Beckman Coulter Diagnostics, Brea, Calif, has released the Access human thyroid stimulating hormone (TSH) 3rd IS assay for use with the company’s Access family of immunoassay systems. Developed to offer confidence in patient results through standardization to the World Health Organization’s 3rd international standard (IS) for human TSH testing, the assay also recently received CE marking, enabling the product to be sold in Europe and certain other markets.

Representing an enhancement to the company’s thyroid assay menu, which includes a full panel of thyroid tests that aid in the diagnosis of thyroid function, the assay is the next generation of the Access HyperSensitive hTSH and Access Fast hTSH assays for the quantitative determination of thyrotropin.

The assay seeks to maximize laboratory workflow with a larger reagent pack size of 100 tests per pack and 200 tests per kit. Its assay range supports measuring patient ?samples as low as 0.005 ?IU/mL.

Photo Blackwood John

John Blackwood, Beckman Coulter Diagnostics.

“CE mark and release of our improved Access TSH (3rd IS) assay, a core assay in the thyroid panel, offers laboratories a necessary thyrotropin-monitoring tool for quicker, more reliable diagnosis and treatment of an underactive or overactive thyroid,” says John Blackwood, senior vice president of the chemistry and immunoassay business unit at Beckman Coulter Diagnostics. “The newly designed assay improves time to first result while maintaining assay throughput.”

The assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using Access immunoassay systems. It was developed to reduce interferences and to deliver robust lot-to-lot performance for reproducible results.

According to the company, the current standards of care necessitate that laboratories use third-generation TSH assays, as this level of sensitivity is necessary for detecting differing degrees of TSH suppression.

For more information, visit Beckman Coulter.