Product Manual

Solana SARS-CoV-2 Assay Page 5 of 13
9. Add 25 µL of Master Mix to each empty reaction tube.
10. Add 25 µL of each heat lysed Process Buffer specimen to the corresponding Reaction Tube directly into the liquid
Master Mix and mix by vigorously pipetting up and down 5 times. Firmly close the Reaction Tubes.
11. Using the Solana Transfer Rack to hold Reaction Tubes at eye-level, visually inspect each Reaction Tube to ensure
there are no air bubbles present at the bottom of the tube and liquid levels are equivalent. Flick tube lightly to
remove any air bubbles observed.
a. NOTE: Only touch Reaction Tubes with gloved hands
12. Open the lid of the Solana instrument and place the Reaction Tubes in Solana via the Transfer Rack. Close the lid.
NOTE: Be sure that all tubes are in tight contact with heat block.
13. Enter User ID, press
↵ (ENTER) and enter Password and press ↵ (ENTER).
14. Select “NEW TEST.” If Solana displays a different screen, go to the home screen.
15. Select the tube positions to use.
16. Scan the assay barcode or manually enter Lot ID/Exp Date, then select “SARS-CoV-2 Assay” from the Select Test drop-
down menu and press “.”
17. Select sample type (patient or QC) from the drop-down menu and enter Sample IDs (optional; see 2
nd
Note in next
step).
18. Press “Start” to initiate the Solana
SARS-CoV-2 Assay. Solana will display the progress and the count-down to assay
completion. Test results will be displayed on the screen in approximately 25 minutes.
NOTE: To avoid laboratory contamination, once the tube has been closed and the amplification reaction started,
DO NOT open the Reaction Tube.
NOTE: While the test is running, sample ID can be entered or edited by pressing the pencil icon.
19. After the run is completed the results can be printed by selecting the print button.
NOTE: Do not navigate away from this screen before printing results. Once the screen is gone, it cannot be revisited.
If this occurs, the results can be viewed individually by going to Home and then selecting Review Results. To
determine if sample is positive for SARS-CoV-2, press the tube sample number.
INTERPRETATION OF RESULTS
The Solana software automatically determines the specimen results for SARS-CoV-2 virus. A positive result indicates that
the viral RNA for the SARS-CoV-2 virus was detected. A negative result indicates that SARS-CoV-2 virus RNA was not
detected, and the process control was detected. Solana reports a specimen result as invalid when both SARS-CoV-2 virus
was not detected, and the process control was undetected. The process control (PRC) is used to monitor sample
processing, to detect HDA inhibitory specimens, and to confirm the integrity of assay reagents and the operation of the
Solana instrument.
Single Sample Results Screen
Assay Result
Interpretation
SARS-CoV-2 POSITIVE
SARS-CoV-2 RNA detected
SARS-CoV-2 NEGATIVE
No SARS-CoV-2 RNA detected/PRC detected
SARS-CoV-2 INVALID
No SARS-CoV-2 RNA and No PRC detected; for invalid test results, re-process
another aliquot of the same sample or obtain a new sample and re-test.
QUALITY CONTROL
The Solana SARS-CoV-2 Assay incorporates several controls to monitor assay performance.
 A positive control (such as a positive patient sample) should be processed and tested with each batch of specimens.
 The process control (PRC) consists of single stranded RNA and is used to monitor HDA inhibitory specimens, and to
confirm the integrity of assay reagents and the operation of the Solana instrument. The process control is included in
the Reaction Tube.
 The external positive control (containing SARS-CoV-2 Synthetic RNA) may be treated as a patient specimen. The
control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay
Procedure. The external positive control is intended to monitor substantial reagent and instrument failure.