PCM313001EN00 Solana SARS-CoV-2 Assay Frozen
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95°C Lysis Block Heating Time Heating Time Workflow Tray 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 Kit Contents Equipment Reaction Tubes Process Buffer Tubes Positive Control Negative Control Assay Procedure – Heat Lysis PCM313001EN00 (05/21) Amplification and Detection 1 Heat for 5 minutes at 95°C. 6 Add 50 μL of a patient sample to a Process Buffer Tube. 4 8 Solana Instrument Close the lid and select appropriate assay protocol. Run complete in 25 minutes. SARS-CoV-2 1111 SARS-CoV-2 2222 SARS-CoV-2 3333 SARS-CoV-2 4444 SARS-CoV-2 5555 SARS-CoV-2 6666 Positive Positive Negative Positive Positive Negative empty empty empty empty empty empty 1 2 3 4 5 6 7 8 9 10 11 12 Test results 06. Aug 2020, 21:41 Review results. 11 10 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 7 Use the Transfer Rack to lift Reaction Tubes from the Workflow Tray and visually inspect. Specimen in transport media. 2 VORTEX 5 seconds 5 VORTEX 5 seconds 3 VORTEX 5 seconds 7 Procedure Card SARS-CoV-2 Assay Frozen Study the Package Insert thoroughly before using this Procedure Card. This is not a complete Package Insert. Transfer Rack 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 8 Lower the Reaction Tubes into Solana. 1 2 3 4 5 6 7 8 9 10 11 12 Lot ID Kit Exp. Date 9 Release the Reaction Tubes from the Transfer Rack by pulling the Transfer Rack toward your body. 1 2 3 4 5 6 7 8 9 10 11 12 Lot ID Kit Exp. Date 2 Vortex Master Mix 5 seconds. 5” 8x Master Mix 3 Transfer 25 μL of Master Mix to each empty reaction tube. 25 μL Master Mix 4 Transfer 25 μL of heat lysed process buffer to each reaction tube. 25 μL heat-lysed process buffer 5 Mix by pipetting up and down a minimum of 5 times. Mix 5x Close lid tightly and proceed to next step. 6 1 Thaw 13-15 Minutes Thaw Master Mix for 13-15 minutes at room temperature before use. One vial will perform 12 reactions. Allow heated buffer tube to return to room temperature prior to adding Master Mix. Setup the Workflow Tray with patient samples, Process Buffer Tubes, and Reaction Tubes.
Transcript of PCM313001EN00 Solana SARS-CoV-2 Assay Frozen
95°CLysis Block
HeatingTime
HeatingTime
WorkflowTray
1 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 12
1 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 12
Kit Contents Equipment
ReactionTubes
ProcessBufferTubes
PositiveControl
NegativeControl
Assay Procedure – Heat Lysis
PCM313001EN00 (05/21)
Amplification and Detection
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Heat for 5 minutesat 95°C.
6
Add 50 µL of apatient sample
to a ProcessBuffer Tube.
4 8
SolanaInstrument
Close the lid and selectappropriate assay protocol.
Run complete in 25 minutes.
SARS-CoV-21111
SARS-CoV-22222
SARS-CoV-23333
SARS-CoV-24444
SARS-CoV-25555
SARS-CoV-26666
Positive
Positive
Negative
Positive
Positive
Negative
empty
empty
empty
empty
empty
empty
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Test results06. Aug 2020, 21:41
Review results.
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1 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 12
7
Use the Transfer Rack to liftReaction Tubes from the
Workflow Tray and visually inspect.
Specimen intransport media.
2VORTEX
5 seconds
5VORTEX
5 seconds
3VORTEX
5 seconds
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Procedure Card
SARS-CoV-2 Assay Frozen
Study the Package Insert thoroughly before using this Procedure Card. This is not a complete Package Insert.
TransferRack
1 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 12
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Lower the Reaction Tubesinto Solana.
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Select TestLot ID
Kit Exp. Date
06. Aug 2020, 21:41
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Release the Reaction Tubesfrom the Transfer Rack bypulling the Transfer Rack
toward your body.
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Select TestLot ID
Kit Exp. Date
06. Aug 2020, 21:41
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Vortex Master Mix5 seconds.
5”
8xMaster
Mix
3
Transfer 25 μL of Master Mix to each
empty reaction tube.
25 μL Master Mix
4
Transfer 25 μL of heat lysed process buffer to
each reaction tube.
25 μL heat-lysedprocess buffer
5
Mix by pipetting up and down a minimum
of 5 times.
Mix 5x
Close lid tightly andproceed to next step.
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Thaw13-15 Minutes
Thaw Master Mix for 13-15 minutes at room temperature
before use. One vial will perform 12 reactions.
Allow heated buffer tube to return to room
temperature prior to adding Master Mix.
Setup the Workflow Tray with patient samples, Process Buffer Tubes, and Reaction Tubes.
