QuickVue In-Line Strep A Test

quidel-strepa-img2

quidel

Strep A

Respiratory

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 readability 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.

The QuickVue In-Line Strep A Test is a lateral-flow immunoassay utilizing an in-the-device antigen extraction. The test, containing a highly specific and sensitive antibody reactive to the Strep A antigen, is specific to group A with no crossreactivity to other groups of Streptococci.

FEATURES & BENEFITS
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 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
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.

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