Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| Product Name |
Infection Disease H.Pylori antibody uncut sheet |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.Pylori in whole blood, serum or plasma to aid in the diagnosis of H.Pylori infection.
PERFORMANCE CHARACTERISTICS
Table: H. pylori Rapid Test vs. Biopsy/Histology/RUT
|
Relative Sensitivity: >95.0% (90.0%-97.9%)* Relative Specificity: >95.7% (92.3%-97.9%)* Overall Agreement: >95.4% (92.8%-97.3%)* *95% Confidence Interval |
H.Pylori Rapid Test | ||||
| + | - | Total | |||
|
Biopsy/ Histology/ RUT |
+ | 131 | 7 | 138 | |
| - | 10 | 225 | 235 | ||
| 141 | 232 | 373 | |||
The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a qualitative membrane device based immunoassay for the detection of H.Pylori antibodies in whole blood, serum, or plasma. In this test, specimen or specimen followed by buffer is added to the specimen well of the test device. The specimen migrates chromatographically along the length of the test strip contained within the device and interacts with the reagents on the strip. If the specimen contains H.Pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H.Pylori antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.