Clinical study on monohaem, an immunological fecal occult blood test reagent.

概要

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Since today colon cancer is on the increase, attention has been drawn to the use of fecal occult blood tests (F. O. B. T.) as a nears of screening have for the disease. However, most of the currently available chemical tests for F. O. B. T. have problems with sensitivity and specificity. Under these circumstances, vaious reagents for immunological F. O. B. T. which react solely with human Hb and specifically have been developed. We carried out a clinical study on Monohaem, one of these reagents, using a multicentral approach. The false-positive rate in healthy volunteers without diet restriction was 8.1% (16/197), indicating the high specificity of this reagent as compared with conventional chemical tests. The detection rate of colon cancer was as high as 91.4% (74/81), confirming the high sensitivity of this test reagent. From these findings, the possibility of early detection of cancer was suggested. In addition, it was found that gereally satisactory results could be obtained by performing tests on 2 consecutive days, unlike conventional methods which require tests ove 3 days. The Monohaem test is an immunological approach utilizing monoclonal antibody. Monohaem can be used easily simply by adding a washing process to conventional chemical tests, and was also confirmed to be a useful reagent for the mass screening of colon cancers.