Quidel 343 - Quickvue In-Line Streptococcus Group A Test Kit 25/Bx, 12 BX/CA

Quidel 343 - Quickvue In-Line Streptococcus Group A Test Kit 25/Bx, 12 BX/CA

Quickvue In-Line Streptococcus Group A Test Kit, 25/BX, 12 BX/CA

The QuickVue In-LineStrep 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.

• 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

Group A Streptococci are organisms that typically cause illnesses such as tonsillitis, pharyngitis and scarlet fever. These infections can lead to serious complications, including rheumatic fever and acute glomerulonephritis.1 Rapid diagnosis and appropriate antibiotic therapy of Group A Streptococcal infections appear to be the best means of preventing these complications. The traditional means of detecting Group A Streptococcal infection involves 24-48 hour culture of throat swab specimens or other exudates, confirming beta-hemolysis, and showing susceptibility to bacitracin. Group A, but generally not other groups of betahemolytic Streptococci, is bacitracin susceptible which provides a presumptive diagnosis of Group A Streptococcal disease.

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 cross-reactivity from other groups of Streptococci.

Principle of the Test

To perform the test, a Throat Swab specimen is collected and inserted into the Swab Chamber of the Test Cassette. The Extraction Solutions are mixed, resulting in a green color change, and added to the Swab in the Swab Chamber in order for the antigenic component of the bacteria to be extracted.

Extraction begins instantaneously, after which the extracted solution flows from the Swab Chamber onto the test strip by capillary action. The extracted sample flows through a label pad consisting of a pink label containing rabbit polyclonal anti-Strep A antibody and a blue control label. If the extracted solution contains Strep A antigen, the antigen will bind to the antibody on the pink test label which, in turn, will bind a rabbit polyclonal anti-Strep A antibody spotted on the membrane, resulting in the formation of a pink-to-red Test Line. A blue Control Line will also appear next to the letter "C" on the Test Cassette indicating that the reagents were mixed and added properly, proper volume of fluid entered the Test Cassette and capillary flow occurred. A blue Control Line should always appear in a properly functioning Test Cassette. If Strep A is not present or present at very low levels, only a blue Control Line will be visible.

Product Specifications

• Sample type: Throat swab
• Time to results: 5 minutes
• Kit storage conditions: Room temperature (15? to 30?/59? to 86?)
• 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