Product Manual

Solana SARS-CoV-2 Assay Page 4 of 13
 Never pool reagents from different tubes even if they are from the same lot.
 Do not use the reagents after their expiration date.
 Do not interchange caps among reagents as contamination may occur and compromise test results.
 Only open the tubes when adding aliquots into tubes or removing aliquots from tubes. Keep the tubes closed at any
other time to avoid contamination.
 For accurate results, pipette carefully using only calibrated equipment. Use of inaccurate volumes may give erroneous
results.
 To avoid contamination of the environment with SARS-CoV-2 amplicons, do not open the reaction tubes post-
amplification.
 Avoid microbial and ribonuclease (RNAse) contamination of reagents when removing aliquots from tubes.
 Performing the assay outside of the recommended time ranges can produce invalid results. Assays not completed
within specified time ranges should be repeated.
 Additional controls may be tested according to guidelines or requirements of local, state, provincial and/or federal
regulations or accrediting organizations.
 Do not pipette by mouth.
 Do not smoke, drink or eat in areas where specimens or kit reagents are being handled.
 Maintenance and decontamination of workspace and equipment should follow and be performed according to
established laboratory protocols and schedules. Testing should be performed in an area with adequate ventilation.
 Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements.
 Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
 Wash hands thoroughly after handling.
 For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please
refer to the Safety Data Sheet (SDS) located at quidel.com.
STORAGE AND HANDLING OF KIT REAGENTS
Store the Master Mix at -70°C or below. Once thawed, the Master Mix is stable for up to 24-hours when stored at 2° to
8°C. The remaining Assay Kit should be stored at 2°C to 8°C until the expiration date listed on the outer kit box.
SPECIMEN COLLECTION, STORAGE AND HANDLING
Nasal and nasopharyngeal specimens should be collected, transported, stored, and processed according to CLSI M41-A
4
.
Specimens collected in BD/Copan UTM are stable at room temperature (RT), 2°C to 8°C or -70°C or below for up to 4 days.
Specimens collected in the CDC Viral Transport Medium should be stored at 2-8°C for up to 72 hours after collection or at
-70°C or below if a delay in testing or shipping is expected.
TEST PROCEDURE
1. Turn on Solana by pressing the power button and wait until it completes self-testing.
NOTE: Do not open the lid during the self-testing.
2. Place the required number of Process Buffer Tubes in the Workflow tray. Label the Process Buffer Tubes on the cap
and/or side of the tube.
NOTE: One (1) Process Buffer Tube is required for each specimen or control to be tested.
NOTE: A maximum of 12 tests can be performed per test run in a single Solana instrument.
3. Remove the required number of Empty Reaction Tubes from the bag and place in the Workflow tray. Label the
Reaction Tubes on the cap.
4. Mix the specimen received in viral transport media by vortexing the tubes for 5 seconds.
5. Remove 50 µL of the mixed specimen or External control and add to labeled Process Buffer Tubes and then vortex the
Tubes for 5 seconds.
6. Heat the Process Buffer Tubes at 95 ±2°C for 5 minutes and then vortex the Tubes for 5 seconds.
NOTE: Begin 5-minute lysis procedure after placing tubes in block and waiting until block returns to 95°C.
NOTE: Samples are stable in process buffer up to 6-days at 2°C to 8°C, –20°C, and -70°C after the heat step.
7. Thaw one (1) Master Mix vial for every 12 tests you wish to perform for 13-15 minutes before proceeding to the next
step. This may also be performed at beginning of test procedure if user intends to perform sample testing through
amplification.
NOTE: Only thaw the volume of Master Mix required to complete testing.
8. Mix thawed Master Mix for 5 seconds.