The FOB Rapid Test Cassette (Feces) is a qualitative, lateral flow immunoassay rapid test to detect low levels of Human Fecal Occult Blood. The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 40ng/mlor higher, or 6μg/g feces. In addition, unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.
Relative sensitivity: 210/222=94.6% (95%CI*: 90.7%~97.2%);
Relative specificity: 850/856=99.3% (95%CI*: 98.5%~99.7%);
Accuracy: (210+850)/(210+6+12+850) =98.3% (95%CI*: 97.4%~99.0%).