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Infectious Disease Testing Rapid Test human Feces for Accurate Rotavirus rapid test Detection

Brand Name:	Alltest
Model Number:	IRO-607
MOQ:	N/A
Payment Terms:	T/T

Detail Information

Product Description

Detail Information

Format:

Cup

Test Time:

10 Minutes

Storage Conditions:

2-30°C

Sample:

Feces

Test Kit:

1T/10T

Shelf Time:

24 Months

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Product Description

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

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

of rotavirus infection.

【SUMMARY】

Acute diarrhea disease in young children is a major cause of morbidity worldwide

and is a leading cause of mortality in developing countries. Rotavirus is the most

common agent responsible for acute gastroenteritis, mainly in young children.1 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. Rotavirus is transmitted by oro-faecal route with an incubation

period of 1-3 days. Although specimen collections taken within the second and fifth

day of the illness are ideal for antigen detection, 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.2 With hospitalized children suffering from acute enteric disease up to

50% of the analyzed specimen were positive for rotavirus.3 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.

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

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

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

rotavirus from human feces specimens.

【PRINCIPLE】

The Rotavirus Rapid Test is a qualitative, lateral flow immunoassay for the

detection of rotavirus in human feces specimens.

In this test, the membrane is pre-coated with anti-rotavirus antibody on the test line

region of the test. During testing, the specimen reacts with the particle coated with

anti-rotavirus antibody. The mixture migrates upward on the membrane

chromatographically by capillary action to react with anti-rotavirus 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-rotavirus antibody coated particles and anti-rotavirus

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 Rotavirus 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 Rotavirus 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.

Tags:

rapid test kit

diagnostic tests for infection

infectious disease diagnostic tests

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products details

Infectious Disease Testing Rapid Test human Feces for Accurate Rotavirus rapid test Detection

Infectious Disease Testing Rapid Test human Feces for Accurate Rotavirus rapid test Detection

8cm Nucleic Acid PCR

Nylon Flocked Tip Nucleic Acid PCR

ABS Shaft Nucleic Acid PCR