The Xpert PML-RARA Linearity Panel C221 is intended for use as a reference material to monitor the reportable range of in vitro laboratory nucleic acid testing procedures for the quantitative detection of PML-RARA transcript isoform bcr1 and ABL1 endogenous control mRNA transcript when analyzed using the Xpert PML-RARA assay on Cepheid GeneXpert Instrument Systems. The Xpert PML-RARA Linearity Panel C221 consists of 5 components. Each component contains an increasing concentration of PML-RARA bcr1 mRNA transcript with fixed concentrations of ABL1 to produce five levels: PML-RARA bcr1 0.1%, PML-RARA bcr1 1%, PML-RARA bcr1 20%, PML-RARA bcr1 100%, and PML-RARA bcr1 450%. Assessing the linearity of an assay is a crucial part of good laboratory practice, as it confirms that the test system accurately measures patient samples throughout the manufacturer’s designated reportable range.