From the Guidelines
Dialysis is not an accurate method for measuring testosterone levels, and the most reliable methods are immunoassays and mass spectrometry-based techniques, with liquid chromatography-tandem mass spectrometry (LC-MS/MS) being the gold standard. The use of dialysis for measuring testosterone levels is not recommended due to its lack of specificity and sensitivity compared to other methods. According to the most recent and highest quality study, 1, the diagnosis of low testosterone should be made using a morning serum testosterone level, and the most accurate methods for measuring testosterone are immunoassays and mass spectrometry-based techniques.
Some key points to consider when measuring testosterone levels include:
- Timing is important, as levels fluctuate throughout the day, with highest levels typically in the morning
- Blood samples should ideally be collected between 7-10 AM for the most accurate baseline measurement
- Immunoassays, including radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), and chemiluminescent immunoassay (CLIA), are more commonly used in clinical settings due to their accessibility and lower cost
- Mass spectrometry methods, such as LC-MS/MS, are more accurate than immunoassays, particularly at low testosterone concentrations found in women and children
It's also important to note that the Endocrine Society clinical practice guideline recommends using an accurate and reliable assay to measure morning total testosterone levels, and to determine free testosterone concentrations either directly from equilibrium dialysis assays or by calculations that use total testosterone, sex hormone binding globulin, and albumin concentrations, as stated in 1. However, the use of equilibrium dialysis assays is not the most recommended method, and LC-MS/MS is considered the gold standard.
In terms of the benefits and risks of testosterone replacement therapy, studies have shown that it may have benefits including improved sexual function, well-being, muscle mass and strength, and bone density, but it may also be associated with increased coronary artery plaque volume and cardiovascular risk, as mentioned in 1 and 1. Therefore, the most reliable method for measuring testosterone levels is LC-MS/MS, and it should be used to diagnose and monitor testosterone deficiency, and to evaluate the effectiveness and safety of testosterone replacement therapy.
From the Research
Accuracy of Dialysis Method for Measuring Testosterone Levels
- The accuracy of measuring testosterone levels by dialysis is supported by a study published in 2022, which suggests that free testosterone level should ideally be measured by equilibrium dialysis method 2.
- Another study from 1985 also supports the use of equilibrium dialysis as a theoretically sound and practicable method for measuring percentage of free testosterone 3.
Alternative Methods for Measuring Testosterone Levels
- Mass spectrometry is considered the gold-standard method for testosterone measurement, but its complexity and cost limit its widespread adoption 4.
- Liquid chromatography-tandem mass spectrometry is also considered a reliable method for measuring total testosterone levels, and it is suitable for use as a high-throughput assay in routine clinical laboratories 5.
- Total testosterone should ideally be measured in a fasting state in the morning using a reliable assay, such as liquid chromatography tandem mass spectrometry, in a laboratory that is certified by an accuracy-based benchmark 6.
Comparison of Methods
- Immunoassays lack the required accuracy when dealing with testosterone concentrations at the lower end of the normal range for men and across the entire range for females 4.
- The equilibrium dialysis method is considered more accurate for measuring free testosterone levels, especially in men with alterations in binding protein concentrations or in whom total testosterone levels are only slightly above or slightly below the lower limit of the normal male range for testosterone 2, 6.
- Liquid chromatography-tandem mass spectrometry offers advantages over immunoassay and is suitable for use as a high-throughput assay in routine clinical laboratories 5.