The BD 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 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate and high complexity tests.
The BD SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA 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).
The BD SARS-CoV-2 Reagents for BD MAX System results are for the identification of SARS-CoV-2 RNA. The 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 patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations, patient history, and epidemiological information. The 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. The BD SARS-CoV-2 Reagents for BD MAX System is only for use under the Food and Drug Administration’s Emergency Use Authorization.
An emerging fungus, Candida auris, is presently listed by the Centers for Disease Control and Prevention (CDC) as a serious global health threat due to its multidrug-resistant properties, the difficulty it poses for identifying the organism via standard laboratory methods, and its history of causing outbreaks in healthcare settings1. C. auris is particularly problematic for healthcare institutions, its practitioners, and patients. The fungus can cause severe illness in hospitalized patients2, particularly as it is associated with nosocomial bloodstream and deep wound infections, which have resulted in a high mortality rate across intensive care unit (ICU) patients3. Furthermore, C. auris is troublesome as patients can remain colonized for extensive time periods and the organism can persist on surfaces in healthcare environments despite routine decontamination efforts2. Due to the heightened awareness of the species, the CDC is currently tracking C. auris cases in the U.S., as well as across the world2.
Two U.S.-based institutions – Tampa General Hospital (Tampa, Florida, USA)3 and the New York State Department of Health (New York, New York, USA)4 – have recently published their work leveraging the BD MAX™ System and the suite of BD MAX™ Open-System Reagents for rapidly identifying C. auris with an automated sample-to-answer solution: