Tumor maker FOB Rapid One Step Test with CE certificate uncut sheet
| Product Name | FOB Rapid One Step Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Feces |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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.
PRINCIPLE
The FOB Rapid Test is a qualitative, lateral flow immunoassay for
the detection of human occult blood in feces. The membrane is
pre-coated with anti-hemoglobin antibody on the test line region of
the strip. During testing, the specimen reacts with the particle
coated with anti-hemoglobin antibody. The mixture migrates upward
on the membrane chromatographically by capillary action to react
with anti-hemoglobin antibody on the membrane and generate a
colored line. The presence of this colored line in the test region
indicates a positive result, while its absence indicates a negative
result. To serve as a procedural control, a colored line will
always appear in the control line region indicating that the proper
volume of specimen has been added and membrane wicking has
occurred.
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
Specificity
The FOB Rapid Test is specific to human hemoglobin. Specimen
containing the following substances at the standard concentrations
were tested on both positive and negative controls with no effect
on test results.
| Substances | Concentrations (Diluted with the extraction buffer) |
| Bovine hemoglobin | 1 mg/mL |
| Chicken hemoglobin | 1 mg/mL |
| Pork hemoglobin | 1 mg/mL |
| Goat hemoglobin | 1 mg/mL |
| Horse hemoglobin | 1 mg/mL |
| Rabbit hemoglobin | 1 mg/mL |
| Turkey hemoglobin | 1 mg/mL |
SUMMARY
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
