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-Reference-Cited by-同舟云学术

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

Published:2024-01-12 Issue:7 Volume:62 Page:1352-1361
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Dirks Niek F.¹²³,den Elzen Wendy P.J.⁴⁵,Hillebrand Jacquelien J.⁶⁷,Jansen Heleen I.⁶⁷⁸^ORCID,Boekel Edwin ten³,Brinkman Jacoline⁹,Buijs Madelon M.²,Demir Ayse Y.¹⁰,Dijkstra Ineke M.¹¹,Endenburg Silvia C.¹²,Engbers Paula¹³,Gootjes Jeannette²,Janssen Marcel J.W.¹⁴,Kniest-de Jong Wilhelmina H.A.¹⁵,Kok Maarten B.¹⁵,Kamphuis Stephan¹⁶,Kruit Adrian¹⁷,Michielsen Etienne¹⁸,Wolthuis Albert¹⁹,Boelen Anita⁶⁷²⁰,Heijboer Annemieke C.¹⁷²⁰⁸

Affiliation:

1. Endocrine Laboratory, Department of Laboratory Medicine , Amsterdam UMC Location University of Amsterdam , Amsterdam , The Netherlands

2. Atalmedial Diagnostic Centers , Amsterdam , The Netherlands

3. Department of Clinical Chemistry, Hematology & Immunology , Northwest Clinics , Alkmaar , The Netherlands

4. Laboratory Specialized Diagnostics & Research, Department of Laboratory Medicine , Amsterdam UMC Location University of Amsterdam , Amsterdam , The Netherlands

5. Amsterdam Public Health Research Institute , Amsterdam , The Netherlands

6. Endocrine Laboratory , Department of Laboratory Medicine, Amsterdam UMC Location University of Amsterdam , Amsterdam , The Netherlands

7. Amsterdam Gastroenterology, Endocrinology & Metabolism , Amsterdam , The Netherlands

8. Endocrine Laboratory, Department of Laboratory Medicine , Amsterdam UMC Location Vrije Universiteit Amsterdam , Amsterdam , The Netherlands

9. Department of Clinical Chemistry , St. Jansdal Hospital , Harderwijk , The Netherlands

10. Laboratory for Clinical Chemistry and Hematology , Meander Medical Center , Amersfoort , The Netherlands

11. Clinical Chemistry , St Antonius Hospital, Nieuwegein , The Netherlands

12. Department of Clinical Chemistry and Hematology , Dicoon, Gelderse Vallei Hospital , Ede , The Netherlands

13. Department of Clinical Chemistry , Treant Care Group , Hoogeveen , The Netherlands

14. Laboratory of Clinical Chemistry and Hematology , VieCuri Medical Center , Venlo , The Netherlands

15. Saltro Diagnostic Center , Unilabs Netherlands , Utrecht , The Netherlands

16. Eurofins Clinical Diagnostics , Gelre Hospitals , Apeldoorn , The Netherlands

17. Medical Laboratory , Nij Smellinghe Hospital , Drachten , The Netherlands

18. Diagnostiek Voor U , Eindhoven , The Netherlands

19. Stichting Certe Medische Diagnostiek en Advies , Groningen , The Netherlands

20. Amsterdam Reproduction & Development Research Institute , Amsterdam , The Netherlands

Abstract

Abstract Objectives Correct interpretation of thyroid function tests relies on correct reference intervals (RIs) for thyroid-stimulating hormone (TSH) and free thyroxine (FT4). ISO15189 mandates periodic verification of RIs, but laboratories struggle with cost-effective approaches. We investigated whether indirect methods (utilizing historical laboratory data) could replace the direct approach (utilizing healthy reference individuals) and compared results with manufacturer-provided RIs for TSH and FT4. Methods We collected historical data (2008–2022) from 13 Dutch laboratories to re-establish RIs by employing indirect methods, TMC (for TSH) and refineR (for FT4). Laboratories used common automated platforms (Roche, Abbott, Beckman or Siemens). Indirect RIs (IRIs) were determined per laboratory per year and clustered per manufacturer (>1.000.000 data points per manufacturer). Direct RIs (DRIs) were established in 125 healthy individuals per platform. Results TSH IRIs remained robust over the years for all manufacturers. FT4 IRIs proved robust for three manufacturers (Roche, Beckman and Siemens), but the IRI upper reference limit (URL) of Abbott showed a decrease of 2 pmol/L from 2015. Comparison of the IRIs and DRIs for TSH and FT4 showed close agreement using adequate age-stratification. Manufacturer-provided RIs, notably Abbott, Roche and Beckman exhibited inappropriate URLs (overall difference of 0.5–1.0 µIU/mL) for TSH. For FT4, the URLs provided by Roche, Abbott and Siemens were overestimated by 1.5–3.5 pmol/L. Conclusions These results underscore the importance of RI verification as manufacturer-provided RIs are often incorrect and RIs may not be robust. Indirect methods offer cost-effective alternatives for laboratory-specific or platform-specific verification of RIs.

Publisher

Walter de Gruyter GmbH

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2023-1237/pdf

Reference23 articles.

1. CLSI, Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline—Third Edition. CLSI document EP28-A3c, Wayne, PA: Clinical and Laboratory Standards Institute; 2008.

2. Ozcurumez, MK, Haeckel, R. Biological variables influencing the estimation of reference limits. Scand J Clin Lab Invest 2018;78:337–45. https://doi.org/10.1080/00365513.2018.1471617.

3. Tate, JR, Yen, T, Jones, GR. Transference and validation of reference intervals. Clin Chem 2015;61:1012–5. https://doi.org/10.1373/clinchem.2015.243055.

4. Haeckel, R, Wosniok, W. The importance of correct stratifications when comparing directly and indirectly estimated reference intervals. Clin Chem Lab Med 2021;59:1628–33. https://doi.org/10.1515/cclm-2021-0353.

5. Clinical and Laboratory Standards Institute (CLSI). Measurement procedure comparison and bias estimation using patient samples; approved guideline—third edition. CLSI document EP09-A3. Wayne, PA. CLSI; 2013.