Rotavirus Ag Rapid Test
CTK Biotech, USA Rotavirus Ag Rapid 25 Test
The OnSite Rotavirus Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of rotavirus antigen in fecal specimens.
- Stool collection device minimizes sample handling
- Utilizes a pair of specific antibodies to detect rotavirus antigen
- Detects Group A rotavirus
- Result is available in 15 minutes
- No cross-reactivity with other gastrointestinal infectious diseases
- Sensitivity: 100%, Specificity: 97.2% (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 extraction buffer
- Plastic droppers (for transferring watery stool)
- Patient ID stickers
- Package insert (instruction for use)
TEST PRINCIPLE :
The OnSite Rotavirus Ag Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a burgundy colored conjugate pad containing monoclonal anti-rotavirus antibody conjugated with colloidal gold (anti-rotavirus conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another monoclonal anti-rotavirus antibody, and the C line is pre-coated with a control line antibody. When an adequate volume of extracted 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 rotavirus antibody forming a burgundy colored T line, indicating a rotavirus positive test result. Absence of the T line suggests that the concentration of rotavirus Ag in the specimen is below the detectable level, indicating a rotavirus 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 the T line. Otherwise, the test result is invalid and the specimen must be retested with another device.
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