Campylobacter Antigen Rapid Test

INTENDED USE

Campylobacter Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Campylobacter spp. antigen in human stool specimen. The test results are intended to aid in the early-stage diagnosis of Campylobacter infection for patients with the symptoms of suspected gastroenteritis caused by the Campylobacter.  

MATERIALS

Materials Provided

Materials Required but Not provided

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 sample bottle, use the attached applicator stick attached on the cap to transfer small piece of stool (4-6 mm in diameter; approximately 50 mg – 200 mg) into the assay buffer tube containing specimen preparation buffer. For liquid or semi-solid stools, add 100 microliters of stool to the vial with an appropriate pipette. Replace the stick in the tube and tighten securely. Mix stool sample with the buffer thoroughly by shaking the bottle for a few seconds.

3. ASSAY PROCEDURE

3.1 Hold the assay buffer tube upright with the tip point toward the direction away from the test performer, snap off the tip.

3.2. Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops (120-150 μL) of diluted stool sample to the sample well (S) and start the timer.

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.

3.3. 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 10 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 colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

Table: Campylobacter Antigen Rapid Test vs. Culture  

Relative Sensitivity: 98.51% （95%CI: 91.25%～>99.99%）  

Relative Specificity: 97.89% （95%CI：95.62%～99.06%） 

Accuracy: 97.99% （95%CI：96.02%～99.05%）