Search Results (666)

Antimicrobial resistance (AMR) is a growing global health threat driven in part by inappropriate and unnecessary antibiotic use resulting from diagnostic uncertainty at the point of care. In outpatient and acute-care settings, clinicians are often unable to rapidly distinguish between viral and bacterial infections, leading to empiric antibiotic prescribing that contributes to the emergence and spread of resistant pathogens. This review examines current and emerging rapid diagnostic technologies for differentiating bacterial and viral infections, including molecular assays, rapid antigen tests, biomarker-based diagnostics, host-response platforms, hematologic methods, and artificial intelligence-based decision-support systems. These technologies are evaluated based on diagnostic accuracy, turnaround time, cost, accessibility, and clinical actionability within real-world healthcare settings. Although several emerging and point-of-care (POC) technologies can provide results within approximately 6–15 min, their ability to consistently align with the timing, workflow, and clinical decision-making requirements of frontline outpatient and emergency-care settings remains variable and incompletely established. Future progress in antimicrobial stewardship will depend on developing rapid, clinically actionable diagnostic systems that integrate seamlessly into patient care and reduce unnecessary antibiotic use. Full article

MicroRNAs (miRNAs) represent highly promising biomarkers for non-invasive clinical diagnostics. To overcome the limitations of conventional methods, Field-Effect Transistor biosensors (bioFETs) emerge as compelling alternatives by providing label-free and real-time readouts. However, bioFETs employing canonical DNA/RNA probes face fundamental limitations due to the Debye screening effect. Peptide Nucleic Acid (PNA), a synthetic nucleic acid analog featuring an uncharged peptide-like backbone, offers an effective solution. PNA’s electroneutrality allows for efficient hybridization at a low ionic strength, thereby mitigating Debye screening constraints. PNA also offers additional key advantages, including high specificity and enzymatic resistance. This work examines recent advancements in PNA–bioFETs, highlighting their potential for the development of robust platforms for clinical miRNA evaluation. Surface Plasmon Resonance (SPR) and Atomic Force Spectroscopy (AFS) are valuable tools to preliminarily characterize probe–target interactions. Key approaches, focused on implementing alternative PNA probe designs and optimizing Self-Assembled Monolayer (SAM) organization, are outlined. By presenting a cross-study comparison that correlates each strategy with the analytical outcomes of a custom-designed bioFET platform targeting miRNA 155, complemented by an overview of PNA–bioFETs across other miRNAs, we illustrate how the synergy between PNA and bioFET can approach reliable miRNA detection, paving the way for the development of Point-of-Care (POC) devices. Full article

Early detection of colorectal cancer (CRC) is challenging in low-resource settings because access to colonoscopy and centralized laboratory testing is limited. Urine-based metabolite biomarkers offer a non-invasive alternative for CRC triage, but translating a laboratory assay into a point-of-care (PoC) system requires standardized fluid handling, operator-independent timing, field-compatible reagents, and quantitative calibration. Here, we present a low-cost, semi-automated PoC platform integrating a validated, sequential, three-metabolite CRC-biomarker assay with robotic fluid handling, a motorized chromatographic module, an optical reader, Bluetooth electronics, and tablet-guided control. The platform measures urinary diacetylspermine and hippuric acid, with creatinine serving as a normalization reference, and reports absolute quantitative concentrations. Automated dilution, tube positioning, timed incubation, controlled column elution, and software-guided transfer reduce operator-dependent variation. Using pooled urine samples spiked at clinically relevant concentrations, the creatinine assay showed a strong quadratic response (0–50 mM, R² = 0.998), as did the diacetylspermine assay (0–4 μM, R² = 0.979), while the hippuric acid assay showed a linear response of R² = 0.989. The RGB sensor tracked the concentration-dependent trend observed with a laboratory microplate reader (R² = 0.968–0.999). Reagents reformulated as lyophilized or pre-weighed, vacuum-sealed kits withstood accelerated heat and humidity (45 °C/70% RH) testing and international shipping to the pilot site very well. At approximately USD 490 for the complete instrument (including tablet) and roughly USD 7.65 in consumables per screening test, the platform offers a practical, quantitative, and portable route for decentralized CRC screening. Full article

Sexually transmitted infections (STIs) remain a public health challenge, with rising incidence rates and significant loss to follow-up in traditional testing models. Point-of-care (POC) testing promises same-day diagnosis and treatment, potentially transforming STI management. We conducted a narrative review with perspective elements of commercially available POC and near-POC tests for STIs, identifying tests through regulatory and product-specific sources including the Food and Drug Administration (FDA), World Health Organization (WHO) prequalification list, Australia’s Therapeutic Goods Administration (TGA), China’s National Medical Products Administration (NMPA), publicly available European regulatory and manufacturer sources for CE-marked in vitro diagnostic devices under the EU In Vitro Diagnostic Regulation framework, and the published literature. Several nucleic acid amplification test (NAAT)-based platforms now deliver results rapidly with excellent sensitivity and specificity for common bacterial and protozoal STIs, including Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. For viral STIs, POC testing is most mature for human immunodeficiency virus (HIV), with numerous approved rapid antibody tests, although viral load and resistance testing remain laboratory-based. Most NAAT platforms require dedicated instruments, specialized training, and significant infrastructure. At-home testing options are emerging but face challenges with sensitivity, public health surveillance, and regulatory oversight. In conclusion, POC testing for STIs is advancing but not yet fully realized, and true POC tests (those usable at the bedside without laboratory support) remain limited. While rapid NAAT platforms represent significant progress over traditional laboratory-based testing, barriers to true POC implementation persist. Future developments in antimicrobial resistance detection, multiplex testing, instrument-free platforms, and integration of at-home testing with public health surveillance will be critical to achieving broader STI testing and control. Full article

Point-of-care (POC) diagnostic testing based on microfluidic technology plays an important role in coagulation management. Its precision is, however, limited by the inefficient mixing between blood and solid activators in laminar microfluidic flow. In this study, a novel micromixer incorporating periodic oscillatory flow was developed to enhance blood-activator mixing. A computational fluid dynamic (CFD) model was established to investigate the microscale hydrodynamic characteristics and solid dispersion behavior in the oscillatory multiphase flow system. The numerical predictions were validated against tracer mixing experiments. Sample calculations for the air-liquid-solid flow system demonstrated that the initial loading position of activator particles significantly affected the dispersion efficiency due to the spatial variation in the radial velocity field. Compared with the center-initialized case, the solid dispersion level in the corner-initialized case decreased by approximately 42% after two oscillation cycles. Furthermore, the influence mechanism of oscillation period on solid dispersion was clarified through multi-physics coupling analysis. This study provided new insights into solid–liquid mixing in oscillatory microfluidic systems and established an effective CFD-based framework for optimizing microdevice design and operating conditions. Full article

Hemoglobin (Hb) and its glycated variant (HbA1c) are essential clinical biomarkers for diagnosing anemia, acute hemorrhage, and long-term glycemic control. The growing demand for decentralized point-of-care (POC) testing has accelerated the development of rapid, inexpensive, and portable electrochemical sensing platforms. These technologies exploit the intrinsic redox activity of the heme prosthetic group, yet achieving efficient direct electron transfer (DET) remains a fundamental challenge because the electroactive iron center is deeply embedded within the globin structure. This review critically examines recent advances in electrochemical Hb sensing, tracing the evolution of electrode architectures from conventional carbon substrates to nanostructured materials, including graphene, MXenes, metal–organic frameworks (MOFs), and molecularly imprinted polymers (MIPs). We compare the advantages and limitations of non-enzymatic biomimetic platforms and affinity-based sensing strategies, including aptamer- and antibody-based biosensors, with emphasis on electron-transfer efficiency, molecular selectivity, analytical performance, and suitability for POC implementation. Beyond analytical performance, we evaluate the principal barriers to clinical translation, including biofouling, whole-blood matrix effects, viscosity-dependent mass transport, manufacturing scalability, and the persistent gap between validation in synthetic media and performance in clinical samples. Finally, we discuss emerging applications in wearable menstrual health monitoring and ingestible gastrointestinal bleeding sensors, highlighting the integration of advanced electrochemical materials with miniaturized electronics as a pathway toward practical, consumer-oriented diagnostics. Full article

Cancer, the second leading cause of death worldwide, is a significant global challenge, and widespread, accessible, and early diagnostics are recognized as the most cost-effective strategies for reducing cancer burdens. Point-of-care (POC) systems offer an attractive alternative by enabling rapid and cost-effective diagnoses. We introduce a novel POC strategy for cancer biomarker identification based on monitoring the isothermal amplification of relevant cancer markers using a portable Arduino-based loop-mediated isothermal amplification (LAMP) system. The trajectory of the LAMP reaction during the first 3 min of the reaction is used as an indicator of the rate of amplification (defined as the m_P3 value). We obtained sets of m_P3 values that showed statistically significant differences in the genetic expression of four genes (ESR 1, PGR, Her2, and Ki67) within and between tissue spheroids derived from the MCF7, MDA-MB-231, Du145, and BJ fibroblast cell lines. We then used principal component analysis and clustering techniques to demonstrate that the m_P3 value sets derived from the expression of the four selected genes are sufficient to distinguish tissue spheroids derived from four different commercial cell lines. Further qPCR and immunostaining assays confirmed the quantitative LAMP (qLAMP) experimental trends. The immunostaining results were consistent with previous literature reports and with our qLAMP and qPCR results. We present a proof-of-concept demonstration of the use of a LAMP-based POC platform for the identification or discrimination of cancer tissues. Our strategy can be extended to other diseases associated with altered gene expression in body tissues or fluids. Full article

Point-of-care (POC) technologies are promising tools to decentralize and accelerate the diagnosis of rare diseases. Among them, electrochemical immunosensors offer advantages such as high sensitivity, low cost, portability, low sample consumption, and suitability for use in resource-limited settings. However, the performance of these devices is dependent on electrode surface properties, which influence electron transfer, biomolecule immobilization, and analytical sensitivity. In this work, screen-printed carbon electrodes (SPCEs) were modified through two strategies: (i) gold electrodeposition and (ii) cold plasma treatment. The modified electrodes were functionalized with EDC/NHS, followed by the immobilization of anti-SMN antibodies and electrochemical characterization using cyclic voltammetry and differential pulse voltammetry. The impact of each modification approach on the electrochemical response and reproducibility of the sensor was evaluated. Gold electrodeposition resulted in higher and more reproducible electrochemical responses, demonstrating improved electron transfer properties and surface homogeneity. The primary objective of this study was to investigate how different surface modification strategies affect the electrochemical performance of SPCE-based immunosensors, employing the detection of Survival Motor Neuron (SMN) protein, a biomarker associated with Spinal Muscular Atrophy (SMA), as a proof-of-concept application. The resulting platform successfully differentiated specific and non-specific protein recognition events through distinct electrochemical patterns, demonstrating the suitability of gold-modified SPCEs for immunosensing applications. These findings provide insights into the influence of surface engineering strategies on sensor performance and support the future development of optimized electrochemical platforms for biomarker detection. Full article

Additive manufacturing, also known as 3D printing (3DP), is intended to enable personalised medicine by producing drug products on demand at the Point of Care (PoC), with dose, drug-release profile, and geometry tailored to the individual patient. Despite its promise, widespread adoption is limited by the absence of ready-to-use quality control (QC) methods for printlets at the PoC. Process Analytical Technology (PAT) tools, particularly vibrational spectroscopic methods like Near-Infrared and Raman spectroscopy, can offer real-time monitoring to ensure the safety and consistency of printed dosage forms. Integrating these tools within a Quality-by-Design (QbD) framework can enhance process understanding, control variability, and minimise risk. Regulatory implementation and technological innovation remain essential for the broader clinical implementation of 3DP in pharmaceutical manufacturing. This review presents an overview of currently existing studies on PAT tools explored for non-destructive quality control across 3DP techniques, examines the correlation between Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and the Critical Quality Attributes (CQAs) of 3D-printed dosage forms within a QbD context, and outlines the current regulatory landscape alongside key limitations and future directions for the broader integration of 3DP into pharmaceutical development and manufacturing. Current evidence shows that PAT application remains uneven across printing technologies and is predominantly directed at final product quality control, rather than the real-time process monitoring required for a fully closed-loop QbD framework. Existing spectroscopic models are largely restricted to single formulations, printers, and APIs, and the absence of standardised validation reporting and transferability assessments represents a key barrier to routine implementation. Full article

Background and Objectives: Despite evidence demonstrating the advantages of rheumatology-led point-of-care (POC) polarised light microscopy (PLM), it remains underutilised in many hospital settings. We aimed to identify barriers to its use and assess typical caseloads of crystal arthropathy, diagnostic methods and frequency of rheumatology-led POC PLM in practice in Ireland. We also assessed reliance on laboratory-led crystal analysis and the turnaround time for results to be reported. Solutions to improve implementation of rheumatologist-led POC PLM were also explored. Material and Methods: We surveyed 29 rheumatologists registered to the Irish Society of Rheumatology via SurveyMonkey, between May and October 2024. Textual responses were categorised into key themes, and word clouds were generated using Tagcrowd to visualise thematic content. Results: Fifty-five percent of respondents faced challenges using POC PLM for crystal analysis. Common barriers included lack of access to a microscope, lack of a polarising light function and lack of training in performing and interpreting of PLM. Fifty-two percent of rheumatologists highlighted the critical need for accessible and functional microscopes. Ninety-two percent of respondents relied on in-house laboratory crystal analysis. Thirty-two percent received inaccurate or incomplete results from laboratory reports and 28% of respondents reported delays in sample analysis from the laboratory. Laboratory turnaround was 1–2 days for 43% of rheumatologists and 3–5 days for 33%. Sixty-nine percent had not received training on PLM and 48% emphasised the need for improved education on POC PLM, including improved integration into the national rheumatology training. Conclusions: Rheumatology-led POC PLM remains underutilised despite its clinical advantage primarily due to equipment and training deficits. Addressing these barriers through improved infrastructure, education and equipment is essential to ensure effective and timely care for patients with crystal arthropathy. Full article

Early detection of lung cancer remains challenging due to the extremely low concentrations of disease-specific biomarkers, which limit the development of highly sensitive and reliable point-of-care (PoC) diagnostic devices. Electrochemical biosensors integrating graphene oxide (GO) and gold nanoparticles (AuNPs) have emerged as promising platforms for the rapid, sensitive, and selective detection of lung cancer biomarkers, enabling more timely diagnosis. Biomarkers such as carcinoembryonic antigen (CEA), cytokeratin-19 fragments (CYFRA 21-1), neuron-specific enolase (NSE), and circulating tumour DNA are increasingly investigated for PoC applications since they can be detected in various biological fluids associated with lung cancer. Nanocomposite materials, particularly GO/AuNP hybrids, provide synergistic advantages by combining the large surface area and abundant functional groups of GO for stable immobilization of biorecognition elements with the excellent conductivity and bioconjugation capability of AuNPs that enhance signal transduction. This review critically discusses key biomarker targets for lung cancer, the properties of GO and Au in biosensing, and the role of AuNP/GO nanocomposites in improving biosensor performance. It further examines the application of electrochemical biosensors for lung cancer biomarker detection, highlighting recent developments. Additionally, the review outlines current challenges limiting clinical translation and PoC implementation, provides recommendations to address these barriers, and discusses future perspectives for improving the detection of low-abundance biomarkers for early lung cancer diagnosis. Ultimately, these technologies seem promising for the development of rapid diagnostic tools equivalent to established platforms such as lateral-flow immunoassays. Full article

Antimicrobial resistance—partly driven by inappropriate antibiotic consumption—is a major public health threat. Point-of-care (POC) procalcitonin testing can reduce antibiotic prescribing safely. Within an implementation-effectiveness trial, we conducted a two-phase participatory context analysis to identify and prioritise determinants of POC procalcitonin adoption, implementation and continued use in Swiss primary care. First, we conducted 32 semi-structured interviews with 34 participants, including physicians, representatives of medical organisations, patient representatives and other stakeholders. By coding transcripts deductively using the Consolidated Framework for Implementation Research and inductively, we identified 86 potential determinants. Second, in a focus group with ten ImpPro research team members, 15 determinants were identified as ‘not requiring change’, and ten were considered ‘unchangeable’. Among the remaining 61 determinants, 41 were prioritised through dot-voting and group discussion. These key implementation determinants were inductively grouped into eight themes. The themes with the highest priority were: (1) physicians’ awareness, knowledge, and access to education regarding POC procalcitonin, (2) scientific evidence supporting POC procalcitonin-guided antibiotic prescribing, (3) physician motivation and (4) endorsement of POC procalcitonin by credible organisations and experts. Addressing these determinants will likely require a tailored, multifaceted (combining several unique strategies), and multilevel (targeting different levels of the system) implementation strategy. Full article

Background: Patients with severe chronic anemia often require frequent blood transfusions. Many are elderly with comorbidities and limited mobility, making regular hospital visits burdensome. In some cases, patients may receive transfusions despite hemoglobin levels being above the clinical threshold due to logistical challenges, leading to unnecessary exposure to risks, inefficient use of blood units, and resource strain. This study aims to evaluate the use of point-of-care (POC) hemoglobin measurements under controlled outpatient clinic conditions, as an initial step toward potential future home-based monitoring by the patients or their caregivers, with the goal of optimizing transfusion timing, aiming to reduce unnecessary hospital visits while maintaining patient safety. Methods: A total of 127 patients from a hemato-oncology outpatient clinic at Carmel Medical Center were evaluated using a nurse-operated POC device to sample capillary blood, with 236 paired measurements concurrently analyzed via venous blood in the laboratory. Demographic and clinical data were assessed to evaluate factors associated with agreement between POC and laboratory measurements. Statistical analysis included Bland–Altman plots and Pearson correlation coefficients. Results: The POC device showed a moderate correlation with laboratory results (r = 0.73, p < 0.001), with a mean difference of 1.20 g/dL (SD = 1.94 g/dL) but wide limits of agreement (−3.20 to 5.50 g/dL). No significant differences were observed across demographic or clinical subgroups. Notably, all 156 paired measurements with POC-measured hemoglobin >7 g/dL were confirmed by laboratory testing. Conclusions: Although POC hemoglobin devices are not suitable as standalone tools for routine monitoring of chronic anemia, the high negative predictive value observed at the 7 g/dL threshold suggests that they may be useful for ruling out severe anemia. If validated in larger multicenter and home-use studies, POC Hb devices might contribute to reducing unnecessary hospital visits and transfusions. Full article

Nanozymes, nanomaterials that mimic enzymatic activity, offer superior stability, tunability, and lower production costs compared to natural enzymes. To date, most nanozyme-based point-of-care (PoC) diagnostic systems have relied on oxidation reactions, such as oxidation of 3,3′,5,5′-tetramethylbenzidine, which often suffer from limited substrate stability and high background signal. This study investigates reduction reactions, particularly those involving tetrazolium salts, as an alternative route for signal generation in PoC devices. For this purpose, monometallic and bimetallic gold, palladium, and platinum nanoparticles were synthesized via chemical reduction using poly(vinyl alcohol) as a stabilizing agent. The resulting nanoparticles were uniform in size and morphology. Their catalytic performance was confirmed through the reduction of 4-nitrophenol. The tetrazole salts were selected as promising substrates for application in PoC settings and further explored by examining the nanozyme-based reduction of 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide (MTT). The nanozymes catalyzed the reduction of MTT in the presence of sodium borohydride, producing a distinct colorimetric signal under selected conditions. The effects of reducing agent concentration, buffer pH, and potential interferents were evaluated, with performance suitable for PoC devices achieved at basic pH and low borohydride concentration. Interference studies showed negligible MTT reduction in the presence of physiological levels of ascorbic acid, human serum albumin, and 10% concentration of human serum. Finally, a proof-of-concept lateral flow assay demonstrated successful signal generation through nanozyme-catalyzed MTT reduction. Results establish tetrazolium salts as suitable substrates for nanozyme-enhanced PoC diagnostics and highlight reduction-based chromogenic systems as a viable alternative to traditional oxidation-based assays. Full article

The rapid expansion of molecular point-of-care (POC) diagnostics into decentralized settings, including emergency departments, retail pharmacies, and home environments, has shifted the burden of diagnostic performance from laboratory professionals to heterogeneous, often non-expert users. While traditional evaluation frameworks focus on analytical and clinical validity, they often overlook the impact of human-system interactions on real-world reliability. This review introduces the concept of Operational Validity: the ability of a diagnostic system to preserve its intended performance when operated by intended users within the constraints of real-world workflows and environments. To establish a rigorous foundation for this concept, this study provides a critical comparative analysis contrasting Operational Validity against traditional clinical evaluation dimensions (analytical validity, clinical validity, and clinical utility) and post-market metrics. While existing literature outlines isolated usability principles, the significance of this study lies in its synthesis of these fragmented concepts into a formalized, lifecycle-based “Operational Validity” framework that explicitly maps the causal mechanisms connecting initial user interaction directly to downstream clinical outcomes. By synthesizing international standards (IEC 62366-1) alongside the newly finalized May 2026 U.S. Food and Drug Administration (FDA) guidance on the Content of Human Factors Information in Medical Device Marketing Submissions, we examine how human factors engineering (HFE) and usability engineering serve as the methodological foundation for operational validity. We analyze the specific complexities of molecular workflows, identify key parameters of use-related failure modes in pre-analytical and interpretation stages, and detail the mandatory role of iterative formative and final summative usability testing in mitigating these risks. Finally, we propose a lifecycle-based approach to HFE that integrates design, simulated-use validation, and post-market surveillance. Establishing operational validity is essential to ensure that the high analytical sensitivity of molecular POC platforms translates into consistent clinical utility across the full spectrum of decentralized care. Full article