CDC STANDARDIZED TOTAL T and ESTRADIOL ASSAYS and soon to be FREE TESTOSTERONE!

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CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Assays (UPDATED 4/2024)
 

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* The data from the present analyses suggest that the interaction of the three sex hormones with their cognate binding proteins is highly complex and dynamic and influenced by their relative circulating concentrations. Therefore, models of testosterones binding to SHBG, based on the assumption of fixed apparent binding affinity of sex hormones with SHBG, that do not consider the influence of estradiol and dihydrotestosterone on the free testosterone fraction are unlikely to provide accurate estimates of free testosterone fraction.

* Because of these complex interactions between various sex hormones as well as other ligands with sex hormone binding globulin, direct measurements of free testosterone using a reliable assay, such as the equilibrium dialysis method, may be a superior marker of testosterone’s treatment effect.






* Collectively, these data highlight the non-linear, concentration-dependent modulation of testosterone repartitioning into bound and free fractions by each of the three sex hormones.

*Our finding that the estradiol, DHT, and testosterone interact to alter free testosterone fraction non-linearly suggests that in men with hypogonadism who are receiving TRT, free testosterone levels should be measured using a reliable method to guide the dose titration. The models that do not consider changes in estradiol and DHT concentrations are susceptible to error in estimating free testosterone concentrations.

*These data suggest that changes in estradiol and dihydrotestosterone concentrations should be considered in evaluating response to testosterone treatment because of their differential influence on free testosterone concentrations in addition to their ability to exert other independent biologic effects. Because of these complex interactions between various sex hormones as well as other ligands with sex hormone binding globulin, direct measurements of free testosterone using a reliable assay, such as the equilibrium dialysis method, may be a superior marker of testosterone’s treatment effect.
 
CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 9/2024)


Siemens Healthcare are the only ones with a CDC HoSt Certified TT Chemiluminescence Immunoassays (Atellica IM TSTII, ADVIA Centaur TSTII, ADVIA Centaur CP TSTII, Dimension Vista TTST)!

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Conclusions

The TSTII assay consistently achieved CDC certification from 2019 to 2023, while the TTST assay was initially certified in 2014. Siemens Healthineers is the only testosterone immunoassay manufacturer to be currently certified, the TSTII assay has achieved certification for four consecutive years.

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CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Assays (UPDATED 9/2024)


Quest Diagnostics still nowhere to be found!
 

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Beyond Testosterone Book by Nelson Vergel
* The data from the present analyses suggest that the interaction of the three sex hormones with their cognate binding proteins is highly complex and dynamic and influenced by their relative circulating concentrations. Therefore, models of testosterones binding to SHBG, based on the assumption of fixed apparent binding affinity of sex hormones with SHBG, that do not consider the influence of estradiol and dihydrotestosterone on the free testosterone fraction are unlikely to provide accurate estimates of free testosterone fraction.

* Because of these complex interactions between various sex hormones as well as other ligands with sex hormone binding globulin, direct measurements of free testosterone using a reliable assay, such as the equilibrium dialysis method, may be a superior marker of testosterone’s treatment effect.






* Collectively, these data highlight the non-linear, concentration-dependent modulation of testosterone repartitioning into bound and free fractions by each of the three sex hormones.

*Our finding that the estradiol, DHT, and testosterone interact to alter free testosterone fraction non-linearly suggests that in men with hypogonadism who are receiving TRT, free testosterone levels should be measured using a reliable method to guide the dose titration. The models that do not consider changes in estradiol and DHT concentrations are susceptible to error in estimating free testosterone concentrations.

*These data suggest that changes in estradiol and dihydrotestosterone concentrations should be considered in evaluating response to testosterone treatment because of their differential influence on free testosterone concentrations in addition to their ability to exert other independent biologic effects. Because of these complex interactions between various sex hormones as well as other ligands with sex hormone binding globulin, direct measurements of free testosterone using a reliable assay, such as the equilibrium dialysis method, may be a superior marker of testosterone’s treatment effect.


* The values derived from the random forest model exhibited high level of concordance with the laboratory-measured values of percent free testosterone ( 0.78, p= 2.2 × 10-74), confirming the robustness of the analytical model (Figure 1).




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