In ELISA, Gastroenterology

The guideline of the Joint National Committee (G-BA) requires laboratories to switch to a new test procedure for early detection of colon cancer. We have summarized what you need to consider in selecting the test.

The new guideline, which took effect in two stages on October 1, 2016, and January 1, 2017, specifies the test procedures that may be used for colon cancer screening. Accordingly, the previously used guaiac-based test must be replaced by a more up-to-date immunological procedure for quantitative analysis of occult blood in stool (iFOBT), which is more sensitive and specific. As of April 1, 2017, health insurance covers immunological stool tests for early detection of colon cancer in those aged 50 and up. The guaiac-based test is no longer used. However, physicians may not bill for all immunological stool tests. According to the G-BA guideline, the test system must meet the following quality criteria:

  • The stool sampling system must come with clear instructions.
  • Collecting the stool specimen must be easy and hygienic. A defined quantity of stool must be transferred into a special sample diluent system and stabilized for at least five days at room temperature.
  • The test of a single stool specimen for detecting colorectal cancer or advanced adenoma must have a sensitivity of at least 25 % and a specificity of at least 90 %.
  • At least one evidence-based study in which a colonoscopy was used as a reference procedure must have proven that the test system meets the above-mentioned requirements.

The RIDASCREEN® Haemoglobin ELISA test together with the RIDA®TUBE Haemoglobin stool collection tube from R-Biopharm meets all these requirements. The study by Haug et al. published in 2009 verified that RIDASCREEN® Haemoglobin exceeds the G-BA specificity and sensitivity requirements. Furthermore, RIDASCREEN® Haemoglobin also meets the test quality criteria with respect to verification of results, study population, test quality evaluation, and language of the publication.

Our manufacturer’s declaration, available on request, has more information and a list of publications.

Questions?

Do you want to learn more about colon cancer screening? Our gastroenterology experts would be happy to help you.

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