CTK Biotech, USA Rota/Adeno Ag Rapid 25 Test

The OnSite  Rota/Adeno Ag Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of rotavirus and adenovirus antigens in fecal specimens.

• Stool collection device minimizes sample handling
• Time saving differentiation between rotavrus and adenovirus in a single test
• Result is available in 15 minutes
• No cross-reactivity with other gastrointestinal infectious diseases

Rotavirus A is the most common cause of viral gastroenteritis in children under 5 years of age. Adenovirus type 40 and type 41 account for up to 20% of viral gastroenteritis in young children globally, primarily affecting  pediatric patients less than 2 years old. Diagnosis of rotavirus and adenovirus gastroenteritis is important towards decreasing the unnecessary use of antibiotics. The OnSite Rota/Adeno Ag Rapid Test qualitatively detects and differentiates rotavirus antigen and adenovirus antigen in fecal specimens in a single test.

• Stool collection device limits handling of fecal specimen
• Time saving differentiation between rotavirus and adenovirus in a single test
• Result is available in 15 minutes
• No cross-reactivity with other gastrointestinal disease such as typhoid, cholera, etc.
• Rotavirus: Sensitivity: 100%, Specificity: 97.2% (vs a commercial rapid test)
• Adenovirus: Sensitivity: 100%, Specificity: 97.9% (vs a commercial rapid test)
• 24 month shelf life at 2-30 °C

Each kit contains:

• Individually sealed foil pouches containing:

• • One cassette device
  • One desiccant
• Stool collection devices, each containing 2 mL  sample extraction buffer
• Plastic droppers (for transferring watery stool)
• Patient ID stickers
• One package insert (instruction for use)

TEST PRINCIPLE : The OnSite Rota/Adeno Ag Rapid Test is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing monoclonal anti-rotavirus antibody conjugated with colloidal gold (anti-rotavirus conjugates) and monoclonal anti-adenovirus antibody conjugated with colloidal gold (anti-adenovirus conjugates) and 2) a nitrocellulose membrane strip containing two test lines (R line and A line) and a control line (C line). The R line is pre-coated with anti-rotavirus antibody, the A line is pre-coated with antiadenovirus antibody, and the C line is pre-coated with a control line antibody.   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. Rotavirus Ag, if present in the specimen, will bind to the anti-rotavirus conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-rotavirus antibody forming a burgundy colored R line, indicating a rotavirus positive test result.   Adenovirus Ag, if present in the specimen, will bind to the anti-adenovirus conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-adenovirus antibody forming a burgundy colored A line, indicating an adenovirus positive test result.   Absence of the test lines suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies, regardless of color development on any of the test lines. Otherwise, the test result is invalid and the specimen must be retested with another device.