INTROL TB Panel M114plus is intended for use as a quality control to monitor the nucleic acid detection of M. tuberculosis (MTB) and the mutations associated with multi-drug resistant MTB (MDR-TB) on the GeneXpert System. INTROL TB Panel M114plus is composed of 3 positive controls and 1 negative control. The positive controls consist of non-infectious, synthetic MTB DNA encapsulated in bacterial cells. The MTB DNA does not include the entire MTB genome. MTB gene segments present among the positive controls are: IS6110, IS1081, hsp65, 16S rRNA, 23S rRNA, inhA, katG, and rpoB. Drug resistance mutations are incorporated in segments inhA, katG, and rpoB, as indicated in Table 1. Not all mutations listed are detected by Xpert MTB assays on the GeneXpert System. The negative control contains buffer and preservative only.