Product Manual

Page 1 of 66QuickVue+ Strep A test
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
INTENDED USE
The QuickVue+ Strep A test is intended for the rapid detection of Group A Streptococcal
antigen directly from throat swabs and beta-hemolytic colonies recovered from culture.
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.
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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.
CLIA Complexity: MODERATE
FOR USE BY HEALTH CARE PROFESSIONALS