A Rapid Saliva-Based LAMP-PCR Platform for Adjunctive Metabolic and Microbial Monitoring in Hemodialysis Patients
摘要
Patients with chronic kidney disease undergoing maintenance hemodialysis require frequent biochemical monitoring, which conventionally relies on invasive blood sampling. Saliva represents a non-invasive biofluid that may reflect systemic metabolic changes and oral microbial dynamics. However, the feasibility of integrating salivary biochemical and microbial assessment into a rapid point-of-care (POC) workflow in dialysis settings remains incompletely explored.
ObjectivesTo evaluate the feasibility of a rapid saliva-based POC platform integrating biochemical assays and LAMP-PCR for assessing within-session metabolic and microbial changes in patients undergoing routine hemodialysis, and to examine its relationship with corresponding serum biochemical trends.
MethodsIn this prospective paired observational study, 70 maintenance hemodialysis patients provided saliva and serum samples immediately before and after a dialysis session. Salivary urea and creatinine were measured using enzymatic POC assays, while salivary microbial DNA burden was assessed using LAMP-PCR targeting bacterial 16 S rRNA and selected oral pathogens. Serum biochemical parameters were measured using standard laboratory methods, with exploratory analysis of protein-bound uremic toxins performed in a subset. Agreement, correlation, and diagnostic performance analyses were conducted.
ResultsSignificant post-dialysis reductions were observed in both serum and salivary urea concentrations (both p < 0.001). Although directional concordance was noted, changes in salivary and serum urea showed weak linear correlation (r = 0.016, p = 0.894). Bland–Altman analysis demonstrated acceptable internal consistency of salivary urea measurements. Salivary urea reduction showed moderate specificity (75.0%) but limited sensitivity (56.5%) for identifying ≥ 30% serum urea reduction. LAMP-based analysis demonstrated a significant increase in time-to-positivity post-dialysis, indicating reduced detectable salivary microbial DNA. The complete saliva-based workflow was completed within approximately 22 min with high reproducibility.
ConclusionThis study demonstrates the feasibility of a rapid saliva-based POC platform for adjunctive metabolic and microbial monitoring in hemodialysis patients. While salivary biomarkers reflected directional biochemical trends, they did not demonstrate quantitative equivalence with serum indices and should not be interpreted as substitutes for established serum-based dialysis adequacy measures. Saliva-based POC testing may serve as a non-invasive complementary tool for bedside surveillance, pending further longitudinal and multicenter validation.