INTENDED USE

The Haemoglobin Antigen Rapid Test Kit is a coloured chromatographic immunoassay (cut-off qualitative test) for the qualitative determination of human haemoglobin(hHb) in stool specimens.

INTRODUCTION

Colorectal cancer is the second leading cause of illness and death in Western word.The screening with faecal occult blood tests is based on the concept that important target colonic neoplasm,such as early-stage cancer and large adenomatous polyps,will bleed,for which may be detected by an occult blood test.Colorectal cancer is also associated with local acute inflammatory reaction being visualized,in some cases,by white cell neutrophil scanning.
Haemoglobin is the iron-containing oxygen-transport protein in the red blood cells of all vertebrates that maybe leaked into gastrointestinal tract and then dischanged with the feces in gastrointestinal bleeding diseases.
When gastrointestinal blood is lost,the stool will contain a combination of intact or nearly intact haemoglobin,intact heme and heme-derived porphyrins in amounts that depend on the site and amount of bleeding and the transit time through the gut. Immunochemical tests detect intact or nearly intact human haemoglobin,being a very specific technique for detecting loss of blood from the lower intestine,because blood from lower sites is less degraded during transit.

PRINCIPLE

The FOB Rapid Test Kit (Colloidal Gold) has been designed to detect human hemoglobin through visual interpretation of color development in the internal strip. The membrane was immobilized with anti‐human hemoglobin antibodies on the test region. During the test, the specimen is allowed to react with colored anti‐human hemoglobin antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough human hemoglobin in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.