Combines RT-PCR accuracy with a simple workflow to provide fast and convenient rapid PCR-based test results. The test’s patented PCR technology enables rapid exponential amplification while reducing overall thermocycling times, resulting in faster test results. The Accula SARS-CoV-2 Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing 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) anterior nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider. The Accula SARS-CoV-2 Test is a nucleic acid amplification test (NAAT) for detection of SARS-CoV-2 viral RNA in approximately 30 minutes. To perform the test, nasal or nasal mid-turbinate specimens are added to the SARS-CoV-2 buffer to solubilize the sample. An aliquot of the SARS-CoV-2 buffer is then dispensed into an Accula SARS-CoV-2 test cassette. The test cassette contains positive and negative internal controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. There are 4 steps in the process:
1. Lysis of the virus
2. Reverse transcription (RT) of viral RNA to cDNA
3. Nucleic acid amplification by PCR
4. Detection
In approximately 30 minutes, clinicians can quickly and reliably identify patients who are positive for COVID-19.