【INTENDED USE】
The Shigella Rapid Test Cassette (Feces) is a rapid chromatographic
immunoassay for the qualitative detection of Shigella flexneri and
Shigella sonnei in human feces.
【SUMMARY】
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).
【PRINCIPLE】
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.
【PRECAUTIONS】
• 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.
【STORAGE AND STABILITY】
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.
【SPECIMEN COLLECTION AND PREPARATION】
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.
| ISHF-CT602 | Shigella Flexneri Antigen Rapid Test Cassette | Feces | Cassette | 10 T |
| ISHS-CT602 | Shigella Sonnei Antigen Rapid Test Cassette | Feces | Cassette | 10 T |
| ISH-CT625 | Shigella Rapid Test Cassette | Feces | Cassette | 10 T |
