Clostridium difficile GDH+ Toxin A +Toxin B Rapid Test, Clostridium difficile infection

In vitro rapid diagnostic test for the detection of Clostridium difficile GDH, Toxin A and Toxin B antigen in human feces samples CE certified.

Applications:

The Clostridium difficile GDH+Toxin A+B Combo Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficile GDH, Toxin A and Toxin B 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. oxinogenic strains of Clostridium difficile cause infections from mild-diarrhea to pseudomembranous colitis, potentially leading to death.

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.

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 Cassette allows the specific detection of C. difficile's GDH in stool specimen. Samples with a positive Clostridium Cassette 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.

1.To collect fecal specimens:Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough virus particles. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.

2.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 50 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 (approximately 80 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.

3.Bring the pouch to room temperature before opening it. 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.

4.Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen(approximately 120 µL) to the specimen well (S) of the test cassette, then start the timer. Avoidtrapping air bubbles in the specimen well (S). See illustration below.

5.Read the results at 10 minutes after dispensing the specimen. Do not read results after20 minutes.

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 Clostridium difficile 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 in the 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.

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.

ORDER INFORMATION

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.