The QuickVue+ Strep A Test is designed for the rapid detection of Group A Streptococcal antigen directly from throat swabs and beta-hemolytic colonies recovered from culture. Intended for use by healthcare professionals, this test aids in diagnosing Group A Streptococcal infection.

Group A Streptococcus is a primary cause of pharyngitis. Early diagnosis and treatment of Group A Streptococcal pharyngitis can reduce the severity of symptoms and prevent serious complications such as rheumatic fever and glomerulonephritis. Traditional culture methods require 24-48 hours for results.

The QuickVue+ Strep A Test is a lateral-flow immunoassay using a highly specific and sensitive antibody to Group A Strep antigen. To perform the test, a throat swab specimen is collected and antigen is extracted with Reagents A and B. The extracted sample is then added to the Test Cassette. If the sample contains Strep A antigen, a pink vertical line (|) appears in the Read Result Window, forming a plus sign (+) with the pre-printed blue horizontal line (–) to indicate a positive result. If Strep A is not present, only the pre-printed blue horizontal line (–) will appear, indicating a negative result. The Control Window will turn pink, confirming that the detection antibody is active and the test is functioning correctly.

Features:

• Two-color, +/- result for easy interpretation.
• Results in only 5 minutes, allowing for test and treatment in the same office visit.
• Two reagents simplify the process with fewer steps and minimal training required.

Contents Included:

• (25) Test Cassettes
• (1) Extraction Reagant A
• (1) Extraction Reagant B
• (25) Sterile Throat Swabs
• (25) Tubes and Tips
• (1) Postive Control
• (1) Negative Control
• (1) Package Insert
• (1) Procedure Card

Warnings and Precautions:

• For in vitro diagnostic use.
• Do not use kit contents after the expiration date printed on the outside of the kit.
• Use appropriate precautions in the collection, storage, handling, and disposal of patient samples and used kit contents.
• Use of Nitrile or Latex gloves is recommended when handling patient samples.
• Dispose of containers and unused contents in accordance with Federal, State, and Local requirements.
• DO NOT interchange caps among reagents.
• The Test Cassette must remain sealed in the foil pouch until just prior to use.
• Reagent A contains 27.6% sodium nitrite and may be harmful if ingested or absorbed.
• Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of water.
• Do not use Reagent B if solution is green prior to mixing with Reagent A in the Tube. If this occurs, contact Quidel Technical Support.
• To obtain accurate results, you must follow the Package Insert instructions.

Storage: Store kit at room temperature, 59–86°F (15–30°C). Kit contents are stable until the expiration date printed on the outer box. Do not freeze.

Test Procedure:

Step 1:

• Remove the test Cassette from the foil pouch and place it on a level surface.
• Put a clean Tube in the Tube Well of the Test Cassette. Squeeze 4 DROPS of Reagent A and 4 DROPS of Reagent B into the Tube. The solution should turn green once Reagent B is added.
• Note: when adding drops, hold bottle vertically so that a complete drop forms.

Step 2:

• Immediately place the Throat Swab into the Tube. Mix solution thoroughly by swirling the swab 5 times (or vortex briefly).
• Wait 1 minute.

Step 3:

• Remove the Tube from the Tube Well. Express all liquid from the Swab head by rolling the Swab against the inside of the Tube and squeezing firmly as it is withdrawn from the Tube. Discard the Swab.
• Put a clean Tip on the Tube.

Step 4:

• Add 2 DROPS from the Tube to the round Sample Well in the test Cassette

Step 5:

• For a valid result the test must be read in 10 minutes or less after adding the sample and there must be ANY shade of blue in the Test Complete Window.
• If there is no shade of blue in the Test Complete Window at 10 minutes, the result is invalid.