Shigella Rapid Test Cassette (Feces) for Detection of Shigella flexneri & Shigella sonnei

The Shigella Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Shigella flexneri and Shigella sonnei in human feces.

Shigella, a pathovar of Escherichia coli, is a Gram-negative bacterial pathogen, which causes bacillary dysentery or bloody diarrhoea in humans. This pathovar comprises four groups, Shigella flexneri, Shigella sonnei, Shigella dysenteriae, and Shigella

boydii.1 S. sonnei causes most shigellosis illnesses in the developed countries, and accounts for approximately 70% of shigellosis cases in the United States. Conversely, S. flexneri is the prevalent species associated with illness in the developing world (CDC, 2009).

The Shigella flexneri Rapid Test is a qualitative, lateral flow immunoassay for the detection of Shigella flexneri in human feces. The membrane is precoated with Shigella flexneri antibody on the test line region of the test. During testing, Shigella flexneri, if present in the specimen reacts with Shigella flexneri antibody conjugated with colored particle. The mixture migrates upward on the membrane by capillary action to react with Shigella flexneri antibody on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

The Shigella sonnei Rapid Test is a qualitative, lateral flow immunoassay for the detection of Shigella sonnei in human feces. The membrane is precoated with Shigella sonnei antibody on the test line region of the test. During testing, Shigella sonnei, if present in the specimen reacts with Shigella sonnei antibody conjugated with colored particle. The mixture migrates upward on the membrane by capillary action to react with Shigella sonnei antibody on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

 

 

• For professional in vitro diagnostic use only. Do not use after the expiration date.

• The test should remain in the sealed pouch until use.

• Do not eat, drink or smoke in the area where the specimens or kits are handled.

• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

• The used test should be discarded according to local regulations.

• Humidity and temperature can adversely affect results.

The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

1. The fecal specimen must be collected in a clean, dry, waterproof container containing no detergents, preservatives or transport media.

2. Bring the necessary reagents to room temperature before use.

3. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.