PerkinElmer launches multiple steroid diagnostic kit for hormone and endocrine disorders

10 September 2009

PerkinElmer, Inc. has introduced a new Child Health System (CHS) steroid profiling kit and data suite software. The kit is the first commercial clinical endocrinology assay that can simultaneously measure ten different steroids in biological samples.

This advanced measurement methodology is also the first commercial kit designed for liquid chromatography tandem mass spectrometry (LC-MS/MS) to accurately measure steroids for diagnosing hormone imbalances or endocrine diseases in both children and adults.

Tandem mass spectrometry is a highly specific and extremely sensitive technique used to identify and measure compounds based on their molecular weight, or mass. It is increasingly being used by clinical laboratories as a diagnostic technique due to this sensitivity and specificity as well as its reproducibility. MS/MS is used worldwide in newborn screening for the simultaneous detection of more than 40 different steroid hormones and metabolites to diagnose and prevent disease.

Current methods to profile steroids require separate assays to generate a complete patient profile. The patient and physician often wait for the return of partial profile results before beginning subsequent tests, which require additional blood draws and can delay a definitive diagnosis. Accurate, high throughput, multiplex testing by MS/MS has the potential to improve and accelerate disease diagnosis for many patients, given that up to 25% of the population will require steroid testing for endocrine disorders during their lifetime.

"As the global leader in utilizing tandem mass spectrometry for newborn screening, deploying our expertise to support childhood and adult health is a natural next step within our spectrum of care," said Ann-Christine Sundell, president, Genetic Screening, PerkinElmer. "The development of our CHS kit demonstrates our commitment to creating first-in-class scientific solutions for earlier diagnoses that improve medical outcomes."

Studies have shown that mass spectrometry provides improved specificity and sensitivity over immunoassays, which is important for detecting low steroid levels mainly seen in children. The CHS Steroid assay and its software are designed for clinical laboratories to aid physicians in obtaining steroid measurements for recognizing and diagnosing diseases affecting the adrenal glands, ovaries, testes, and placenta. The test can also be used for both children and adult samples.

PerkinElmer's CHS Steroid Profiling Kit requires a small sample size of 100ul and provides analyte specific controls and internal standards plus specialized and qualified calibrators. Because tandem mass spectrometry generates large amounts of data, PerkinElmer is introducing labour saving data solutions via the dedicated CHS Data Suite Software which will enable laboratory researchers to evaluate and easily analyze patient results. The CHS Steroid Profiling Kit and its software are expected to be available for sale this fall in countries outside the United States.

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