RT-PCR Control Set Accula™ SARS-CoV-2 Low Positive / High Positive / Negative Level 3 X 3 Swabs

Features

• Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Product ships with minimum 30 days dating
• Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests
• The Accula SARS-CoV-2 Test using nasal swab specimens is also authorized to be distributed and used in patient care settings outside of the clinical laboratory environment
• Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA; the SARS-CoV-2 RNA is generally detectable in nasal swab specimens 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
• Testing facilities 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 Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and Silaris Dock; the Accula SARS-CoV-2 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization
• 9 Control swabs: 3 Sets of Controls (High Positive, Low Positive, Negative)

More Information

• Accula SARS-CoV-2 Test FDA EUA Letter
• Accula SARS-CoV-2 Control Kit IFU
• Accula SARS-CoV-2 Test Healthcare Providers Fact Sheet
• Accula SARS-CoV-2 Test Patients Fact Sheet