Contents

Gate-Linked Readiness Analysis of Piezoelectric Diagnostic Sensors for Near-Patient Analytical Instrumentation

Author(s): Louis E. Brus1
1Department of Chemistry, Columbia University, New York, New York 10027, USA
Louis E. Brus
Department of Chemistry, Columbia University, New York, New York 10027, USA

Abstract

Piezoelectric chemosensors and biosensors translate molecular binding, microbial capture, cellular adhesion, and biomarker recognition into label-free mechanical responses. Their diagnostic value, however, depends on more than a low limit of detection. This study asks which piezoelectric diagnostic sensors satisfy a linked set of near-patient requirements: analyte-relevant signal, explicit sample-to-answer time, transferable resonator format, practical receptor chemistry, medical decision relevance, and sufficient operational documentation. Twelve named sensor architectures were organized as a seventy-two-cell gate matrix using Bottleneck-Resolved Evidence Concordance (BREC), with each architecture evaluated across six readiness gates. The clinical-concordant group consisted of the quartz crystal microbalance aptasensor for K562 cells, the quartz crystal microbalance immunosensor for Staphylococcus aureus, and the quartz crystal microbalance procalcitonin biosensor. Heat shock protein and miR-106b sensors showed high analytical strength but were limited respectively by hardware transferability and incomplete sample-to-answer definition. Prostate-specific antigen, lactoferrin, and N\textsuperscript{6}-methyladenine assays required protocol completion, time compression, or proof that added instrument complexity improves diagnostic discrimination. Molecularly imprinted polymer assays were most coherent as chemical-recognition or toxicology tools rather than bedside medical tests, while the SARS-CoV-2 antibody wafer assay required exact analytical limits and timing before fair comparison. The main conclusion is that piezoelectric diagnostic translation is controlled by the identity of the first unresolved bottleneck, not by detection limit alone.

Keywords: piezoelectric biosensor; quartz crystal microbalance; bottleneck analysis; analytical validation; point-of-care diagnostics; assay documentation; recognition chemistry; diagnostic instrumentation
Copyright © 2025 Louis E. Brus. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.