Abstract
BackgroundCurrent blood based diagnostic assays to detect heart failure (HF) have large intra-individual and inter-individual variations which have made it difficult to determine whether the changes in the analyte levels reflect an actual change in disease activity. Human saliva mirrors the body’s health and well being and ∼20% of proteins that are present in blood are also found in saliva. Saliva has numerous advantages over blood as a diagnostic fluid which allows for a non-invasive, simple, and safe sample collection. The aim of our study was to develop an immunoassay to detect NT-proBNP in saliva and to determine if there is a correlation with blood levels.MethodsSaliva samples were collected from healthy volunteers (n = 40) who had no underlying heart conditions and HF patients (n = 45) at rest. Samples were stored at −80°C until analysis. A customised homogeneous sandwich AlphaLISA(R) immunoassay was used to quantify NT-proBNP levels in saliva.ResultsOur NT-proBNP immunoassay was validated against a commercial Roche assay on plasma samples collected from HF patients (n = 37) and the correlation was r2 = 0.78 (p<0.01, y = 1.705× +1910.8). The median salivary NT-proBNP levels in the healthy and HF participants were <16 pg/mL and 76.8 pg/mL, respectively. The salivary NT-proBNP immunoassay showed a clinical sensitivity of 82.2% and specificity of 100%, positive predictive value of 100% and negative predictive value of 83.3%, with an overall diagnostic accuracy of 90.6%.ConclusionWe have firstly demonstrated that NT-proBNP can be detected in saliva and that the levels were higher in heart failure patients compared with healthy control subjects. Further studies will be needed to demonstrate the clinical relevance of salivary NT-proBNP in unselected, previously undiagnosed populations.
Highlights
Heart failure (HF) is a global health problem, associated with poor clinical outcomes and substantial economic burden to the healthcare system [1,2]
The salivary NT-proBNP and plasma concentrations from the heart failure (HF) patients were compared with the clinical diagnostic criteria used by cardiologists in order to determine the diagnostic utility of the salivary NT-proBNP immunoassay
The group of HF patients consisted of 23 males and 22 females, with a median age of 73 years, body mass index (BMI) of 29.14, and systolic and diastolic blood pressure of 125 mm Hg and 71 mm Hg, respectively
Summary
Heart failure (HF) is a global health problem, associated with poor clinical outcomes and substantial economic burden to the healthcare system [1,2]. Current blood-based ‘sandwich’ immunoassays use monoclonal and polyclonal antibodies targeting different epitopes to quantify plasma levels of NT-proBNP and BNP [11,12,13,14]. This may complicate interpretation of plasma levels of NT-proBNP/BNP for diagnosing and monitoring HF, especially if a patient accesses different laboratory services that use different assays/platforms. These differences will only be minimised with improved understanding of the molecular forms and glycosylation patterns of NTproBNP and BNP in the circulation. The aim of our study was to develop an immunoassay to detect NT-proBNP in saliva and to determine if there is a correlation with blood levels
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