INTENDED USE

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

SUMMARY

Rotavirus,Adenovirus and Astrovirus are most common and major casues of severe gastroenteritis in infants and young children.Pattern also observed in adults.They are transmitted by faecal-oral contact.The main symptoms of viral gastroenyeritis are watery diarrhoea and vomiting.The affected person may also have headache,fever and abdominal cramps(“stomach ache”).In general,the symptoms begin 1 to 2 days following infection with a virus that causes gastroenteritis and may last for 1 to 10days, depending on which virus causes the illness(Rotavirus 3 days,Adenovirus 5-8 days and Astrovirus 3 days).

PRINCIPLE

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