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Related Experiment Videos

Generating method-specific Reference Ranges - A harmonious outcome?

Graham R Lee1, Alison Griffin1, Kieran Halton1

  • 1Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Eccles Street, Dublin, D7, Ireland.

Practical Laboratory Medicine
|October 17, 2017
PubMed
Summary

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This summary is machine-generated.

Determining method-specific Reference Ranges (RRs) is crucial for accurate patient classification and management. This study found significant differences between laboratory RRs and those derived from specific analytical methods, highlighting the need for tailored RRs.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biomarker Analysis

Background:

  • Laboratory Reference Ranges (RRs) are essential for interpreting patient results.
  • Discrepancies between laboratory RRs and analytical methodology can lead to patient misclassification and inappropriate management.
  • Method-specific RRs are vital for accurate clinical decision-making.

Purpose of the Study:

  • To determine and implement method-specific Reference Ranges (RRs).
  • To mitigate patient misclassification and inappropriate management caused by non-reflective RRs.
  • To compare newly derived RRs with existing ranges from manufacturers and external quality schemes.

Main Methods:

  • Serum samples from over 120 healthy volunteers were analyzed.
  • Analysis was performed on Abbott c16000 (chemistry) and i2000SR (immunoassay) analyzers.
Keywords:
ALP, Alkaline PhosphataseALT, Alanine AminotranfseraseAST, Aspartate AminotransferaseAnti-TPO, Anti-Thyroid peroxidaseAnti-Tg, Anti-ThyroglobulinCI, Confidence IntervalCK, Creatine KinaseCRP, C Reactive ProteinFO, Far Out (Outliers)HarmonisationLIS, Laboratory Information SystemLRL, Lower Reference LimitMethod-specificOS, Outside (Outliers)PH, Pathology HarmonisationRR, Reference RangeReference RangesTSH, Thyroid Stimulating HormoneURL, Upper Reference LimitfT3, free Tri-iodothyroninefT4, free Tetra-iodothyronine (thyroxine)

Related Experiment Videos

  • Non-parametric RRs were generated using the Tukey method after statistical outlier exclusion, stratified by gender where applicable.

    • Main Results:

    • Significant differences (>20%) were observed between method-specific and manufacturer/external RRs for 25% of chemistry and 38% of immunoassay tests.
    • Method-specific RRs for sodium, potassium, and chloride were narrower than external ranges.
    • Pronounced gender differences in ferritin levels were noted, with greater disparity than manufacturer-reported ranges.

    Conclusions:

    • Method-specific RRs should be prioritized when resources permit.
    • This approach is particularly important where method bias and lack of standardization hinder RR transferability.
    • Accurate interpretation of laboratory results relies on RRs tailored to the specific analytical methodology used.