“For many years, there has been a problem analyzing steroids in the laboratory, because of their tight binding to proteins,” explains Dr. C. E. Pippenger, Adjunct Professor of Neurosciences, University of Vermont College of Medicine. “Many commercially marketed Quality Controls use buffers or a stripped serum matrix; but no matter what you do with serum, there may be steroids present bound to various proteins. Stripping still leaves some endogenous level of steroid and alters the matrix to be extracted. Thus, depending on how they are prepared, “home brewed” calibrators and controls vary greatly between labs. This inter-laboratory variability means the same sample assayed in different labs yields different results. UTAK’s Steroid Control doesn’t start with serum, and that is an industry first for this type of control,” said Dr. Pippenger.
“Accurate and precise measurement of steroids enables optimization of both diagnosis and treatment in patients with steroid hormone disorders,” notes Dr. Steven Soldin, Senior Scientist at National Institutes of Health. The UTAK Steroid Control contains seven analytes of interest: Corticosterone, Cortisol, Cortisone, Dehydroepiandrosterone (DHEA), Progesterone, 17α-Hydroxyprogesterone, and Testosterone at clinically relevant levels for most testing methodologies.
“Our goal is always to craft Quality Controls for clinical and esoteric laboratories that are as close to human serum as possible,” said Jim Plutchak, CEO of UTAK. “Due to the issue of endogenous steroid levels in serum-based matrix products, we developed a Steroids Control in our SMx™ Specialty Matrix that begins with human components.” The result is a 3rd party control that any lab, anywhere, can use to compare their results with any other laboratory.
“Inter-laboratory comparison of results, made possible with a uniform control, allows labs to be confident that test results generated are accurate,” said Dr. Pippenger. ISO accreditation guidelines note that independent third party quality controls should be used instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer (1).
UTAK SMx™ Specialty matrices for Oral Fluid, Hair, Sweat, Urine, and now Serum, help Laboratorians with their most unique testing requirements. For use with any methodology, UTAK’s stock and custom quality controls are handcrafted in Valencia, CA and sold to clinical, toxicology and esoteric laboratories globally. For more information on UTAK’s new Steroid Control in SMx™ Serum, offered in individual packs for Levels 1, 2, 3, 4 and a Negative Control, and to request a free evaluation sample, visit: www.UTAK.com.
Reference:
1. International Standard: Medical Laboratories – Requirements for Quality and Competence. ISO 15189:2012(E)ss5.6.2.2
About UTAK Laboratories, Inc.
Founded in 1973, UTAK Laboratories, Incorporated is a recognized market leader of handcrafted quality control products used for analytical measurement in forensic and clinical laboratories. UTAK offers hundreds of stock and custom serum, whole blood, urine and oral fluids controls for use with any methodology, on any testing platform. Headquartered in Valencia, CA, UTAK serves clients globally, including many top university hospitals, government facilities, forensic and research laboratories. ISO-certified, UTAK is family-owned and renowned for its quality products and personalized customer service. For further information and to request a free evaluation sample, visit: www.UTAK.com.