Search Results (348)

Visible-Near-Infrared (Vis-NIR) spectroscopy, spanning approximately 400 to 2500 nm, is an innovative technology with growing relevance for diagnostics performed at the point of care (POC). This review explores the potential of Vis-NIR in veterinary medicine, highlighting its advantages over complex techniques like Raman and Fourier transform infrared spectroscopy (FTIR) by being rapid, non-invasive, reagent-free, and compatible with miniaturized, portable devices. The methodology involves directing a broadband light source, often using LEDs, toward the sample (e.g., blood, urine, faeces), collecting spectral information related to molecular vibrations, which is then analyzed using chemometric methods. Successful veterinary applications include hemogram analysis in dogs, cats, and Atlantic salmon, and quantifying blood in ovine faeces for parasite detection. Key limitations include spectral interference from strong absorbers like water and hemoglobin, and the limited penetration depth of light. However, combining Vis-NIR with Self-Learning Artificial Intelligence (SLAI) is shown to isolate and mitigate these multi-scale interferences. Vis-NIR spectroscopy serves as an important complement to centralized laboratory testing, holding significant potential to accelerate clinical decisions, minimize stress on animals during assessment, and improve diagnostic capabilities for both human and animal health, aligning with the One Health concept. Full article

Pharmacy-based point-of-care (POC) services have evolved from pilot initiatives to an essential component of decentralized healthcare delivery. These services—ranging from rapid infectious-disease screening to chronic-disease monitoring—improve access, reduce diagnostic delays and empower pharmacists as front-line healthcare providers. The present paper is an updated, in-depth review of the evolution of pharmacy POC services worldwide, combined with the analysis of the regulatory and educational frameworks supporting implementation, technological drivers such as biosensors, mobile health and artificial intelligence and in-depth socioeconomic considerations. Benefits for patients, pharmacies and healthcare systems are contrasted with challenges including variable reimbursement, uneven regulatory oversight and workforce preparedness. Full article

Each year, around 23 million miscarriages occur worldwide, which have a substantial emotional impact on parents, and impose significant societal costs. While medical care accounts for most expenses, work productivity loss contributes significantly. Addressing underlying causes of miscarriage could improve parents’ mental health and potentially their economic impact. In most countries, investigations into miscarriage causes are only recommended after recurrent cases, focusing mainly on maternal factors. Fetal and placental tissue are rarely examined, as current guidelines do not advise routine genetic analyses of pregnancy tissue, because the impact of further clinical decision making and individual prognosis is unclear. However, this leaves over 90% of all miscarriage cases unexplained and highlights the need for alternative methods. We therefore conducted a narrative review on genetic analysis, autopsy, and imaging of products of conception (POC). Karyotyping, QF-PCR, SNP array, and aCGH were reviewed in different research settings, with QF-PCR being the most cost-effective, while obtaining the highest technical success rate. Karyotyping, historically being considered the gold standard for POC examination, was the least promising. Post-mortem imaging techniques including post-mortem ultrasound (PMUS), ultra-high-field magnetic resonance imaging (UHF-MRI), and microfocus computed tomography (micro-CT) show promising diagnostic capabilities in miscarriages, with micro-CT achieving the highest cost-effective performance. In conclusion, current guidelines do not recommend diagnostic testing for most cases, leaving the majority unexplained. Although genetic and imaging techniques show promising diagnostic potential, they should not yet be implemented in routine clinical care and require thorough evaluation within research settings—assessing not only diagnostic and psychosocial outcomes but also economic implications. Full article

Pulpitis is the inflammatory response of the dental pulp to microbial challenge and can range from mild to severe in nature, with severe pulpitis traditionally resulting in pulp removal and root canal treatment (RCT). In the pursuit of more conservative treatments, recent clinical practice guidelines have recommended strategies that preserve the vitality of the dental pulp, rather than RCT, when possible. This has increased the focus on improving the accuracy of pulp diagnosis, which will direct treatment and improve management outcomes. Unfortunately, current point-of-care (PoC) tools are subjective, lack discrimination and rely on the stimulation of pulpal neurons, limiting dentists’ ability to objectively identify the level of inflammation. Molecular biomarker assessment has the potential to dynamically analyse pulpitis and correlate this with inflammatory thresholds and treatment outcomes. Numerous chemokines, cytokines, proteases and growth factors exhibit altered expression during pulpitis and can be collected intraoperatively as part of routine dental treatment. Although current data indicate several markers that could be used as next-generation diagnostic chairside tools for pulpitis, there are currently no commercial kits. Considering the interest in vital pulp treatment, there is an urgent need to engage researchers, industry, dentists and other stakeholders in the development of PoC diagnostic assays for pulpitis. Full article

Organic field-effect transistor (OFET) biosensors have emerged as a transformative technology for clinical biomarker detection, offering unprecedented sensitivity, selectivity, and versatility in point-of-care (POC) diagnostics. This review examines the fundamental principles, materials innovations, device architectures, and clinical applications of OFET-based biosensing platforms. The unique properties of organic semiconductors, combined with advanced biorecognition strategies, enable the detection of clinically relevant biomarkers at low concentrations. Recent developments in organic semiconductor materials have significantly enhanced device performance and stability. The integration of novel device architectures such as electrolyte-gated OFETs (EGOFETs) and extended-gate configurations has expanded the operational capabilities of these sensors in aqueous environments. Clinical applications span a broad spectrum of biomarkers, demonstrating the versatility of OFET biosensors in disease diagnosis and monitoring. Despite remarkable progress, challenges remain in terms of long-term stability, standardization, and translation to clinical practice. The convergence of organic electronics, biotechnology, and clinical medicine positions OFET biosensors as a promising platform for next-generation personalized healthcare and precision medicine applications. Full article

Background: Monkeypox (MPX), caused by the Monkeypox virus (MPOX) of the Orthopoxvirus genus, has re-emerged as a significant global health threat. Once confined to Central and West Africa, the 2022–2025 multi-country outbreaks, predominantly caused by Clade IIb, demonstrated sustained human-to-human transmission and global spread. Objective: This review summarizes current knowledge on MPX virology, epidemiology, clinical presentation, and diagnostic technologies, with a focus on innovations supporting rapid and field-deployable detection in resource-limited settings. Methods: The recent literature (2019–2025), including peer-reviewed studies, WHO and Africa CDC reports, and clinical guidelines, was critically reviewed. Data were synthesized to outline key developments in diagnostic methodologies and surveillance approaches. Results: MPX comprises two genetic clades: Clade I (Congo Basin) and Clade II (West African), which differ in virulence and transmission. Clade IIb is associated with sexual and close-contact transmission during recent outbreaks. Clinical manifestations have shifted from classic disseminated rash to localized anogenital lesions and atypical or subclinical infections. RT-PCR remains the diagnostic gold standard, while emerging assays such as loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and CRISPR/Cas-based platforms show promise for rapid point-of-care (POC) testing. Complementary serological tools, including ELISA and lateral flow assays, enhance surveillance and immune profiling. Conclusions: The resurgence of MPX highlights the urgent need for accessible, sensitive, and specific diagnostic platforms to strengthen surveillance and outbreak control, especially in endemic and resource-constrained regions. Full article

The microscopic agglutination test (MAT) is the diagnostic standard for canine leptospirosis. However, it is a time-consuming process and does not differentiate between infection- and vaccine-induced antibodies. Canine Leptospira spp.-specific antibody point-of-care (POC) tests provide the rapid detection of immunoglobulin M (IgM) and/or G (IgG). IgM POC tests are considered to become negative more rapidly after vaccination, making them more effective at diagnosing leptospirosis in not-recently vaccinated dogs. This study analysed 582 serum samples of 97 healthy dogs using five different POC tests and the MAT before vaccination and 2, 4, 12, 26, and 52 weeks afterwards. Among the POC tests, three detected IgM antibodies, one detected IgG antibodies, and one detected both IgM and IgG. The results were analysed using mixed-effects logistic regression. Before vaccination, only 2/291 IgM tests were positive (0.7%), compared to 45/194 IgG tests (23.2%). All the POC tests became positive after vaccination, but IgM positivity occurred significantly less frequently (59/1746), especially >4 weeks post-vaccination (7/59 positive results), with 94.5–99.6% specificity compared to 41.4–77.8% in IgG tests. These findings support the use of IgM POC tests in vaccinated dogs, while IgG POC tests are more difficult to interpret. Full article

Point-of-care (POC) infectious disease diagnostics are reshaping global health by delivering rapid, decentralized, and clinically actionable results that link bedside testing to population-level surveillance. Valued at approximately USD 53 billion in 2024 and projected to nearly double by 2033, the global POC diagnostics market is driven by infectious disease assays and accelerated by innovations in molecular amplification, biosensors, microfluidics, and artificial intelligence (AI). This review integrates current evidence across technological, clinical, regulatory, and public health domains. Immunoassays remain the backbone of volume deployment, while molecular nucleic acid amplification tests (NAATs) and emerging CRISPR-based platforms achieve laboratory-grade sensitivity at the point of care. AI has transitioned from an experimental tool to an embedded analytical layer that enhances image interpretation, multiplex signal deconvolution, and automated quality control. Rigorous validation, including analytical accuracy, clinical performance in intended-use settings, and usability testing under CLIA guidance, remains central to ensuring reliability in decentralized environments. Regulatory frameworks are adapting in parallel: FDA’s lifecycle oversight of AI-enabled devices, the European IVDR’s expanded evidence requirements, and the WHO Prequalification all emphasize continuous post-market surveillance. From a public health perspective, POC diagnostics have improved early case detection, treatment initiation, and outbreak containment for HIV, tuberculosis, malaria, influenza, RSV, and COVID-19. Yet persistent challenges (including limited harmonization of standards, uneven reimbursement, and scarce real-world data from low- and middle-income countries) continue to constrain equitable adoption. POC infectious disease diagnostics are thus entering a pivotal phase of digitization and regulatory maturity. Addressing remaining gaps in validation, lifecycle monitoring, and implementation equity will determine whether these technologies achieve their full promise as clinical accelerators and as cornerstones of global infectious disease preparedness. Full article

Cholesterol blood levels in low-density lipoproteins (LDLs) are a key parameter for assessing the risk of cardiovascular diseases. Direct quantification of LDL cholesterol at the point of care would be possible if all other lipoproteins, particularly the high-density lipoproteins (HDLs), could be removed prior to measurement. Here, we investigated whether a molecularly imprinted membrane (MIM) could be used for the solid-phase affinity extraction (SPAE) of HDL in a paper-based lateral flow test. Samples traveled by capillarity through the MIM before reaching a detection zone where LDL cholesterol was quantified enzymatically. MIMs were produced by impregnation of the membrane with a dispersion of molecularly imprinted polymers (MIPs) selective for HDL. MIPs were synthesized using precipitation polymerization and exhibited good selectivity for HDL compared with LDL and an uptake capacity of 5.0–7.0 µg of HDL-C/mg of MIP. The MIM enabled the removal of HDL with an efficiency of typically 68%. However, quantification of LDL cholesterol suffered from strong non-specific binding of LDL, likely due to its inherent colloidal instability. Overall, our results highlight the challenges associated with SPAE of colloidal particles. Furthermore, our study demonstrates a novel, efficient, and potentially generic modality to integrate SPAE into paper-based POC diagnostic tests. Full article

Exhaled breath (EB) contains numerous volatile organic compounds (VOCs) that can reflect pathological metabolic processes, making breath analysis a promising non-invasive diagnostic approach. In particular, volatile aldehydes and ketones have been identified as disease biomarkers in EB. Gas sensors are expected to play a crucial role in the diagnosis of numerous diseases at an early stage. Among the various available approaches, sensors stand out as especially attractive tools for diagnosing diseases such as lung cancer (LC) and diabetes, due to their affordability and operational simplicity. There is an urgent need in the field of disease detection for the development of affordable, non-invasive, and user-friendly sensors capable of detecting various biomarkers. Devices of the new generation should also demonstrate high repeatability of measurements and extended operational stability of the employed sensors. Due to these demands, the past few years have seen significant advancements in the development and implementation of electronic noses (ENs), which are composed of an array of sensors for the determination of VOCs present in EB. To meet these requirements, the development and integration of advanced receptor coatings on sensor transducers is essential. These coatings include nanostructured materials, molecularly imprinted polymers, and bioreceptors, which collectively enhance selectivity, sensitivity, and operational stability. However, reliable biomarker detection in point-of-care (PoC) mode remains a significant challenge, constrained by several factors. This review provides a comprehensive and critical evaluation of recent studies demonstrating that the detection of VOCs using gas sensor platforms enables disease detection and can be implemented in PoC mode. Full article

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-Cas (CRISPR-associated) systems, originally identified as prokaryotic adaptive immune mechanisms, have rapidly evolved into powerful tools for molecular diagnostics. Leveraging their precise nucleic acid targeting capabilities, CRISPR diagnostics offer rapid, sensitive, and specific detection solutions for a wide array of targets. This review delves into the fundamental principles of various Cas proteins (e.g., Cas9, Cas12a, Cas13a) and their distinct mechanisms of action (cis- and trans-cleavage). It highlights the diverse applications spanning infectious disease surveillance, cancer biomarker detection, and genetic disorder screening, emphasizing key advantages such as speed, high sensitivity, specificity, portability, and cost-effectiveness, particularly for point-of-care (POC) testing in resource-limited settings. The report also addresses current challenges, including sensitivity limitations without pre-amplification, specificity issues, and complex sample preparation, while exploring promising future trajectories like the integration of artificial intelligence (AI) and the development of universal diagnostic platforms to enhance clinical translation. Full article

Liquid biopsies promise major advantages for cancer screening and diagnosis. By detecting biomarkers in peripheral blood samples, liquid biopsies reduce the need for invasive techniques and provide important genetic information integral to the emerging molecular classification of cancers. Unfortunately, the concentrations of most biomarkers, particularly circulating tumour nucleic acids, are vanishingly small—beyond the sensitivity and specificity of most assays. Clustered Regularly Interspaced Short Palindromic Repeats diagnostics (herein labelled ‘CRISPR-Dx’) use gene editing tools to detect, rather than modify, nucleic acids with extremely high specificity. These tools are commonly combined with isothermal nucleic acid amplification to also achieve sensitivities comparable to high-performance laboratory-based techniques, such as digital PCR. CRISPR assays, however, are inherently well suited to adaptation for point-of-care (POC) use, and unlike antigen-based POC assays, are significantly easier and faster to develop. In this review, we summarise current CRISPR-Dx platforms and their analytical potential for cancer biomarker discovery, with an emphasis on enhancing early diagnosis, disease monitoring, point-of-care testing, and supporting cancer therapy. Full article

Background/Objectives: We have previously reported the engineering of a point-of-care (POC) system that fully automates the procedures for nucleic acid extraction and multiplexed real-time RT-PCR, with a major advantage of high-level multiplexing. In this study, we applied and validated the system in a respiratory tract infection setting. Methods: An automatic nested real-time RT-PCR assay was developed (POCm). It was a 40-plex assay that simultaneously detected 39 epidemiologically important respiratory pathogens in 1.5 h in the POC system. The analytical and clinical performance was evaluated. Results: The analytical sensitivities of the POCm assay were comparable to those of its single-plex counterparts performed manually on a bench-top. The minimum detectable concentrations ranged from 53 copies/mL to 5.3 × 10³ copies/mL for all pathogen targets except hCoV-NL63 (5.3 × 10⁴ copies/mL). The quantitative performance was demonstrated by the linear correlations between Ct values and input concentrations for all pathogen targets, with 24 of them demonstrating coefficients of correlation (r) greater than 0.9. The POCm assay was subsequently evaluated in 283 clinical samples. A high level of agreement (98.2–100%) was achieved for pathogen detection results between POCm and standard diagnostic methods. The POCm result was also fully concordant with the result of another commercial POC multiplex platform. For positive clinical samples, pairwise Ct values measured by POCm closely correlated with those of the bench-top reference method (r = 0.70). The feasibility of mutation genotyping of the viral subtype was further demonstrated. Conclusions: This study demonstrated the practicality of POCm for routine testing in clinical laboratories. Further clinical trials are being conducted to evaluate the clinical performance of the system. Full article

Biliary tract diseases, including both benign and malignant conditions such as cholangitis, cholelithiasis, primary sclerosing cholangitis, cholangiocarcinoma, and gallbladder cancer, present significant challenges for timely diagnosis and effective clinical management. Conventional diagnostic approaches, which primarily rely on imaging and standard laboratory tests, often lack the sensitivity and specificity needed for early detection, accurate risk stratification, and personalized treatment planning. In recent years, advancements in point-of-care (POC) diagnostic technologies, along with the identification and validation of novel biomarkers, have begun to reshape the diagnostic landscape. This review provides a comprehensive overview of the clinical utility and limitations of current POC tests and biomarkers, ranging from well-established markers such as carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) to emerging molecular indicators such as circulating microRNAs and circulating tumor DNA. We examine their applications across acute management, chronic disease monitoring, and cancer detection; identify existing gaps in diagnostic practice; and discuss strategies for incorporating these tools into standard clinical workflows to enhance patient outcomes. Full article

Tryptophan (Trp) and tryptamine (Tryp), critical biomarkers in mood regulation, immune function, and metabolic homeostasis, are increasingly recognized for their roles in both oral and systemic pathologies, including neurodegenerative disorders, cancers, and inflammatory conditions. Their rapid, sensitive detection in biofluids such as saliva—a non-invasive, real-time diagnostic medium—offers transformative potential for early disease identification and personalized health monitoring. This review synthesizes advancements in electrochemical sensor technologies tailored for Trp and Tryp quantification, emphasizing their clinical relevance in diagnosing conditions like oral squamous cell carcinoma (OSCC), Alzheimer’s disease (AD), and breast cancer, where dysregulated Trp metabolism reflects immune dysfunction or tumor progression. Electrochemical platforms have overcome the limitations of conventional techniques (e.g., enzyme-linked immunosorbent assays (ELISA) and mass spectrometry) by integrating innovative nanomaterials and smart engineering strategies. Carbon-based architectures, such as graphene (Gr) and carbon nanotubes (CNTs) functionalized with metal nanoparticles (Ni and Co) or nitrogen dopants, amplify electron transfer kinetics and catalytic activity, achieving sub-nanomolar detection limits. Synergies between doping and advanced functionalization—via aptamers (Apt), molecularly imprinted polymers (MIPs), or metal-oxide hybrids—impart exceptional selectivity, enabling the precise discrimination of Trp and Tryp in complex matrices like saliva. Mechanistically, redox reactions at the indole ring are optimized through tailored electrode interfaces, which enhance reaction kinetics and stability over repeated cycles. Translational strides include 3D-printed microfluidics and wearable sensors for continuous intraoral health surveillance, demonstrating clinical utility in detecting elevated Trp levels in OSCC and breast cancer. These platforms align with point-of-care (POC) needs through rapid response times, minimal fouling, and compatibility with scalable fabrication. However, challenges persist in standardizing saliva collection, mitigating matrix interference, and validating biomarkers across diverse populations. Emerging solutions, such as AI-driven analytics and antifouling coatings, coupled with interdisciplinary efforts to refine device integration and manufacturing, are critical to bridging these gaps. By harmonizing material innovation with clinical insights, electrochemical sensors promise to revolutionize precision medicine, offering cost-effective, real-time diagnostics for both localized oral pathologies and systemic diseases. As the field advances, addressing stability and scalability barriers will unlock the full potential of these technologies, transforming them into indispensable tools for early intervention and tailored therapeutic monitoring in global healthcare. Full article