Merck Introduces New Calibration Kit for In Vitro Diagnostic Use

• First CE-marked calibration kit for more sensitive testosterone measurement in men, women and children
• Wide analytical range offers increased accuracy at low levels

Darmstadt, Germany, January 13, 2017 – Merck, a leading science and technology company, 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.

Merck’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. Merck 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.

 

About Merck

 

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of € 12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

 

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