FOB Rapid Test Uncut Sheet Rtk Self Test 3mm Strip 4mm Device

Tumor maker FOB Rapid One Step Test with CE certificate uncut sheet

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.

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.