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Wide variability in laboratory reference values for serum testosterone.
Stephen Lazarou1, Luis Reyes-Vallejo1, Abraham Morgentaler1
1Harvard Medical School, Division of Urology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Laboratory testosterone testing for hypogonadism faces challenges due to numerous assays and diverse reference ranges. Current testosterone reference values lack clinical relevance, prompting a call for improvement.
Area of Science:
- Endocrinology
- Clinical Chemistry
- Laboratory Medicine
Background:
- Accurate laboratory determination of testosterone is crucial for diagnosing hypogonadism.
- Multiple testosterone assays and inconsistent reference ranges complicate diagnosis.
Purpose of the Study:
- To evaluate current laboratory practices for testosterone assays and reference value utilization.
- To identify variations in testosterone testing methodologies and reference standards across different laboratory types.
Main Methods:
- A telephone survey was conducted among academic, community, and national medical laboratories.
- The survey focused on the types of androgen assays offered and the methods for determining reference values.
Main Results:
- Significant variability exists in testosterone assays and reference ranges among surveyed laboratories.
- Eight different assays for total testosterone and four for free testosterone were identified.
- Reference values for total testosterone showed a 350% difference in low values and 325% in upper values.
Conclusions:
- Laboratory reference values for testosterone are highly variable and not based on clinical considerations.
- Lab directors expressed a preference for clinically relevant testosterone reference ranges.
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