Alzheimer's disease is among the neurodegenerative diseases for which there is a lack of rapid, effective, and non-invasive diagnostic methods. The development of a phospho-Tau 181 assay biosensor is therefore a response to the need for methods to diagnose AD. The present work was aimed at developing a fast, selective, and repeatable method for the quantitative determination of phospho-Tau 181, which could be used even during routine blood tests. Our method is a form of what is called liquid biopsy. The developed method underwent validation, as a result of which its analytical parameters were determined. An LOQ of 3.35 pg mL-1 was obtained, confirming the possibility of trace analysis of phospho-Tau 181 in human plasma. Relative percentage error values below 15 % and CVs in the range 1.47-7.09 % attest to the high accuracy and precision of the presented method. Also, the sample matrix was not found to significantly affect the results obtained for phospho-Tau 181 concentrations. The new SPRi biosensor provides reproducible measurements of the analyte under study (CV = 3.18-4.26 %). Although the method requires absolute adherence to the recommendations of the analytical procedure protocol, it achieves high selectivity and provides 90 % certainty of the correctness of the diagnosis based on measurements of phospho-Tau 181 concentration.
Keywords: Medical diagnostics; Phospho-Tau 181; SPRi biosensor.
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