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CE ISO Rotavirus Uncut Sheet Rapid Test Rtk Antigen Test Kit

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Hangzhou Aichek Medical Technology Co.,Ltd

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CE ISO Rotavirus Uncut Sheet Rapid Test Rtk Antigen Test Kit

Name: CE ISO Rotavirus Uncut Sheet Rapid Test Rtk Antigen Test Kit
Brand: Aichek
Price: 1 USD

Brand Name : Aichek

Model Number : ROT-A01

Certification : CE

Place of Origin : China

MOQ : 5000 Test

Price : negotiable

Payment Terms : T/T

Supply Ability : negotiable

Packaging Details : 40box/carton

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 Uncut sheet

For the crowd : Preliminary screening of infected people

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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	Total Results
	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.

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