商品编号


00281



品牌


Quidel



公司


Quidel,inc.



公司分类


hCG


商品信息

Description:
Serum, hCG Control Set
Features & Benefits:






The QuickVue+ hCG Combo Test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in serum or urine using a monoclonal antibody specific to the beta subunit of hCG in a single-step technology for the early detection of pregnancy. Clearly distinguishable +/– result and flex
IBL
e specimen collection options make rapid hCG testing easy.










Feature
Benefit



One-step procedure
Easy to use, fewer procedural errors



Results in 3 to 5 minutes
Fast time to results



Two-color plus/minus result
Popular endpoint for easy to read and interpret pregnancy test results



High sensitivity
ABI
lity to detect low hCG levels as early as 2-3 days before expected menses



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



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



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



External controls available
Facilitates internal laboratory quality control



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



Two kit sizes
Choice that best suits workflow












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Serum, urine



Sample size
4 drops



Time to results
Serum – 5 minutes; Urine – 3 minutes



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



Internal Controls
Positive and negative



External Controls
Low positive, high positive and negative set available separately



Sensitivity
10 mIU/mL (serum); 20 mIU/mL (urine)



Accuracy*
> 99%



Shelf life
21 months from date of manufacture



CLIA complexity
Waived for urine, moderate for serum








*Refer to Package Insert for additional performance claims.