Harmonization of indirect reference intervals calculation by the Bhattacharya method

Clinical Chemistry and Laboratory Medicine (CCLM), vol. 61, pp. 266–274

Abstract

OBJECTIVES: The aim of this study was to harmonize the criteria for the Bhattacharya indirect method Microsoft Excel Spreadsheet for reference intervals calculation to reduce between-user variability and use these criteria to calculate and evaluate reference intervals for eight analytes in two different years. METHODS: Anonymized laboratory test results from outpatients were extracted from January 1st 2018 to December 31st 2019. To assure data quality, we examined the monthly results from an external quality control program. Reference intervals were determined by the Bhattacharya method with the St Vincent's hospital Spreadsheet firstly using original criteria and then using additional harmonized criteria defined in this study. Consensus reference intervals using the additional harmonized criteria were calculated as the mean of four users' lower and upper reference interval results. To further test the operation criteria and robustness of the obtained reference intervals, an external user validated the Spreadsheet procedure. RESULTS: The extracted test results for all selected laboratory tests fulfilled the quality criteria and were included in the present study. Differences between users in calculated reference intervals were frequent when using the Spreadsheet. Therefore, additional criteria for the Spreadsheet were proposed and applied by independent users, such as: to set central bin as the mean of all the data, bin size as small as possible, at least three consecutive bins and a high proportion of bins within the curve. CONCLUSIONS: The proposed criteria contributed to the harmonization of reference interval calculation between users of the Bhattacharya indirect method Spreadsheet.

Authors 15

1. Luisa María Martínez-Sánchez corresponding Aachen Department of Clinical Chemistry Laboratory Medicine

   Leiden University · Universitat Autònoma de Barcelona · Leiden University Medical Center · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

   Departament de Bioquímica i Biologia Molecular , Universitat Autònoma de Barcelona , Bellaterra , Spain

   Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Centre , Leiden , The Netherlands

   Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands

2. Pablo Gabriel-Medina

   Universitat Autònoma de Barcelona · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

   Departament de Bioquímica i Biologia Molecular , Universitat Autònoma de Barcelona , Bellaterra , Spain

3. Yolanda Villena-Ortiz

   Universitat Autònoma de Barcelona · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

   Departament de Bioquímica i Biologia Molecular , Universitat Autònoma de Barcelona , Bellaterra , Spain

4. Alba-Estela Garcia-Fernandez

   Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

5. Albert Blanco‐Grau

   Universitat Autònoma de Barcelona · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

   Departament de Bioquímica i Biologia Molecular , Universitat Autònoma de Barcelona , Bellaterra , Spain

6. Christa M. Cobbaert Aachen Department of Clinical Chemistry Laboratory Medicine

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Centre , Leiden , The Netherlands

7. Daniel Bravo-Nieto

   Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

8. Sarai Garriga-Edo

   Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

9. Clara Sanz-Gea

   Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

   Affiliation as printed

   Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

   Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

10. Gonzalo Gonzalez-Silva

    Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

    Affiliation as printed

    Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

    Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

11. Joan López-Hellín

    Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

    Affiliation as printed

    Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

    Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

12. Roser Ferrer

    Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

    Affiliation as printed

    Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

    Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

13. Ernesto Casís

    Vall d'Hebron Hospital Universitari

    Affiliation as printed

    Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

14. Francisco Rodríguez‐Frias

    Universitat Autònoma de Barcelona · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari

    Affiliation as printed

    Biochemistry Department , Clinical Laboratories, Vall d’Hebron University Hospital , Barcelona , Spain

    Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

    Departament de Bioquímica i Biologia Molecular , Universitat Autònoma de Barcelona , Bellaterra , Spain

15. Wendy P. J. den Elzen

    Vall d'Hebron Institut de Recerca · Amsterdam Public Health · Amsterdam University Medical Centers · University of Amsterdam

    Affiliation as printed

    Clinical Biochemistry Research Team, Vall d’Hebron Institute of Research (VHIR) , Barcelona , Spain

    Department of Clinical Chemistry , Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute , Amsterdam , The Netherlands

    Department of Clinical Chemistry, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands