Bionexia hCG Pregnancy Serum/Urine Cassette

The Bionexia hCG Pregnancy Serum/Urine Cassette is a qualitative chromatographic immunoassay designed specifically for healthcare professional use, including physician's office laboratories (POLs). Its primary differentiator from standard over-the-counter tests is its dual-matrix capability, allowing for the detection of human chorionic gonadotropin (hCG) in both serum and urine specimens. This hybrid functionality enables clinicians to use a single device for rapid urine screening and subsequent serum confirmation. The device features an analytical sensitivity of 20 mIU/mL, which is superior to the 25-50 mIU/mL threshold found in standard diagnostic tests. In multi-site clinical evaluations, the Bionexia system demonstrated high concordance with laboratory-grade reference methods and clinical findings such as ultrasound results. The cassette format utilizes a standardized lateral flow methodology with clear red bands in the test and control regions to indicate results. Furthermore, the product offers a robust 30-month shelf life, making it highly suitable for clinical environments with variable testing volumes. While not intended for self-testing by lay consumers, it remains a gold standard for professional early pregnancy determination.