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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Subq vs IM impact on Hematocrit
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<blockquote data-quote="madman" data-source="post: 206800" data-attributes="member: 13851"><p>Regarding free testosterone, there is much more going on behind the scenes.</p><p></p><p>Even then it will have no impact on the reference ranges for Total Testosterone.</p><p></p><p>The harmonized reference range for Total Testosterone was already changed as of 2017.</p><p></p><p><strong>CDC Hormone Standardization Program<em> (CDC HoSt) Certified Total Testosterone </em></strong>was already completed and has been around for a while now.</p><p></p><p>As I stated previously.....<strong>CDC Hormone Standardization Program<em> (CDC HoSt) Certified Free Testosterone Procedures</em> </strong>is in the works as we speak.</p><p></p><p></p><p></p><p></p><p><strong>The Solution Standardized Laboratory Measurements</strong></p><p></p><p><em>In 2007, CDC began a project to <u>standardize hormone measurements to ensure accurate and comparable results across testing systems (assays), across laboratories and over time</u>. The <u>two key elements of the solution are the development of reference materials that have highly accurate and precise values, and reference methods that provide highly precise and accurate measurements</u>.</em></p><p><em></em></p><p><em>Reference methods are used to assign concentrations to reference materials. Reference materials are used to calibrate assays and to verify calibrations. <u>Thus, laboratories performing research or patient care testing can anchor their results to a common standard, regardless of the technology employed</u>. <u>This approach simultaneously minimizes method bias and improves method precision</u>.</em><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>WHAT PROGRESS HAS CDC MADE WITH STANDARDIZING TOTAL TESTOSTERONE AND ESTRADIOL TESTS?</strong></p><p></p><p><em>Since HoSt began in 2010, CDC has had more than 350 participants in 15 countries. Participants have shown measurable improvements for both total testosterone (TT) and estradiol (E2). <u>Specifically, the among-laboratory bias has decreased from 16.5% in 2007 to 2.8% in 2017 for TT and from 54.8% in 2012 to 13.9% in 2017 for E2</u>. Not only has bias improved, but data from proficiency testing programs also show that standardized testosterone assays are more accurate and consistent compared to non-standardized assays.</em></p><p><em></em></p><p><em>Recently, <u>CDC CSP also collaborated with the Endocrine Society and PATH to develop reference ranges for testosterone in non-obese men ages 19-39 years old</u>. <u>These reference ranges are now part of an Endocrine Society clinical practice guideline and according to this guideline can be used by laboratory tests standardized to CDC’s criteria</u>.</em></p><p></p><p></p><p></p><p></p><p><strong>Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe (2017)</strong></p><p><strong></strong></p><p><strong>Conclusion:</strong> <em><u>Harmonized normal range in a healthy nonobese population of European and American men, 19 to 39 years, is 264 to 916 ng/dL</u>. A substantial proportion of intercohort variation in testosterone levels is due to assay differences. <u>These data demonstrate the feasibility of generating harmonized reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator</u>. (J Clin Endocrinol Metab 102: 1161–1173, 2017)</em></p></blockquote><p></p>
[QUOTE="madman, post: 206800, member: 13851"] Regarding free testosterone, there is much more going on behind the scenes. Even then it will have no impact on the reference ranges for Total Testosterone. The harmonized reference range for Total Testosterone was already changed as of 2017. [B]CDC Hormone Standardization Program[I] (CDC HoSt) Certified Total Testosterone [/I][/B]was already completed and has been around for a while now. As I stated previously.....[B]CDC Hormone Standardization Program[I] (CDC HoSt) Certified Free Testosterone Procedures[/I] [/B]is in the works as we speak. [B]The Solution Standardized Laboratory Measurements[/B] [I]In 2007, CDC began a project to [U]standardize hormone measurements to ensure accurate and comparable results across testing systems (assays), across laboratories and over time[/U]. The [U]two key elements of the solution are the development of reference materials that have highly accurate and precise values, and reference methods that provide highly precise and accurate measurements[/U]. Reference methods are used to assign concentrations to reference materials. Reference materials are used to calibrate assays and to verify calibrations. [U]Thus, laboratories performing research or patient care testing can anchor their results to a common standard, regardless of the technology employed[/U]. [U]This approach simultaneously minimizes method bias and improves method precision[/U].[/I][B][I][/I] WHAT PROGRESS HAS CDC MADE WITH STANDARDIZING TOTAL TESTOSTERONE AND ESTRADIOL TESTS?[/B] [I]Since HoSt began in 2010, CDC has had more than 350 participants in 15 countries. Participants have shown measurable improvements for both total testosterone (TT) and estradiol (E2). [U]Specifically, the among-laboratory bias has decreased from 16.5% in 2007 to 2.8% in 2017 for TT and from 54.8% in 2012 to 13.9% in 2017 for E2[/U]. Not only has bias improved, but data from proficiency testing programs also show that standardized testosterone assays are more accurate and consistent compared to non-standardized assays. Recently, [U]CDC CSP also collaborated with the Endocrine Society and PATH to develop reference ranges for testosterone in non-obese men ages 19-39 years old[/U]. [U]These reference ranges are now part of an Endocrine Society clinical practice guideline and according to this guideline can be used by laboratory tests standardized to CDC’s criteria[/U].[/I] [B]Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe (2017) Conclusion:[/B] [I][U]Harmonized normal range in a healthy nonobese population of European and American men, 19 to 39 years, is 264 to 916 ng/dL[/U]. A substantial proportion of intercohort variation in testosterone levels is due to assay differences. [U]These data demonstrate the feasibility of generating harmonized reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator[/U]. (J Clin Endocrinol Metab 102: 1161–1173, 2017)[/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Subq vs IM impact on Hematocrit
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