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Adenovirus Uncut Sheet Rapid Test OEM Rtk Swab Test Uncut Sheet

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Hangzhou Aichek Medical Technology Co.,Ltd

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Adenovirus Uncut Sheet Rapid Test OEM Rtk Swab Test Uncut Sheet

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Brand Name :	Aichek
Model Number :	ADE-A01
Certification :	CE
Price :	negotiable
Payment Terms :	T/T
Supply Ability :	negotiable

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Adenovirus Uncut Sheet Rapid Test OEM Rtk Swab Test Uncut Sheet

Infection Disease Adenovirus Antigen Rapid Test with CE certificate uncut sheet

Product Name	Adenovirus 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 Adenovirus Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative presumptive detection of adenovirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of adenovirus infection.

Accuracy

The Adenovirus Antigen Rapid Test Device has been compared with other rapid test using clinical specimens.

Table: Adenovirus Rapid Test vs. Other Rapid Test

Method		Other Rapid Test		Total Results
Adenovirus Antigen Rapid Test	Results	Positive	Negative	Total Results
	Positive	82	1	83
	Negative	0	156	156
Total Results		82	157	239

Relative Sensitivity:100% (95.6%-100%)

Relative Specificity: 99.4% (96.5%-99.9%)*

Overall Agreement:99.6% (97.7%-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 Adenovirus 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

Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Research has shown that enteric adenoviruses, primarily Ad40 and Ad41, are a leading cause of diarrhea in many of these children, second only to the rotaviruses. These viral pathogens have been isolated throughout the world, and can cause diarrhea in children year round. Infections are most frequently seen in children less than two years of age, but have been found in patients of all ages. Further studies indicate that adenoviruses are associated with 4-15% of all hospitalized cases of viral gastroenteritis.

Rapid and accurate diagnosis of gastroenteritis due to adenovirus is helpful in establishing the etiology of gastroenteritis and related patient management. Other diagnostic techniques such as electron microscopy (EM) and nucleic acid hybridization are expensive and labor-intensive. With the self-limiting nature of adenovirus infection, such expensive and labor-intensive tests may not be necessary..

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