Ortho Clinical Diagnostics announced US Food and Drug Administration (FDA) 510(k) clearance of the 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, 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 tumour was successful.”
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 overactivity in the parathyroid glands. Complications of hyperparathyroidism are primarily related to the long-term effect of calcium imbalances in a patient’s bones and bloodstream, and may be associated with a number of health conditions, such as cardiovascular disease, kidney stones and osteoporosis.
“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 Votros Systems, laboratorians will be able to consolidate their workload onto a single system, helping to further improve productivity and efficiency.”
Ortho Clinical Diagnostics has a broad, world-class menu of assays offering all of the most important clinical chemistry tests that cover major disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anaemia. The Vitros assay menu covers up to 90 per cent of the top 100 assays and 99 percent of laboratory test volume, with numerous other assays in development. In addition, standardized Vitros reagents will enable laboratories to better manage inventories and costs in addition to producing consistent test results from platform-to-platform. This is particularly beneficial for laboratories with multiple Vitros platforms in their facilities.