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A statistical method for determining normal ranges from laboratory data including values below the minimum detectable

J Y Tsay, I W Chen, H R Maxon

    Clinical Chemistry
    |December 1, 1979
    PubMed
    Summary
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    Determining normal ranges for lab tests with undetectable values is challenging. Maximum-likelihood estimation offers a robust statistical method for calculating accurate normal ranges, even with censored data.

    Area of Science:

    • * Endocrinology
    • * Laboratory Medicine
    • * Biostatistics

    Background:

    • * Radioimmunoassay (RIA) of peptide hormones frequently yields undetectable values, complicating normal range determination.
    • * Traditional methods like midpoint or Winsorized methods, and graphic approaches, have limitations with censored data.
    • * Type I censored data, common in RIA, requires specialized statistical handling for accurate range estimation.

    Purpose of the Study:

    • * To propose and evaluate maximum-likelihood estimation (MLE) as a superior statistical method for determining normal ranges from laboratory data with undetectable values.
    • * To establish the normal range for serum thyrotropin (TSH) in healthy individuals using MLE.
    • * To assess the performance of MLE in handling censored RIA data.

    Main Methods:

    Related Experiment Videos

    • * Application of maximum-likelihood estimation (MLE) for parameter estimation (mean, standard deviation) from Type I censored data.
    • * Assumption of a log-normal distribution for serum thyrotropin values.
    • * Calculation of tolerance limits for 95% population coverage with 90% confidence.

    Main Results:

    • * MLE successfully calculated a normal range for serum thyrotropin despite 14% undetectable values in 93 healthy subjects.
    • * The determined normal range for serum thyrotropin was 0.51-5.75 milliunits/L, with a mean of 1.71 milliunits/L.
    • * It was predicted that 91.4% of undetectable serum thyrotropin values would fall within this calculated normal range.

    Conclusions:

    • * Maximum-likelihood estimation is a statistically appropriate and effective method for determining normal ranges from laboratory data containing undetectable values.
    • * This method provides reliable estimation of mean, standard deviation, and tolerance limits for censored RIA data.
    • * MLE facilitates accurate normal range calculation for peptide hormones like thyrotropin, improving diagnostic utility.