Analytical and clinical validation of the Immulite 1000 hCG assay for quantitative analysis in urine.

Background: The Siemens Immulite hCG assay detects all major hCG variants in serum. Currently, this assay is only FDA approved for qualitative measurement of hCG in urine.

Methods: Complete validation of the hCG assay in urine was performed on the Siemens Immulite 1000 immunoassay platform.