Rapid FOB test TFO-602

colorectal canceroncologyhemoglobin

Overview
The FOB Rapid Test Device (feces) is a rapid visual immunoassay for the qualitative presumptive detection of human hemoglobin in human fecal specimens. This in vitro diagnostic cassette provides a simple one-step procedure to assist in screening for lower gastrointestinal pathologies.

Clinical background
Colorectal cancer is among the most commonly diagnosed cancers and a leading cause of cancer-related death. Screening increases early detection and reduces mortality. Immunochemical FOB tests detect human hemoglobin specifically and avoid dietary restrictions required by guaiac-based tests, improving specificity for lower gastrointestinal lesions such as colorectal cancer and adenomas.

Intended use and format
The FOB Rapid Test is an in vitro diagnostic, qualitative immunochromatographic assay for fecal specimens. Available as a cassette or strip; read visually within 10–15 minutes as an aid in the diagnosis of lower GI pathologies.

Product information

• Product name: FOB Rapid Test Device
• Specimen: Feces
• Method: Colloidal Gold immunochromatographic assay
• Format: Cassette or strip
• Reading Time: 10–15 minutes
• Accuracy: about 99.4%
• Certifications: CE / SFDA / ISO13485 / FSC
• Shelf Time: 24 months
• Package: 25 tests/box

Notes on operation
Simple visual immunoassay. Follow manufacturer instructions for sample collection and application to the cassette; wait 10–15 minutes before reading the result. Interpret results according to the kit instructions and clinical context.

Technical specifications

• Assay principle: Colloidal gold immunochromatography
• Intended use: Qualitative presumptive detection of human hemoglobin in fecal specimens (aid in diagnosing lower GI pathologies)
• Reading time: within 10–15 minutes
• Reported accuracy: about 99.4%
• Certification: CE, SFDA, ISO13485, FSC
• Package configuration: 25 tests per box