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A special issue of Biosensors (ISSN 2079-6374). This special issue belongs to the section "Biosensor and Bioelectronic Devices".

Deadline for manuscript submissions: 31 August 2025 | Viewed by 14964

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Special Issue Editors

Prof. Dr. Niancai Peng

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Guest Editor

State Key Laboratory for Manufacturing Systems Engineering, Xi'an, China
Interests: biomedical testing technology and instrumentation

Dr. Fei Hu

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Guest Editor

School of Instrument Science and Technology, Xi’an Jiaotong University, Xi’an 710054, China
Interests: biosensor; nucleic acid; diagnostics

Special Issue Information

Dear Colleagues,

As an effective means of obtaining biological information, biosensing is a pioneering and core technology in medical diagnostics. Innovation and application progress in this technology are critical for the development of new diagnostic methods and instruments. Biosensing-based analytical methods, including early and rapid diagnosis, bedside supervision, and in vivo monitoring, provide important guidance for immediate and precision medical care.

This Special Issue focuses on the innovative advances and applications of biosensing technologies in medical diagnostics. The Issue invites manuscripts (research papers, perspectives, and review articles) related to biosensing applications including, but not limited to, bioassay, bioseparation, point-of-care tests, gene engineering, cell analysis, drug screening, tissue engineering, regenerative medicine, personalized healthcare, etc. Articles regarding the integration of advanced diagnostic techniques and testing devices are also encouraged to be submitted. We look forward to receiving your contributions and sharing the latest advances in the application of biosensing technologies in medical diagnosis with our readers.

Prof. Dr. Niancai Peng
Dr. Fei Hu
Guest Editors

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Biosensors is an international peer-reviewed open access monthly journal published by MDPI.

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Keywords

diagnostics
biodetection
biosensors
bioseparation
biomaterial
genomics
nucleic acid detection
immunoassay
wearable medical testing
microfluidics and its application to medical testing
cell analysis
point-of-care testing
drug screening
tissue engineering
regenerative medicine
personalized healthcare

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Published Papers (9 papers)

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Research

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21 pages, 2081 KiB

Open AccessArticle

Translation of COVID-19 Serology Test on Foil-Based Lateral Flow Chips: A Journey from Injection Molding to Scalable Roll-to-Roll Nanoimprint Lithography

by Pakapreud Khumwan, Stephan Ruttloff, Johannes Götz, Dieter Nees, Conor O’Sullivan, Alvaro Conde, Mirko Lohse, Christian Wolf, Nastasia Okulova, Janine Brommert, Richard Benauer, Ingo Katzmayr, Nikolaus Ladenhauf, Wilfried Weigel, Maciej Skolimowski, Max Sonnleitner, Martin Smolka, Anja Haase, Barbara Stadlober and Jan Hesse

Biosensors 2025, 15(4), 229; https://doi.org/10.3390/bios15040229 - 4 Apr 2025

Viewed by 479

Abstract

Lateral flow tests (LFTs) had a pivotal role in combating the spread of the SARS-CoV-2 virus throughout the COVID-19 pandemic thanks to their affordability and ease of use. Most of LFT devices were based on nitrocellulose membrane strips whose industrial upscaling to billions of devices has already been extensively demonstrated. Nevertheless, the assay option in an LFT format is largely restricted to qualitative detection of the target antigens. In this research, we surveyed the potential of UV nanoimprint lithography (UV-NIL) and extrusion coating (EC) for the high-throughput production of disposable capillary-driven, foil-based tests that allow multistep assays to be implemented for quantitative readout to address the inherent lack of on-demand fluid control and sensitivity of paper-based devices. Both manufacturing technologies operate on the principle of imprinting that enables high-volume, continuous structuring of microfluidic patterns in a roll-to-roll (R2R) production scheme. To demonstrate the feasibility of R2R-fabricated foil chips in a point-of-care biosensing application, we adapted a commercial chemiluminescence multiplex test for COVID-19 antibody detection originally developed for a capillary-driven microfluidic chip manufactured with injection molding (IM). In an effort to build a complete ecosystem for the R2R manufacturing of foil chips, we also recruited additional processes to streamline chip production: R2R biofunctionalization and R2R lamination. Compared to conventional fabrication techniques for microfluidic devices, the R2R techniques highlighted in this work offer unparalleled advantages concerning improved scalability, dexterity of seamless handling, and significant cost reduction. Our preliminary evaluation indicated that the foil chips exhibited comparable performance characteristics to the original IM-fabricated devices. This early success in assay translation highlights the promise of implementing biochemical assays on R2R-manufactured foil chips. Most importantly, it underscores the potential utilization of UV-NIL and EC as an alternative to conventional technologies for the future development in vitro diagnostics (IVD) in response to emerging point-of-care testing demands. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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17 pages, 3277 KiB

Open AccessArticle

Signal Differentiation of Moving Magnetic Nanoparticles for Enhanced Biodetection and Diagnostics

by Kee Young Hwang, Dakota Brown, Supun B. Attanayake, Dan Luu, Minh Dang Nguyen, T. Randall Lee and Manh-Huong Phan

Biosensors 2025, 15(2), 116; https://doi.org/10.3390/bios15020116 - 17 Feb 2025

Cited by 1 | Viewed by 744

Abstract

Magnetic nanoparticles are extensively utilized as markers/signal labelling in various biomedical applications. Detecting and distinguishing magnetic signals from similarly sized moving magnetic nanoparticles in microfluidic systems is crucial yet challenging for biosensing. In this study, we have developed an original method to detect and differentiate magnetic signals from moving superparamagnetic (SPM) and ferrimagnetic (FM) nanoparticles of comparable sizes. Our approach utilizes a highly sensitive magnetic-coil-based sensor that harnesses the combined effects of giant magnetoimpedance (GMI) and an LC-resonance circuit, offering performance superior to that of conventional GMI sensors. Iron oxide nanoparticles, which have similar particle sizes but differing coercivities (zero for SPM and non-zero for FM) or similar zero coercivities but differing particle sizes, flow through the magnetic coil at controlled velocities. Their distinct effects are analyzed through changes in the complex impedance of the sensing system. Our findings provide a unique pathway for utilizing SPM and FM nanoparticles as innovative magnetic markers to identify specific biological entities, thereby expanding their potential applications. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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18 pages, 5789 KiB

Open AccessArticle

Non-Invasive Point-of-Care Detection of Methamphetamine and Cocaine via Aptamer-Based Lateral Flow Test

by Bilge Erkocyigit, Ezgi Man, Ece Efecan, Ozge Ozufuklar, Deniz Devecioglu, Basak Bagci, Ebru Aldemir, Hakan Coskunol, Serap Evran and Emine Guler Celik

Biosensors 2025, 15(1), 31; https://doi.org/10.3390/bios15010031 - 9 Jan 2025

Cited by 1 | Viewed by 1474

Abstract

Drug abuse is a major public problem in the workplace, traffic, and forensic issues, which requires a standardized test device to monitor on-site drug use. For field testing, the most important requirements are portability, sensitivity, non-invasiveness, and quick results. Motivated by this problem, a point of care (POC) test based on lateral flow assay (LFA) was developed for the detection of cocaine (COC) and methamphetamine (MET) in saliva which has been selected as the matrix for this study due to its rapid and non-invasive collection process. In the design strategy of an LFA test, the use of gold nanoparticles (AuNPs) with strong optical properties has been combined with the advantages of selecting aptamers under in vitro conditions, making it a highly specific and stable recognition probe for the detection of small molecules in saliva. The developed aptamer-based LFA in a competitive format, was able to detect COC and MET in synthetic saliva at concentrations as low as 5.0 ng/mL. After analytical performance studies, the test system also detected COC and MET in real patient samples, which was verified by chromatographic methods. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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23 pages, 3153 KiB

Open AccessArticle

Sensing Biomechanical Alterations in Red Blood Cells of Type 1 Diabetes Patients: Potential Markers for Microvascular Complications

by Riccardo Di Santo, Benedetta Niccolini, Alessandro Rizzi, Laura Bertini, Denise Pires Marafon, Maria Vaccaro, Federica Cristallo, Enrico Rosa, Linda Tartaglione, Laura Leo, Marco De Spirito, Gabriele Ciasca and Dario Pitocco

Biosensors 2024, 14(12), 587; https://doi.org/10.3390/bios14120587 - 2 Dec 2024

Viewed by 1091

Abstract

In physiological conditions, red blood cells (RBCs) demonstrate remarkable deformability, allowing them to undergo considerable deformation when passing through the microcirculation. However, this deformability is compromised in Type 1 diabetes mellitus (T1DM) and related pathological conditions. This study aims to investigate the biomechanical properties of RBCs in T1DM patients, focusing on identifying significant mechanical alterations associated with microvascular complications (MCs). We conducted a case-control study involving 38 T1DM subjects recruited from the Diabetes Care Unit at Fondazione Policlinico Gemelli Hospital, comprising 22 without MCs (control group) and 16 with MCs (pathological group). Atomic Force Microscopy was employed to assess RBC biomechanical properties in a liquid environment. We observed significant RBC stiffening in individuals with MCs, particularly during large indentations that mimic microcirculatory deformations. Univariate analysis unveiled significant differences in RBC stiffness (median difference 0.0006 N/m, p = 0.012) and RBC counts (median difference −0.39 × 10¹²/L, p = 0.009) between the MC and control groups. Bivariate logistic regression further demonstrated that combining these parameters could effectively discriminate between MC and non-MC conditions, achieving an AUC of 0.82 (95% CI: 0.67–0.97). These findings reveal the potential of RBC biomechanical properties as diagnostic and monitoring tools in diabetes research. Exploring RBC mechanical alterations may lead to the development of novel biomarkers, which, in combination with clinical markers, could facilitate the early diagnosis of diabetes-related complications. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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15 pages, 8475 KiB

Open AccessArticle

A Novel High-Throughput Sample-in-Result-Out Device for the Rapid Detection of Viral Nucleic Acids

by Fangning Wang, Fei Hu, Yunyun Zhang, Xichen Li, Qin Ma, Xincheng Wang and Niancai Peng

Biosensors 2024, 14(11), 549; https://doi.org/10.3390/bios14110549 - 13 Nov 2024

Viewed by 1397

Abstract

Clustered regularly interspaced short palindromic repeats (CRISPR) molecular diagnostic technology is one of the most reliable diagnostic tools for infectious diseases due to its short reaction time, high sensitivity, and excellent specificity. However, compared with fluorescent polymerase chain reaction (PCR) technology, CRISPR molecular diagnostic technology lacks high-throughput automated instrumentation and standardized detection reagents for high sensitivity, limiting its large-scale clinical application. In this study, a high-throughput automated device was developed by combining reagent lyophilization, extraction-free technology, and a one-pot consumable system. This innovative approach enabled the rapid sample-in-result-out detection of 48 samples in 25 min and demonstrated high sensitivity and specificity for the qualitative analysis of clinical samples. The obtained results show that the detection limit of the designed system for African swine fever virus (ASFV) is 0.5 copies/μL. As a proof concept, a single-tube dual-target nucleic acid detection method was developed, achieving a detection limit of 5 copies/μL for the ORF1ab and N genes of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) within 45 min. The method is highly specific, reliable, and stable, providing a feasible solution for the clinical application of CRISPR nucleic acid detection technology. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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13 pages, 8057 KiB

Open AccessCommunication

ZnS and Reduced Graphene Oxide Nanocomposite-Based Non-Enzymatic Biosensor for the Photoelectrochemical Detection of Uric Acid

by Yao Zhao, Niancai Peng, Weizhuo Gao, Fei Hu, Chuanyu Zhang and Xueyong Wei

Biosensors 2024, 14(10), 488; https://doi.org/10.3390/bios14100488 - 8 Oct 2024

Cited by 1 | Viewed by 1259

Abstract

In this work, we report a study of a zinc sulfide (ZnS) nanocrystal and reduced graphene oxide (RGO) nanocomposite-based non-enzymatic uric acid biosensor. ZnS nanocrystals with different morphologies were synthesized through a hydrothermal method, and both pure nanocrystals and related ZnS/RGO were characterized with SEM, XRD and an absorption spectrum and resistance test. It was found that compared to ZnS nanoparticles, the ZnS nanoflakes had stronger UV light absorption ability at the wavelength of 280 nm of UV light. The RGO significantly enhanced the electron transfer efficiency of the ZnS nanoflakes, which further led to a better photoelectrochemical property of the ZnS/RGO nanocomposites. The ZnS nanoflake/RGO nanocomposite-based biosensor showed an excellent uric acid detecting sensitivity of 534.5 μA·cm⁻²·mM⁻¹ in the linear range of 0.01 to 2 mM and a detection limit of 0.048 μM. These results will help to improve non-enzymatic biosensor properties for the rapid and accurate clinical detection of uric acid. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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12 pages, 3399 KiB

Open AccessArticle

Characterization of Receptor Binding Affinity for Vascular Endothelial Growth Factor with Interferometric Imaging Sensor

by Nese Lortlar Ünlü, Monireh Bakhshpour-Yucel, Elisa Chiodi, Sinem Diken-Gür, Sinan Emre and M. Selim Ünlü

Biosensors 2024, 14(7), 315; https://doi.org/10.3390/bios14070315 - 24 Jun 2024

Cited by 1 | Viewed by 1757

Abstract

Wet Age-related macular degeneration (AMD) is the leading cause of vision loss in industrialized nations, often resulting in blindness. Biologics, therapeutic agents derived from biological sources, have been effective in AMD, albeit at a high cost. Due to the high cost of AMD treatment, it is critical to determine the binding affinity of biologics to ensure their efficacy and make quantitative comparisons between different drugs. This study evaluates the in vitro VEGF binding affinity of two drugs used for treating wet AMD, monoclonal antibody-based bevacizumab and fusion protein-based aflibercept, performing quantitative binding measurements on an Interferometric Reflectance Imaging Sensor (IRIS) system. Both biologics can inhibit Vascular Endothelial Growth Factor (VEGF). For comparison, the therapeutic molecules were immobilized on to the same support in a microarray format, and their real-time binding interactions with recombinant human VEGF (rhVEGF) were measured using an IRIS. The results indicated that aflibercept exhibited a higher binding affinity to VEGF than bevacizumab, consistent with previous studies using ELISA and SPR. The IRIS system’s innovative and cost-effective features, such as silicon-based semiconductor chips for enhanced signal detection and multiplexed analysis capability, offer new prospects in sensor technologies. These attributes make IRISs a promising tool for future applications in the development of therapeutic agents, specifically biologics. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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16 pages, 6549 KiB

Open AccessArticle

Integrated High-Throughput Centrifugal Microfluidic Chip Device for Pathogen Detection On-Site

by Shuyu Lu, Yuanzhan Yang, Siqi Cui, Anyi Li, Cheng Qian and Xiaoqiong Li

Biosensors 2024, 14(6), 313; https://doi.org/10.3390/bios14060313 - 19 Jun 2024

Cited by 5 | Viewed by 2166

Abstract

An integrated and high-throughput device for pathogen detection is crucial in point-of-care testing (POCT), especially for early diagnosis of infectious diseases and preventing the spread of infection. We developed an on-site testing platform that utilizes a centrifugal microfluidic chip and automated device to achieve high-throughput detection. The low-power (<32 W), portable (220 mm × 220 mm × 170 mm, 4 kg) device can complete bacterial lysis, nucleic acid extraction and purification, loop-mediated isothermal amplification (LAMP) reaction, and real-time fluorescence detection. Magnetic beads for nucleic acid adsorption can be mixed by applying electromagnetic fields and centrifugal forces, and the efficiency of nucleic acid extraction is improved by 60% compared to the no-mixing group. The automated nucleic acid extraction process achieves equivalent nucleic acid extraction efficiency in only 40% of the time consumed using the kit protocol. By designing the valve system and disc layout, the maximum speed required for the centrifugal microfluidic chip is reduced to 1500 rpm, greatly reducing the equipment power consumption and size. In detecting E. coli, our platform achieves a limit of detection (LOD) of 10² CFU/mL in 60 min. In summary, our active centrifugal microfluidic platform provides a solution for the integration of complex biological assays on turntables, with great potential in the application of point-of-care diagnosis. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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Review

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22 pages, 4802 KiB

Open AccessReview

CRISPR-Based Biosensors for Medical Diagnosis: Readout from Detector-Dependence Detection Toward Naked Eye Detection

by Kai Hu, Weihong Yin, Yunhan Bai, Jiarui Zhang, Juxin Yin, Qiangyuan Zhu and Ying Mu

Biosensors 2024, 14(8), 367; https://doi.org/10.3390/bios14080367 - 28 Jul 2024

Cited by 1 | Viewed by 3571

Abstract

The detection of biomarkers (such as DNA, RNA, and protein) plays a vital role in medical diagnosis. The CRISPR-based biosensors utilize the CRISPR/Cas system for biometric recognition of targets and use biosensor strategy to read out biological signals without the employment of professional operations. Consequently, the CRISPR-based biosensors demonstrate great potential for the detection of biomarkers with high sensitivity and specificity. However, the signal readout still relies on specialized detectors, limiting its application in on-site detection for medical diagnosis. In this review, we summarize the principles and advances of the CRISPR-based biosensors with a focus on medical diagnosis. Then, we review the advantages and progress of CRISPR-based naked eye biosensors, which can realize diagnosis without additional detectors for signal readout. Finally, we discuss the challenges and further prospects for the development of CRISPR-based biosensors. Full article

(This article belongs to the Special Issue Biosensing Technologies in Medical Diagnosis)

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