Clostridium difficile Antigen Rapid Test

INTENDED USE

Clostridium difficile (GDH) Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Glutamate dehydrogenase in human stool specimen. The test results are designed to help diagnose antibiotic-associated diarrhea colitis and pseudomembranous colitis caused by infection with Clostridium difficile.

PRINCIPLE

Using the principle of colloidal gold immunochromatography, goat anti-mouse polyclonal antibody (Series c) and mouse anti-Clostridium difficile monoclonal antibody were coated in nitrate cellulose film. Mouse monoclonal antibodies to C. difficile were fixed on gold plates with colloidal gold labels. When a positive sample is tested, the Clostridium difficile antigen in the sample binds to the mouse Clostridium difficile monoclonal antibody on the gold pad, forming a complex that moves along the membrane through the chromatography. After the detection line, it formed sandwich complex with the pre-coated antibody for color development, and combined with the goat anti-mouse IgG polyclonal antibody at the quality control line for color development, negative samples Color display only on quality control line.

TEST PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

2. SPECIMEN PREPARATION:

Unscrew the cap of the specimen collection tube, then randomly stab the sampling rod into the stool specimen in at least 3 different sites to collect approximately of stools (equivalent to 1/4 of a pea). Hold the Specimen collection tubes with extraction buffer vertically, insert the sampling rod, squeeze the bottom of the tube. Mix stool specimen with the buffer thoroughly by shaking the bottle for a few seconds.

3. ASSAY PROCEDURE:

 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 tube alone for 2 minutes.

 Remove the small lid at the top.

 Hold the bottle in a vertical position over the sample well of the test device, deliver 3 drops (about 90μl) of diluted stool sample to the sample well (S) and start the timer.

Note: Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result region.

As the test begins to work, color will migrate across the result region in the center of the device.

 Wait for the colored band(s) to appear. Read the result between 5-10 minutes. A strong positive sample may show result earlier. Do not interpret the result after 15 minutes. As the test begins to work, color will

migrate across the result region in the center of the device.

INTERPRETATION OF RESULTS

Positive (+) : Two purple red bands appear. One is located in the detection region (T), the other is located in the quality control region (C).

Note: The purple red band in the detection region (T) can show the phenomenon of dark and light color. However, during the specified observation time, regardless of the color of the band, even very weak band

should be interpreted as a positive result.

Negative (-) : Only a purple red band appears in the quality control region (C). No purple red bands were found in the detection region (T). A negative result indicates no Clostridium difficile infection.

Invalid: No purple red band in quality control region (C). Indicates incorrect operation or deterioration of the test. In this case, read the instructions carefully again and retest with a new test. If the problem

persists, you should immediately stop using the batch number and contact your local supplier

LIMITATION

1. 1. The Clostridium difficile (GDH) Antigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human Clostridium difficile.

2. 2. The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.

3. 3. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen.

4. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.

4. 5. As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
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