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CE ISO Rotavirus Uncut Sheet Rapid Test Rtk Antigen Test Kit

Hangzhou Aichek Medical Technology Co.,Ltd
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Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China

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Hangzhou Aichek Medical Technology Co.,Ltd

CE ISO Rotavirus Uncut Sheet Rapid Test Rtk Antigen Test Kit

Country/Region china
City & Province hangzhou zhejiang
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Product Details

Infection Disease Rotavirus Antigen Rapid Test with CE certificate Uncut sheet

Product Name

Rotavirus Antigen Rapid Test

FormatsStrip(3mm)Device(4mm) Uncut sheet
Place of OrigenChina
SpecimenUrine
Read Time15 minutes
Shelf life2 years
PackageUncut sheet
Storage2℃-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

MethodOther Rapid TestTotal Results

Rotavirus Antigen Rapid

Test

ResultsPositiveNegative
Positive2240224
Negative2156158
Total Results226156382

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 aureusProteus mirabilisNeisseria gonorrhea
Pseudomonas aeruginosaAcinetobacter sppGroup B Streptococcus
Enterococcus faecalisSalmonella choleraesiusProteus vulgaris
Group C StreptococcusGardnerella vaginalisEnterococcus faecium
Klebsiella pneumoniaeAcinetobacter calcoaceticusHemophilus influenzae
Branhamella catarrhalisE.coliNeisseria meningitidis
Candida albicansChlamydia 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.

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