Item Brochure

Time to 12 results

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

2-tube chamber

Culture

with typing

Single Test

Isothermal System

single-tube chamber

60 min 120 min 24 Hours 48 Hours

*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

Solana GAS Assay – 48 Test Kit: Cat. #M301

Quidel Molecular Strep A+G Control Set – 20-Reaction Kit: Cat. #M111

Solana GAS Startup Kit:* Cat. #M905QA

and Solana

trademarks used are owned by Quidel Corporation.

Cardinal Health trademark used is owned as indicated at cardinalhealth.mediaroom.com/brand-guidelines.

*Includes 1 leased Solana Instrument, GAS Assay Kit, Quidel Molecular Strep A+G Control Set, 95°C Lysis Heat Block, Printer,

Labels, Tray, 3 Racks and Stylus

SSM301102EN00 (01/18)

SSM301102EN00.qxp_Layout 1 1/18/18 10:53 AM Page 2