This assay is a one-step 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) anitrocellulose 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 an adequate volume of test specimen is dispensed into the sample well of the device, the test specimen migrates by capillary action across the test strip. If the concentration of hHb in the specimen is at or above 50 ng/ ml, 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.
Materials and Components
1.100 test devices (strips), each sealed in a foil pouch.
2.Fecal sample tube including 1.2ml dilute buffer (0.85% NaCL) for each test.
3.One package insert (instructions for use).
Randomly pierce the fecal specimen with the swab or stick at least 5 different sites to pick up and put into the fecal collection tubes with buffer.
Wait for red colored bands to appear. The test should be read in approximately 10 minutes. Do not interpret results after 10 minutes.