DiaSorin, Inc., receives clearance for the LIAISON N-TACT PTH Gen II assay

April 28, 2014

DiaSorin, Inc., has announced that it has received Food and Drug Administration (FDA) clearance for the company’s LIAISON N-TACT PTH Gen II immunoassay. The assay is intended for the quantitative determination of intact human parathyroid hormone in human serum and plasma samples.

The measurement of PTH is used in conjunction with calcium determinations to assess disorders in calcium metabolism. The maintenance of proper calcium concentrations in cells and extracellular fluids is essential for fundamental biological processes. PTH is one of the important regulators of calcium homeostasis.

DiaSorin has been a provider of Vitamin D testing for more than 25 years. PTH and 25 OH Vitamin D can be used in conjunction to aid in the diagnosis of bone-related disease. Laboratories can now run both LIAISON N-TACT PTH Gen II assay and the LIAISON 25 OH Vitamin D assay together on either a LIAISON or LIAISON XL platform. The new LIAISON N-TACT PTH Gen II is a 200-test kit with improved precision and improved open kit shelf life of eight weeks; meeting the needs of small- and large-volume laboratories. Additionally, the LIAISON N-TACT PTH Gen II has low cross-reactivity to the 7-84 and other inactive fragments, supporting conservative patient management.

More than 5000 LIAISON systems are in use worldwide with a menu of 107 diagnostic tests including endocrinology, bone and mineral, infectious disease, autoimmune, and hepatitis assays. DiaSorin’s focus on expanding the LIAISON menu will further increase versatility. Read the FDA’s 510(K) summary for the LIAISON N-TACT PTH Gen II immunoassay.

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