Product Manual

Page 2 of 124QuickVue RSV 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.
PRINCIPLE OF THE TEST
The QuickVue RSV test is a dipstick immunoassay that allows the capture and visual
detection of RSV antigen (viral fusion protein). The patient specimen is placed in the
Extraction Tube containing the Extraction Reagent, enhancing the exposure of the viral
fusion protein antigen. After extraction, the Test Strip is placed in the Extraction Tube
where the RSV fusion proteins in the specimen will react with the reagents in the Test
Strip.
If the extracted specimen contains RSV antigens, a pink-to-red Test Line, along with a
blue procedural Control Line, will appear on the Test Strip indicating a positive result.
If RSV type antigens are not present, or are present at very low levels, only a blue
procedural Control Line will appear.
REAGENTS AND MATERIALS SUPPLIED
20-Test Kit:
n Shelf box containing:
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Individually Packaged Test Strips (20): Mouse monoclonal anti-RSV viral fusion
protein and control line protein
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Extraction Reagent Bottle (1): With detergents and 0.2% sodium azide
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Extraction Tubes (20)
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Disposable Droppers (20)
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Nasopharyngeal Swabs (20)
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Positive RSV Control Swab (1): Swab is coated with non-infectious RSV antigen
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Negative Control Swab (1): Swab is coated with formalin-inactivated,
non-infectious Streptococcus C antigen
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Package Insert (1)
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Quick Reference Instructions (1)
MATERIALS NOT SUPPLIED
n Timer or watch
n Specimen containers