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Certified Reference Material of Testosterone in Serum for Clinical Research Mass Spectrometry Applications

Cerilliant tubesThe critical importance of testosterone in the physiological development and function of males and females underscores its significant role in endocrine disorders and disease. Testosterone test results are used to diagnose many endocrine disorders, from low testosterone levels in men to suspected polycystic ovary syndrome (PCOS) and its impact on fertility and pregnancy in women. Testosterone measurements also assist in the diagnosis of androgen-secreting tumors in women as well as monitoring of drug treatment responses in men with prostate cancer.

Highly accurate and reproducible results are paramount in testosterone testing, given the clinical implications of a missed diagnosis such as one of low testosterone, PCOS, or androgen-secreting tumors or an incorrect drug dosing level in the treatment of prostate cancer. Testosterone presents a unique challenge with the wide range of endogenous levels across female, male and age-based patient populations. Historical testing methods (immunoassay) suffered from high inaccuracy and inconsistent results, especially at the low levels present in women and children. Recent literature reports that reference ranges for testosterone assays – as well as the methodologies used to develop them – can vary significantly among laboratories.

The development of mass spectrometry (MS)-based methods provides the necessary sensitivity and analytical range needed to test the low testosterone levels found in women and children. Two major challenges of MS methods in testosterone testing involve consistency in performance and accuracy of results at the low levels across different laboratories. Standardization of the analytical methods and assays, calibrators, and end-user test performance is needed to overcome these challenges which in turn, improve accuracy of the testing.  

To support industry’s calibrator standardization efforts for testosterone MS testing, MilliporeSigma’s Cerilliant® brand introduced the first Certified Reference Material (CRM) of testosterone in stripped serum for clinical research applications in the US by mass spectrometry. Individual levels are offered separately at concentrations ranging from 2 to 2,000 ng/dL. Each individual level is ready to use as a linearity standard or for calibration verification in LC-MS/MS testosterone methods. Separate options for a blank and 13C- or deuterium labeled internal standards of testosterone are also available.

The pre-prepared, matrix-matched format of each individual level offers laboratory benefits such as increased efficiency of labor and convenience of use while avoiding potential preparations errors or errors in dilution during in-house preparation. With manufacturing and testing under quality accreditations such as ISO Guide 34, ISO/IEC 17025, and ISO 13485, accuracy of concentration can be assured for critical research applications in calibration verification or verification of linear range within the laboratory’s LC-MS/MS testosterone method.

Cerilliant® Certified Spiking Solutions® and CRMs of endogenous biomarkers in biological matrices such as serum are manufactured and tested using validated processes to ensure the highest level of accuracy for critical quantitative mass spectrometry-based applications. The portfolio spans testing applications from therapeutic drug monitoring, diagnostic testing, clinical chemistry and endocrinology to pharmaceutical research, clinical toxicology, and forensic analysis.

  • Suitable for clinical research applications in the US by LC-MS/MS.
  • Individual levels of testosterone in stripped serum available separately at concentrations ranging from 2 to 2,000 ng/dL.
  • Each level is ready to use as a linearity standard or for calibration verification.
  • CRM grade – High accuracy of concentration in each of the individual levels.
  • Ready to use – Reduces labor & cost.
  • Pre-prepared – Eliminates preparation step as one source of error.
  • Matrix-matched format – Compensates for matrix effects.
  • Stability pre-determined – Supported with real-time data.
  • Serum blank and 13C- or deuterium labeled internal standards of testosterone are also available.

Certified Reference Material - Certificate of Analysis


Products available for US customers only.

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