Rotavirus Antigen (Colloidal Gold) is a test intended for use by healthcare professionals and as qualitative screening in vitro diagnostic test for detection of rotavirus antigens in feces of infant or young children to aid in the diagnosis of rotavirus infection. This test is not automated and does not require any additional instrument.
Cat. No: ROT-A01
Benefits
Fast：Instant results within 15 minutesConvenient: Room temperature storage (2-30℃) , valid for 24 months
Easy to Use: No equipment is required to process the specimens or read the results
Non-Invasive Sampling: urine
Description
| Storage: | 2℃-30℃ | Sample Type: | Blood |
|---|---|---|---|
| User: | Professional | Accuracy: | 99.5% (98.1%-99.9%) |
| Certificate: | CE ISO 13485 | OEM: | OEM Customized Packing Avaliable |
| Formats: | 25T/box 1T/box | After-sales Service: | Available |
| Key Words: | Rotavirus Antigen Rapid Test | For The Crowd: | Preliminary Screening Of Infected People |
| High Light: | 99.9% Rotavirus Test Kit,Rotavirus Infectious Disease Rapid Test Kits,Rotavirus Test Kit Single Pack | ||
Specification
| Product Name | Rotavirus Antigen Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
Intended Use
The Rotavirus Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative presumptive detection of rotavirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of rotavirus infection.
Accuracy
The Rotavirus Antigen Rapid Test Device has been compared with other rapid test using clinical specimens.
Table: Rotavirus Antigen Rapid Test vs. Other Rapid Test
| Method | Other Rapid Test | Total Results | ||
Rotavirus Antigen Rapid Test | Results | Positive | Negative | |
| Positive | 224 | 0 | 224 | |
| Negative | 2 | 156 | 158 | |
| Total Results | 226 | 156 | 382 | |
Relative Sensitivity: 99.1% (96.8%-99.9%)*
Relative Specificity: 100% (97.7%-100.0%)*
Overall Agreement: 99.5% (98.1%-99.9%)*
*95% Confidence Interval
Storage
1.Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2.The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
3.Keep away from sunlight, moisture and heat.
4.The manufacturing date is printed on the outer box.