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Quidel l Rapid Diagnostics l quidel.com l 800.874.1517 l 858.552.1100
The ART of Lyme Testing
3ART ≥minsAdvance Result Technology
Sofia 2 withAdvance Result TechnologyDelivering accurate, objective and automated
results in as few as three minutes!
Accurate, objective and automated results in as few as 3 minutes
Excellent performance compared toWestern Blot
Flexible, dual mode testing andsimple, CLIA-waived proceduresfor a variety of laboratory environments
Secure, remote instrument managementthrough the Virena ecosystem
Integrated data management automatically stores test and user history
User and patient ID captured with onboard barcode scanner
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WALK AWAY Mode – Walk away and multitask READ NOW Mode – Batch multiple samples per hourSofia 2 Development Modes
Lyme Lyme
3-15mins
Lyme
Lyme
Lyme
Lyme
Lyme
Lyme
15
Finger-stick Whole BloodSofia 2 Lyme FIA – Procedure
AllowTube to Empty Twist
off
Squeeze
Shake Upand Down
5x
Invert
Lyme
Squeeze
2x
Place sample here
Lyme
Fill toBlack Line
Sofia 2 Lyme FIA – 15 Test Kit: Catalog #20319
Sofia 2 Lyme FIADifferentiated IgM and IgG results with a singletest
Objective and automated results with noequivocal zone
CLIA-waived for finger-stick whole bloodsamples
Room temperature storage
18-month shelf life from date of manufacture
SL2603 l SS2031901EN00 (08/18)
Agreement with Predicate Assay andWestern Blot*
Result Type
Tier One PPA
Tier One NPA
Tier Two PPA
IgM
82.4%
79.8%
94.1%
IgG
88.9%
85.9%
95.7%
Category
Endemic
Non-Endemic
IgM
86%
93%
IgG
95%
98%
Specificity*
*Refer to the Package Insert for additional performance claims.
Comparator Method
Predicate Assay
Predicate Assay
Western Blot
CLIAWAIVED
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