Cryptosporidium Rapid Test

Intended Use

Cryptosporidium Rapid Test is an in vitro immunoassay for the direct and qualitative detection of Cryptosporidum from human feces. Cryptosporidium Rapid Test is intended to aid in the rapid diagnosis of Cryptosporidiosis.

Introduction

Cryptosporidium is a genus of apicomplexan parasitic alveolates that can cause a respiratory and gastrointestinal illness (cryptosporidiosis) that primarily involves watery diarrhea (intestinal cryptosporidiosis) with or without a persistent cough (respiratory cryptosporidiosis) in both immunocompetent and immunodeficient humans.

A number of Cryptosporidium species infect mammals. In humans, the main causes of disease are C. parvum and C. hominis. C. canis, C. felis, C. meleagridis, and C. muris can also cause disease in humans. Infection is through contaminated material such as earth, water, uncooked or cross-contaminated food that has been in contact with the feces of an infected individual or animal.

Cryptosporidiosis is found worldwide. It causes 50.8% of water-borne diseases that are attributed to parasites. In developing countries, 8–19% of diarrheal diseases can be attributed to Cryptosporidium. In developed countries, the number is lower at 1–3%. The age groups most affected are children from 1 to 9 years old.

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) Use clean, dry specimen containers for specimen collection. Best results will be obtained if the assay is performed within 2 hours after collection.

Note: Specimens collected in the specimen container may be stored for 3 days at 2~8oC or for 6 months at -20°C.

2) For solid specimens: Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 120 mg of feces.

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 3 drops (approximately 120 uL) of the liquid specimen into the sample diluent tube.

3) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

4) Shake the specimen collection tube to mix the specimen and the diluent buffer thoroughly.

2. Testing

1) Remove the test device from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within 2 hours.

2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

3) Wait for the colored band(s) to appear. The result should be read at 10 minutes.

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