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The application of standard samples and reference techniques of implementation of measurements is needed for a valid support of reliability of analyses applied in clinical diagnostic laboratories. They play role of landmarks under metrologic monitoring, calibration of devices and control of quality of results. The article presents analysis of shortcomings interfering with formation of national reference system in Russia harmonized with possibilities provided by international organizations. Among them are the joint Committee on metrologic monitoring in laboratory medicine under the auspices of the International Bureau of Weights and Measures, the International Federation of clinical chemistry and laboratory medicine, etc. The results of the recent development of national normative documents, standard samples and techniques assisted by the authors of article are considered. They are the first steps to organization of national reference system which would comprise all range of modern analytical technologies of laboratory medicine. The national and international measures are proposed to enhance the promptest resolving of task of organization of national reference system for laboratory medicine in the interests of increasing of effectiveness of medical care to citizen of Russia.

The article presents information concerning development of device Cell-CTtm by the American specialists to implement cytological analysis of 3D images of cells using technology of computer tomography by means of visible photons and not x-rays beams. Since density of single cell is insufficient for x-ray analysis. The isotropic resolution of Cell-Cttm permits receiving highly contrast and neatly separating signal from noise image of cell structures in 200 nm range. The device is able to apply mathematical apparatus of computer tomography under analysis and classification of cells.

The optimization of money expenditure for healthcare is leading to the reorganization of the structure of medical organizations, to reducing of small establishments, to centralization of laboratory analyses with cessation of their performing in some hospitals and out patient offices. This tendency is based on medical (enlargement of laboratory tests spectrum) and economical (high productivity, relative reducing of net cost of laboratory determinations) reasons. But the repercussions of switch-over to centralization of laboratory analyses performance must be evaluated from the position of laboratory information accessibility tacking in account the need in express analyses for patient, situated on territories outlying from the centralized laboratory. Using of the portative analytical devices and therefore the possibility to perform the urgent analyses by non-laboratory personal in point of care and by patients themselves as a matter of self-testing can help to solve the problem of accessibility of laboratory tests in conditions of laboratory centralization in some regions.

The article is composed in the form of discussion with authors of another article published in the same issue of journal. The publication considers factors impacting analytical quality of results of clinical laboratory analyses. The cases in question are content of normative documents in force, expedience to complete them with more specific requirements to producers of laboratory analysis tools and recommendations for laboratories on implementation of verification of characteristics of techniques and medical tools for diagnostic in vitro. The article also considers requirements to metrologic traceability of control materials and necessity of formation of national reference system for laboratory medicine. The description of projects of methodical documents proposed to be considered by the profile expert commission on clinical laboratory diagnostic of Minzdrav of Russia is presented. These documents include complex of requirements to producers of medical tools for diagnostic in vitro. The proposal is expressed to develop a normative document of top status to establish a unified system of requirements implemented in all executive and methodical documents concerning regulation of access of medical tools for diagnostic in vitro, supporting security of application and quality of clinical laboratory analyses.

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

The external evaluation of quality of clinical laboratory examinations was gradually introduced in USSR medical laboratories since 1970s. In Russia, in the middle of 1990 a unified all-national system of external evaluation quality was organized known as the Federal center of external evaluation of quality at the basis of laboratory of the state research center of preventive medicine. The main positions of policy in this area were neatly formulated in the guidance documents of ministry of Health. Nowadays, the center of external evaluation of quality proposes 100 and more types of control studies and permanently extends their specter starting from interests of different disciplines of clinical medicine. The consistent participation of laboratories in the cycles of external evaluation of quality intrinsically promotes improvement of indicators of properness and precision of analysis results and increases reliability of laboratory information. However, a significant percentage of laboratories does not participate at all in external evaluation of quality or takes part in control process irregularly and in limited number of tests. The managers of a number of medical organizations disregard the application of the proposed possibilities to increase reliability of laboratory information and limit financing of studies in the field of quality control. The article proposes to adopt the national standard on the basis of ISO 17043 "Evaluation of compliance. The common requirements of professional competence testing".

The diagnostic and curative measures during medical care support can be related with direct and indirect risks for patient. The clinical safety of patient is determined by both proper and timely diagnostic of pathology and application of appropriate curative measures on purpose to achieve safe outcome of case of disease. The important condition of clinical safety is the reliability of applied laboratory information which depends on degree of impact of factors deflecting value of analytical test result from true value of analyzed variable in organism of patient. The implementation of system of corrective measures, quality indicators, inner laboratory and external quality control and the referent system of laboratory medicine are needed to overcome the impact of deflecting factors.

The cytological analysis is an important diagnostic method in many clinical disciplines. In particular cases, the cytological and histologic analysis provides ultimate interpretation of observed form of human pathology, including the most intricate for clinical diagnostic cases of oncologic diseases. The verity of cytological and histologic conclusion about the results of analysis of tissue assay is based on the structural characteristics of tissues, cells and their components. All this, in its turn, significantly depends on stain applied In the laboratory medicine, the standardization provides settings of requirements to applied reagents with purpose to increase the validity of laboratory information. The project of national standard of the Russian Federation is presented founded on ISO 19001 regulating information provided by manufacturer with diagnostic reagents in vitro for staining in biology i.e. in cytological and histochemical analysis.

The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

The article explains the importance of standardization, the development and maintenance of rules and recommendations regulating the conditions and order of implementation of particular parts of preanalytical stage. The order of these conditions is noted including the rules stated and published in such normative documents as national standards GOST R 15 189-2009, GOST R 53079.4-2008, GOST R ISO 6710-209 and in the recommendations of foreign National societies ofclini-cal chemistry and laboratory medicine. These requirements concern all the analytes, enzymes included. The cited data have a practical significance for acquisition of reliable results in everyday functioning of laboratories. Enough to mention data concerning the anticoagulants influence on catalytic concentration of enzymes, the most often measured concentrations of alpha-amylase, lipase, amynotransferase, alkaline and acid phosphatase, creatine kinase, lactate dehydrogenase, choline esterase, hemolysis impact, the increased concentration of bilirubin and hyperlipemia in samples and significance of measurement of indices of serum and plasma as well. The possible mechanisms of impact of these interferents on the results of measurement of catalytic concentration of enzymes are discussed.

The issues of application of the Federal Law "On the provision of the unification of measurements" to the means of clinical laboratory analysis are discussed. The data of normative documents is presented to be used in the elaboration of agreed-on documents of health authorities concerning metrology.

The provision of matching of clinical laboratory examinations results needs the application of unified technologies on all stages of medical care. The project of regulations of standardized analytical technologies is presented. The basic principles of description of standardized analytical technologies and development of all stages of examinations is exposed including requirements to specialists, security techniques, preanalytical stage, quality control, labor expenditures.

The paper gives the main points of a reference system for laboratory medicine. It describes the possibilities of using reference methods and certified reference materials for the standardization of methods to measure the catalytic activity of enzymes and those to evaluate thyroid function.

The conformity of medical articles was assessed for in vitro diagnosis is the most importance procedure for their entering the market. This paper describes the basic elements of assessment of the conformity of these articles, analyzes worldwide experience, shows differences in the Russian regulatory system in the circulation of medical articles for in vitro diagnosis, and gives recommendations for its improvement.

Aim: Development of the approaches to detection of hyperuricosuric stage of purin metabolism derangement and specification of methods for early diagnosis of urate damage to the kidney., Materials and Methods: The study included 115 young subjects whose parents suffer from gout with renal involvement or isolated urate nephropathy. Each patient was examined clinically with evaluation of family history for gout risk factors. Three times for 9 months measurements were made of uricemia and uricosuria, microalbuminuria and activity of tubular enzyme NAG., Results: 45 (39.1%) patients had neither disturbances of purin metabolism nor renal affection. 70 (60.9%) patients had hyperuricosuria. In 23 (32.9%) of them microalbuminuria increased to > 20 mg/day, NAG activity to 5 u/l. Chronic tubulointerstitial nephritis was diagnosed in 17 (73.9%) patients. Six patients (26.1%) developed asymptomatic affection of the kidneys. The rest 47 patients had normal levels of microalbuminuria and NAG. There were 3 cases of hyperuricemia with microalbuminuria rising to 160-200 mg/day and further development of urinary syndrome. Hyperuricemia in them was registered at microalbuminuria higher that 160 mg/day., Conclusion: Microalbuminuria higher than 20 mg/day and NAG activity higher than 5 u/day are important diagnostic indicators of renal affection in hyperuricosuria including asymptomatic one. Microalbuminuria above 160 mg/day gives grounds to discuss the role of morphological changes prior to proteinuria.