FOB Rapid Test

FOB Rapid Test

The FOB cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human hemoglobin in human fecal specimens. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.

INTRODUCTION

Colorectal cancer is one of the most commonly diagnosed cancers and a leading cause of cancer-related death in the United States. Screening for colorectal cancer is likely to improve the odds of detecting cancer at an early stage, reducing mortality.

Earlier commercially available FOB tests utilized a guaiac test, requiring special dietary restrictions to minimize false positive and false negative results. The FOB Rapid Test Device (Feces) is designed especially to detect human hemoglobin in fecal specimens using immunochemical methods, improving specificity for the detection of lower gastrointestinal disorders, including colorectal cancers and adenomas, without the need for dietary restrictions.

PRINCIPLE

The FOB cassette detects human hemoglobin through visual interpretation of color development on the internal strip. Anti-human hemoglobin antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with colored anti-human hemoglobin antibody-colloidal gold conjugates precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient human hemoglobin in the specimen, a colored line will form at the test region of the membrane. The presence of this colored line indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Materials Supplied

- 25 individually packed test devices
- 25 sample-taking tubes: with approx.2ml extraction buffer – contains very small amounts of sodium azide below the declaration limit
- 1 instruction sheet

Sensitivity: 40 ng Hemoglobin/ml
Specificity: Human Hemoglobin
Shelf life: 24 months from date of manufacture
Storage temperature: +2ºC to +30ºC

Content of the kit:

• Singles pouched test cassettes
• Sample collection tubes
• Patient instruction for the stool sample collection
• Stool collection paper
• Instructions for use
• Patient information sheet