The use of testosterone assays for patient care and research is on the rise as new research links testosterone to a variety of diseases and conditions. Although the assays are heavily used, discrepancies and inaccuracies in measurements resulting from the various assays are widespread.
Seeking to address this critical health issue, a multidisciplinary group of experts convened by The Endocrine Society and the US Centers for Disease Control and Prevention just issued recommendations for improving and standardizing testosterone testing in a consensus statement to be published in the October 2010 issue of The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).
Testosterone assays are tests that measure testosterone levels which, in turn, are used to diagnose and treat patients with a number of disorders. These disorders may include: testicular or pituitary diseases in men potentially leading to erectile dysfunction and decreased sexual drive; polycystic ovarian syndrome which may cause menstrual disturbances and infertility in women; and early or late pubertal development in children.
"The development of this consensus statement has been a collaborative effort among key stakeholders including professional societies, laboratories and regulatory agencies," said William Rosner, MD, a lead author of the consensus statement and a member of The Endocrine Society. "Not only does this entire group benefit from better assays, but all bear some responsibility in working to improve accuracy."
Aimed at improving the quality of research, patient care and public health through broad implementation of standardized testosterone measurements that are accurate, reliable and comparable over time, the consensus statement recommends the following:
"The recommendations in this consensus statement emphasize the need for the research, medical and industry communities to each play their part in improving testosterone assays," said Rosner. "High quality testosterone testing will not only provide for better patient care outcomes but will rein in the cost of health care as they will lessen the need for frequent retesting."
The consensus statement has been endorsed by the following organizations:
The Coalition for Quality Testing, comprising most of the groups listed above and other interested organizations, has been formed to address the technical aspects of reference intervals and performance criteria; to develop guidelines and protocols; and to educate third-party payers, funding entities, journals and other relevant stakeholders.
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