Total hCG (5th IS) assay
Access Total βhCG (5th IS)
Having recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, the Access Total βhCG (5th IS) assay is the first βhCG 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. 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 cover women over the age of 40 and post-menopausal women. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, the Total βhCG (5th IS) assay has been improved to make it more resilient to pre-analytical factors. Access reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.