INTENDED USE

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

SUMMARY

Rotavirus ,Adenovirus and Astrovirus are most common and major causes of severe gatroenteritis in infants and young children.Pattern also observed in adults.They are transmitted by facel-oral contact.The main symptoms of viral gastroenteritis 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 infections with a virus that causes gastroenteritis and may last for 1 to 10 days,depending on which virus causes the illness(Rotavirus 3 days,Adenovirus 5-8 days and Astrovirus 3 days).

PRINCIPLE

The Rota and Adenovirus Antigen Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-Rota virus and anti-Adenovirus Antibdoy conjugated with colloid gold and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of Rota virus, T2 band is coated with antibody for the detection of Adenovirus, 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. Rota virus if present in the specimen will bind to the mouse anti-Rota virus conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating Rota virus positive test result and suggesting a recent infection. Adeno virus, if present in the specimen, will bind to the mouse anti-adenovirus antibody conjugates. The immunocomplex is then captured by the reagent pre-coated on theT2 band, forming a burgundy colored T2 band, indicating Adenovirus positive test result and suggesting a fresh infection. Absence of any test bands (T1 and T2) 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 T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.