商品编号


20193



品牌


Quidel



公司


Quidel,inc.



公司分类


RSV



Size

20/12

商品信息

Description:
Test Kit
Features & Benefits:






The QuickVue RSV Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). A single sample can be used to run both the QuickVue RSV Test and QuickVue brand Influenza tests.










Feature
Benefit



Dipstick
Easy to use, approx. 30 seconds to 1 minute hands-on time



Results in 15 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



3 step procedure
Easy to use, fewer procedural errors



Quick Reference Instructions
Clear and simple illustrations to guide the RSV test procedure and interpretation of results



All components included in kit
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 RSV tests can be run immediately as needed












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash



Time to results
15 minutes or less



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



Internal controls
Positive and negative included



External controls
Positive and negative included



Sensitivity*
92% - Nasopharyngeal swab; 99% - Nasopharyngeal aspirate; 83% - Nasal/nasopharyngeal wash



Specificity*
92% - Nasopharyngeal swab; 92% - Nasopharyngeal aspirate; 90% - Nasal/nasopharyngeal wash



PPV*
56% - Nasopharyngeal swab; 84% - Nasopharyngeal aspirate; 86% - Nasal/nasopharyngeal wash



NPV*
99% - Nasopharyngeal swab; 99% - Nasopharyngeal aspirate; 88% - Nasal/nasopharyngeal wash



Overall accuracy *
92% - Nasopharyngeal swab; 94% - Nasopharyngeal aspirate 87% - Nasal/nasopharyngeal wash



Shelf life
24 months from date of manufacture



CLIA complexity
Waived








*Refer to Package Insert for additional performance claims.