Product Name |
Rotavirus Antigen Rapid Test |
Formats | Strip(3mm)Device(4mm) Uncut sheet |
Place of Origen | China |
Specimen | Urine |
Read Time | 15 minutes |
Shelf life | 2 years |
Package | Uncut sheet |
Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
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.
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
Specificity:
Cross reactivity with following organisms has been studied at 1.0 x 107 organisms/mL. The following organisms were found negative when tested with the Rotavirus Antigen Rapid Test Device .
Staphylococcus aureus | Proteus mirabilis | Neisseria gonorrhea |
Pseudomonas aeruginosa | Acinetobacter spp | Group B Streptococcus |
Enterococcus faecalis | Salmonella choleraesius | Proteus vulgaris |
Group C Streptococcus | Gardnerella vaginalis | Enterococcus faecium |
Klebsiella pneumoniae | Acinetobacter calcoaceticus | Hemophilus influenzae |
Branhamella catarrhalis | E.coli | Neisseria meningitidis |
Candida albicans | Chlamydia trachomatis |
Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advancement in the study of gastro-enteritis not caused by acute bacterial infection. The rotavirus may still be found while diarrhoea continues. Rotaviral gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and immunocompromised patients. In temperate climates, rotavirus infections occur mainly in the winter months. Endemics as well as epidemics affecting some thousand people have been reported. With hospitalised children suffering from acute entric disease up to 50% of the analysed specimen were positive for rotavirus. The viruses replicate in the cell nucleus and tend to be host species specific producing a characteristic cytopathic effect (CPE). Because rotavirus is extremely difficult to culture, it is unusual to use isolation of the virus in diagnosing an infection. Instead, a variety of techniques have been developed to detect rotavirus in feces.