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Norovirus Rapid Test Cup Human Feces for Accurate and Convenient Diagnosis of Norovirus Infection

Brand Name:	Alltest
MOQ:	N/A
Payment Terms:	T/T

Detail Information

Product Description

Detail Information

Certification:

Format:

Cup

Shelf Time:

24 Months

Precision:

Highly Precise

Accuracy:

Highly Accurate

Specimen:

Feces

Highlight:

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8cm nylon flocked swabs

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Product Description

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

the qualitative detection of Norovirus in human fecal specimens to aid in the

diagnosis of Norovirus infection.

【SUMMARY】

Noroviruses (NoV) are a genetically diverse group of single stranded RNA,

nonenvelopped viruses belonging to the Caliciviridae family. 1

Noroviruses are a major cause of acute gastroenteritis worldwide, often causing

explosive outbreaks in institutions. They are highly contagious, with an inoculum

of as few as ten particles being able to cause infection. Transmission occurs

through ingesting contaminated food and water and by person-to-person spread.

Transmission is predominantly fecal-oral but may be airborne due to

aerosolisation of vomitus, which typically contains abundant infectious virus

particles. Outbreaks may involve several routes of transmission. The illness is

acute, usually mild, although it has caused fatalities among the frail elderly, and

self-limiting and follows an incubation period of 24-48 hours although cases can

occur within 12 hours of exposure.2

The symptoms of Norovirus illness usually include nausea, vomiting, diarrhea,

and some stomach cramping. Sometimes people additionally have a low-grade

fever, chills, headache, muscle aches, and a general sense of tiredness. The

illness often begins suddenly, and the infected person may feel very sick. In most

people the illness is self-limiting with symptoms lasting for about 1 or 2 days. In

general, children experience more vomiting than adults.2, 3

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

the qualitative detection of norovirus in human feces specimen, providing results

in 10 minutes. The test utilizes antibody specific for adenovirus to selectively

detect norovirus from human feces specimens.

【PRINCIPLE】

The Norovirus Rapid Test (Feces) is a qualitative, lateral flow immunoassay for

the detection of Norovirus in human feces. The assay uses Genogroup 1 and

Genogroup 2 specific monoclonal antibodies coated on the test membrane.

During testing, the stool specimen reacts with the conjugate antibodies. The

mixture migrates upward on the membrane chromatographically by capillary

action to react with Genogroup 1 and 2 antibodies on the membrane and

generates a colored line at the level of the T line. The presence of a colored line in

T region indicates a positive result for Genogroup 1 and/or Genogroup 2, while its

absence indicates a negative result. To serve as a procedural control, a colored

line will always appear in the control reaction zone (C) indicating that proper

volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains Norovirus Genogroup 1 and Genogroup 2 monoclonal antibody

coated particles and Norovirus Genogroup 1 and Genogroup 2 monoclonal

antibodies 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 Norovirus 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 Norovirus 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 15 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

Norovirus Rapid Test Cup Human Feces for Accurate and Convenient Diagnosis of Norovirus Infection

Norovirus Rapid Test Cup Human Feces for Accurate and Convenient Diagnosis of Norovirus Infection

sampling nylon flocked swabs

8cm nylon flocked swabs

flocked swabs for sample collection