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.
- Collection Swabs: 25 sterile nasal swabs
- SARS-CoV-2 Buffer: 25 single-use vials of solution containing 5 mL of buffer
- Transfer Pipette: 25 single-use, fixed volume pipettes
- Accula SARS-CoV-2 Test Cassette: 25 Single-use, foil-pouched with desiccant and Test Cassette
- SARS-CoV-2 High Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab well-above the limit of detection
- SARS-CoV-2 Low Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab near the limit of detection
- SARS-CoV-2 Negative Control Swab: Buffer solution dried onto a swab
- Documentation: 1 each - Self-collection Quick Reference, 1 each - Electronic Instructions for Use, (EIFU) card
This test has not been FDA cleared or approved but has been authorized for emergency use by FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests.