Immunoassay Measures Intact Parathyroid Hormone

The assay involves the reaction of iPTH present in a serum sample with biotinylated antibody (ant-iPTH) and horseradish peroxidase labeled antibody conjugate. The bound HRP conjugate is measured by a luminescent technique.

The VITROS iPTH assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intra-operative testing with results available in 18 minutes. The assay has a range of 0 pg/mL - 5,000 pg/mL, with minimal cross reactivity and no high dose hook. The VITROS iPTH Assay is designed to be run in a fully automated, random access format on the VITROS ECi/ECiQ and 3600 Immunodiagnostic Systems, and can also be run on the VITROS 5600 Integrated System to combine clinical chemistry, routine and infectious disease immunoassay testing on a single platform. Equivalent analytical results are generated across all three systems.

The assay and the immunodiagnostic systems are manufactured by Ortho Clinical Diagnostics (Rochester, NY, USA). The VITROS iPTH assay has received U.S. Food and Drug Administration (FDA, Silver Spring, MD, USA) 510(k) clearance. Measuring intact parathyroid hormone levels aids in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy. Hyperparathyroidism is excess production of calcium resulting from over activity in the parathyroid glands.

Matthew Burtelow, M.D., Ph.D., of St. Luke's Boise Medical Center (Boise, ID, USA), said, "The VITROS iPTH Assay will allow our hospital to provide expanded surgical options for our patients, and during parathyroid surgery, we can now run the iPTH test on our VITROS Systems to help us determine if the procedure to remove the suspected parathyroid tumor was successful."

Related Links:
Ortho Clinical Diagnostics
FDA
St. Luke's Boise Medical Center