FOBCHECK

Healthy intestines?

FOBCHECK is a rapid one-step test for the qualitative detection of human haemoglobin in faecal samples. FOBCHECK is designed to help diagnose gastrointestinal disorders and detects human haemoglobin (Hb) with a cut-off level of 40 ng/ml. In addition to possible intestinal diseases such as diverticulitis, colitis, or colon polyps, the blood in the stool sample may indicate an early stage of colorectal cancer. The final diagnosis must be confirmed and treated by a healthcare practitioner.

Background

Hidden blood in the stool can be an indicator of various diseases such as diverticulitis, colitis, colon polyps or colorectal cancer. Screening for hidden blood can significantly reduce mortality from colorectal cancer. In the case of a positive test result, further investigation by a doctor is necessary for correct diagnosis and treatment.

Various gastrointestinal diseases can lead to hidden bleeding:

• Cancer (8,9%)
• Adenoma or polyps (>40%)
• Diverticular disease (15,5%)
• Haemorrhoid disease (5,8%)
• Inflammatory bowel disease (1,8%)
• Angiodysplasia of the colon (0,7%)

Colorectal cancer is the third most common cancer in the world, with nearly 1,4 million new cases diagnosed in 2012 (https://www.wcrf.org/int/cancer-facts-“gures/data-speci”c-cancers/colorectal-cancer-statistics).

Survival rates are highly depending on early diagnosis.

Symptoms 

Persistent abdominal pain, blood in the stool, a change in bowel habits, diarrhoea or constipation.

Who should get tested?

Adults suspecting colorectal cancer, polyps or other gastrointestinal diseases, or patients with a family history of gastrointestinal diseases. Symptoms could be, among others, lower abdomen pain, frequent diarrhoea, changes in stool appearance (e.g. black stool) and weight loss.

Advantages

• Rapid screening for early detection.
• Minimal sample contact.
• Easy to use.
• Detects human occult blood as low as 40 ng/ml haemoglobin as the threshold level.
• No cross-reactivity to haemoglobin from other species.

Results are accurate and reliable:

• ○ Sensitivity of 97,1%
• ○ Specificity of 98,8%
• ○ Proven Accuracy of 98,6%

Each kit contains everything necessary for the test performance: a test cassette, an instruction leaflet, a sampling tube with developer solution and sample transfer device. The results can be read within 5 minutes.

FOBCHECK Instructions for use:

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