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Rapid one-step immunoassay for the detection of H. pylori antigens in human stool. Utilizes a monoclonal anti-H. pylori antibody as the capture and detector antibodies. A diluted patient stool sample is dispensed into the sample port of the test device and the appearance of a pink-red line in the reading window next to the letter T after 5 minutes of incubation at room temperature (20°–26° C) indicates a positive result. |
| Meridian Catalogue #: | 750720 |
| Kit Size | 20 Tests |
| Shelf Life from date of manufacture | 24 Months |
| Storage Requirements | 2°-8° C |
| Specimen Type | Stool |
| Assay Format | Test Card |
| CE Marked | Yes |
| Sensitivity | 90.6% |
| Specificity | 91.5% |
| Hazardous | No |
| Country of Origin | USA |
| Available Within/Outside USA | Yes |
| Suggested CPT Code | 87338 or 87899 |
| Weight | |
| Results Interpretation |
Positive Test BLUE band at Control Line plus PINK-RED band at Test Line. No other bands should be seen. Negative Test BLUE band at control line only. No other bands should be seen. Invalid Results 1. Band at Test Line without band at Control Line, or 2. Band of wrong color at Test Line, or 3. No Test Line AND no Control Line, or 4. Test Line band that appears after 6 minutes.
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