商品编号


00343IN XUS



品牌


Quidel



公司


Quidel,inc.



公司分类


Strep



Size

25/12

商品信息

Description:
Test Kit
Features & Benefits:






The QuickVue In-Line?Strep A Test uses a unique in-line extraction to detect group A streptococcal antigen directly from patient throat swab specimens. Two-color results give clear read
ABI
lity and proven accuracy provides for dependable results. This is a true one-step test and is the first rapid strep A test waived under CLIA '88.










Feature
Benefit



Results in 5 minutes
Test and treat in the same office visit



One reagent
Fewer steps, easy to perform, requires minimal training



Two-color result
Easy to read and interpret



Pictorial Procedure Card
Clear and simple illustrations to guide the rapid strep A test procedure



All components included in kit, including internal controls
Ready to use, no need for additional equipment



Internal controls included
Provides verification of test strip functional integrity, increasing confidence in results



External controls included
Facilitates internal laboratory quality control



Room temperature storage
No refrigerator space needed. No need to wait for reagents to warm up. Rapid Strep A tests can be run immediately as needed












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Throat swab



Time to results
5 minutes



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



Internal controls
Positive and negative



External controls
Positive and negative



Overall accuracy*
96% overall agreement to SBA culture



Shelf life
24 months from date of manufacture



CLIA complexity
Waived








*Refer to Package Insert for additional performance claims.