Quidel QuickVue H. pylori gII (For whole blood)
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Quidel QuickVue H. pylori gII (for whole blood). The QuickVue H. pylori gII test is a lateral flow immuno chromatographic assay intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma or whole blood. FDA Cleared and CLIA Waived. (FDA 510K#: K991747)
QuickVue Brand H. pylori gII (TM) Test:
- Rapid Diagnosis and Treatment: Results in 5 minutes or less means patients can be tested and treated in the same office visit.
- Excellent Performance: 92% overall agreement with EIA.
- Convenient: Room temperature storage, 12 month shelf life, and no costly instrumentation needed.
- Easy to Use: Simple, one-step procedure from only 2 hanging drops of whole blood; serum and plasma can also be used.
- CLIA waived when using whole blood specimens; CLIA Moderately Complex when using serum or plasma.
-The QuickVue H. pylori gII (TM) test is a lateral-flow immuno-chromatographic assay intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. It utilizes a convenient, non-invasive, and easy to perform test methodology to aid physicians in the diagnosis of H. pylori. This test is intended for use by health care professionals.
- Test cassettes (10): Murine monoclonal antibody to human IgG (Test line) and rabbit polylonal antibody (Control Line).
- Disposable Droppers (10)
- Capillary Tubes (10)
- Positive Control (1): Diluted human plasma containing H. pylori-specific IgG, 0.1% thimerosal.
- Negative Control (1): Diluted human plasma, 0.1% thimerosal.
- Package Insert (1)
- Procedure Card (1)
For in vitro diagnostic use. The contents of this kit are for use in the qualitative detectin of H. pylori-specific IgG antibodies and do not indicate the titer of the antibody in the sample. The test should be used only to evaluate adult patients with clinical signs and symptoms suggestive of gastrointestinal disease.
Order No. QDL-0W009
CLIA: Moderately Complex/Non-Waived (Serum/Plasma)
FDA Cleared/CLIAwaived (Whole Blood)
*It is always the provider's responsibility to establish appropriate coding & charges.