Beckman Coulter Diagnostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance as well as the CE Mark clearance for its new Access Total ßhCG (5th IS) assay. The Access Total ßhCG (5th IS) assay is the first ßhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for chorionic gonadotropin, a glycoprotein hormone most commonly measured for pregnancy determination. The assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing age who require treatment which could potentially be harmful to a fetus. Access reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations, among them women over the age of 40 and post-menopausal women. Additionally, company representatives say that Beckman Coulter has responded to changing laboratory environments and the challenges faced in collecting serum samples, by making the Total ßhCG (5th IS) more resilient to pre-analytical factors.
“The new ßhCG assay is an example of Beckman Coulter’s continuing dedication to this important diagnostic field,” says John Blackwood, senior vice president of Product Management for Beckman Coulter Diagnostics. “The new assay is just one example of the innovations that comprise Beckman Coulter’s reproductive health portfolio.”
