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

A real time RT-PCR test for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

• 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

Detectable Analytes

SARS-CoV-2 RNA

Sample Type

Nasopharyngeal, Anterior Nasal, Mid-turbinate, and Oropharyngeal Swab Specimens as well as Nasopharyngeal Wash/Aspirate or Nasal Aspirates

For Use With (Application)

Detection of SARS-CoV-2 RNA

For Use With (Equipment)

BD MAX™ Systems

Includes

BD MAX™ ExK™ TNA-3 Sample Buffer Tubes (24), Primers and Probes Tubes (24), TNA MMK Tubes (24), Extraction Tubes (24), Unitized Reagents Strips (24), and Septum Caps (25)

Quantity

24 Tests

¹This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; this product has been authorized only for the detection of nucleic acid of SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.