As of June 2021, there are no FDA-approved salivary diagnostic tests for evaluating risk of periodontal disease or dental caries, or head and neck cancer.Several diagnostic tests that use saliva or oral fluid samples for detection of SARS CoV-2 have received emergency use authorization from the U.S.Challenges to the use of oral fluids for diagnostic purposes include identification of disease-specific markers, sensitivity and specificity of tests, and standardization of collection/storage of salivary samples.Oral fluid testing by clinical laboratories for the detection of viral infection (e.g., SARS CoV-2, HIV, HPV, HSV) or other infectious agents (e.g., Candida albicans), drug metabolizer status, and detection of illicit drugs is generally regulated through the Clinical Laboratory Improvement Amendments of 1988 ( CLIA ). Biocomponents found in oral fluid include proteins and related molecules, nucleic acid components (e.g., human and microbial DNA, mRNA and microRNA), and endogenous and exogenous metabolites.Saliva and other oral fluids (e.g., gingival crevicular fluid, combined secretions of minor salivary glands) support the health of soft and hard tissues in the oral cavity.
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