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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