A large study of more than 9,000 men has established harmonized reference ranges for total testosterone in men that when applied to assays that have been appropriately calibrated will effectively enable clinicians to make a correct diagnosis of hypogonadism, according to a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism.
In this study, researchers obtained serum testosterone samples from men who had already had their testosterone levels assayed locally. The samples were sent to the Centers for Disease Control and Prevention's (CDC) Clinical Standardization Programs at the National Center for Environmental Health where testosterone concentrations were measured using a higher order liquid chromatography tandem mass spectrometry method.
Researchers used the results from both measurements to generate harmonized values, which were in turn used to derive standardized, age-specific reference ranges overall. The harmonized normal range for testosterone in a non-obese population of European and American Men, 19-39 years, is 264-916 ng/dL.
"Without harmonized reference ranges and standardized assays, tests can lead to misdiagnoses and unfortunately this happens every day around the world," said Hubert Vesper, PhD who is also a co-author of the study and co-chair of The Partnership for the Accurate Testing of Hormones (PATH). "Now we have a reference range for testosterone, and it's important that we take this into consideration in the tests that clinicians and patients depend on for accurate diagnoses."
Link to original article.
In this study, researchers obtained serum testosterone samples from men who had already had their testosterone levels assayed locally. The samples were sent to the Centers for Disease Control and Prevention's (CDC) Clinical Standardization Programs at the National Center for Environmental Health where testosterone concentrations were measured using a higher order liquid chromatography tandem mass spectrometry method.
Researchers used the results from both measurements to generate harmonized values, which were in turn used to derive standardized, age-specific reference ranges overall. The harmonized normal range for testosterone in a non-obese population of European and American Men, 19-39 years, is 264-916 ng/dL.
"Without harmonized reference ranges and standardized assays, tests can lead to misdiagnoses and unfortunately this happens every day around the world," said Hubert Vesper, PhD who is also a co-author of the study and co-chair of The Partnership for the Accurate Testing of Hormones (PATH). "Now we have a reference range for testosterone, and it's important that we take this into consideration in the tests that clinicians and patients depend on for accurate diagnoses."
Link to original article.