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Evgina S.A.

LLC «Beckman Coulter», Moscow, Russia

Saveliev L.I.

The Ural state medical university of Ministry of Health of Russia, Ekaterinburg, Russia;
Regional children’s clinical hospital №1, Ekaterinburg, Russia

Current theory and practice of reference interval36

Authors:

Evgina S.A., Saveliev L.I.

More about the authors

Journal: Laboratory Service. 2019;8(2): 36‑44

Read: 19519 times


To cite this article:

Evgina SA, Saveliev LI. Current theory and practice of reference interval36. Laboratory Service. 2019;8(2):36‑44. (In Russ.)
https://doi.org/10.17116/labs2019802136

References:

  1. Siest G, Henny J, Gräsbeck R, Wilding P, Petitclerc C, Queraltó J, Petersen P. The theory of reference values: an unfinished symphony. CCLM. 2013;51(1):47-64. https://doi.org/10.1515/cclm-2012-0682
  2. CLSI Document C28-A3c. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline — third edition. Wayne, Pa., USA: CLSI; 2010.
  3. GOST R 53022.3-2008 Tekhnology laboratornye klinicheskye. Trebovaniya k kachestvu klinicheskikch laboratornykh issledovaniy. Chast 3. Pravila otsenky klicheskoy informativnosti laboratornykh testov. (In Russ.)
  4. Ozarda Y, Sikaris K, Streichert T, Macri J. Distinguishing reference intervals and clinical decision limits — A review by the IFCC Committee on Reference Intervals and Decision Limits. Critical Reviews in Clinical Laboratory Sciences. 2018;55(6):420-431. https://doi.org/10.1080/10408363.2018.1482256
  5. Jones G, Haeckel R, Loh T, Sikaris K, Streichert T, Katayev A, et al. Indirect methods for reference interval determination — review and recommendations. CCLM. 2018;57(1):20-29 https://doi.org/10.1515/cclm-2018-0073
  6. Hoffmann R. Statistics in the Practice of Medicine. JAMA. 1963;185(11):864-873. https://doi.org/10.1001/jama.1963.03060110068020
  7. Arzideh F, Wosniok W, Gurr E, Hinsch W, Schumann G, Weinstock N, Haeckel R. A plea for intra-laboratory reference limits. Part 2. A bimodal retrospective concept for determining reference limits from intra-laboratory databases demonstrated by catalytic activity concentrations of enzymes. CCLM. 2007;45(8):1033-1042. https://doi.org/10.1515/cclm.2007.250
  8. Ozarda Y, Ichihara K, Barth J, Klee G. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values. CCLM. 2013;51(5):1027-1040. https://doi.org/10.1515/cclm-2013-0249
  9. Henny J, Vassault A, Boursier G, Vukasovic I, Mesko Brguljan P, Lohmander M, et al. Recommendation for the review of biological reference intervals in medical laboratories. CCLM. 2016;54(12):1893-1900. https://doi.org/10.1515/cclm-2016-0793
  10. Ichihara K, Ozarda Y, Barth J, Klee G, Qiu L, Erasmus R, et al. A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals. Clin Chim Acta. 2017;467:70-82. https://doi.org/10.1016/j.cca.2016.09.016
  11. Ozarda Y. Reference intervals: current status, recent developments and future considerations. Biochemia Medica. 2016;26(1):5-16. https://doi.org/10.11613/bm.2016.001
  12. Ozarda Y, Higgins V, Adeli K. Verification of reference intervals in routine clinical laboratories: practical challenges and recommendations. CCLM. 2018;57(1):30-37. https://doi.org/10.1515/cclm-2018-0059
  13. CLSI document EP09-A3. Method procedure comparison and bias estimation using patient samples; approved guideline — third edition. Wayne (PA): CLSI; 2013.
  14. Araújo P, Thomas D, Sadeghieh T, Bevilacqua V, Chan M, Chen Y, et al. CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays. Clin Biochem. 2015;48(13-14):870-880. https://doi.org/10.1016/j.clinbiochem.2015.06.002
  15. Tate J, Yen T, Jones G. Transference and Validation of Reference Intervals. Clin Chem. 2015;61(8):1012-1015. https://doi.org/10.1373/clinchem.2015.243055

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