Additional Information

Description

The Pregnancy Test Control Urine Positive and Negative 4 mL provides a reliable standard for validating the performance of urine-based hCG pregnancy tests. Designed for both positive and negative controls, it ensures that diagnostic assays function accurately and consistently. The control material supports CLIA-waived urine tests and moderately complex serum assays, providing versatility across multiple clinical settings.

The product is formulated to offer high precision and sensitivity, with a detection limit of 25 mIU/mL for hCG in urine and, in combination cassettes, serum samples. Its specificity exceeds 99%, allowing laboratories and point-of-care settings to confidently verify assay accuracy. A built-in control confirms proper test execution, ensuring that an adequate specimen volume has been absorbed and that capillary action has occurred correctly.

Each kit is packaged for convenience, with individually wrapped test devices, a disposable pipette, and a package insert for proper usage instructions. The 4 mL volume provides sufficient material for multiple control runs, facilitating routine quality assurance without interruption of laboratory workflow.