( RV/ADV Ag)Rotavirus and Adenovirus Antigens 3-line IVD Rapid Test kit Stool/Cassette ISO13485/CE

Product Name : Rotavirus and Adenovirus Antigens 3-line( RV/ADV Ag)2-in -1 Rapid Test Kits

Intended Use:

The EUGENE ^® RV/ADV Ag Rapid Test is a lateral flow immunochromatographic assay for the qualitative simultaneous rapid detection and differentiation of Rotavirus and Adenovirus antigens in stool. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Rotavirus and/or Adenovirus. The test is recommended for professional use only. All results must be interpreted together with other clinical information available to the physician.

S ummary: Human gastroenteritis is a multifactorial disease. It can be caused by various pathogens agent viruses (Adenovirus or Rotavirus), bacteria (Salmonella, E. coli) or protozoan microorganisms such as Cryptosporidium parvum. Rotavirus and Adenovirus are the main cause of acute gastroenteritis, especially in children under the age of two years. Rotaviruse and adenovirus have been identified in almost 50% of the feces of children with gastroenteritis. Rotavirus and Adenovirus infections occur frequently during the winter months. Gastroenteritis from enteric viruses can be mortal in risk populations such as children, the elderly or immunosuppressed individuals. Characteristic symptoms include vomiting, hydrodiarrhoea for between 3 and 8 days, high temperature and stomach pains. Rotaviruses and adnoviruses transferred via the fecal-oral route are eliminated in large quantities into the intestine, so that hospital-borne infections from rotaviruses and/or Adenoviruses are regarded very seriously, particularly in baby stations and paediatric clinics, and are difficult to control. Early and reliable detection so that rotaviruses and/or Adenoviruses can be recognized and further infections avoided is therefore very important.

The EUGENE ^® RV/ADV Ag Rapid Test is an immunochromatographic assay that uses antibody-coated colloidal gold to detect the presence of Rotavirus and Adenovirus antigens in stool specimens. The test detects directly antigens in specimens for an active infection. It is simple and easy to perform and the test results can be visually interpreted within 15 minutes.

Relevant Data

Storage&Stability : The test kit is to be stored at refrigerator (2-8℃) or at room temperature (up to 30℃) in the sealed pouch. The test device is stable before the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze or expose the kit over 30°C.