COMPANY
CLIA WAIVED RAPID TESTS
CLIA LABORATORY
CONTACT US
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
Quickvue® H. Pylori GII, CLIA Waived
Due to FDA regulations, this product needs to be shipped to a CLIA-Waived or Moderately Complex licensed location.
We kindly ask that you provide an licensed facility address during checkout to ensure prompt delivery.
Thank you for your understanding and cooperation.
description
The QuickVue H. pylori Test detects IgG antibodies specific to Helicobacter pylori in human serum, plasma or whole blood. It utilizes a convenient, non-invasive, and easy to perform test methodology to aid in the diagnosis of H. pylori. The test is easy to perform in a one-step procedure using two hanging drops of whole blood. Serum and plasma can also be used.
|
Sample type
|
Whole blood, serum or plasma |
|
Sample size
|
Whole blood: 1 capillary tube or 2 hanging drops; Plasma: 1 drop (50 µL); Serum: 1 drop (50 µL) |
|
Time to
results
|
5 minutes or less |
|
Kit storage
conditions
|
Room temperature (15°C to 30°C/59°F to 86°F) |
|
Internal
Controls
|
Included |
|
External Controls
|
Included |
|
Sensitivity*
|
Biopsy: 90% |
|
Specificity*
|
Biopsy: 78% |
|
Agreement
(overall)*
|
Biopsy: 84%, EIA: 92% |
|
Activity
|
≥ 350 units/vial |
|
Form
|
Liquid |
CLIA WAIVED RAPID TESTS
CLIA LABORATORY
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
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