Self-Screen Ultimed Fob Test
You can now perform the fecal occult blood test at home, whenever you wish, and receive results within a few minutes.
You can now perform the fecal occult blood test at home, whenever you wish, and receive results within a few minutes. If you test positive, speak with your Doctor.
Self-Screen Ultimed Fob Test
Packaging: kit for 1 test
Retail price in Italy: € 10.00
Rapid immunochromatographic test device based on human hemoglobin-specific antibodies for the detection of fecal occult blood and prevention of colorectal cancer.
This new device has been discussed in a study ublished in the prestigious journal Annals of Internal Medicine. Therefore, it is our best choice.
It has the European Certificate of Conformity for “home use”, recognized by the Ministries of Health of the European Union. You can purchase it from any pharmacy/drugstore in Italy.
In vitro diagnostic tests certified for “home use” make it possible for the Consumer to both collect the biological sample and perform the test on his/her own.
The test detects the presence of human hemoglobin in the stool in quantities equal to or greater than 50 ng/mL. The test uses an immunological method, which means it is based on human hemoglobin-specific antibodies that are not likely to react with other substances: therefore, no food restrictions to be adopted in the days prior to the test.
A positive test only means that blood in the stool was detected. This presence is often not a sign of organic disease and, therefore, implies that you should speak with your Doctor but not draw any conclusions on your own.
RATIONALE OF THE TEST: FECAL OCCULT BLOOD TESTING REDUCES MORTALITY
A simple fecal occult blood test reduces mortality from large bowel cancer.
The American College of Gastroenterology recommends primary colonoscopy as a standard first-line test for colorectal cancer screening, but colonoscopy capacity is often limited even in the more developed regions.
It has been shown that fecal occult blood test followed by invasive testing has a better benefit-cost ratio and is more acceptable to the general population than primary colonoscopy or sigmoidoscopy.
Colorectal cancer is the fourth most common cancer in incidence worldwide, affecting more economically developed countries in particular. It is the second most common cause of death from cancer after lung cancer in males and the third after breast cancer and lung cancer in females.
(Gut online 2007, published on November 30).
FAVORABLE CONDITIONS FOR THE DETECTION OF BLOOD IN THE STOOL
There are many conditions, more or less symptomatic, that help determine the presence of blood in the stool, for example alcoholism, dental avulsion (complete displacement of a tooth from its socket in alveolar bone owing to trauma), liver cirrhosis, hemorrhoids, hiatal hernia, esophagitis, cancer of the digestive system, platelet deficiency, purpura, thrombocytopenia, Mallory Weiss syndrome, trauma, salicylates, esophageal varices, gastritis, ulcerative colitis, diverticulitis, epistaxis, polyposis, etc., so that the detection of fecal occult blood is not always associated with colorectal cancer (false positives are rather common for this type of test, even if performed at a hospital or laboratory). For this reason, you should always see your doctor if you test positive.
INFORMATION AND PROCEDURES (in German, Italian, and English)
No scheduling, collection, biopsy, or handling of fecal material.
Repeatability of the test throughout the year with increased diagnostic accuracy.
No dietary restrictions in the days prior to testing.
CE MARKING: IVD in compliance with directive 98/79/EC – CE0123 for home use – Manufacturer: ulti med Products – Ahrensburg, Germany.
EDMA CODE: 11 70 03 01 00 cr Fecal Occult Blood (CC) IC=>12.03.90.04 FOB.
CATEGORY: prEN1874 – EDMA: 06 In vitro diagnostic devices.
ANALYTICAL METHOD: Antibodies selectively detecting human hemoglobin at concentrations =/> 50 ng/ml or of 2 µg/g in fecal samples.
QUALITY ASPECTS OF THE TEST: Relative sensitivity 96.8%, specificity 99.6%. For colonoscopy: sensitivity 68.0%, specificity 99.1%.
TIME FOR RESULTS: Read the results after 8 minutes. Do not read any results after 10 minutes. The test is valid if the red control line appears (C).
STORAGE: The device should be stored at a temperature not exceeding 30°C. Storage at temperatures not exceeding 23 ° C is recommended.
STABILITY DURATION OF THE DEVICE: p to 3-4 days, provided that it is stored at a temperature between 2 and 8°C in a refrigerator.
STABILITY DURATION OF THE DEVICE: 24 months after manufacture.
VERSION: April 2010.
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