BD SARS-CoV-2 Reagents for BD MAX™ System1

Description

• A real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 Sample types include nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens as well as nasopharyngeal wash/aspirate or nasal aspirates SARS-CoV-2 RNA is generally detectable in upper respiratory samples during the acute phase of infection Positive results are indicative of the presence of SARS-CoV-2 RNA Clinical correlation with patient history and other diagnostic information is necessary to determine a patient's infection status Positive results do not rule out bacterial infection or co-infection with other viruses as the agent detected may not be the definite cause of disease Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
• §263a, that meet requirements to perform moderate or high complexity tests Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities BD SARS-CoV-2 Reagents for BD MAX™ System is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR, in vitro diagnostic procedures, and use of the BD MAX™ System Only for use under the Food and Drug Administration’s Emergency Use Authorization