The BioGX SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.
The BioGX SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting R.N.A. from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus and the human RNase P gene. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2).