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Infectious Disease Testing Rapid Detection of Clostridium difficile in Feces rapid diagnostic test cup

Basic Information
Brand Name: ALLTEST
Certification: CE
Model Number: ICD-637
Minimum Order Quantity: N/A
Price: negotiation
Packaging Details: 0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube
Delivery Time: 5-10 days
Payment Terms: Ex works
Supply Ability: 2000ml/month
Feature: Precise,accurate And High Sensitivity Kit Size: 1/10T
Sample: Feces Storage Temperature: 2-30°C
Highlight:

polyclonal antibodies

,

polyclonal antibody production

A rapid diagnostic test for the detection of Clostridium difficile GDH, Toxin A and
Toxin B antigens in human feces.
For in vitro professional use only.
【INTENDED USE】
The Clostridium difficile GDH +Toxin A +Toxin B Combo Rapid Test (Feces) is a
rapid chromatographic immunoassay for the qualitative detection of Clostridium
difficile GDH, Toxin A and Toxin B antigens in human feces.
【SUMMARY】
Clostridium difficile is an anaerobic bacteria acting as an opportunistic pathogen: it
grows in the intestine when the normal flora has been altered by treatment with
antibiotics.1,2 Toxinogenic strains of Clostridium difficile cause infections from
mild-diarrhea to pseudomembranous colitis, potentially leading to death. 3
Disease is caused by two toxins produced by toxinogenic strains of C.difficile:
Toxin A (tissue-damaging enterotoxin) and Toxin B (cytotoxin). Some strains
produce both toxins A and B, some others produce Toxin B only. The potential role
of a third (binary) toxin in pathogenicity is still debated.3
The use of Glutamate Dehydrogenase (GDH) as an antigen marker of C.difficile
proliferation has been shown to be very effective because all strains produce high
amount of this enzyme.4, 5
Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test allows the
detection of GDH, Toxin A and Toxin B specific to C. difficile in fecal specimen.
【PRINCIPLE】
Clostridium difficile Rapid Test detects three distinct antigens in fecal specimens
for C. difficile, viz., GDH, Toxin A and Toxin B on three different test strips in a
single test, thus simultaneously detecting three antigens specific of Clostridium
difficile.
For C. difficile-specific GDH Testing
The membrane is precoated with anti-C.diff. GDH antibody on the test line region.
During testing, the specimen reacts with the particle coated with anti-C.diff GDH
antibody. The mixture migrates upward on the membrane chromatographically by
capillary action to react with anti-C.diff GDH antibody on the membrane and
generate a colored line.
For C. difficile-specific Toxin A Testing
The membrane is precoated with anti-C.diff. Toxin A antibody on the test line
region. During testing, the specimen reacts with the particle coated with anti-C.diff
Toxin A antibody. The mixture migrates upward on the membrane
chromatographically by capillary action to react with anti-C.diff Toxin A antibody on
the membrane and generate a colored line. The presence of this colored line in
the test line region indicates a positive result, while its absence indicates a
negative result.
For C. difficile-specific Toxin B Testing
The membrane is precoated with anti-C.diff Toxin B antibody on the test line
region. During testing, the specimen reacts with the particle coated with anti-C.diff
Toxin B antibody. The mixture migrates upward on the membrane
chromatographically by capillary action to react with anti-C.diff Toxin B antibody
on the membrane and generate a colored line. The presence of this colored line in
the test line 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 of all the three test strips, indicating that the proper volume of
specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-Clostridium difficile GDH, anti-Clostridium difficile Toxin A
and anti-Clostridium difficile Toxin B antibody coated particles and anti-Clostridium
difficile GDH, anti-Clostridium difficile Toxin A and anti-Clostridium difficile Toxin B
antibody coated on the membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the
test.
• For professional 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.
• 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.
• Keep out of the reach of children.
• 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 Clostridium difficile
GDH +Toxin A +Toxin B Combo 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 a clean, dry, waterproof container
containing no detergents, preservatives or transport media.
• No dietary restrictions are necessary before using the Clostridium difficile GDH
+Toxin A +Toxin B Combo Rapid Test.
• Bring the necessary reagents and fecal 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.
【MATERIAL】
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. 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 80 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

Contact Details
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Phone Number : +8615857153722

WhatsApp : +8613989889852