商品编号


20218 US



品牌


Quidel



公司


Quidel,inc.



公司分类


Influenza



Size

25/12

商品信息

Description:
Test Kit
Features & Benefits:






For use with Sofia 2 and Sofia

The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens.

Sofia 2 with Advance Result Technology (ART) delivers accurate, objective and automated results in as few as three minutes.










Feature
Benefit



CLIA waived for nasal and nasopharyngeal swabs, nasal aspirate and wash
Easy to perform testing



Compat
IBL
e with RSV Extraction Reagent
A single sample can be used to run both Sofia Influenza A+B and Sofia RSV



Dual work modes
Adjusts to your volume fluctuations



Self-contained test cassette
Clean, easy to use and dispose of



Fixed-volume
Pipette
Collects and dispenses correct amount of sample needed for testing



Objective result
Eliminates the subjectivity of a visual result



All components included in kit
Ready to use with Sofia or Sofia 2, no need for additional equipment



Room temperature storage
No refrigerator space needed. Rapid influenza tests can be run immediately as needed












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash



Time to results
Sofia 2: Positive result in as few as 3 minutes, negative result 15 minutes
Sofia: 15 minutes


Kit storage conditions
Room temperature (15°C to 30°C/59°F to 86°F)



Controls
Positive and negative



Nasal Swab Sensitivity*
A: 90%, B: 89%



Nasopharyngeal Swab Sensitivity*
A: 97%, B: 90%



Nasopharyngeal Aspirate/Wash Sensitivity*
A: 99%, B: 88%



Nasal Swab Specificity*
A: 95%, B: 96%



Nasopharyngeal Swab Specificity *
A: 95%, B: 97%



Nasopharyngeal Aspirate/Wash Specificity*
A: 96%, B: 96%



Shelf life
24 months from date of manufacture



Transport Media Compatibility
Copan Universal Transport Media, Hank’s Balanced Salt Solution, M4, M4-RT, M5, M6, Modified Liquid Stuarts, Saline, Starplex Multitrans



CLIA Complexity
Waived








*Refer to Package Insert for additional performance claims.