You have accessJournal of UrologySexual Function/Dysfunction: Evaluation I1 Apr 2017PD45-11 IMPROVED DIAGNOSIS AND TREATMENT OF PATIENTS THROUGH ACCURATE AND STANDARDIZED TESTOSTERONE TESTS Julianne Cook Botelho, Krista Poynter, Ashley Ribera, Otoe Sugahara, and Hubert W Vesper Julianne Cook BotelhoJulianne Cook Botelho More articles by this author , Krista PoynterKrista Poynter More articles by this author , Ashley RiberaAshley Ribera More articles by this author , Otoe SugaharaOtoe Sugahara More articles by this author , and Hubert W VesperHubert W Vesper More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2396AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Accurate T measurements are needed to assess a patient′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. METHODS HoSt is assisting clinical, research, and public health laboratories in improving T measurements by·assessing measurement accuracy in the context of clinical needs to identify potential sources of inaccurate results·creating measurement results that are traceable to one accuracy base and comparable across methods, time, and location·monitoring the measurement performance over time and certifying participants testing in patient care, research studies, and clinical trials RESULTS 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). 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′s quarterly challenges participant performance is monitored at regular intervals and laboratories maintaining annual certification through HoSt have high accuracy over time. 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. 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. CONCLUSIONS 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). © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e889 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Julianne Cook Botelho More articles by this author Krista Poynter More articles by this author Ashley Ribera More articles by this author Otoe Sugahara More articles by this author Hubert W Vesper More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...