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Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography)

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Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography)

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Introduction

[Product Name]

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography)
[Packaging Size]
1 test/kit, 20 tests/kit

[Intended Use]

This kit is intended for in vitro qualitative detection of Glutamate Dehydrogenase(GDH) and Toxin A/B in stool samples of suspected clostridium difficile cases.
Clostridium difficile(CD) is an obligate anaerobic gram-positive bacillus, which is a normal flora in the human body. Other flora will be inhibited from multiplying due to the antibiotics used in large doses, and CD reproduces in the human body in large quantities. CD is divided into toxin-producing and non-toxin-producing species. All CD species produce glutamate dehydrogenase (GDH) when they reproduce, and only toxigenic strains are pathogenic. Toxin-producing strains can produce two toxins, A and B. Toxin A is an enterotoxin, which can cause inflammation of the intestinal wall, cell infiltration, increased permeability of the intestinal wall, hemorrhage and necrosis. Toxin B is a cytotoxin, which damages the cytoskeleton, causes cell pyknosis and necrosis, and directly damages intestinal parietal cells, resulting in diarrhea and pseudomembranous colitis.

[Test Principle]

This kit uses the double antibody sandwich method to detect GDH and toxin A/B. Toxin A/B monoclonal antibody and GDH antibody were labeled with red tracer, respectively. The labeled complexes were mixed and coated on glass cellulose membrane at the test region T1 on the nitrocellulose membrane. Coated with Clostridium difficile toxin A/B antibody, detection line T2 was coated with GDH antibody, and control line C was coated with goat anti-mouse IgG antibody.

During the assay, the sample is allowed to conjunct with the pre-coated antibody complex and the mixture then migrates chromatographically on the membrane by the capillary action. A GDH positive sample produces a red band in the test region (T2). A GDH positive sample which produces difficultin A/B will produce red bands in the test region (T1) and test region(T2). A GDH positive sample which do not produce difficultin A/B will produce a red band in the test region(T2). A red band always appears in the control region (C) serving as procedural control regardless of the specimen contains GDH or not, unless the test is invalid. (Refer to information below regarding Invalid test results).

[Storage Condition and Shelf-life]

Stored at 4-30°C, it should be placed in a cool and dry place. DO NOT FREEZE. The shelf life is 12 months. The test cassette should be used within 1 hour after opening the aluminum foil bag. The used test cassette should be discarded.
See label for production and expiry dates.

[Requirements for Samples]

1. Precautions before sampling: Subjects with menstrual bleeding and internal hemorrhoids should avoid sampling. Before defecation, the urine should be drained to prevent interference with the test results.
2. If the stool sample contains identifiable food residues, the sampling of food residues should be avoided.

3. Fresh samples should be tested within 2 hours. If the samples cannot be tested in time, they should be stored in a refrigerator at 2~ 8°C for no more than 24 hours. Else, the samples should be frozen below -18°C for a long time. Repeated freezing and thawing of the sample should not exceed 4 cycles. If frozen samples are used, they should be thawed at room temperature.

4. Frozen samples should be thawed, mixed well and returned to room temperature before testing.

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