Infection Disease Rotavirus Antigen Rapid Test with CE certificate
Uncut sheet
| 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.
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
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 | |
SUMMARY
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.
