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Clostridium difficile Rapid Tests CE Marking


Biopanda Reagents offers three types of Rapid Tests for C. difficile as follows:

Clostridium difficile GDH Antigen Rapid Test

Product Number: RAPG-CDG-001

Pack size

10 tests

Product Description

The Biopanda C. difficile GDH Ag Rapid test qualitatively detects for the presence of Clostridium difficile Glutamate Dehydrogenase (GDH) Antigen in faeces. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

Test Attributes

  • Faecal samples may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of C. difficile Infections

Test Procedure

  1. Remove the test cassette 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.
  2. Hold the specimen collection tube upright and unscrew the cap of the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120 μl) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
  3. Read the results at 15 minutes after dispensing the specimen. Do not read results after 20 minutes.
Faecal sample drawing Rapid cassette result drawing

Principle

This test is based on the use of a membrane technology with colloidal gold. A nitrocellulose membrane is sensitised with antibody directed against C. difficile antigen (GDH). The test's specificity is ensured by an antibody specific to the C. difficile GDH that is conjugated to the colloidal gold. The faecal sample must be diluted into the extraction buffer that is supplied with the test. When the faecal suspension come into contact with the strip, the solubilised conjugate migrates with the sample by passive diffusion and the conjugate and sample material come into contact with the anti-Clostridium antibody adsorbed onto the nitrocellulose. If the sample contains C. difficile GDH, the conjugate-antigen complex will remain bound to the anti-C. difficile GDH reagent and a red line will develop. The solution continues to migrate to encounter a second reagent that binds the migration control conjugate, thereby producing a red control line that confirms that the test is working properly. The result is visible within 15 minutes.

Performance Characteristics

  • Relative sensitivity: >99.9%
  • Relative specificity: 93.0%
  • Accuracy: 94.7%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

Clostridium difficile Toxin A+B Rapid Test

Product Number: RAPG-CDT-001

Pack size

10 tests

Product Description

The Biopanda C. difficile Toxin A+B Rapid test qualitatively detects for the presence of Clostridium difficile Toxin A+Bantigens in faeces. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

Test Attributes

  • Faecal samples may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of C. difficile infections

Test Procedure

  1. Remove the test cassette 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.
  2. Hold the specimen collection tube upright and unscrew the cap of the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120 μl) to each specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
  3. Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.
Faecal sample drawing Rapid cassette result drawing

Principle

The Biopanda Clostridium difficile Rapid Test detects two distinct antigens in faecal specimens for C. difficile; Toxin A and Toxin B on two different test strips in a single test cassette, thus simultaneously detecting two antigens specific to Clostridium difficile.

For C. difficile-specific Toxin A Testing
The membrane is pre-coated 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 coloured line. The presence of this coloured 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 pre-coated 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 coloured line. The presence of this coloured line in the test line region indicates a positive result, while its absence indicates a negative result.
To serve as a procedural control, a coloured line will always appear in the control line region of both test strips, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity: 98.2%
  • Relative specificity: 98.6%
  • Accuracy: 98.5%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

Clostridium difficile Combo Rapid Test

Product Number: RAPG-CDC-001

Pack size

10 tests

Product Description

The Biopanda C. difficile Combo Rapid test qualitatively detects for the presence of Clostridium difficile Glutamate Dehydrogenase (GDH), Toxin A, and Toxin B antigens in faeces. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

Test Attributes

  • Faecal samples may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of C. difficile infections

Test Procedure

  1. Remove the test cassette 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.
  2. Hold the specimen collection tube upright and unscrew the cap of the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120 μl) to each specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
  3. Read the results at 10 minutes after dispensing the specimen.
Faecal sample drawing Rapid cassette result drawing

Principle

The Biopanda Clostridium difficile Rapid Test detects three distinct antigens in faecal specimens for C. difficile; GDH, Toxin A and Toxin B on three different test strips in a single test cassette, thus simultaneously detecting three antigens specific to 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 coloured line.

For C. difficile-specific Toxin A Testing
The membrane is pre-coated 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 coloured line. The presence of this coloured 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 pre-coated 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 coloured line. The presence of this coloured line in the test line region indicates a positive result, while its absence indicates a negative result.
To serve as a procedural control, a coloured 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.

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

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