Billerica, Massachusetts, January 13, 2017 — MilliporeSigma today announced the introduction of its new testosterone calibrator kit for in vitro diagnostic (IVD) use. The certified kit allows users to calibrate assays and verify calibrations, and is the first of its kind to receive CE mark approval, indicating compliance with the European Union's Medical Device Directive. The CE mark allows the kit to be marketed and sold in the European Union and in any country recognizing CE mark approval.
The diagnostic range of the new kit encompasses both male and female testosterone clinical reference ranges. The kit’s broad reference range enables ample analytical sensitivity for accurate testing using new mass spec-based methods, from the lowest levels needed for testing of women and children to the highest levels used in testing of men. The new calibration kit delivers more accurate and consistent test results for more reliable clinical diagnosis and monitoring. Traditional immunoassays used for measuring testosterone levels in patient samples can be inaccurate and deliver inconsistent results, especially at the low levels present in women and children.
The kit is manufactured and tested under the most stringent international quality standards, assuring calibration accuracy. The calibrator kit includes a set of 10 levels of testosterone serum concentration standards ranging from 2-2,000 ng/dL, along with a blank and internal standard.
MilliporeSigma’s portfolio of Cerilliant® certified reference materials are used to validate analytical measurement methods and calibration, and are manufactured and authorized to ensure the highest level of accuracy. Solutions are used in quantitative mass spectrometry-based applications that range from diagnostic testing and endocrinology to therapeutic drug monitoring, forensic analysis, clinical toxicology and pharmaceutical research. MilliporeSigma manufactures a comprehensive list of parent drug, metabolite, endogenous biomarker and internal standard Certified Spiking Solutions® used for clinical diagnostic test applications of steroids and hormones, biogenic amines, hydroxyvitamin D, bile acids, fatty acids, vitamins, immunosuppressants, antifungals and cardiac drugs.