INTENDED USE

The Cryptosporidium Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Cryptosporidium in human Fecal Specimen. It is suitable for the auxiliary diagnosis of Cryptosporidium infection.

SUMMARY

Cryptosporidium parvum is the major cause of persistent diarrhoea in developing countries. This parasite is recognised as a highly infectious enteric pathogen and infective stage is transmitted by the fecal-oral route. Symptoms of cryptosporidiosis include watery diarrhoea, stomach cramps, weight loss, naausea and sometimes fever.

PRINCIPLE

The Cryptosporidium Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (monoclonal mouse anti-Cryptosporidium antibody conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing test band (T bands) and a control band (C band). The T band is pre-coated with monoclonal mouse anti-Cryptosporidium antibody for the detection of Cryptosporidium antigen, and the C band is pre-coated with goat anti rabbit IgG. 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.
Cryptosporidium if present in the specimen will bind to the monoclonal mouse anti-Cryptosporidium antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-Cryptosporidium antibody, forming a burgundy colored T band, indicating a Cryptosporidium antigen positive test result. Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid, and the specimen must be retested with another device.