The Accula™ System is a sample-to-answer nucleic acid PCR amplification platform for rapid testing, with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. This is a highly accurate test and is the same rapid test used by the NFL. Test purpose: Used to detect an active COVID-19 infection Accuracy/Sensitivity: ~97%+ Sample Type: Shallow nasal swab Results Time: Results will be communicated to patients within 24 hours
The Accula™ SARS-CoV-2 Test is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses nasal swab specimens, collected from patients suspected of COVID-19 by their healthcare provider.
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.
Test type: Molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA.
Specimen type: Nasal
Turnaround time: Approximately 30 minutes
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.