Toward Excellence in Testosterone Testing: A Consensus Statement
Introduction: Even though testosterone assays are commonly used, they have deficiencies, making it difficult to broadly and effectively rely upon the assays in patient care. These deficiencies are a threat to effective care for them.
Testosterone assays—both research and clinical—need to be held to a higher standard if the medical community wants to move forward in translating research results into more effective patient care, including the creation of evidence-based guidelines.
To address this issue, a group of stakeholders met.
Methods: The stakeholders represented various professional societies. They also came from the government sector and industry. All participants would like to see testosterone levels more accurately and reliably measured. In their meeting, they worked to identify the goals, objectives, and actions needed to achieve testosterone assay standardization.
Results: The group agreed on several recommendations. These include:
- All those with an interest in accurate testosterone assays need to work with the CDC in order to develop standardized testing that’s used in the medical community.
- The medical and research communities should aim to cover the full range of expected values for testosterone assays—from children to adult males and females.
- Medical and research communities should also collaborate to outline the testosterone reference ranges for adults and children (both males and females).
- Guidelines should be developed by the medical and research communities in order to ensure standard patient preparation and handling of samples.
- To promote the use of standardized assays (achieved through the above recommendations), third-party payers and health care organizations should allow payment only for the standardized assays.
- Groups involved in research in some capacity—including funding entities and journals—should support the effort to standardize testosterone assays.
- Manufacturers and laboratories should continue in their work to create new methodological approaches that achieve the goal of ensuring sensitive, specific, accurate, and cost-effective testosterone assays.
They suggest these goals be met by 2012—with a review every 2 to 4 years after that in order to assure accuracy.
There are considerable discrepancies between the various testosterone assays available in North America and worldwide. These inaccuracies are greatest at lower testosterone ranges, and they often compromise diagnosis in men and women. Given the increasing use of testosterone testing in research, epidemiological studies, and patient care, it is important that we have accurate and standardized methods of measurement.
All T assays must use the same gravimetric standard. Inaccurate testing results in significant misdiagnosis, cost, and patient risk. The Centers for Disease Control and Prevention (CDC) and The Endocrine Society are coordinating efforts with multiple stakeholders to ensure that only accurate, standardized, and cost-effective testosterone assays are utilized.