The FDA has awarded 510(k) clearance of Ortho Clinical Diagnostics’ VITROS® intact Parathyroid Hormone (iPTH) Assay. The VITROS iPTH Assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intraoperative testing with results available in 18 minutes. 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 VITROS iPTH Assay will allow our hospital to provide expanded surgical options for our patients,” said Matthew Burtelow, MD, PhD, of Boise Pathology at St. Luke’s Boise Medical Center in Boise, Idaho. “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.”
Measuring intact parathyroid hormone levels aids in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
“The launch of the VITROS iPTH Assay underscores the commitment Ortho Clinical Diagnostics has to expanding its menu offerings to best meet the needs of clinical laboratories and their patients,” said Bob Roda, vice president, worldwide marketing, clinical laboratories, and donor screening. “By being able to run an iPTH test as part of routine assay testing on the VITROS Systems, laboratorians will be able to consolidate their workload onto a single system, helping to further improve productivity and efficiency.”
Source: Ortho Clinical Diagnostics
