Campylobacter Antigen Rapid Test

Intended Use

Campylobacter Antigen Rapid Test is an in vitro immunoassay for the direct and qualitative detection of Campylobacter antigens from human feces. Campylobacter Antigen Rapid Test is intended to aid in the rapid diagnosis of Campylobacter infection. Negative results do not preclude Campylobacter infection and should be confirmed via bacterial culture or molecular assay.

Introduction

Campylobacter is a genus of Gram-negative, microaerophilic bacteria that are typically spiral-shaped and able to move via unipolar or biopolar flagella1. Most Campylobacter species are human pathogens, with C. jejuni, C. coli, and C. lari the most common2. C. jejuni is now recognized as one of the main causes of bacterial foodborne disease in many developed countries3.

Campylobacter has been associated with both diarrheal and systemic disease in all parts of the world. Campylobacteriosis is an infection caused by Campylobacter species, which is characterized by inflammatory, sometimes bloody diarrhea or dysentery syndrome, mostly including cramps, fever, and pain4. Symptoms typically last about 5~7 days4. As a self-limited disease, antimicrobial therapy is not generally indicated. Complications are rare, however, it has been reported that infectious may be concurrent with reactive arthritis, meningitis, recurrent colitis, acute cholecystitis, pancreatitis, cystitis, and Guillain-Barre's yndrome5~10.

For diagnosis of Campylobacter infection, typical cultivation from stool specimens requires isolation on a selective solid medium and microaerobic atmosphere. With specific equipment and professional techniques, a wide range of PCR assays based on a variety of genes for Campylobacter have also been described. For those microbiology laboratories without Campylobacter culture capability and PCR tests, a rapid non-culture assay for detection of Campylobacter is of interest to both the clinician and the microbiology laboratory.

The Campylobacter Antigen Rapid Test takes only 10 minutes and requires a small quantity of human feces to perform. It is an easy, rapid and sensitive diagnostic method for Campylobacter infection.

Test Procedure

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