<p>Prostate cancer (PCa) remains one of the most common malignancies, and early diagnosis critically depends on accurate detection of prostate‑specific antigen (PSA). While conventional laboratory methods like ELISA offer high sensitivity, they are time‑consuming and require centralized infrastructure, limiting point‑of‑care (POC) use. This review focuses on passive capillary flow microfluidic platforms (LFIAs, μPADs, and hybrid systems) that rely on capillary, gravity, vacuum or slug‑flow for fluid transport. Active microfluidic devices (pump‑based) and standalone sensors are excluded due to their complexity and limited POC compatibility. We systematically evaluate these platforms in terms of materials, fabrication, detection methods, and their alignment with the REASSURED criteria for POC diagnostics. A weighted analysis shows that LFIAs excel in speed and simplicity but suffer from insufficient sensitivity. μPADs offer design flexibility and multiplexing but face challenges in reproducibility and integration. Hybrid pump‑free devices achieve the best overall balance, combining sensitivity comparable to ELISA with the simplicity required for POC use. The article critically discusses technological barriers to the implementation of research results: the lack of an integrated plasma separation system, insufficient stability of reagents, and the difficulty of interpreting multiparameter data. Future directions highlight machine‑learning‑based risk prediction, digital twins for personalized diagnostics, and the translation of prototypes into commercial products. This review provides a roadmap for implementing pump‑free microfluidic PSA testing in real‑world settings.</p> Graphical Abstract

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Comprehensive Review of Microfluidic Devices for Prostate-Specific Antigen Detection: From μPADs to Advanced Pump-Free Systems

  • Kseniya Miniailo,
  • Anzhelika Martynenko,
  • Lomova Mariia,
  • Petkov Andrei

摘要

Prostate cancer (PCa) remains one of the most common malignancies, and early diagnosis critically depends on accurate detection of prostate‑specific antigen (PSA). While conventional laboratory methods like ELISA offer high sensitivity, they are time‑consuming and require centralized infrastructure, limiting point‑of‑care (POC) use. This review focuses on passive capillary flow microfluidic platforms (LFIAs, μPADs, and hybrid systems) that rely on capillary, gravity, vacuum or slug‑flow for fluid transport. Active microfluidic devices (pump‑based) and standalone sensors are excluded due to their complexity and limited POC compatibility. We systematically evaluate these platforms in terms of materials, fabrication, detection methods, and their alignment with the REASSURED criteria for POC diagnostics. A weighted analysis shows that LFIAs excel in speed and simplicity but suffer from insufficient sensitivity. μPADs offer design flexibility and multiplexing but face challenges in reproducibility and integration. Hybrid pump‑free devices achieve the best overall balance, combining sensitivity comparable to ELISA with the simplicity required for POC use. The article critically discusses technological barriers to the implementation of research results: the lack of an integrated plasma separation system, insufficient stability of reagents, and the difficulty of interpreting multiparameter data. Future directions highlight machine‑learning‑based risk prediction, digital twins for personalized diagnostics, and the translation of prototypes into commercial products. This review provides a roadmap for implementing pump‑free microfluidic PSA testing in real‑world settings.

Graphical Abstract