The INTROL TB-XDR Panel M345 is intended for use as an external quality control to monitor analytical performance of the extraction, amplification and detection steps of in vitro laboratory nucleic acid testing procedures for the qualitative detection of extensively drug resistant (XDR) Mycobacterium tuberculosis (MTB) complex by the Xpert MTB/XDR Assay on Cepheid GeneXpert Instrument Systems. INTROL TB-XDR Panel M345 consists of non-infectious, synthetic MTB DNA encapsulated in chemically fixed and killed bacterial cells. The MTB DNA is comprised of the following MTB gene segments: eis promoter, fabG1, gyrA, gyrB, inhA promoter, katG, oxyR-ahpC, and rrs. The controls must undergo a stringent extraction process in order to effectively release the MTB DNA from the cells. INTROL TB-XDR Panel M345 is compatible with the Xpert MTB/XDR Assay (Cepheid). It does not include the entire MTB genome.