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Immunochemical fecal occult blood tests viable alternative to colonoscopy

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Qualitative immunochemical fecal occult blood tests could be used for mass screening as an alternative to colonoscopy, according to the results of a prospective, multicenter study conducted in Germany.

Researchers enrolled 1,319 patients. Thirty-one percent of patients had an adenoma; 10% had advanced adenoma.

The researchers tested fecal hemoglobin levels with five qualitative immunochemical fecal occult blood tests: Bionexia FOB-plus (Dima), PreventID CC (Preventis), immoCARE-C (CAREdiagnostica), FOB advanced (Ulti Med) and QuickVue iFOB (Quidel). They used Bionexia Hb/Hp Complex (Dima) to test both fecal hemoglobin and hemoglobin-haptoglobin levels.

Two tests had specificity above 90%: immoCARE-C (96.7%) and FOB advanced (92.9%). Those two tests had the highest rates of detection for advanced adenoma: 25.4% for immoCARE-C and 26.9% for FOB advanced.

However, compared with immoCARE-C the FOB advanced test showed a higher sensitivity to detect other adenoma (4.7% vs. 13.8%) and any adenoma (11.4% vs. 18.0%). The guaiac-based HemOccult test had a 9.4% sensitivity to detect advanced adenoma and a 95.9% specificity.

Positive predictive values for the test ranged from a high of 60.5% for immoCARE-C and a low of 40.2% for QuickVue iFOB. Negative predictive values ranged from a low of 71.1% for immoCARE-C and a high of 76.0% for Bionexia Hb/Hp Complex.

The researchers wrote that qualitative immunochemical fecal occult blood tests combine the advantages of immunochemical tests with the ease of use for mass screening of guaiac-based tests, and may become a viable alternative to colonoscopy. – by Jason Harris

Ann Intern Med. 2009;150:162-169.

The strength of the study is that the researchers followed up with immediate colonoscopy so they had a direct assessment of the efficacy of the screening procedures. It's a very ambitious study and it does suggest that some of these newer products may offer some advantage, but these products have to be evaluated in a larger series, and we need an economic analysis to see if the cost differentials will be worth any improved rates of detection.

– David H. Ilson, MD

HemOnc Today Editorial Board member