The site of the Media Sphera Publishers contains materials intended solely for healthcare professionals.
By closing this message, you confirm that you are a certified medical professional or a student of a medical educational institution.

Login
EN
+7 (495) 482-4118
+7 (495) 482-0604
+8 800 250-18-12
  • (toll-free number for subscriptions)
    Mon-Fri from 10 a.m. to 6 p.m.

  • © 1998-2025
+7 (495) 482-43-29
EN
All journals
Journal
Year
Year
Search result: 0

Plekhanova O.S.

Ural State Medical University;
JSC Medsi Group

Tsvirenko S.V.

Ural State Medical University

Kalacheva O.S.

JSC Medsi Group

Saveliev L.I.

Ural State Medical University;
Regional Children Hospital;
Research Institute of Medical Cell Technologies

Evaluation of various indirect methods for calculating the reference intervals of the main CBC parameters in newborns 0—3 days of life

Authors:

Plekhanova O.S., Tsvirenko S.V., Kalacheva O.S., Saveliev L.I.

More about the authors

Journal: Laboratory Service. 2023;12(2): 33‑43

DOI: 10.17116/labs20231202133

Read: 1269 times

Download PDF (RU)
Contact the author
Table of contents

EVALUATION OF VARIOUS INDIRECT METHODS FOR CALCULATING THE REFERENCE INTERVALS OF THE MAIN CBC PARAMETERS IN NEWBORNS 0—3 DAYS OF LIFE
EVALUATION OF VARIOUS INDIRECT METHODS FOR CALCULATING THE REFERENCE INTERVALS OF THE MAIN CBC PARAMETERS IN NEWBORNS 0—3 DAYS OF LIFE

To cite this article:

Plekhanova OS, Tsvirenko SV, Kalacheva OS, Saveliev LI. Evaluation of various indirect methods for calculating the reference intervals of the main CBC parameters in newborns 0—3 days of life. Laboratory Service. 2023;12(2):33‑43. (In Russ.)
https://doi.org/10.17116/labs20231202133

 
Подписка 2025 Лабораторная служба (Laboratory Service)
МСФ на ЯМ
Использование инфографики авторами научных работ
Close metadata
Recommended articles:
Should we depend on refe­rence inte­rvals from manu­facturer package inse­rts? Comparing TSH and FT4 refe­rence inte­rvals from four manu­facturers with resu­lts from modern indi­rect methods and the direct method. Labo­ratory Service. 2024;(3):50-60
TSH refe­rence inte­rvals in adolescents in the iodine defi­ciency region. Comparison of direct and indi­rect approaches for esti­mating refe­rence limits. Labo­ratory Service. 2025;(1):21-31
Abstract:

BACKGROUND

The use of indirect methods for estimating reference intervals (RIs) is important in population groups that are difficult to recruit in order to use direct methods to determine them. Several indirect methods are currently available. The percentage of possible pathological data in a database remains unknown.

THE AIM OF THE STUDY

Was to evaluate the possibilities of various mathematical algorithms to calculate the correct boundaries of RI in the presence of a certain proportion of pathological values.

MATERIAL AND METHODS

RIs of the main indicators of CBC for three parameters of the CBC test (leukocytes, hemoglobin, platelets) were studied, using four available methods for indirect assessment of reference intervals: TMC, Bhattacharya, Kosmic, RefineR in 0—3 days newborns.

RESULTS

The possibility of adding pathological data, 10-50% at different distances and in different locations (to the upper, lower border of the RI and on both sides), was assessed relative to the initial boundaries of the RIs in accordance with the of pD and Total Error (+/–1TE) criteria. When using indirect methods for calculating RI, it is necessary to take into account the dependence of the methods on various factors, such as the permissible percentage of pathological data in the database, and the possible difference in the results. Calculations have shown that these properties can vary from parameter to parameter, as well as depending on the characteristics of pathological values in the database.

CONCLUSIONS

In this study, for almost all analytes, it was possible to calculate RIs with at least 10% of pathological data in a database at different distances, which confirms the general trend, and makes it possible to calculate RI with indirect methods.

Keywords:

reference intervals
indirect methods

Authors:

Plekhanova O.S.

Ural State Medical University;
JSC Medsi Group

Tsvirenko S.V.

Ural State Medical University

Kalacheva O.S.

JSC Medsi Group

Saveliev L.I.

Ural State Medical University;
Regional Children Hospital;
Research Institute of Medical Cell Technologies

Received:

20.06.2023

Accepted:

26.06.2023

Close metadata

References:

  1. CLSI Document C28—A3c. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline — third edition. Wayne, Pa., USA: CLSI; 2010.
  2. Clinical laboratory technologies. Requirements for quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance. (In Russ.).
  3. Bhattacharya CG. A simple method of resolution of a distribution into Gaussian components. Biometrics. 1967;23:115-135. 
  4. Pryce JD. Level of haemoglobin in whole blood and red blood cells, and proposed convention for defining normality. Lancet. 1960;2:333-336. 
  5. Benaglia T, Chauveau D, Hunter DR, Young DS. Mixtools: an R package for analyzing finite mixture models. J Stat Software. 2009;32:1-29. 
  6. Neumann GJ. The determination of normal ranges from routine laboratory data. Clin Chem. 1968;14:979-988. 
  7. Zierk J, A rzideh F, Kapsner LA, et al. Reference Interval Estima- tion from Mixed Distributions using Truncation Points and the Kolmogorov-Smirnov Distance (kosmic). Sci Rep. 2020;10:1704. Assessed december 2021. https://doi.org/10.1038/s41598-020-58749-2
  8. Ammer T, Schützenmeister A, Prokosch HU, Rauh M, Rank CM, Zierk J. Refine R. A Novel Algorithm for Reference Interval Estimation from Real-World Data. Sci Rep. 2021;11:16023. https://doi.org/10.1038/s41598-021-95301-2
  9. Arzideh F, Brandhorst G, Gurr E, Hinsch W, Hoff T, Roggenbuck 59. L. An improved indirect approach for determining reference limits from intra-laboratory data bases exemplified by concentrations of electrolytes. J Lab Med. 2009;33:52-66. 
  10. Plekhanova OS, Tsvirenko SV, Kalacheva OS, Saveliev LI. Principles of methods for indirect determination of reference intervals. Laboratory Service = Laboratornaya sluzhba. 2022;11(2):27-39. (In Russ.). https://doi.org/10.17116/labs20221102127
  11. Hoffmann RG. Statistics in the practice of medicine. JAMA. 1963;185:864-873. 
  12. Hoffmann G, Lichtinghagen R, Wosniok W. Simple estimation of reference intervals from routine laboratory tests. J Lab Med. 2015;39:389-402. 
  13. Holmes DT, Buhr KA. Widespread Incorrect Implementation of the Hoffmann Method, the Correct Approach, and Modern Alternatives. American Journal of Clinical Pathology. 2019;151(3):328-336. 
  14. Wosniok W, Haeckel R. A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach. Clin Chem Lab Med (CCLM). 2019;57(12):1933-1947. https://doi.org/10.1515/cclm-2018-1341
  15. Eliseeva NA, Saveliev LI, Philinkova EA, Tsvirenko SV. Reference intervals for complete blood count parameters in newborns during first day of life for the analyzer Sysmex XN-1000. Laboratory Service. 2019;8(3):31-36. (In Russ.). https://doi.org/10.17116/labs2019803131
  16. https://analyse-it.com. Accessed June 1, 2023.
  17. Horn PS, Feng L, Li Y, Pesce AJ. Effect of outliers and non-healthy individuals on reference interval estimation. Clin Chem. 2001;47:2137-2145.
  18. https://biologicalvariation.eu Accessed June 1, 2023.
  19. Haeckel R, Wosniok W, Arzideh F. Equivalence limits of reference intervals for partitioning of population data. Relevant differences of reference limits. J Lab Med. 2016;40:199-205.  https://doi.org/10.1515/cclm-2014-0874
  20. Haeckel R, Wosniok W, Torge A, Junker R, Bertram A, Krebs A, Özcürümez M, Orth M, Streichert T. Age and sex dependent reference intervals for random plasma/serum glucose concentrations related to different sampling devices and determined by an indirect procedure with data mining: Urgent plea for studying the diagnostic efficiency of various concepts proposed to improve the pre-examination phase for determining blood glucose concentrations. Journal of Laboratory Medicine. 2021;45(2):95-101.  https://doi.org/10.1515/labmed-2020-0064
  21. Henny J, Vassault A, Boursier G, Vukasovic I, Brguljan PM, Lohmander M. Recommendation for the review of biological reference intervals in medical laboratories. Clin Chem Lab Med. 2016;54:1893-1900.
  22. Farrell CJL, Nguyen L, Carter AC. Data mining for age-related TSH reference intervals in adulthood. Clin Chem Lab Med. 2017;55:213-215. 
  23. https://www.pedref.org/reference-intervals.html. Accessed June 1, 2023 
  24. Christensen RD, Henry E, Jopling J, Wiedmeier SE. The CBC: Reference Ranges for Neonates. Seminars in Perinatology. 2009;33(1):3-11.  https://doi.org/10.1053/j.semperi.2008.10
  25. Henry E, Christensen RD. Reference Intervals in Neonatal Hematology. Clinics in Perinatology. 2015;42(3):483-497.  https://doi.org/10.1016/j.clp.2015.04.005
  26. Hermann W, Risch L, Grebhardt C, Nydegger U, Sakem B, Imperiali M, Renz H, Risch M. Reference intervals for platelet indices in seniors and frequency of abnormal results in a population-based setting: a comparison between directly and indirectly estimated reference intervals. Journal of Laboratory Medicine. 2021;45(2):125-129.  https://doi.org/10.1515/labmed-2020-0097
Contact the author
Email
Message
The publishing house "Media Sphere" does not provide treatment services, does not give recommendations on contacting medical institutions and specific specialists, on the prescription of medicines and dietary supplements.

Email Confirmation

An email was sent to test@gmail.com with a confirmation link. Follow the link from the letter to complete the registration on the site.

Email Confirmation

Contact us
If you have any questions, complaints or suggestions, please use this feedback form.
Email
Message
The publishing house "Media Sphere" does not provide treatment services, does not give recommendations on contacting medical institutions and specific specialists, on the prescription of medicines and dietary supplements.
Submit Application

You can become an author of one of our magazines, send a request and we will consider it in during the day.

Name
Phone
E-mail
Message
Login
Registration
E-mail
Password
Forgot Password?

Log in to the site using your account in one of the services

Password recovery
E-mail
Login
Register

We use cооkies to improve the performance of the site. By staying on our site, you agree to the terms of use of cооkies. To view our Privacy and Cookie Policy, please. click here.