CTK Biotech, USA  FOB Rapid 25 Test

The OnSite   FOB Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of fecal occult blood in human fecal specimens in laboratories or physician offices. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the detection of bleeding caused by a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.

• Designed to specifically detect low levels of fecal occult blood, hHB ? 25 ng/mL
• Higher accuracy, sensitivity and specificity than the Guaiac Test
• No dietary restrictions
• Clear, easy-to-interpret result
• Shelf time 24 month
• Specificity >98%, highly specific for human Hb

Clinical Performance Relative Sensitivity: 95.8%; Relative Specificity: 98.8%; Overall Agreement: 97.8% Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette test device
  • One desiccant
• Stool collection devices, each containing 2 mL of extraction buffer (REF SB-R2011)
• Patient ID stickers
• One package insert (instruction for use)

TEST PRINCIPLE  : The OnSite FOB-Hi Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a burgundy colored conjugate pad containing monoclonal anti-hHb antibody conjugated with colloid gold (anti-hHb conjugates) and 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another monoclonal anti-hHb antibody, and the C line is pre-coated with a control line antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. hHb, if present in the specimen at or higher than 25 ng/mL, will bind to the anti-hHb conjugates. The immunocomplex is then captured by the pre-coated reagent forming a burgundy colored T line, indicating a FOB positive test result. Absence of the T line suggests a negative result. Each test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control line antibodies regardless of the color development on the T line. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.