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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Reference ranges for testosterone assays vary significantly among labs.
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<blockquote data-quote="Nelson Vergel" data-source="post: 30029" data-attributes="member: 3"><p>Le M, Flores D, May D, Gourley E, Nangia AK. </p><p></p><p><strong>Current Practices of Measuring and Reference Range Reporting of Free and Total Testosterone in the United States. </strong></p><p><strong></strong></p><p>J Urol. <a href="http://www.sciencedirect.com/science/article/pii/S0022534715054464" target="_blank">http://www.sciencedirect.com/science/article/pii/S0022534715054464</a> </p><p></p><p>PURPOSE: The evaluation and management of male hypogonadism should be based on symptoms and serum testosterone levels. Diagnostically, this relies on accurate testing and reference values. Our objective was to define the distribution of reference values and assays for free and total testosterone by clinical laboratories in the US.</p><p></p><p>MATERIALS AND METHODS: Upper and lower reference values, assay methodology, and source of published reference ranges were obtained from labs across the country. A standardized survey was reviewed with laboratory staff via telephone. Descriptive statistics were used to tabulate results.</p><p></p><p>RESULTS: 120 laboratories from 47 states were surveyed. Total testosterone was measured in-house at 73% of labs. The remaining sent their studies to larger centralized reference facilities.</p><p></p><p>The mean lower reference value for total testosterone was 231 ng/dL (range 160-300, SD 46) and the mean upper limit was 850 ng/dL (range 726-1130, SD 141). Only 9% of labs performing in-house total testosterone testing created a reference range unique to their region, while others validated their instrument's recommended reference values with a small number of internal test samples.</p><p></p><p>For free testosterone, 82% of labs sent testing to larger centralized reference labs that used equilibrium dialysis and/or liquid chromatography with mass spectrometry. Remaining labs used published algorithms to calculate serum free testosterone.</p><p></p><p>CONCLUSION: Reference ranges for testosterone assays vary significantly among labs. They are predominantly defined by limited population studies of men with unknown medical and reproductive history. These poorly defined and variable reference values, especially lower limit, affect how clinicians determine treatment.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 30029, member: 3"] Le M, Flores D, May D, Gourley E, Nangia AK. [B]Current Practices of Measuring and Reference Range Reporting of Free and Total Testosterone in the United States. [/B] J Urol. [url]http://www.sciencedirect.com/science/article/pii/S0022534715054464[/url] PURPOSE: The evaluation and management of male hypogonadism should be based on symptoms and serum testosterone levels. Diagnostically, this relies on accurate testing and reference values. Our objective was to define the distribution of reference values and assays for free and total testosterone by clinical laboratories in the US. MATERIALS AND METHODS: Upper and lower reference values, assay methodology, and source of published reference ranges were obtained from labs across the country. A standardized survey was reviewed with laboratory staff via telephone. Descriptive statistics were used to tabulate results. RESULTS: 120 laboratories from 47 states were surveyed. Total testosterone was measured in-house at 73% of labs. The remaining sent their studies to larger centralized reference facilities. The mean lower reference value for total testosterone was 231 ng/dL (range 160-300, SD 46) and the mean upper limit was 850 ng/dL (range 726-1130, SD 141). Only 9% of labs performing in-house total testosterone testing created a reference range unique to their region, while others validated their instrument's recommended reference values with a small number of internal test samples. For free testosterone, 82% of labs sent testing to larger centralized reference labs that used equilibrium dialysis and/or liquid chromatography with mass spectrometry. Remaining labs used published algorithms to calculate serum free testosterone. CONCLUSION: Reference ranges for testosterone assays vary significantly among labs. They are predominantly defined by limited population studies of men with unknown medical and reproductive history. These poorly defined and variable reference values, especially lower limit, affect how clinicians determine treatment. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Reference ranges for testosterone assays vary significantly among labs.
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