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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.

Citation

V V Men'shikov. The assurance of analytical validity of results of cytological analysis: the requirements to reagents]. Klinicheskaia laboratornaia diagnostika. 2013 Apr(4):53-4

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PMID: 23984560

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