Product Manual
60061-7 (2021-01) Accula SARS-CoV-2 IFU 3
process positive and negative controls, 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 thermocycling polymerase chain reaction (PCR)
4. Detection
The Accula Dock controls reaction temperatures, timing, and fluid movements within the Test Cassette resulting in a fast and automated
SARS-CoV-2 RT-PCR assay. After approximately 30 minutes, the test results are interpreted by the visualization of Blue Test Lines on
the detection strip in the Test Cassette. A blue process control line at the control (C) area is used to ensure proper reagent and Accula
Dock function and to confirm a valid negative test result.
REAGENTS AND MATERIALS
MATERIALS PROVIDED
ACCULA SARS-CoV-2 TEST MATERIALS PROVIDED:
• Collection Swabs (25): Sterile swabs for nasal sample collection.
• SARS-CoV-2 Buffer (25): Single-use vial of solution containing 5 mL of buffer with dimethyl sulfoxide and < 0.01% sodium azide.
• Transfer Pipette (25): Single-use, fixed volume pipette used to transfer sample from the SARS-CoV-2 Buffer vial into the
Test Cassette. NOTE: Supplied within the Test Cassette Pouch. 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 Control Swab (1): DNA Based Synthetic Oligo dried onto a swab well-above the limit of detection of the
test.
• SARS-CoV-2 Low Positive Control Swab (1): DNA Based Synthetic Oligo dried onto a swab near the limit of detection of the test.
• SARS-CoV-2 Negative Control swab (1): buffer solution dried onto a swab.
• Self-Collection Quick Reference Guide (1)
• Electronic Instructions for Use (eIFU) Card (1)
• Instructions for Use and Quick Reference Guide is provided on the Mesa Biotech website, https://www.mesabiotech.com/about-
us/#product-documentation