New Pregnancy Assay Receives CE Marking and FDA Clearance

The approved new pregnancy determination assay features a broad dynamic range and is the first to standardize to the World Health Organization's latest international standard.

To help move reproductive health management forward, Beckman Coulter Diagnostics of Beckman Coulter (Brea, CA, USA) has received the CE marking and US Food and Drug Administration (FDA) 510(k) clearance for its new "Access Total βhCG (5th IS)" assay. It is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for glycoprotein chorionic gonadotropin. The βhCG 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. The expanded utility of the assay has also been CE Mark approved for Down syndrome assessment during pregnancy.


“As the first manufacturer to standardize to the WHO 5th IS, the new βhCG 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 comprise Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”

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 that include women over the age of 40, postmenopausal women, and men. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, Beckman Coulter has further improved the Total βhCG (5th IS) to make it more resilient to preanalytical factors.

"Access" reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.

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