Shigella Antigen Rapid Test

Intended Use

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

Introduction

Shigella is a genus of Gram-negative, facultative anaerobic, non-spore-forming, non-motile bacilli and is the causative agent of human shigellosis. Shigella is one of the leading bacterial causes of diarrhea worldwide. Shigella species are classified by four serogroups (Group A, B, C and D) with multiple serotypes based on the serological and biochemical analysis1. The most common symptoms of shigellosis are diarrhea, fever, nausea, vomiting, stomach cramps, and flatulence1, 2. It is also commonly known to cause large and painful bowel movement. In rare cases, young children may have seizures. Symptoms usually begin two to four days after ingestion and last for several days or for weeks. Depending on the immunological status of individuals, symptoms range from asymptomatic infection to severe bacillary dysentery. Hemolytic uremic syndrome can occur after S. dysenteriae type 1 or S. flexneri infection3. Shigella is also implicated as one of the pathogenic causes of reactive arthritis worldwide4. 

Shigellosis is endemic in developing countries where sanitation is poor. Typically 10~20% of enteric disease, and 50% of the bloody diarrhea or dysentery of young children, can be characterized as shigellosis1. Infection is initiated by ingestion of shigellae and is spread via fecal-oral route primarily by contaminated hands, less frequently by contaminated food or water. Shigella species are very contagious with a low infectious dose (102~104 CFU), and the incubation period is 1~3 days 5. Carriage of the organism persists for approximately one month following convalescence. Therefore, the rapid diagnosis presents a significant role in disease surveillance and control.

The diagnosis of shigellosis can be made by isolating the organism from diarrheal fecal sample cultures and subsequent morphological and biochemical analysis. With specific equipment and professional techniques, PCR amplification of plasmid genes of Shigella species and DNA hybridization can provide sensitive and rapid identification of Shigella1. Enzyme-linked immuosorbent assay (ELISA) and immunochromatography assay (ICA) using antiserum or antibody recognizing specific antigens of Shigella can also be used to screen stools for the pathogen. 

Shigella Antigen Rapid Test takes only 10~20 minutes and requires only a small quantity of human feces to perform. It is an easy and rapid diagnostic method for Shigella infection.

Test Procedure

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