High Quality Campylobacter Rapid Test Cassette With CE

High Quality Campylobacter Rapid Test Cassette With CE

A rapid test for the qualitative detection of Campylobacter in human stool samples. For professional in vitro diagnostic use only.

Applications:

Campylobacter enteritis is a food- and waterborne zoonotic illness and one of the most common causes of infectious diarrhea in the United States . While identification of the etiological agent does not typically affect treatment outcomes, as the majority of these infections are self-limited, laboratory diagnosis is essential for epidemiological studies and outbreak tracking through strain identification and typing. Conventional laboratory diagnosis of campylobacteriosis is based on the recovery of the organism from stool specimens by microaerophilic culture.

Current recommendations for the recovery of Campylobacter stipulate that cultures be held for a minimum of 72 h prior to signing out a negative result ; however, a recent laboratory surveillance by the Centers for Disease Control and Prevention found that, of laboratories surveyed, 66% reported negative results at 48 h, while only 33% reported negative results after 72 h.

In contrast to traditional culture methods, more rapid methods for the detection of Campylobacter antigens in stool, including enzyme immunoassay (EIA) and lateral flow systems, require only 1 to 2 h until results.

Description:

Campylobacter Rapid Test Cassette (Feces) is based on the use of a membrane with colloidal gold. A nitrocellulose membrane is sensitized with antibody directed against Campylobacter.

The test’s specificity is ensured by an antibody specific to a Campylobacter antigen that is conjugated to the colloidal gold. This conjugate is dried on a membrane.

The fecal sample must be diluted into the extraction buffer that is supplied with the test kit. When extracted specimen come into contact with the strip, the conjugate migrates with the sample by passive diffusion and the conjugate and sample material come into contact with the anti-Campylobacter antibody in the T line.

If the sample contains the Campylobacter antigen, the conjugate-antigen complex will remain bound to the anti-Campylobacter reagent and a colored line will develop. Solution continues to migrate to encounter a second reagent that binds the migration control conjugate, thereby producing a colored control line that confirms that the test is working properly. The result is visible within 10 minutes.

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 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 specimencollection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.

2. 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.

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

4. Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.

5. Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S).of a new test cassette and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)

POSITIVE:* Two 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 Campylobacter 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 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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.