Certification

The QuickVue+ Strep A test is considered Moderate complexity by CLIA and requires competency and continued education. This is accomplished by reading the following tutorial. At the end there is a form that needs to be filled out and kept on file in the Department of Emergency Medicine. The guidelines state one must prove competency 6 months after initial introduction then annually there after. Please ensure that you follow these guidelines to allow continued use of the Rapid Strep test by all physicians in the ED.

Intended Use

The QuickVue+ Strep A test is intended for the rapid detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for use as an aid in the diagnosis of Group A Streptococcal infection.

Summary and Explanation

Group A Streptococcus is the most significant cause of pharyngitis. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and serious complications such as rheumatic fever and glomerulonephritis. Conventional culture methods require 24-48 hours for results.

Principles of the Procedure

• QuickVue+ Strep A is a lateral-flow immunoassay, containing a highly specific and sensitive antibody to Group A Strep antigen.
• To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Test Cassette.
• If the sample contains Strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line (-), forms a plus sign (+) to indicate a positive result. If Strep A is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result.
• As the sample continues to move through the test, the Control Window containing Strep A antigen becomes pink. Pink color in the Control Window indicates that the detection antibody is functionally active and is also evidence that the detection part of the test is functioning properly.
• The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs approximately 5 minutes after the addition of the extracted sample to the Test Cassette.

Storage and Stability

Store kit at room temperature, 59-86 degrees F. Kit contents are stable until the expiration date printed on the outer box. Do not freeze.

Warnings and Precautions

• Do not use beyond the expiration date printed on the outside of the box.
• Use appropriate precautions in the collection, handling, storage and disposal o specimens, controls and the used kit contents. Discard used materials in a proper biohazard container. Dispose of all containers and unused contents in accordance with Federal, State and local requirements.
• The Test Cassette must remain sealed in the foil pouch until just prior to use.
• Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of water
• Do not interchange reagent bottle caps
• Do not use Reagent B if solution is green prior to mixing with Reagent B in the Tube. If this occurs, contact Quidel Technical Support.
• To obtain accurate results, you must follow the package insert instructions.

Specimen Collection and storage

1. Collect throat swab specimens by standard clinical methods. When swabbing the throat, be careful not to touch the tongue, sides or top of the mouth with the swab. Rub the swab on the back of the throat, on the tonsils and in any other area where there is redness, inflammation or pus. Bloody specimens can create an interfering background and can cause an invalid results. Consult reference procedures such as the collection method described by Auckland.
2. Use rayon-tip or dacron-tip swabs with solid plastic shafts; individually packaged sterile rayon-tipped swabs are provided in the kit. Do not use calcium alginate, cotton-tip or wooden shafted swabs. Swab specimens should be processed as soon as possible after collection. However, swabs can be stored in a clean, dry, seal able plastic tube or in 1 cc or less liquid media, such as modified Stuart's Transport Media, for up to eight hours at room temperature or 72 hours refrigerated . Do not use charcoal agar or semi-solid transport media.
3. If culture results are also desired, lightly streak the swab on a5% sheep blood agar plate before using the QuickVue+ Strep A test. The culture plate must be streaked prior to running the QuickVue+ test, as the reagents will kill the bacteria on the swab. Throat swab specimens can also be obtained by dual swabs or by two swabs taken in sequence for the culture procedure.

Culture Confirmation

The QuickVue+ Strep A test can be used to confirm the identification of Group A Streptococcus on SBA culture plates. Lightly touch a colony using a sterile swab. Do not sweep the plate. Follow the instructions in the TEST PROCEDURE section to test the sample.