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Rapid Chromatographic Immunoassay Campylobacter Antigen Detection in Human Feces infectious disease testing

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

Detail Information

Product Description

Detail Information

Certification:

Formot:

Cup

Test Convenience:

Convenient

Test Sample:

Feces

Temperature:

2℃-30℃

Certificate:

Test Equipment Operation:

Simple

Test Type:

Infectious Disease Testing

Packaging Details:

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

Supply Ability:

2000ml/month

Highlight:

polyclonal antibodies

polyclonal antibody production

Product Description

A rapid test for the qualitative detection of Campylobacter in human feces.

For professional in vitro diagnostic use only.

【INTENDED USE】

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

the qualitative detection of Campylobacter antigen in human feces.

【SUMMARY】

Campylobacter enteritis is a food- and waterborne zoonotic illness and one of the most

common causes of infectious diarrhea in the United States.1 While identification of the

etiological agent does not typically affect treatment outcomes, as the majority of these

infections are self-limited, laboratory diagnosis is essential for epidemiological studies

and outbreak tracking through strain identification and typing. Conventional laboratory

diagnosis of Campylobacteriosis is based on the recovery of the organism from stool

specimens by microaerophilic culture. Current recommendations for the recovery of

Campylobacter stipulate that cultures be held for a minimum of 72 h prior to signing out

a negative result; however, a recent laboratory surveillance by the Centers for Disease

Control and Prevention found that, of laboratories surveyed, 66% reported negative

results at 48 h, while only 33% reported negative results after 72 h.2 In contrast to

traditional culture methods, more rapid methods for the detection of Campylobacter

antigens in stool, including enzyme immunoassay (EIA) and lateral flow systems,

require only 1 to 2 h until results.3

【PRINCIPLE】

The Campylobacter Rapid Test (Feces) is based on the use of a membrane technology

with colloidal latex. A nitrocellulose membrane is sensitized with antibody directed

against Campylobacter. The test’s specificity is ensured by an antibody specific to a

Campylobacter antigen that is conjugated to the colloidal latex. This conjugate is dried

on a membrane.

The fecal sample must be diluted into the extraction buffer that is supplied with the test

kit. When extracted specimen come into contact with the strip, the conjugate migrates

with the sample by passive diffusion and the conjugate and sample material come into

contact with the anti-Campylobacter antibody in the T line. If the sample contains the

Campylobacter antigen, the conjugate-antigen complex will remain bound to the

anti-Campylobacter reagent and a colored line will develop. Solution continues to

migrate to encounter a second reagent that binds the migration control conjugate,

thereby producing a colored control line that confirms that the test is working properly.

The result is visible within 10 minutes.

【REAGENTS】

The test contains anti-Campylobacter antibody particles and anti-Campylobacter

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 Campylobacter 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 Campylobacter 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)

 Droppers

 Package Insert

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 Campylobacter Antigen Detection in Human Feces infectious disease testing

Rapid Chromatographic Immunoassay Campylobacter Antigen Detection in Human Feces infectious disease testing

polyclonal antibodies

polyclonal antibody production