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The origin of reference intervals.

Richard C Friedberg1, Rhona Souers, Elizabeth A Wagar

  • 1Department of Pathology, Baystate Medical Center, Springfield, Mass, USA.

Archives of Pathology & Laboratory Medicine
|May 23, 2007
PubMed
Summary
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Clinical laboratories often adopt reference intervals from manufacturers without internal validation. While most intervals show slight variation, some outlier intervals exist, with no on-site testing not significantly impacting results.

Area of Science:

  • Clinical Laboratory Science
  • Medical Diagnostics
  • Biochemistry

Background:

  • Established standards for reference intervals exist, but practical application, interlaboratory variability, and error sources remain unclear.
  • Reference intervals are crucial for accurate medical diagnosis and patient management.

Purpose of the Study:

  • To investigate methods used by clinical laboratories for establishing reference intervals for seven common analytes.
  • To assess the variation in these reference intervals among laboratories.
  • To identify factors contributing to the establishment of outlier reference intervals.

Main Methods:

  • Surveyed 163 clinical laboratories regarding their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time.

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  • Collected data on the sources and validation methods for these intervals.

    • Main Results:

    • Approximately 50% of laboratories conducted internal validation studies for adult reference intervals; most used external sources for pediatric intervals.
    • Slight variation was observed within the central 80% of laboratories, with some exhibiting significant outlier intervals.
    • Inconsistent interpretations of values (e.g., hemoglobin) were noted between laboratories, with 3% of intervals classified as statistical outliers.

    Conclusions:

    • Many laboratories adopt manufacturer-provided reference intervals without independent validation.
    • Lack of on-site validation did not lead to statistically significant differences in reference intervals compared to those validated internally.