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The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens by in situ hybridization (ISH).

The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow (core biopsy and clot section) indicates inconclusive results. It enables the assessment of both markers in the context of one another on a single slide as an aid in differentiating between a reactive process or B-cell lymphoma and plasma cell neoplasms.

This is not a standalone test, and results should be evaluated by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.

This product is intended for in vitro diagnostic (IVD) use.

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (hereafter referred to as VENTANA K/L Probe Cocktail) is a qualitative mRNA reagent designed to detect expression of kappa and lambda immunoglobulin light chains in FFPE human lymphoid and bone marrow tissue by in situ hybridization (ISH). The VENTANA K/L Probe Cocktail contains sufficient reagent for 30 tests. One 6 mL dispenser contains approximately 0.120 microgram/mL labeled probe in a formamide-based hybridization buffer (approximately 50% CH3NO). The kit contents are listed in Table 1. Materials Required but Not Provided are shown in Table 2.

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