Purpose: A new salivary multi-test system (AL-55) has been developed to check dental caries, periodontal disease and oral cleanliness. This test system can simultaneously assay seven saliva analytes for five minutes measuring color changes of the test strip as reflectance: [Dental caries] cariogenic bacteria, pH, buffer capacity, [Periodontal disease] blood, leukocyte, protein, [Oral cleanliness] ammonia. Our previous study demonstrated the clinical usefulness of AL-55 by investigating the correlation between oral conditions and reflectance measured by this system. While AL-55 can measure seven saliva analytes simultaneously, there are various standards measuring methods for saliva analytes such as cultivation, electrode or enzyme methods. This study was designed to examine the validity and reliability of AL-55 by evaluating correlation and concordance rates between test results measured by the standard methods and AL-55.
Methods: Oral rinse samples (3 m
l of distilled water, 10 sec rinse) were collected from 231 volunteer adults of the previous study. Ten μ
l of the sample was dropped on each pad of the strip, and the reflectance was measured after 1 and 5 min. The reference values were also measured by the following standard methods: [cariogenic bacteria] cultivation method, [pH, buffer capacity] pH electrode, [blood, leukocyte] latex immune agglutination turbidimetry, [protein] pyrogallol red method, [ammonia] glutamate dehydrogenase method. The correlation between the reflectance and the reference value was assessed with the Pearson correlation test (p<0.01). In addition, the results from standard methods and AL-55 were stratified into 3 groups (high, middle and low) and the concordance rates between them were calculated.
Results: The reflectance of each analyte pad was significantly correlated with the reference value (p<0.01). The correlation coefficients were 0.59 (cariogenic bacteria), −0.74 (pH), −0.86 (buffer capacity), −0.74 (blood), −0.67 (leukocyte), −0.75 (protein) and −0.89 (ammonia). The concordance rates between the stratified measured values of the standard methods and AL-55 (high, middle and low) were 70% (cariogenic bacteria), 82% (pH), 73% (buffer capacity), 71% (blood), 72% (leukocyte), 84% (protein) and 90% (ammonia).
Conclusion: This particular study revealed that the reflectance measured by AL-55 was highly correlated with the reference values measured by the standard methods and that the concordance rates between them were from 70% to 90%, leading to high validity and reliability of AL-55.
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