The Xpert SARS-CoV-2 Control Panel M430 is intended for use as an external positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of SARS-CoV-2 by the Xpert Xpress SARS-CoV-2 assay on the GeneXpert DX, GeneXpert Infinity and GeneXpert Xpress systems (Cepheid). The Xpert SARS-CoV-2 Control Panel M430 is composed of 2 controls, Xpert SARS-CoV-2 Positive and Xpert SARS-CoV-2 Negative. The Xpert SARS-CoV-2 Control Panel M430 is comprised of 6 tubes, 3 tubes of Xpert SARS-CoV-2 Positive and 3 tubes of Xpert SARS-CoV-2 Negative, 300µL each.