Abstract: PD45-11
Sources of Funding: Centers for Disease Control and Prevention

Introduction

_x000D_ Accurate T measurements are needed to assess a patient&[prime]s hormone status and ensure correct diagnosis and treatment of diseases and disorders, such as hypogonadism. CDC Hormone Standardization Program (HoSt) is improving the accuracy of T testing._x000D_ _x000D_

Methods

_x000D_ HoSt is assisting clinical, research, and public health laboratories in improving T measurements by _x000D_ _x000D_ &[middot]assessing measurement accuracy in the context of clinical needs to identify potential sources of inaccurate results_x000D_ _x000D_ &[middot]creating measurement results that are traceable to one accuracy base and comparable across methods, time, and location _x000D_ _x000D_ &[middot]monitoring the measurement performance over time and certifying participants testing in patient care, research studies, and clinical trials_x000D_

Results

_x000D_ Participation in HoSt is voluntary. Since 2010, the CDC has had 89 enrollments, which include reenrollments. Laboratories meeting the performance criteria are listed on the CDC website (www.cdc.gov/labstandards/hs.html). _x000D_ _x000D_ 76% of HoSt participants have met analytical performance criteria. T calibration bias has improved with an among laboratory bias decreasing from 16.5% in 2007 to 2.7% in 2016. Through the HoSt program&[prime]s quarterly challenges participant performance is monitored at regular intervals and laboratories maintaining annual certification through HoSt have high accuracy over time. _x000D_ _x000D_ HoSt provides unique measurements and services. Additional sources of bias, such as sample-to-sample variability, can now be detected and corrected through the availability of single-donor serum reference materials. Assay variability in well calibrated T methods has been detected with HoSt reference materials. This variability appears to be concentration dependent, with higher bias in low concentration samples, typically found in women and men with hypogonadism (<300 ng/dL). The source of the bias seems to be related to method sensitivity and analytical interferences. Additional evaluations are underway to identify and address the source of bias. _x000D_ _x000D_ CDC is expanding its programs by including free testosterone and SHBG. Furthermore, it increases its services by providing new sets of reference samples to participants to better evaluate the analytical test performance and to better monitor the accuracy of research studies. _x000D_

Conclusions

_x000D_ CDC Clinical Standardization Programs ensure that laboratory results in research and patient care are accurate, reliable, and continue to meet the needs defined by stakeholders such as The Partnership for Accurate Testing of Hormones (PATH).

Funding

Centers for Disease Control and Prevention