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QuickVue H. pylori Test
GastrointestinalThe 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.
INTENDED USE
The QuickVue H. pylori gII test is a lateral-flow immunoassay intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood. The test is intended for use as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use by health care professionals.
FEATURES & BENEFITS
| Feature | Benefit |
| One-step procedure | Easy to use, fewer procedural errors |
| Results in 5 minutes or less | Test and treat in the same office visit |
| Two-color result | Easy to read and interpret |
| Self-contained test Cassette | Clean, easy to use and dispose of |
| Pictorial procedure card | Clear and simple illustrations to guide the H. pylori test procedure |
| All components included in kit | Ready to use, no need for additional equipment |
| Internal controls included | Provides verification of test strip functional integrity, increasing confidence in results |
| External controls included | Facilitates internal laboratory quality control |
| Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. |
PRODUCT SPECIFICATIONS
| 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 | Positive and negative |
| External Controls | Positive and negative |
| Sensitivity* | Biopsy: 90% |
| Specificity* | Biopsy: 78% |
| Agreement (overall)* | Biopsy: 84%, EIA: 92% |
| Activity | ≥ 350 units/vial |
| Form | Liquid |
* For more information about QuickVue H. pylori Test Click Here