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Related Experiment Videos

Estimation of reference ranges: how many subjects are needed?

J A Lott1, L C Mitchell, M L Moeschberger

  • 1Department of Pathology, Ohio State University, Columbus 43210.

Clinical Chemistry
|May 1, 1992
PubMed
Summary

Determining reference limits for common blood tests requires a substantial population size. Approximately 200 individuals are needed to establish stable reference ranges for sodium, potassium, and glucose levels.

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Area of Science:

  • Clinical Chemistry
  • Biostatistics
  • Medical Education

Background:

  • Establishing accurate reference ranges is crucial for interpreting patient results.
  • Previous studies have not definitively determined the optimal sample size for reference population studies.

Purpose of the Study:

  • To determine the minimum sample size required for stable reference limits.
  • To define acceptable reference population size for common clinical laboratory tests.

Main Methods:

  • Serum and blood samples were collected from medical students (800 males, 200 females).
  • Measurements included sodium (Na), potassium (K), chloride (Cl), glucose, hemoglobin, erythrocytes, and hematocrit.
  • Monte Carlo simulations were used to analyze sample sizes ranging from 10 to 400.

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Main Results:

  • Approximately 200 participants are needed to achieve stable lower (2.5%) and upper (97.5%) reference limits for most tested analytes.
  • This sample size aligns with statistical criteria for a 99% confidence level.

Conclusions:

  • A reference population of around 200 individuals is statistically sound for establishing reliable clinical laboratory reference ranges.
  • These findings can inform future reference population studies and improve diagnostic accuracy.