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

[madman]

How the CDC Clinical Standardization Programs Are Improving Hormone Tests - AACC.org

WHAT PROGRESS HAS CDC MADE WITH STANDARDIZING TOTAL TESTOSTERONE AND ESTRADIOL TESTS?



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). 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. 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, 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. 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.

Testosterone Therapy for Hypogonadism Guideline Resources

Recommends making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations.

www.endocrine.org

WHAT ARE THE NEXT STEPS NOW THAT CDC HAS RECEIVED ADDITIONAL FUNDING FROM CONGRESS FOR HARMONIZATION IN 2018?

This is the first time CDC has received dedicated funding from Congress to improve the quality and reliability of diagnostic tests for hormones. With these funds, CDC CSP plans to increase in size and scope through the addition of new programs, such as the Accuracy-based Monitoring Program for routine laboratories, and new biomarkers such as parathyroid hormones, free thyroxine, and free testosterone. CDC CSP will continue to work with stakeholders and participants to reduce calibration bias and individual sample bias in order to enhance patient care and public health.




I and many others will be looking forward to the FREE TESTOSTERONE CDC (HoSt) PROGRAM!

 

[madman]

The CDC HoSt Testosterone program started in January 2010.

 

[madman]

Phase 2 of the CDC HoSt Estradiol (E2) program started in 2014.

 

[madman]

Congress Funds AACC-Led Harmonization Initiative - AACC.org

The $1.3 trillion omnibus spending bill passed by Congress in March will fund efforts to harmonize laboratory tests, the culmination of more than a decade of AACC advocacy efforts. AACC worked closely with Rep. Kevin Yoder (R-Kan.) and other lawmakers, as well as a partnership of 17 clinical associations. The bill provides $2 million to the Centers for Disease Control and Prevention (CDC). The agency plans to use the new funding for materials and monitoring that will enable harmonization of tests for free testosterone, thyroid stimulating hormone, and estrogen.







Great news for us going into 2019!

 

[Nelson Vergel]

Thanks for posting. Very interesting and I am happy this is taking place.

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 03/2019)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 06/2019)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Procedures (UPDATED 06/2019)

 

[Systemlord]

It would be beneficial to have receptor sensitivity testing rather than only relying on Total T and Free T measurements.

 

[madman]

CDC’s Clinical Standardization Programs to improve accuracy and reliability of hormone tests

 

[madman]

 

[madman]

Standardization and harmonization program for Free Testosterone is just a matter of time

 

[Nelson Vergel]

Thank you, @madman

You always find good stuff

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 03/2020)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Assays (UPDATED 03/2020)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 09/2020)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Assays (UPDATED 09/2020)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Total Testosterone Procedures (UPDATED 12/2020)

 

[madman]

CDC Hormone Standardization Program (CDC HoSt) Certified Estradiol Assays (UPDATED 12/2020)

 

[madman]

The Need to Harmonize Clinical Laboratory Test Results

Laboratory test results are a critical component of patient care. These values help physicians diagnose disease and are critical to developing clinical guidelines that direct treatment options and are instrumental in ongoing efforts to improve and measure the quality of patient care. Most tests report a numeric value for healthcare providers to interpret and the range of numbers reported for a test for a certain condition may vary depending on the method used.

Different test methods, however, may report different numeric values for the same condition. Although these test results may be accurate within the context of its own method, this variation can create confusion for physicians and patients. Clinical laboratory test results need to be harmonized so that healthcare providers and the public receive the same numeric result regardless of the method or instrument used or the setting where it was performed.

Harmonized test results ensure that clinical guidelines based on the results of laboratory tests assure more reliable diagnoses and prevent treatment errors. In addition, harmonized clinical laboratory test results may prevent unnecessary — and expensive — follow-up diagnostic procedures and treatments that could arise due to misinterpretation of results.




AACC and its partners call on Congress to provide $9.2 million for harmonization activities directed by the Environmental Health Laboratory in fiscal year (FY) 2021.

Congress has demonstrated its support for this effort by providing CDC with $2 million annually for harmonizing test results since 2018. This funding has given the agency needed resources to advance harmonization for select hormone tests that will improve diagnosis and treatment for diseases such as hypothyroidism, chronic kidney disease, and osteoporosis.


The Trump Administration is recommending $7 million for CDC’s harmonization efforts in the Department of Health and Human Services Budget in the FY 2021 budget, $5 million above FY 2020 enacted levels, which will permit CDC to continue “delivering the unique diagnostic methods, profiles of measurements, and measurement quality needed for public health decisions.”