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Testosterone Serum Calibrator Kit – CE Mark

  • CE marked calibrant kit for IVD use in mass spectrometry-based testing methods
  • Ten calibrant levels + Blank + 13C-labeled internal standard
  • Calibrants delivered in stripped serum
  • Certified Reference Material (CRM)
  • Covers diagnostic decision points for male and female testosterone levels
  • Kit components can be ordered separately as needed

The critical importance of testosterone in the physiological development and function of males and females underscores its significant role in endocrine disorders and disease. Clinical assessment of testosterone levels in males and females is performed for a variety of diagnostic applications, 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.1,2

This CE marked serum calibrant, containing the steroid hormone testosterone, is now available in Europe for in vitro diagnostic (IVD) use in LC-MS/MS-based laboratory developed tests (LDTs). The Certified Reference Material (CRM) grade kit, designed to bracket male and female testosterone clinical reference ranges, includes ten levels from 2-2,000 ng/dL along with a blank and 13C-labeled internal standard.

Recent literature reports that reference ranges for testosterone assays – as well as the methodologies used to develop them – can vary significantly among laboratories.3 According to these studies, variation in testosterone results may be due to underutilization among laboratories of testosterone reference ranges specific to clinically relevant populations and potential limited use of serum-based specimen calibration programs.3

Cerilliant’s certified reference material (CRM) grade testosterone calibrator in stripped serum is manufactured and tested to the highest industry standards. This kit is affixed with a CE mark, demonstrating its conformance to the in vitro diagnostic (IVD) Medical Device Directive (98/79/EC) for availability in Europe. Cerilliant is accredited to ISO Guide 34 and ISO/IEC 17025, certified to ISO 13485 and ISO 9001, and compliant with ISO 17511 and ISO 15194.
 

Testosterone Calibrator Kit                                                                            T-107
10 levels, Blank, & 13C-labeled internal standard
Calibrator Level
Concentration (in stripped serum) Product No.
1 2 ng/dL
20 pg/mL 0.069 nM
T-096
2 4 ng/dL 40 pg/mL 0.14 nM T-097
3 9 ng/dL 90 pg/mL 0.31 nM T-098
4 17.5 ng/dL 175 pg/mL 0.61 nM T-099
5 35 ng/dL 350 pg/mL 1.21 nM T-100
6 52.5 ng/dL 525 pg/mL 1.82 nM T-101
7 150 ng/dL 1.5 ng/mL 5.2 nM T-102
8 500 ng/dL 5 ng/mL 17.34 nM T-103
9 750 ng/dL 7.5 ng/mL 26 nM T-104
10 2000 ng/dL 20 ng/mL 69.3 nM T-105
Blank 0 ng/dL 0 ng/mL 0 nM T-106
Internal Standard Testosterone-2,3,4-13C3 in 10 µg/mL Acetonitrile            
T-095

†For more details, including individual country availability, please visit sial.com.

Download the Testosterone Serum Calibrator Kit Flyer (PDF, 0.4 MB)