Respiratory Test Kit Accula™ SARS-CoV-2 25 Tests CLIA Waived Sample Dependent

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
• The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• 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 performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider
• 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 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
• Materials provided separately: Accula Dock (Catalog # D2000) or Silaris Dock (Catalog #1026), Accula SARS-CoV-2 Control Kit (Catalog #COV4100-1)
• Accurate results - Positive percent agreement (PPA) 95.8% to 100% and negative percent agreement 100% in prospective and retrospective clinical studies

More Information

• Accula SARS-CoV-2 Test FDA EUA Letter
• Accula SARS-CoV-2 Test IFU
• Accula SARS-CoV-2 Test Healthcare Providers Fact Sheet
• Accula SARS-CoV-2 Test Patients Fact Sheet
• Accula SARS-CoV-2 Test FDA EUA Letter March 2023