Beckman Coulter has received FDA clearance for its new Access Total ?hCG (5th IS) assay.

The assay is the first ?hCG assay standardized to the World Health Organization (WHO) 5th International Standard (IS) for chorionic gonadotropin, a glycoprotein hormone most often measured for pregnancy determination. Frequently ordered for women of childbearing age who require a procedure that could potentially harm a fetus, the assay is important for emergency diagnosis.

Featuring a dynamic range with automatic onboard dilution capability, the assay reduces the need for manual sample dilutions. Updated reference ranges now include additional populations for women over the age of 40 and postmenopausal women. The Total ?hCG (5th IS) assay is also more resilient to preanalytical factors to address changing laboratory environments and the challenges of collecting serum samples. Access reproductive assays are available on the Access and UniCel immunoassay systems.

“The new ?hCG assay is an example of Beckman Coulter’s continuing dedication to lead the way in this important diagnostic field,” said John Blackwood, senior vice president of product management for Beckman Coulter Diagnostics. “The new assay is just one example of the innovations that make up Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”

For more information, visit Beckman Coulter.