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Absolute Quantification of Aβ1-42 in CSF Using a Mass Spectrometric Reference Measurement Procedure

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Harmonization of indirect reference intervals calculation by the Bhattacharya method.

Luisa Martinez-Sanchez^1,2,3,4, Pablo Gabriel-Medina^1,2,4, Yolanda Villena-Ortiz^1,2,4

¹Biochemistry Department, Clinical Laboratories, Vall d'Hebron University Hospital, Barcelona, Spain.

Clinical Chemistry and Laboratory Medicine

|November 17, 2022

Summary

Harmonized criteria for the Bhattacharya indirect method in Microsoft Excel reduced variability in reference interval calculations. This improved consistency for laboratory test results across different users and years.

Keywords:

Bhattacharya harmonization indirect approach reference intervals

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Area of Science:

Clinical Chemistry
Laboratory Medicine
Biostatistics

Background:

Reference intervals are crucial for interpreting laboratory test results.
Variability in calculation methods can lead to inconsistent reference intervals.
The Bhattacharya indirect method is widely used but can be subject to user interpretation.

Purpose of the Study:

To harmonize criteria for the Bhattacharya indirect method using a Microsoft Excel Spreadsheet.
To reduce between-user variability in reference interval calculations.
To evaluate the impact of harmonized criteria on reference intervals for eight analytes over two years.

Main Methods:

Anonymized outpatient laboratory test results from 2018-2019 were analyzed.
Reference intervals were calculated using the Bhattacharya method with original and harmonized criteria.
Harmonized criteria included specific guidelines for data binning and curve fitting.
Consensus reference intervals were derived from multiple users' results.

Main Results:

Differences in reference intervals were frequent using original criteria.
Proposed additional criteria (e.g., central bin, bin size, consecutive bins) were applied.
These criteria led to more consistent reference interval calculations among users.
External validation confirmed the robustness of the procedure.

Conclusions:

The proposed harmonized criteria effectively reduced between-user variability.
This standardization improves the reliability of reference interval calculations.
The study provides a practical approach for consistent laboratory data interpretation.