Item Brochure
Time to 11 results
SL3205 | SSM313000EN00 (12/20)
Solana SARS-CoV-2 Assay (includes controls) – 96 Test Kit: Cat. #M313
A –80°C Ultra-Low Temperature Freezer is required on-site to purchase and store this assay
Solana Instrument – Cat. #20278
Procedure
ug 2020, 21
06 A
Kit Exp. Date
Lot ID
e
s
t
Te
Select T
ioneparat
12x Master
Mix
50 μL
25 μL
95°C
5 Min.
Process
Buffer
Tube
Sample Pr
Specimen in
transport media
1
2
3
4
5
6
7
8
9
10
11
12
25 μL
uff
Reaction
Tube
Process
B
fe
er
Tube
Reaction
Tube
Sample Prep/Hands-on Time
Assay Run Time
Solana
12-tube chamber
CLIA Waived, Single
Test MDx System
single-tube chamber
Real-Time PCR
Assays
60 min 120 min 180 min 240 min 300 min
0
A study was performed comparing the Solana SARS-CoV-2 Assay to an authorized EUA RT-PCR assay. Two hundred forty (240) nasal swab samples and fifty-one (51) nasopharyngeal swabs in viral
transport media were tested with both devices according to respective Package Inserts. Two hundred four (204) samples were tested with the Solana assay after storage of the viral transport media
at –70°C. Eighty-seven (87) were tested with the Solana assay after storage of the viral transport media at 2°C to 8°C.
Clinical Performance
# Tested True POS False POS True NEG False NEG PPA% NPA% PPA 95% CI NPA 95% CI
Nasal 240 69 0 169 2 97.2% 100% 90.3% to 99.2% 97.8% to 100%
Nasopharyngeal 51 19 1 31 0 100% 96.9% 83.2% to 100% 84.3% to 99.5%
Total 291 88 1 200 2 97.8% 99.5% 92.3% to 99.4% 97.2% to 99.9%
Comparison of Solana SARS-CoV-2 Assay and Authorized EUA Comparator Assay
Solana SARS-CoV-2
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