Accula™ SARS-CoV-2 Rapid PCR Test

Accula ⇒ Visby

Accula’s COVID-19 RT-PCR test has been discontinued by the manufacturer, but we have a GREAT, NEW replacement this year!

Visby’s Respiratory PCR Test:

• RT-PCR Test for Covid-19, Flu A, and Flu B

• Same laboratory-grade RT-PCR performance as Accula > 97%

• CLIA Waived

• Results in 30 minutes

• Nasopharyngeal or anterior nasal swab

• No dock or instrument required, just a power cord

• First-in-class disposable PCR Cassette

• Just run and dispose of the cassette, like a rapid antigen

• Three CPT codes

• Increases office visit level from 2/3 to 4/5

• Manufacturer: Visby Medical

General Details

• Clia Complexity: Waived

• Detectable Analytes: SARS-CoV-2 RNA

• DoA Calibrators: No

• Format: Test Cassette Kit

• Sample Type: Nasal swab, Nasal Mid-turbinate Swab

• Sensitivity: Product LoD is 150 copies/mL with inactivated virus or 4.75 x 102 NDU/mL with the FDA Reference Panel

• Type: SARS-CoV-2 Assay

• For Use With (Application): RT-PCR, Rapid PCR

• Quantity: 25

• Shelf Life: Minimum of 6 months from date of manufacture

• Test Time: ∽30 min.

• Manufacturer: ThermoFisher

Box Components

• Collection swabs (25): sterile swabs for nasal sample collection

• SARS-CoV-2 buffer (25): single-use vial of solution containing 5 mL of buffer

• Transfer pipette (25): single-use, fixed volume pipette used to transfer sample from the SARS-CoV-2 Buffer vial into the test cassette. Extra pipettes provided for your convenience.

• Accula SARS-CoV-2 test cassette (25): single-use, foil-pouched with desiccant and test cassette containing lyophilized reagents for the targeted amplification and detection of viral nucleic acid

• SARS-CoV-2 high positive, low positive, and negative control swab (1 each): DNA-based synthetic oligo dried onto a swab well above the limit of detection of the test

Intended use

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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. 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.

Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory 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 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.