Product Manual

Solana SARS-CoV-2 Assay Page 3 of 13
MATERIALS PROVIDED
Cat. #M313
96 Tests per Kit
Component
Quantity
Storage
Box 1
Process Buffer 96 tubes/kit 0.75 mL 2°C to 8°C
Empty Reaction Tubes
96 tubes/kit
2°C to 30°C
Negative Control
1 tube/kit 2.0 mL
2°C to 8°C
Positive Control
1 tube each/kit 1.0 mL 2°C to 8°C
Box 2
Master Mix Tubes
8 tubes/kit 0.300 mL
≤ -70°C
MATERIALS REQUIRED BUT NOT PROVIDED
 Sterile DNAse-free filter-blocked positive displacement micropipettor tips
 Micropipettor
 Stopwatch or timer
 Vortex Mixer
 Scissors or a blade
 Workflow tray
 Transfer Rack
 Heat block capable of 95°C ± 2°C temperature
 Thermometer
 Solana instrument (firmware version 2.0.11)
 Transport Media (BD/Copan UTM, CDC Viral Transport Media)
 Ultra-low temperature freezer -70°C or below
WARNINGS AND PRECAUTIONS
 For In Vitro Diagnostic Use under Emergency Use Authorization only.
 This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA
for use by authorized laboratories.
 This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens.
 The emergency use of this product is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
 All reagents are for in vitro diagnostic use only.
 Refer to the Solana Operator’s Manual for further information regarding instrument installation and operation.
 Only use the protocol described in this package insert. Deviations from the protocol may give erroneous results.
 Treat all specimen/samples as potentially infectious. Follow universal precautions when handling samples, this kit and
its contents.
 All tubes should be capped tightly prior to vortexing.
 Proper sample collection, storage and transport are essential for correct results.
 Master Mix should remain frozen until use. Do not refreeze. Once thawed, Master Mix is stable for up to 24-hours
when stored at 2° to 8°C.
 Store assay reagents as indicated on their individual labels.
 Reagents are not interchangeable between lots.