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.
MATERIALS
Materials Provided
- Individually packed test devices
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- Specimen collection tubes with extraction buffer
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Materials Required but Not provided
- Specimen collection containers
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TEST PROCEDURE
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
- 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.
- 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.
- 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.
PERFORMANCE CHARACTERISTICS
Table: Clostridium difficile (GDH) Antigen Rapid Test vs. RT-PCR
| Method |
RT-PCR |
Total Results |
| Clostridium difficile (GDH) Antigen Rapid Test |
Results |
Positive |
Negative |
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| |
Positive |
120 |
3 |
123 |
| |
Negative |
6 |
312 |
318 |
| Total Result |
126 |
315 |
441 |
Relative Sensitivity: 95.24% (95%CI: 89.92%~98.23%)
Relative Specificity: 99.05% (95%CI: 97.24%~99.80%)
Accuracy: 97.96% (95%CI: 96.16%~99.06%)
Audited Supplier 
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