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Evgina S.A.

Federation of Laboratory Medicine

Klimenkova O.A.

Consultative and Diagnostic Center for Children;
Almazov National Medical Research Centre

Plekhanova O.S.

Ural State Medical University;
JSC Medsi Group

Mayansky N.A.

Russian Children’s Clinical Hospital — Pirogov Russian National Research Medical University;
Pirogov Russian National Research Medical University

Analysis of legal documents in the field of reference intervals

Authors:

Evgina S.A., Klimenkova O.A., Plekhanova O.S., Mayansky N.A.

More about the authors

Journal: Laboratory Service. 2023;12(2): 44‑50

DOI: 10.17116/labs20231202144

Read: 1727 times

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Table of contents

ANALYSIS OF LEGAL DOCUMENTS IN THE FIELD OF REFERENCE INTERVALS
ANALYSIS OF LEGAL DOCUMENTS IN THE FIELD OF REFERENCE INTERVALS

To cite this article:

Evgina SA, Klimenkova OA, Plekhanova OS, Mayansky NA. Analysis of legal documents in the field of reference intervals. Laboratory Service. 2023;12(2):44‑50. (In Russ.)
https://doi.org/10.17116/labs20231202144

Подписка 2025 Лабораторная служба (Laboratory Service)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

The development of reference intervals (RI) is one of the important tasks of clinical diagnostic laboratories. The authors have identified 8 Russian regulatory legal documents in the field of RI, each of which is given a detailed assessment in the article for its practical use in the laboratory. Cases of terminological discrepancies between documents are shown. The article analyzes the steps of the procedure for establishing RI by the direct method according to GOST R 53022.3-2008, which require a more detailed description. The development of practical recommendations for the calculation of RI by indirect methods is proposed. The proposed improvement of the regulatory field will make it easier for the laboratory to implement the task of establishing RI assigned to it by GOST R ISO 15189-2015.

Keywords:

reference interval
legal document
direct method
indirect method

Authors:

Evgina S.A.

Federation of Laboratory Medicine

Klimenkova O.A.

Consultative and Diagnostic Center for Children;
Almazov National Medical Research Centre

Plekhanova O.S.

Ural State Medical University;
JSC Medsi Group

Mayansky N.A.

Russian Children’s Clinical Hospital — Pirogov Russian National Research Medical University;
Pirogov Russian National Research Medical University

Received:

17.06.2023

Accepted:

27.06.2023

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References:

  1. ISO 15189-2015. Medical laboratories — Particular requirements for quality and competence. (In Russ.).
  2. GOST R 53022.3-2008. National standard of Russian Federation. Clinical laboratory technologies. Requirements for quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance.
  3. GOST R 18113-1-2015. National standard of Russian Federation. In Vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
  4. https://cr.minzdrav.gov.ru/schema/290_2 
  5. Приказ Минздрава России от 18.05.2021 №464н (ред. от 23.11.2021) «Об утверждении Правил проведения лабораторных исследований» (зарегистрирован в Минюсте России 01.06.2021 за №63737).
  6. https://fedlab.ru/upload/docs/%D0%93%D0%9E%D0%A1% D0%A2%20%D0%A0%2015189.pdf 
  7. GOST R 18113-1-2022. National standard of Russian Federation. In Vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements https://fedlab.ru/upload/docs/%D0%93%D0%9E%D0%A1%D0%A2%20%D0%A0%2018113-1%20%D0%9B%D0%9B%201804+.pdf
  8. GOST R ISO 18113-2-202 (draft, first edition). National standard of the Russian Federation. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use  https://fedlab.ru/upload/docs/%D0%93%D0%9E%D0%A1%D0%A2%20%D0%A0%2018113-1%20%D0%9B%D0%9B%201804+.pdf
  9. GOST R ISO 18113-4-2022 (draft, first edition). National standard of the Russian Federation. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for professional use  https://fedlab.ru/upload/docs/%D0%93%D0%9E%D0%A1%D0%A2%20%D0%A0%2018113-4.pdf
  10. CLSI Document C28-A3c. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline — third edition. Wayne, Pa., USA: CLSI; 2010.
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  12. GOST R 53133.1-2008. national standard. Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories.
  13. Arauzho P, Tomas D, Sadegie T, Bevilakva V, Chan MK, Chen Yu, Rendell E, Adeli K. CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays45. Laboratory Service. 2019;8(2):45-61. (In Russ.) https://doi.org/10.17116/labs2019802145
  14. CLSI Document EP09c. Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd edition, USA, CLSI, 2018.
  15. Fraser CG. Biological variation: from principles to practice. AACC Press; 2001.
  16. GOST R ISO 18113-2-2015. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use. 
  17. GOST R ISO 18113-4-2015. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing.
  18. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Accessed May 23, 2023. https://eur-lex.europa.eu/eli/dir/1998/79/2012-01-11
  19. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. Accessed May 23, 2023. https://eur-lex.europa.eu/eli/reg/2017/746/2017-05-05
  20. Federal state budgetary institution. Center for Monitoring and Clinical and Economic Expertise. Roszdravnadzor”. Suggestions (practical recommendations) for internal quality and safety control activities in medical laboratory. M. 2018.
  21. Приказ Министерства труда и социальной защиты РФ от 14 марта 2018 г. №145н «Об утверждении профессионального стандарта «Специалист в области клинической лабораторной диагностики».
  22. International Standard ISO 15189-2022. Medical laboratories — Requirements for quality and competence. Fourth edition 2022-12. 
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