Tumor maker FOB Rapid One Step Test with CE certificate Test Device
| Product Name |
FOB Rapid One Step Test
|
| Formats |
Strip(3mm)Device(4mm) |
| Place of Origen |
China |
| Specimen |
Feces |
| Read Time |
15 minutes |
| Shelf life |
2 years |
| Package |
25 device/box or 50 strip/Box |
| Storage |
2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The FOB Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in feces.
Accuracy
The FOB Rapid Test has been compared with another leading commercial rapid test using clinical specimens.
| Method |
Other Rapid Test |
Total Results |
|
FOB Rapid
Test
|
Results |
Positive |
Negative |
| Positive |
183 |
4 |
187 |
| Negative |
11 |
802 |
813 |
| Total Results |
194 |
806 |
1000 |
Relative Sensitivity:94.3% (90.1% - 97.1%)*
Relative Specificity: 99.5% (98.7% - 99.9%)*
Relative Accuracy: 98.5% (97.5% - 99.2%)*
* 95% Confidence Intervals
SUMMARY
Many diseases can cause hidden blood in the stool. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based method lacks sensitivity and specificity, and has diet-restrictions prior to testing.1,2
The FOB Rapid Test is a rapid test to qualitatively detect low levels of fecal occult blood in feces. The test uses double antibody sandwich assay to selectively detect hemoglobin/g feces. In addition, unlike the guaiac assays, the accuracy of the test is not affected by the diet of the patients.
Product Tags:
|
|
98.5% One Step FOB Rapid Test Cassette Feces Tumor Maker Test Images
|
