological assessment of acceptability, showed that the obtained values of total and direct bilirubin levels can be considered accurate and reliable.

Conclusions. Validation of the methods for the determination of total and direct bilirubin in human blood by photometric method has proved that these techniques have performance characteristics that correspond to regulated ones that meet the established criteria, and the parameters measured with them correspond to the proper ones.

Author Biographies

S. V. Mіsiurova, National University of Pharmacy

Candidate of Pharmacy (PhD), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

V. Ye. Dobrova, National University of Pharmacy

Doctor of Pharmacy (Dr.habil.), professor of the Clinical Pharmacology and Clinical Pharmacy Department

N. O. Svid, National University of Pharmacy

Рaramedicine assistant of the Clinical Diagnostics Laboratory of Clinical and Diagnostics Center

I. A. Otrishko, National University of Pharmacy

Candidate of Pharmacy (PhD), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

T. S. Sakharova, National University of Pharmacy

Doctor of Pharmacy (Dr. habil.), professor of the Department of Clinical Pharmacology and Clinical Pharmacy


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Laboratory diagnostics