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Rapid Chromatographic Immunoassay for Astrovirus Detection Infectious Disease Testing Rapid Test Cup

Brand Name:	ALLTEST
Model Number:	IAS 607
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works
Supply Ability:	2000mg/month

Detail Information

Product Description

Detail Information

Certification:

Target Disease:

Infectious Disease

Temperature:

2℃-30℃

Regulatory Approval:

Specimen:

Feces

Usage:

Point-of-Care Testing

Principle:

Chromatographic Immunoassay

Cut Off:

See Insert

Test Results:

Accurate

Packaging Details:

0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube

Supply Ability:

2000mg/month

Highlight:

Custom Monoclonal Antibodies

mono clonal antibody

Product Description

The Astrovirus Rapid Test (Feces) is a rapid chromatographic immunoassay for the

qualitative detection of astrovirus in human fecal specimens to aid in the diagnosis of

astrovirus infection.

【SUMMARY】

Astrovirus is a type of virus that was first discovered in 1975 using electron microscopes

following an outbreak of diarrhea in humans. In addition to humans, astroviruses have

now been isolated from numerous mammalian animal species (and are classified as

genus Mammoastrovirus) and from avian species such as ducks, chickens, and turkey

poults (classified as genus Avastrovirus). Astroviruses are 28–35 nm diameter,

icosahedral viruses that have a characteristic five- or six-pointed star-like surface

structure when viewed by electron microscopy. Along with the Picornaviridae and the

Caliciviridae, the Astroviridae comprise a third family of nonenveloped viruses whose

genome is composed of plus-sense, single-stranded RNA.1 Astrovirus has a

non-segmented, single stranded, positive sense RNA genome within a non-enveloped

icosahedral capsid. 2 Human astroviruses have been shown in numerous studies to be

an important cause of gastroenteritis in young children worldwide.1

The Astrovirus Rapid Test (Feces) is a rapid chromatographic immunoassay for the

qualitative detection of astrovirus in human feces specimen, providing results in 10

minutes. The test utilizes antibody specific for astrovirus to selectively detect astrovirus

from human feces specimens.

【PRINCIPLE】

The Astrovirus Rapid Test is a qualitative, lateral flow immunoassay for the detection of

astrovirus in human feces. In this test, the membrane is pre-coated with anti-astrovirus

antibody on the test line region of the test. During testing, the specimen reacts with the

colored particle conjugated with anti-astrovirus antibody. The mixture migrates upward

on the membrane by capillary action to react with anti-astrovirus antibody on the

membrane and generate a colored line in the test line region. The presence of this

colored line in the test region indicates a positive result, while its absence indicates a

negative result. To serve as a procedural control, a colored line will always appear in the

control line region indicating that proper volume of specimen has been added and

membrane wicking has occurred.

【REAGENTS】

The test contains anti-astrovirus antibody coated particles and anti-astrovirus antibody

coated on the membrane.

【PRECAUTIONS】

Please read all the information in this package insert before performing the test.

• For professional use only. For in vitro diagnostic use only.

• Do not use after the expiration date. Do not reuse the test.

• Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil

packaging is damaged or has been opened, please do not use.

• Do not eat, drink or smoke in the area where the specimens or kits are handled.

• Handle all specimens as if they contain infectious agents. Observe established

precautions against microbiological hazards throughout all procedures and follow the

standard procedures for proper disposal of specimens.

• Wear protective clothing such as laboratory coats, disposable gloves and eye

protection when specimens are assayed.

• The used test should be discarded according to local regulations.

• Humidity and temperature may adversely affect results.

• Wash hands thoroughly before and after handling.

• Any serious incident that has occurred in relation to the device shall be reported to

the manufacturer and the competent authority.

• Use the test only once. Keep the test upright while testing. Do not move or turn

the test upside down.

• The kit must not be frozen or used after the expiration date printed on the package.

• Components provided in the kit are approved for use in the Astrovirus Rapid Test. Do

not use any other commercial kit component.

【STORAGE AND STABILITY】

The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable

through the expiration date printed on the sealed pouch. The test must remain in the

sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

NOTE: It is suggested to use the test within one hour after removing it from the foil

pouch.

【SPECIMEN COLLECTION AND PREPARATION】

• The fecal specimen must be collected in clean, dry, waterproof container containing

no detergents, preservatives or transport media.

• No dietary restrictions are necessary before using the Astrovirus Rapid Test.

• Bring the necessary reagents and feces specimen to room temperature before use.

• If specimens are to be shipped, they should be packed in compliance with local

regulations covering the transportation of etiologic agents.

【MATERIALS】

Materials Provided

 Test Cups (with dilution buffer)

 Package Insert

 Droppers

Materials Required but Not Provided

 Timer

 Centrifuge

 Specimen Container

 Pipette

【DIRECTIONS FOR USE】

Before performing the test, allow the test and specimen to reach room

temperature (15-30°C), stool samples must be collected following the instruction

below.

1. Wash your hands with soap and rinse with clear water.

2. Collect fecal specimens:

Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen

collection container. Best results will be obtained if the assay is performed within 6

hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not

tested within 6 hours. For long term storage, specimens should be kept below

-20°C.

3. Bring the pouch to room temperature before opening it. Remove the test cup from

the foil pouch and use it as soon as possible. Best results will be obtained if the test

is performed immediately after opening the foil pouch.

4. Process fecal specimens:

•

For Solid Specimens:

Unscrew the cap of the test cup and take out the specimen collection applicator.

Randomly stab the specimen collection applicator into the fecal specimen in at

least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of

a pea). Do not scoop the fecal specimen.

•

For Liquid Specimens:

Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of

the liquid specimen (approximately 50 µL) into the test cup containing the dilution

buffer.

5. Insert the specimen collection applicator back into the test cup and tighten the cap.

6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction

for 2 minutes.

7. Remove the plastic limit strip of the test cup.

8. Put the test cup on a clean and level surface, press the cup body from the top to the

bottom and start the timer.

NOTE: Keep the test cup upright during the test developing. Do not move or turn the test

cup upside down.

9. Read results at 10 minutes. Do not read results after 20 minutes.

NOTE: If the specimen does not migrate (presence of particles), open a new test cup,

repeat step 4 and centrifuge the diluted specimen contained in the test cup with a clean

tube. Pipette 1-1.5 mL of supernatant, dispense into the test cup and insert the

specimen collection applicator back into the test cup and tighten the cap. Continue from

step 7-8 onwards in the above instructions for use and start the timer.

Tags:

rapid test kit

diagnostic tests for infection

infectious disease diagnostic tests

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products details

Rapid Chromatographic Immunoassay for Astrovirus Detection Infectious Disease Testing Rapid Test Cup

Rapid Chromatographic Immunoassay for Astrovirus Detection Infectious Disease Testing Rapid Test Cup

Custom Monoclonal Antibodies

mono clonal antibody