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Clostridium difficile 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.

Clostridium difficile Antigen Rapid Test     HCDI058G

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.

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%)

Components

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 feces (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:

(1)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.

(2)Remove the small lid at the top

(3)Hold the bottle in a vertical position over the sample well of the test card, 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 area.

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

(4)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 area in the center of the device.

INTERPRETATION OF RESULTS

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

Note: The purple red band in the detection area (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 area (C). No purple red bands were found in the detection area (T). A negative result indicates no Clostridium difficile infection.

Invalid: No purple red band in quality control area (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.

COMPANY INTRODUCTION

Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.