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Updated: Sep 22, 2025

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
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Indirect determination of biochemistry reference intervals using outpatient data.

Luisa Martinez-Sanchez1,2,3, Christa M Cobbaert2, Raymond Noordam4

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

Plos One
|May 19, 2022
PubMed
Summary

This study found that an indirect method effectively calculated laboratory reference intervals for outpatient populations, showing consistency with a Dutch study. This approach is cost-efficient for determining clinical test ranges.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biostatistics

Background:

  • Establishing accurate laboratory reference intervals is crucial for diagnosing and monitoring patient health.
  • Existing methods for determining reference intervals can be resource-intensive.

Purpose of the Study:

  • To determine reference intervals in a Spanish outpatient population using an indirect approach.
  • To compare these intervals with those from a previously studied Dutch population (NUMBER project).

Main Methods:

  • An indirect method was applied to anonymized clinical laboratory test results from 509,408 requests.
  • Data were analyzed for outliers, transformed to a normal distribution, and stratified by age and sex.
  • Reference intervals were calculated using both the indirect method and the reference limit estimator method.

Main Results:

  • Reference intervals calculated indirectly were comparable to the Dutch study for normally distributed biochemical tests.
  • Age-dependent increases in reference intervals were observed for creatinine and urea in both populations.
  • Discrepancies were noted for Gamma-glutamyl transferase, creatine kinase, and uric acid compared to conventional or Dutch study intervals.

Conclusions:

  • The indirect method is a feasible and cost-efficient approach for calculating laboratory reference intervals.
  • Test standardization and bias assessment are essential for generating traceable, standardized reference intervals.