Product Manual

Page 1 of 64QuickVue Dipstick 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 Dipstick Strep A test is intended for the rapid, qualitative detection of
Group A Streptococcal antigen from throat swabs or confirmation of presumptive
Group A Streptococcal colonies recovered from culture. The test is to be used to aid
in the diagnosis of Group A Streptococcal infection. For use by healthcare professionals.
sUmmary and explanatIon
Group A Streptococcus is one of the most important causes of acute upper respiratory
tract infection. 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.
1
Conventional identification procedures
for Group A Streptococcus from throat swabs involve the isolation and subsequent
identification of viable pathogen techniques that require 24 to 48 hours or longer for
results.
2
prIncIple of the test
The QuickVue Dipstick Strep A test is a lateral-flow immunoassay utilizing Quidel’s
patented antibody-labeled particles. The test detects either viable or nonviable
organisms directly from throat swabs or culture colonies within 5 minutes.
To perform the test, a throat swab specimen is collected. Antigen is extracted from the
swab specimen with Reagents A and B. The Dipstick is then added to the extracted
sample.
If the sample contains Strep A antigen, a pink-to-purple Test Line along with a blue
procedural Control Line will appear on the Dipstick, indicating a positive result. If Strep A
antigen is not present, or present at very low levels, only a blue procedural Control Line
will appear.