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Cerilliant Introduces Certified Spiking Solutions® of Hormones for Pregnancy and Newborn Screenings by LC-MS/MS

ROUND ROCK, TEXAS – November 1, 2010 – Cerilliant Corporation introduces fourteen new certified Snap-N-Spike® solutions of hormones monitored by LC-MS/MS for pregnancy or newborn screenings. New products for newborn screening applications include 1.0 mg/mL concentrations of 17a-Hydroxyprogesterone, Cortisol, 11-Deoxycortisol, Dehydroepiandrosterone (DHEA), and DHEA 3-sulfate sodium salt in methanol and 100 µg/mL concentrations of 21-Deoxycortisol and the internal standard DHEA-D5 in methanol. New Certified Spiking Solutions® for pregnancy or female hormones diagnostic testing consists of 1.0 mg/mL concentrations of Estrone, Estriol, and 17a-Ethynylestradiol in methanol and 17ß-Estradiol and Progesterone in acetonitrile with 100 µg/mL concentrations of internal standards 17ß-Estradiol-D5 and Progesterone-D9 in acetonitrile. These certified solutions are suitable for critical quantitative applications in clinical and endocrinology settings including: for use in preparation of controls and calibrators for LC-MS/MS assays; linearity verification; internal proficiency testing; system tuning/suitability standards; and for OEM use in preparation of reagents, development of assays, and instrument IQ/OQ. The stable, quantitative solution format provides significant benefits to the user including material savings, increased efficiency of labor, and convenience of use. The shelf stable Snap-N-Spike® format allows laboratories to eliminate painstaking weighing operations and provides the ability to spike a certified concentration of analyte into their matrix of choice at the concentration desired just before use.

Accurate preparation of a quantitative reference is highly critical for accurate assessment of hormone levels in determination of congenital adrenal hyperplasia (CAH) in newborns or Down-Syndrome-affected fetuses during pregnancy. According to Cerilliant Vice President, Mitzi Rettinger, "We believe clinical and research laboratories who have developed or are developing LC-MS/MS assays for female diagnostic hormone testing and neonatal screening, will appreciate the convenience, accuracy and additional assurance of consistency in results that these new Certified Spiking Solutions® provide."

Cerilliant certified Snap-N-Spike® solutions are prepared and certified to the highest industry standards including ISO Guide 34 and ISO 17025. These solutions are gravimetrically prepared via a validated process for minimal uncertainty; flame sealed under argon into ampoules to promote stability; and rigorously tested to ensure accuracy and shelf life through and real time studies. Cerilliant Snap-N-Spike® reference solutions are supported by comprehensive Certificates of Analysis which provide all analytical data and uncertainty and traceability information to support regulatory requirements.


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