商品编号


20242 XUS



品牌


Quidel



公司


Quidel,inc.



公司分类


RSV



Size

25/12

商品信息

Description:
Test Kit
Features & Benefits:






For use with Sofia 2 and Sofia

The Sofia RSV Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients.?The high sensitivity of the Sofia RSV FIA offers confidence in rapid RSV testing.

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










Feature
Benefit



CLIA waived for children less than 7 years of age
Easy to perform testing



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



Dual work modes
Adjusts to your volume fluctuations



Self-contained test cassette
Clean, easy to use and dispos
IBL
e



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



Objective result
Eliminates the subjectivity of a visual result interpretation



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. No need to wait for reagents to warm up












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Nasopharyngeal swab, 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



Nasopharyngeal swab sensitivity*
86% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 87% [Ages 0 to less than 7 years])



Nasopharyngeal swab specificity*
97% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 96% [Ages 0 to less than 7 years])



Aspirate/wash sensitivity*
89% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 92% [Ages 0 to less than 7 years])



Aspirate/wash specificity*
98% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 98% [Ages 0 to less than 7 years])



Shelf life
24 months from date of manufacture








*Refer to Package Insert for additional performance claims.