Cryptosporidium Antigen Rapid Test

INTENDED USE

Cryptosporidium Parvum Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Cryptosporidium parvum antigen in human stool specimen. The test results are intended to aid in the diagnosis of Cryptosporidium parvum infection and to monitor the effectiveness of therapeutic treatment.

INTRODUCTION

Cryptosporidiosis is an infectious disease caused by Cryptosporidium parvum, which is occasionally caused by other species of Cryptosporidium. Symptoms usually appear about 7 days after infection, including abdominal pain, watery diarrhea, vomiting and fever. The symptoms of most patients last 6 to 10 days, but they may last for several weeks. Patients with immune system problems, such as infection, can be very serious and even life-threatening. Since the official report in 1976, it has been found that the disease is widespread, and it is a common pathogen of tourist diarrhea. There are many patients with AIDS complicated with the disease.

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 sample bottle 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 bottle 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 sample bottle 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.

1. QUALITY CONTROL

   • Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
   • External controls are not supplied with this kit. 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.

LIMITATIONS OF THE TEST

1. TheCryptosporidium Parvum Antigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human Cryptosporidium Parvum.
2. The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
3. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.

• As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.