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The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.

an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease

Tandem®-R Ostase® is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, two-site immunoradiometric assay. Samples containing sALP are reacted with a plastic bead (solid phase) that is coated with a monoclonal antibody directed toward a specific site on the sALP molecule and, simultaneously, with a second radiolabeled monoclonal antibody directed toward a different antigenic site on the sALP molecule. Following formation of the solidphase/sALP/radiolabeled antibody sandwich, the bead is washed to remove unbound labeled antibody. The radioactivity bound to the solid phase is measured in a gamma counter. The amount of radioactivity measured is directly proportional to the concentration of sALP in the test sample, which is determined from a standard curve. The standard curve is based on the concurrent testing of Tandem-R Ostase calibrators ranging from 0 to 120 µg sALP/L.