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Xpert NPM1 Control Panel C194v1.1

The Xpert NPM1 Control Panel C194v1.1 is intended for use as an assayed external quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of the NPM1 Type A, Type B, and Type D mutant mRNA transcripts and ABL1 endogenous control mRNA transcript when analyzed using the Xpert® NPM1 Mutation assay on Cepheid GeneXpert® Instrument Systems.

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Maine Molecular Quality Controls, Inc. (MMQCI)

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Xpert NPM1 Control Panel C194v1.1 is comprised of 10 single use bottles, 2 bottles of each % NPM1 mutation level. The C194v1.1 bottles contain 4mL of synthetic RNA transcripts, suspended in a stabilizing matrix with a non-infectious solution of buffers and preservatives. Level 0% contains wildtype NPM1 and ABL1 RNA transcript only. Levels 1%, and 5% contain varying ratios of NPM1 Type A mutant RNA transcript, Type B Mutant RNA transcript, or Type D Mutant RNA transcript to ABL1 RNA transcript, in a background of NPM1 wildtype RNA.

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