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Statistical considerations for determining high-sensitivity cardiac troponin reference intervals

Peter E Hickman1, Gus Koerbin2, Julia M Potter1

  • 1Department of Chemical Pathology, The Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia; Australian National University Medical School, Canberra, Australian Capital Territory 2605, Australia.

Clinical Biochemistry
|March 7, 2017
PubMed

Insights

Statistical outlier removal methods significantly impact troponin 99th percentile calculations, affecting acute myocardial infarction diagnosis. Standardizing these methods is crucial for consistent laboratory results and reliable reference intervals.

Area of Science:

  • Clinical Chemistry
  • Biostatistics
  • Cardiology

Background:

  • The 99th percentile of troponin is a critical threshold for diagnosing acute myocardial infarction.
  • Previous research indicates outlier removal techniques can substantially alter calculated troponin 99th percentiles.
  • Variability in outlier removal impacts the reliability of laboratory diagnostic cutoffs.

Purpose of the Study:

  • To independently evaluate the impact of different outlier removal methods on troponin 99th and 97.5th percentile calculations.
  • To assess the influence of outlier removal on upper reference intervals for various analytes.
  • To highlight the need for standardized statistical approaches in clinical laboratory science.

Main Methods:

  • Utilized a large database from the Canberra Heart Study.
  • Applied various statistical methods for outlier removal to troponin data.
  • Calculated 99th and 97.5th percentiles using different outlier removal strategies.
  • Assessed results for high-sensitivity cardiac troponin I (hs-cTnI) and troponin T (hs-cTnT).

Main Results:

  • For healthy males (<75 years), the hs-cTnI 99th percentile varied over threefold based on outlier removal method.
  • The hs-cTnI 97.5th percentile showed over 50% variation in healthy males.
  • For women, hs-cTnI 99th percentile variation approached twofold.
  • Similar variability was observed for hs-cTnT, indicating a broader issue beyond troponin.

Conclusions:

  • The choice of outlier removal method significantly affects calculated troponin reference intervals.
  • This variability extends to other analytes, impacting the comparability of laboratory studies.
  • Urgent standardization of outlier removal procedures is necessary for consistent clinical chemistry and diagnostics.

Keywords:
99th percentileCardiac troponinOutlier removalStatistics

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