Quidel Sofia NATtrol
The Influenza Rapid Test Verification Panel I is intended for use within vitro assay procedures to determine the absence or presence of Influenza. This panel is for Research Use Only and should not be used in diagnostic procedures.
The Influenza Rapid Test Verification Panel I is composed of twenty members representing various influenza strains and a range of reactivities. Each panel member contains 0.5mL of material prepared from inactivated viral culture fluid. This panel can be used for training, lot-to-lot comparison of reagent test kits, and to evaluate and compare intra laboratory and inter-laboratory performance of Influenza testing platforms.
Platform: Abbott ID NOW, BD Veritor System Reader, Quidel Sofia Analyzer; Test: Influenza / +2° to +8° C.
NAME AND INTENDED USE:
The Influenza Rapid Test Verification Panel I is intended for use within vitro assay procedures to determine the absence or presence of Influenza. This panel is for Research Use Only and should not be used in diagnostic procedures.
SUMMARY:
The Influenza Rapid Test Verification Panel I is composed of twenty members representing various influenza strains and a range of reactivities. NATtrol panel member contains 0.5mL of material prepared from inactivated viral culture fluid. This panel can be used for training, lot-to-lot comparison of reagent test kits and to evaluate and compare intra laboratory and inter-laboratory performance of Influenza testing platforms.
PRINCIPLES OF THE PROCEDURE:
The Influenza Rapid Test Verification Panel I reagents have been designed for use within vitro assay procedures for monitoring assay performance across a range of reactivity levels. These materials are prepared from inactivated viral culture fluids. Source materials have been processed and treated to eliminate unwanted components and to ensure the stability of the final product. The Influenza Rapid Test Verification Panel I members should be evaluated as an unknown specimen per the instructions supplied by the manufacturer of the test kit being used.
LIMITATION OF THE PROCEDURE:
The Influenza Rapid Test Verification Panel I reagents must not be substituted for the positive and negative control reagents provided with commercially available test kits.
The Influenza Rapid Test Verification Panel I reagents are provided for Research Use Only and must not be used for calibration or as primary reference preparations for any test kit.
PROCEDURE and INTERPRETATION OF RESULTS provided in the package insert of each commercially available test kit must be followed closely when testing the Influenza Rapid Test Verification Panel I reagents. Deviations from the recommended procedures may produce unreliable results.
It is the responsibility of each laboratory to determine the suitability of the Influenza Rapid Test Verification Panel I reagents for their particular use. They also must establish guidelines for the interpretation of results.
SPECIFIC PERFORMANCE CHARACTERISTICS:
The Influenza Rapid Test Verification Panel I reagents was tested using commercially available test systems following the procedures provided by the manufacturer for the testing of unknown specimens. The data contained in this document is intended to be representative of typical test procedures and should be used for informational use only. Each laboratory should establish its own performance characteristics.
