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ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instruments Phadia 100 and Phadia 250.

ImmunoCAP Tryptase reagents are modular in concept and are available individually in different package sizes dependent on instrument system used. The reagents needed to perform the ImmunoCAP Tryptase assay are listed below. ImmunoCAP Tryptase/ImmunoCAP Tryptase Conjugate 50 (10-9525-02/10-9522-02) ImmunoCAP Tryptase Calibrators/ImmunoCAP Tryptase Calibrator Strip (10-9526-01/10-9523-01) ImmunoCAP Tryptase Curve Control/ImmunoCAP Tryptase Curve Control Strip (10-9527-01/10-9524-01) ImmunoCAP Tryptase Anti-Tryptase (14-4518-01), ImmunoCAP Tryptase Control (10-9370-01)

ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instruments Phadia 100, Phadia 250, or Phadia 1000.

ImmunoCAP Tryptase is a fluorescence immunoassay for the measurement of human tryptase based on ImmunoCAP solid phase. ImmunoCAP Tryptase measures the total tryptase levels including all forma of a-tryptase and B-tryptase. ImmunoCAP Tryptase concentrations are quantitatively reported in microgram/L (ug/L). ImmunoCAP Tryptase consists of assay specific reagents to be used as part of Phadia Laboratory Systems along with already cleared instruments (including instrument and data management software) and system reagents (system reagents were cleared in k051218). ImmunoCAP Tryptase kits (for the Phadia 100, Phadia 250, and Phadia 1000) contain the following reagents: - ImmunoCAP Tryptase Conjugate - ImmunoCAP Tryptase Anti-Tryptase bound to ImmunoCAP carrier - Development solution - Stop solution - Washing solution - IgE/ECP/Tryptase sample diluent (available separately, not included in the ImmunoCAP Tryptase kit) - ImmunoCAP Tryptase Control (prepared from selected pooled human serum and lyophilized) In addition, the Phadia 100 kit includes the following reagents: - Tryptase calibrators (1, 5, 12.5, 50, and 200 µg/L human tryptase in buffer) - Tryptase Curve Control 1 (single dose vials of human tryptase in buffer) In addition, the Phadia 250 and Phadia 1000 kits include the following reagents: - ImmunoCAP Tryptase Calibrator Strip (1, 5, 12.5, 50, and 200 µg/L human tryptase in buffer) - Tryptase Curve Control Strip (human tryptase in buffer)