Diagnostic Accuracy of a Point-Of-Care aMMP-8 Test for Discriminating Periodontal Health Status in Adults: Validation Trials and Updated Meta-Analysis.

AIM: To evaluate the diagnostic accuracy of an active matrix metalloproteinase-8 (aMMP-8) point-of-care oral rinse test (POC-ORT) for predicting periodontitis in treatment-naive subjects in two independent studies and update a recent meta-analysis. METHODS: The aMMP-8 POC-ORT index test was performed in a representative population in Hong Kong, China, and a consecutive convenience sample in Shanghai, China. The reference standard was the 2017 World Workshop classification of periodontal diseases. Sensitivity, specificity, and the area under the receiver operating characteristic (AUROC) curve were assessed. The original data were used to update a recent Bayesian meta-analysis following the current Cochrane guideline for diagnostic trials. The GRADE framework was used to interpret the strength and certainty of the evidence. RESULTS: Three-hundred and eighty-four and 390 subjects were enrolled in the Hong Kong and Shanghai studies, respectively; 74.5% and 67.2% had periodontitis. An aMMP-8-positive test predicted periodontitis with an AUROC of 0.661 and 0.669 in the two studies. The updated systematic review and meta-analysis included eight studies and 2048 subjects. After considering the risk of bias, indirectness, inconsistency, imprecision and publication bias, it showed moderate certainty of a sensitivity of 0.59 (95% CrI: 0.42-0.75), a specificity of 0.82 (95% CrI: 0.68-0.93) and a hierarchical summary AUROC of 0.77 (95% CrI: 0.74-0.81). CONCLUSION: There is moderate certainty that the aMMP-8 POC-ORT test predicts periodontitis with low to moderate sensitivity, moderate to high specificity, and moderate accuracy. Its high false-negative rate does not allow the replacement of clinical examinations when available. The moderate to high positive predictive value shows the potential utility of a positive test for self-detection or co-management of periodontitis in a medical setting and its incorporation in multi-test diagnostics. Further investigations are highly warranted.