AmpliVue
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AjnpliVue Anytime, Anywhere Molecular Assays Implement anywhere ■ No specialized thermocycling equipment, minimal bench space ■ CLIA Moderately Complex ■ Sealed, disposable cartridge reduces risk of amplicon contamination and need for an isolation room Fast and easy anytime ■ Results in 80 minutes with less than 5 minutes hands-on time, after overnight enrichment ■ Intuitive workflow - can be run by any technician 24/7 ■ Simple results interpretation Cost effective ■ No capital investment ■ Built-in internal control ■ Scalable batch size ■ Lyophilized reagents extend shelf life, reduces waste and re-ordering Quidel | Molecular Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

Sample Preparation Dilution Tube *Fifty-two (52) discordant specimens (AmpliVue Positive/Bacterial Culture Negative) reported above were tested with an FDA-cleared molecular device for the detection of GBS, thirty-nine (39) of these specimens were positive for GBS, and thirteen (13) were negative. **The one (1) discordant specimen (AmpliVue Negative/Bacterial Culture Positive) reported above were tested with an FDA-cleared molecular device for the detection of GBS, and was negative. Prior to discordant analysis, the Negative Predictive Value was 99.8%, and the Positive Predictive Value was...