Product Manual

60061-7 (2021-01) Accula SARS-CoV-2 IFU 5
• When transferring the eluted patient sample, avoid drawing up large particulates, which may clog the Transfer Pipette.
• Due to the high sensitivity of the Accula SARS-CoV-2 Test, contamination of the work area with previous samples may cause
false positive results. Clean the Accula Dock or Silaris Dock and surrounding surfaces as described in the procedure in the
Accula Dock or Silaris Dock Operators Guide.
• Do not attempt to open a used Test Cassette or a Test Cassette with closed sample port.
• Do not touch the heads of the Control Swabs. Cross contamination may occur due to the high sensitivity of the test.
• Use the Results Interpretation table in this Instructions for Use to interpret results accurately.
QUALITY CONTROL
Process Controls
Each Accula SARS-CoV-2 Test Cassette contains two internal process controls:  on the Test
Cassette)  on the Test Cassette). The positive process control is a non-infectious RNA bacteriophage
in the Test Cassette and is used as the positive process control to verify assay steps (RNA extraction, reverse transcription,
amplification, and detection) were executed properly. A non-SARS-CoV-2 nucleic acid probe is used as a negative control for false
positive results due to nonspecific binding.
Refer to the Interpretation of Results section of this Instruction for Use for instructions on interpreting the results for the Process Control.
External Positive and Negative Controls
External controls may be used to show that the Accula SARS-CoV-2 Test is working properly. The Accula SARS-CoV-2 Test kit
contains three Control Swabs:
• 1 SARS-CoV-2 High Positive Control Swab
• 1 SARS-CoV-2 Low Positive Control Swab
• 1 SARS-CoV-2 Negative Control Swab
Mesa Biotech recommends that a SARS-CoV-2 negative and SARS-CoV-2 positive controls be run:
• Once for each new lot or shipment of kits received.
• Once for each new operator.
• As deemed additionally necessary to conform with your internal quality control procedures, with local, state and/or federal
regulations, or accrediting groups.
Additional Control Swabs may be purchased from Mesa Biotech (Catalog # COV4100-1). Run Control Swabs using the same procedure
as for a patient specimen.
If External QC testing fails, repeat the test using a new Control Swab, reagent and Test Cassette or contact Mesa Biotech Technical
Support for assistance before testing patient samples.