Infectious disease testing Clostridium difficile GDH Rapid Test Cassette

Lateral Flow Immunochromatographic Assays Clostridium difficile GDH Rapid Test Cassette Feces

In vitro rapid diagnostic test for the detection of Clostridium difficile GDH antigen in human feces samples For in vitro use. For professional use only.

Applications:

The Clostridium difficile GDH Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficile GDH antigen in the human feces specimen.

Description:

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.1,2,3 Toxinogenic strains of Clostridium difficile cause infections from mild-diarrhea to pseudomembranous colitis, potentially leading to death. 4

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.4

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.5,6 Clostridium difficile GDH Rapid Test Cassette allows the specific detection of C. difficile's GDH in stool specimen. Samples with a positive result should be investigated further to test for toxigenicity of the bacteria.

How to use?

Allow the test, specimen, stool collection buffer and/or control to equilibrate to room temperature (15-30°C) prior to testing.

To process fecal specimens:

• For Solid Specimens:

Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen at least 3 different sites to collect approximately 60 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 (approximately60 µL) into the specimen collection tube containing the extraction

buffer.

Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.

  2. 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.

  3. 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 120mL) 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.

 4. Read the results at 10 minutes after dispensing the specimen. Do not read results after

20 minutes.

5. Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S).of a new test cassette and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

The results are to be interpreted as follows:

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Adenovirus antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears inthe test line region (T).

INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor

Note: during the drying process, a very faint shadow may appear at the Test lineposition. It should not be regarded as a positive result.

QUALITY CONTROL

An internal procedural control is included in the test. A colored line appearing in the control line region (C) is an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.