Intended Use:

Test for qualitative detection of faecal occult blood in human faecal sample.

Introduction:

The iFOB (immunochemical Faecal Occult Blood) test is an immunochemical device intended for the qualitative detection of faecal occult blood by laboratories or physicians’ offices. It is useful in determining gastrointestinal (GI) bleeding found in a number of gastrointestinal disorders, such as: diverticulitis, colitis, polyps, and colorectal cancer. This test is recommended for use in: (1) routine physical examinations or when hospital patients are first admitted, (2) hospital monitoring for GI bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding from any source.

Method Principal:

The iFOB test is a lateral flow chromatographic immunoassay. The test strip consists of: (1) a burgundy colored conjugate pad containing mouse anti-hHb antibodies conjugated with colloidal gold and (2) a nitrocellulose membrane strip containing a Test line (T-line) and a Control line (C-line). The T-line is coated with anti-hHb antibodies, and the C-line is coated with goat anti-mouse IgG antibodies. When the correct volume of test specimen is dispensed into the sample well of the device, the test specimen migrates across the test strip. If the concentration of hHb in the specimen is at or above 50 ng hHb/mL or 50μg hHb/g feces, the T-line appears as a visible burgundy line. If the concentration of hHb in the specimen is below the detectable level, no T-line develops. The C-line is coated with goat anti-mouse antibody, which binds to the conjugated monoclonal antibody, regardless of the presence of hHb in the specimen.