the art of flu te st ing...sofia influenza a+b fia –25 test kit: catalog #20218 sofia influenza...

2
Quidel l Rapid Diagnostics l quidel.com l 800.874.1517 l 858.552.1100 The ART of Flu Testing 3 ART mins Advance Result Technology Sofia 2 with Advance Result Technology Delivering 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 to molecular and viral culture methods Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments Secure, remote instrument management through 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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Page 1: The ART of Flu Te st ing...Sofia Influenza A+B FIA –25 Test Kit: Catalog #20218 Sofia Influenza A+B FIA Cleared as a Class II rapid antigen test under the new FDA reclassification

Quidel l Rapid Diagnostics l quidel.com l 800.874.1517 l 858.552.1100

The ART of Flu 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 tomolecular and viral culture methods

Flexible, dual mode testing and simple, CLIA-waived proceduresfor a variety of laboratory environments

Secure, remote instrument managementthrough the Virena ecosystem

Integrated data managementautomatically stores test and user history

User and patient ID captured with onboard barcode scanner

Sofia2 SS_Flu_10.qxp_Layout 1 5/10/17 4:59 PM Page 1

Page 2: The ART of Flu Te st ing...Sofia Influenza A+B FIA –25 Test Kit: Catalog #20218 Sofia Influenza A+B FIA Cleared as a Class II rapid antigen test under the new FDA reclassification

WALK AWAY Mode – Walk away and multitask READ NOW Mode – Batch multiple samples per hour

Sofia 2 Development Modes

153-15mins

Nasal/Nasopharyngeal Swab Procedure Nasopharyngeal Aspirate/Wash Procedure

Sofia Influenza A+B FIA – ProceduresOR

CLIA Waiver Studies

*Refer to the Package Insert for additional performance claims.

Samples

Influenza A

Influenza B

Sens

93%

99%

90%

88%

Spec

95%

96%

96%

96%

NS/NPS

NPA/NPW

NS/NPW

NPA/NPW

Sofia Influenza A+B FIA Results vs. Culture*

Class IICERTIFIED

Sofia Influenza A+B FIA – 25 Test Kit: Catalog #20218

Sofia Influenza A+B FIACleared as a Class II rapid antigen test underthe new FDA reclassification requirements

Approved for collection with Nasal swabs, NPswabs and NP aspirate/wash samples

Single specimen may be used for both SofiaRSV and Sofia Influenza

Compatible with viral transport media

Room temperature storage

21-month shelf life from date of manufacture

SL9014 l SS2021803EN00 (05/17)

CLIAWAIVED

Sofia2 SS_Flu_10.qxp_Layout 1 5/10/17 4:59 PM Page 2