INTENDED USE The StrongStep^® Giardia lamblia Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative, presumptive detection of Giardia lamblia in human fecal specimens. This kit is intended for use as an aid in the diagnosis of Giardia lamblia infection. INTRODUCTION Parasitary infections remain a very serious health problem worldwide. Giardia lamblia is the most common protozoa known to be responsible for one of the main causes of severe diarrhoea in humans, particularly in immunodepressed people. Epidemiological studies, in 1991, showed that infections with Giardia increased in the United States with a prevalence of around 6% on 178,000 samples. Generally, the disease passes through a short acute phase followed by a chronic phase. Infection by G. lamblia, in the acute phase, is the cause of watery diarrhoea with principally the elimination of trophozoites. The stools become normal again, during the chronic phase, with transient emissions of cysts. The presence of the parasite on the wall of the duodenal epithelium is responsible for a malabsorption. The disappearance of villosities and their atrophy lead to problems with the digestive process at the level of the duodenum and the jejunum, followed by weight loss and dehydration. The majority of infections remain asymptomatic, however. The diagnosis of G. lamblia is carried out under microscopy after flotation on zinc sulphate or by direct or indirect immunofluorescence, on non-concentrated samples displayed on a slide. More and more ELISA methods are also now available for the specific detection of cysts and/or trophozoïtes. Detection of this parasite in surface or distribution water can be undertaken by PCR type techniques. The StrongStep® Giardia lamblia Antigen Rapid Test Device can detect Giardia lamblia in non-concentrated faecal samples within 15 minutes. The test is based on the detection of a 65-kDA coproantigen, a glycoprotein that is present in the cysts and trophozoites of G. lamblia. PRINCIPLE The Giardia lamblia Antigen Rapid Test Device (Feces) detects Giardia lamblia through visual interpretation of color development on the internal strip. Anti-Giardia lamblia antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-Giardia lamblia antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Giardia lamblia in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. STORAGE AND STABILITY • The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch. • The test must remain in the sealed pouch until use. • Do not freeze. • Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results. StrongStep^® Giardia lamblia Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative, presumptive detection of Giardia lamblia in human fecal specimens. This kit is intended for use as an aid in the diagnosis of Giardia lamblia infection. Benefits Technology Colored latex immune-chromatography. Rapid Results come out in 10 minutes. Room temperature storage Specifications Sensitivity 94.7% Specificity 98.7% Accuracy 97.4% CE marked Kit Size=20 tests File: Manuals/MSDSGiardia lamblia Instructions