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Methodological aspects of ensuring and improving diagnostic effectiveness of quantitative immunochemiluminescent studies. Model of ‘clinical uncertainty’ as part of laboratory modules of clinical recommendations and educational programs

https://doi.org/10.33667/2078-5631-2022-6-30-34

Abstract

Technological capabilities make it possible to increase the diagnostic efficiency of quantitative immunochemiluminescent studies but require expanding the glossary of the clinical and laboratory consultation, taking into account metrological approaches to quality assurance. The variants of quantitative assessment of the “clinical uncertainty of assessing the patient’s condition based on a laboratory test”, formed taking into account the models of analytical quality requirements, are proposed. The clinical significance of the introduction of metrological approaches to ensuring and expressing accuracy in the practice of quantitative immunochemiluminescent studies in order to reduce risks and improve the safety of medical activities is demonstrated.

About the Authors

N. A. Kovyazina
All-Russian Centre for Emergency and Radiation Medicine n.a. A.M. Nikiforov
Russian Federation

Kovyazina Nadezhda A., PhD Med, head of the Laboratory for Serological Research and Allergy Diagnostics, Dept of Laboratory Diagnostics

Saint Petersburg



S. S. Aleksanin
All-Russian Centre for Emergency and Radiation Medicine n.a. A.M. Nikiforov
Russian Federation

Aleksanin Sergey Sergeevich, DM Sci (habil.), pofessor, Corresponding Member of RAS, director

Saint Petersburg



A. G. Chunovkina
All-Russian Scientific Research Institute for Metrology n.a. D. I. Mendeleev;Interregional Public Association ‘Metrological Academy
Russian Federation

Chunovkina A.G., DTech. Sic, head of the Research Laboratory

Saint Petersburg



V. L. Emanuel
Interregional Public Association ‘Metrological Academy; First Saint Petersburg State Medical University n.a. academician I.P. Pavlov
Russian Federation

Emanuel Vladimir L.2,4, DM Sci (habil.), professor, head of Dept of Clinical Laboratory Diagnostics with a Course in Molecular Medicine, director of Scientific and Methodological Center for Molecular Medicine, academician of Metrological Academy

Saint Petersburg



References

1. F.Ceriotti, P. Fernandez-Calle, G.G. Klee, G. Nordin, S. Sandberg, T. Streichert, J.-L. Vives-Corrons, M. Panteghini, on behalf of the EFLM Task and Finish Group on Allocation of laboratory tests to different models for performance specifications (TFG-DM). Clin Chem Lab Med. 2017;55(2):189–194. https://doi.org/10.1515/cclm 2016–0091

2. Kovyazina N.A., Altukhova N.A., Bardysheva N.A., Zybina N.N., Kalinina N.M. From theory to practice. The role of quality control of analytical staqe of studies in increasing clinical informativeness of laboratory tests. [Ot teorii k praktike. Rol` kontrolya kachestva analiticheskogo e`tapa issledovanij v povy`shenii klinicheskoj informativnosti laboratorny`x testov] Russian clinical laboratory diagnostic. 2016. Vol.3. P. 188–192. (in Russian).

3. Kovyazina N.A., N.A. Alhutova. Laboratornye aspekty standartizacii preanaliticheskogo etapa issledovaniya gomocisteina. Spravochnik zaveduyushchego KDL. 2017 g. № 11. S. 20–32. (in Russian)

4. Alhutova N.A., Kovyazina N.A., Boyarkina M.P., Zybina N.N., Kalinina N.M., Grigor’eva T.A «Procedura validacii kak instrument rasshireniya diagnosticheskih vozmozhnostej laboratorii na primere testov Sa125 «Access2», Beckman Coulter, SSHA & belka HE4 «Fujirebio», SHveciya v raschete indeksa ROMA pri diagnostike epitelial’nogo raka yaichnikov» CHasti 2. Procedura validacii testa Sa125 «Access2», Beckman Coulter, SSHA v raschete indeksa ROMA. Medicinskij alfavit. № 13. 2016. T. 1. S. 50–56. (in Russian)

5. Kovyazina N.A. Alhutova N.A., Bardysheva N.A. Validaciya preanaliticheskogo etapa issledovaniya gastrinov. Spravochnik zaveduyushchego KDL. 2017 g. № 1. S35–51. (in Russian)

6. Patent № 2679906 Rossijskaya Federaciya. Sposob ocenki adaptacionnyh rezervov organizma cheloveka: № 2018119064: zayavleno 23.05.2018: opublikovano 14.02.2019/ Alhutova N.A., Kovyazina N.A.; patentoobladatel’ FGBU VCERM im. A.M. Nikiforova MCHS Rossii. Н.А.; патентообладатель ФГБУ ВЦЭРМ им. А.М. Никифорова МЧС России.

7. V. L. Emanuel’ V.L., A.N. Pronin, M.S. Vonskiy, A.G. Chunovkina, V.N. Kustova, T.S. Martynova, I.V. Ivanov. Towards the Concept of ensuring the uniformity of measurements in laboratory medicine. [Na puti k Koncepcii obespecheniya edinstva izmerenij v laboratornoj medicine] Mir Izmereniy (Measurements World). 2 (192) 2021.S.22–26. (in Russian)


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For citations:


Kovyazina N.A., Aleksanin S.S., Chunovkina A.G., Emanuel V.L. Methodological aspects of ensuring and improving diagnostic effectiveness of quantitative immunochemiluminescent studies. Model of ‘clinical uncertainty’ as part of laboratory modules of clinical recommendations and educational programs. Medical alphabet. 2022;1(6):30-34. (In Russ.) https://doi.org/10.33667/2078-5631-2022-6-30-34

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ISSN 2078-5631 (Print)
ISSN 2949-2807 (Online)