Product Manual (.pdf)

Description

This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human hemoglobin levels in stool samples. This assay specifically measures human hemoglobin without cross-reaction with animal blood. It is useful for detecting the severity of gastrointestinal bleeding and aiding the screening for colorectal adenoma/polyps and cancer, as well as other inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, etc.

For research use only. Not for use in diagnostics procedures.

Background

Testing for abnormally high levels of fecal hemoglobin is recommended by the American Cancer Society (ACS), Center for Disease Control and Prevention (CDC), and the Center for Medical Service (CMS) of the Department of Health of the United States.  The fecal occult blood (FOB) rapid test has been used in the past 40 years toward this purpose.

However, screening for occult blood by means of guaiac tests has an unsatisfactory sensitivity for the detection of colorectal neoplasm in addition to a dietary restriction drawback. They also do not give any insight into the severity of bleeding in the lower gastrointestinal system. Immunochemical FOB tests dramatically increases the analytical sensitivity and specificity in the detection of human hemoglobin in feces. Several clinical trials have shown that immunochemical FOB tests are superior in clinical diagnostics sensitivity and specificity compared to guaiac FOB tests.

This q-FOB™ assay uses human hemoglobin-specific antibodies and brings significant advantages over the qualitative FOB rapid test. The assay does not require dietary restrictions to be placed on a subject or patient. This q-FOB™ assay detects human hemoglobin levels in 100-fold lower concentrations than the guaiac FOB test to avoid false-negatives. Because highly specific human hemoglobin antibodies are used, false positive results are also practically excluded.

Specifications

Catalog no.

Target:

Species

Method

Tests Per Kit

Detection

Sensitivity / LLOD

Dynamic Range

Total Incubation Time

Sample Type

Sample Volume

Storage Temperature

KTR-850

Hemoglobin

Human

Sandwich ELISA

96 tests

Colorimetric

0.5 ng/mL

0 - 745 ng/mL

1 hours, 45 minutes

Stool

100 µL

2-8 °C