The impact of assay quality and reference ranges on clinical decision making in the diagnosis of androgen disorders.
Level 5 - mechanism / opinion, no new human data
Narrative review and expert commentary without new human data or systematic review methodology.
PubMed 18687348 · doi:10.1016/j.steroids.2008.07.003
What was done
This narrative commentary examined the clinical implications of testosterone assay accuracy and the need for standardized, population-based reference ranges for diagnosing androgen disorders across men, women, and children.
What was found
The abstract reports no numerical data. It states that direct radioimmunoassays lack accuracy at low testosterone concentrations and that the lack of population-based reference limits for total and free testosterone creates a substantial risk of diagnostic misclassification.
Why it matters
Inaccurate testosterone assays and non-standardized reference ranges risk widespread misclassification and inappropriate clinical management in androgen disorders.
Limits
The abstract describes a narrative perspective rather than an empirical study or systematic review, presenting no original data, sample size, or quantitative comparisons.
Cited by
- supports Standard clinical hormone assays used historically have lacked the sensitivity to accurately detect normal low circulating testosterone levels in women.