Intended use

This device is intended to be used for the in vitro qualitative detection of fecal occult blood (FOB) in human feces. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood (FOB), Human Occult Blood, or Human Hemoglobin. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based methods lack sensitivity and specificity, and also have diet restrictions prior to testing.

The FOB Rapid Test Cassette (Feces) is a rapid test to qualitatively detect low levels of Fecal Occult Blood. The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50ng/ml or higher, or 6μg/g feces. In addition, unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.

The current clinical methods for detecting FOB include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® FOB
Format	Cassette	Reaction Time	10min
Linearity	-	Reference	Negative ≤ 1 Positive > 1
Sample	Feces	Certificate	CE

ORDERING
Cat. No.	LMTMFO25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LATMFO25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T