Item Brochure

Time to 12 results
SL8008 | SSM301001EN00 (11/16)
Solana GAS Assay – 48 Test Kit: Cat. #M301
Quidel Molecular Strep A+G Control Set – 20-Reaction Kit: Cat. #M111
Solana Instrument – Cat. #20278
Procedure
Performance Results of Solana GAS Assay for Group A β-hemolytic Streptococcus
Composite Culture
POS NEG Total Sensitivity 98.2%
POS 220 24 244 Specificity 97.2%
NEG 4** 833 837
Total 224 857 1081
Solana GAS
Sample Prep/Hands-on Time
Assay Run Time
Solana
1
2-tube chamber
Culture
with typing
Single Test
Isothermal System
single-tube chamber
60 min 120 min 24 Hours 48 Hours
0
*Of the twenty-four (24) discordant specimens, sixteen (16) of these specimens were positive for GAS when tested with an additional FDA-
cleared molecular device, eight (8) were negative.
**Of the four (4) discordant specimens, three (3) were negative when tested with an additional FDA-cleared molecular device.
Refer to Package Insert for additional performance claims.
Clinical performance
180 min
*Boston Strategic Partners analysis of primary research
conducted November 1, 2015 – December 4, 2015
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