Objectives: An improved test paper strip coated with anti-human hemoglobin monoclonal antibody together with an oral rinse sample for immunological detection of salivary occult blood (improved immunological method: IIM) was used in a trial screening test for periodontal disease, and clinically evaluated in comparison with a commercially available conventional test paper using the peroxidase method (PM). Methods: The subjects were 103 healthy adults (76 men and 27 women ranging in age between 35 and 55 years; average 43.2 years). Prior to periodontal examination for probing depth (PD) and bleeding on probing (BOP), oral rinse samples (3 ml of water, 10-s rinse) and non-stimulated saliva were collected to detect the presence of blood by the IIM test and the PM test, respectively. Results: According to the IIM test, 47 samples were positive, 9 were weakly positive, and 47 were negative. In the PM test, 57 were positive, 28 were weakly positive, and 18 were negative. Subjects having over 20% BOP and/or having exceeding 6 mm PD at one or more sites were defined as having periodontal disease. The results of the IIM and PM test findings were analyzed with clinical parameters using gold standard analysis. In the IIM test, sensitivity was 90.9%, specificity was 87.5%, positive predictive value was 89.3%, and negative predictive value was 89.4%. In the PM test, on the other hand, the corresponding values were 94.5%, 31.3%, 61.2%, and 83.3%, respectively. Conclusions: Therefore, the IIM test was considered to be useful as a novel screening method for periodontal disease.

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