INTENDED USE

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

SUMMARY

Giardia,a flagellated protozoan,inhabits the upper part of the small intestine of its host and has a two major states in the life cycle:trophozoites which produces the antigens(α-1 giardin) and cyst with produces the antigens(CWP1).After the host ingest the cysts,which are the infective stage, the trophozoites emerge from the cysts in the duodenum and attach to the small intestinal mucosa.They undergo mitotic division in the intracellular lumen,some will encyst to protect themselves and will be eliminated from the host in the feces.The trophozoite is the vegetative form and replicates in the small intestine.
Giardiasis is a diarrheal illness caused by a very small parasite,Giardia intestinalis(also known as Giardia lamblia and Giardia duodealis). Once an animal or person is infected with Giardia,the parasite lives in the intestine and is passed in the stool.The parasite is protected by an outer shell and can survive outside the body and in the environment for a long time.The most common symptoms of giardiasis include:diarrhea,loose or watery stool,stomach cramps and upset stomach.These symptoms generally begin 1-2 weeks after infection,and may last 2-6 weeks in healthy indiciduals.Sometimes symptos last longer and may lead to weight loss and dehydration.Some people will have no symptos.However,people with weakened immune systems(e.g.persons with HIV/AIDS,camcer patients,and transplant patients) ot the elderly may have a more serious infection that can lead to severe illness or death.

PRINCIPLE

The Giardia 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-Giardia 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-Giardia antibody for the detection of Giardia 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.
Giardia if present in the specimen will bind to the monoclonal mouse anti-Giardia antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-Giardia antibody, forming a burgundy colored T band, indicating a Giardia 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.