Rapid Adeno Rota Test Kit Cassette Card Adeno/rota Virus Stool Antigen Test

For professional and in vitro diagnostic use only.
[INTENDED USE]
The Rotavirus/Adenovirus Antigen Triline Rapid Test Cassette is a lateral
flow immunoassay for the qualitative detection of Rotavirus and Adenovirus
antigens in human feces. This kit is intended to be used as an aid in the
diagnosis of Rotavirus or Adenovirus infection.

[SUMMARY]
Acute diarrheal disease in young children is a major cause of morbidity
worldwide and is a leading cause of mortality in developing countries.
Research has shown that enteric adenoviruses, primarily Ad40 and Ad41,
are a leading cause of diarrhea in many of these children, second only to the
rotaviruses. These viral pathogens have been isolated throughout the world,
and can cause diarrhea in children year round. Infections are most frequently
seen in children less than two years of age, but have been found in patients
of all ages. Further studies indicate that adenoviruses are associated with
4-15% of all hospitalized cases of viral gastroenteritis. Rapid and accurate
diagnosis of gastroenteritis due to adenovirus is helpful in establishing the
etiology of gastroenteritis and related patient management. Other diagnostic
techniques such as electron microscopy (EM) and nucleic acid hybridization
are expensive and labor-intensive. With the self-limiting nature of adenovirus
infection, such expensive and labor-intensive tests may not be necessary.
Rotavirus is the most common agent responsible for acute gastroenteritis,
mainly in young children. Its discovery in 1973 and its association with
infantile gastro-enteritis represented a very important advancement in the
study of gastro-enteritis not caused by acute bacterial infection. The
rotavirus may still be found while diarrhoea continues. Rotaviral
gastroenteritis may result in mortality for populations at risk such as infants,
the elderly, and immunocompromised patients. In temperate climates,
rotavirus infections occur mainly in the winter months. Endemics as well as
epidemics affecting some thousand people have been reported. With
hospitalised children suffering from acute entric disease up to 50% of the
analysed specimen were positive for rotavirus. The viruses replicate in the
cell nucleus and tend to be host species specific producing a characteristic
cytopathic effect (CPE). Because rotavirus is extremely difficult to culture, it
is unusual to use isolation of the virus in diagnosing an infection. Instead, a
variety of techniques have been developed to detect rotavirus in feces.