Search Results (385)

Chronic kidney disease (CKD) requires assessment of both glomerular filtration and kidney damage, particularly albuminuria, for diagnosis, risk stratification, and longitudinal care. Point-of-care testing (POCT) can shorten turnaround time and improve access when conventional laboratory testing is unavailable or would delay a clinical pathway. This narrative review summarizes established and emerging POCT approaches for kidney assessment in CKD, with emphasis on creatinine/eGFR and urine albumin-to-creatinine ratio (UACR), and distinguishes analytical validity from workflow utility and patient-level clinical utility. Evidence is strongest for rapid creatinine measurement in selected workflows, especially pre-imaging assessment and decentralized screening, while quantitative/semiquantitative UACR POCT can support CKD detection when abnormal results are appropriately confirmed. Cystatin C microfluidic systems remain investigational, and kidney injury/stress or molecular biomarkers such as NGAL, KIM-1, L-FABP, [TIMP-2]·[IGFBP7], extracellular vesicles, and microRNAs should be regarded primarily as a research horizon rather than direct measures of GFR. Important implementation requirements include assay-specific validation, calibration traceability, quality assurance, recognition of biological and analytical interference, and confirmation of results near major clinical decision thresholds. Evidence that POCT improves long-term CKD outcomes, safety, adherence, or cost-effectiveness remains limited. Future studies should prioritize prospective clinical utility, implementation, cost-effectiveness, home-use validation, and patient-centered outcomes. Full article

The emergence of highly pathogenic avian influenza viruses (AIVs) poses significant threats to global public health and the poultry economy. Rapid detection methods targeting the hemagglutinin (HA) protein have become increasingly unreliable due to ongoing antigenic drift and genetic mutations. In this study, we screened two monoclonal antibodies (mAbs) against the highly conserved neuraminidase (NA) protein, which were characterized by high affinity and specificity for the N9 subtype. Using the paired mAbs 12A2 and 12F12, an NA-targeting lateral flow immunoassay (NA-LFIA) was developed for the rapid detection of N9 subtype AIVs. The NA-LFIA demonstrated exceptional specificity, exhibiting no cross-reactivity with the N1, N2, or N6 subtypes. The limits of detection (LODs) were established at 10^3.3 TCID₅₀/0.1 mL for the virus and 98 ng/mL for the recombinant NA protein. The test strips exhibited excellent reproductivity for detecting the NA antigen, with intra-assay and inter-assay variations of 5.32% and 6.05%, respectively. Stability testing confirmed a six-month shelf life without any loss of sensitivity. These finds indicate that the NA-LFIA is a robust, rapid point-of-care testing (POCT) tool for the early detection of N9 subtype AIV infection. Full article

The widespread use of tetracycline (TC) has resulted in its frequent occurrence in aquatic environments because of incomplete metabolism and continuous release, raising increasing concerns regarding water quality and environmental safety. Reliable determination of trace TC in real water samples remains challenging owing to its low concentration and the complex sample matrix. In this work, an aptamer-functionalized extended-gate ion-sensitive field-effect transistor (EG-ISFET) was developed for sensitive TC detection. The sensing interface was constructed by immobilizing a TC-specific aptamer on a Ta₂O₅ extended gate. Upon target recognition, aptamer folding redistributes the interfacial charge, thereby modulating the surface potential of the extended gate and producing a measurable field-effect response. The proposed sensor exhibits a broad linear detection range from 1 pM to 1 μM with a detection limit of 0.33 pM. To facilitate practical applications, a compact plug-and-play point-of-care testing (POCT) platform integrating the EG-ISFET sensor was further developed for rapid on-site analysis. The portable system demonstrated satisfactory accuracy and reliability for the determination of TC in river water samples, highlighting its potential for environmental monitoring and point-of-use water quality assessment. Full article

The coronavirus disease 2019 (COVID-19) pandemic highlighted the critical need for rapid, accessible, and accurate diagnostic tools to support timely clinical decision-making, outbreak control, and public health surveillance. Point-of-care testing (POCT) has emerged as an essential component of decentralized healthcare by enabling diagnostic testing outside conventional laboratory settings. This review was based on a structured literature search of PubMed, Scopus, and Web of Science databases covering studies published between January 2020 and January 2026. The review evaluates current advances in COVID-19 POCT technologies, including molecular assays, antigen-based tests, antibody-based assays, biosensor platforms, and artificial intelligence (AI)-assisted diagnostic approaches. Molecular POCT methods, including rapid reverse transcription polymerase chain reaction (RT-PCR), loop-mediated isothermal amplification (LAMP), and CRISPR-based technologies, provide high analytical sensitivity and specificity and are increasingly suitable for decentralized diagnostic applications. Antigen-based assays offer rapid and cost-effective screening solutions, although diagnostic performance may vary depending on viral load, symptom onset, and circulating variants. Antibody-based POCT remains valuable for seroprevalence studies, retrospective diagnosis, and immune-response monitoring rather than acute infection detection. Emerging biosensor technologies and AI-enabled diagnostic systems demonstrate promising analytical capabilities and operational advantages; however, many remain at the prototype or early-validation stage and require further clinical evaluation before widespread implementation. The findings indicate that no single POCT modality is optimal for all clinical scenarios. Instead, molecular, antigen, antibody, biosensor, and AI-assisted approaches provide complementary strengths that support different diagnostic and public health objectives. Continued advances in assay design, digital connectivity, multiplex testing, and variant-resilient detection strategies are expected to further enhance the role of POCT in COVID-19 management and future infectious disease preparedness. Full article

Pathogenic bacterial infections remain a persistent global public health crisis. However, traditional clinical detection methods—such as culture-based assays and polymerase chain reaction (PCR)—are often time-consuming and labor-intensive, and they lack sufficient sensitivity for low-abundance pathogens, hindering rapid point-of-care diagnosis. With label-free, ultra-sensitive molecular fingerprinting, Surface-Enhanced Raman Scattering (SERS) has emerged as a powerful tool for rapid pathogen identification. This review summarizes the evolution of SERS-based bacterial detection from fundamental nanomaterials to integrated clinical diagnostic platforms. The article explores four core dimensions: functional integration and enrichment strategies of colloidal probes; structural design and multifaceted capture mechanisms of solid substrates; synergistic advantages of microfluidic systems in enabling automated “sample-to-answer” architectures; and the translational potential of SERS-based lateral flow assays (LFAs) for robust point-of-care testing (POCT). This review reveals a research shift from maximizing electromagnetic enhancement toward overcoming matrix effects in clinical samples and ensuring robustness. In synergy with microfluidics, LFAs, and AI, SERS technology is bridging the bench-to-bedside gap, offering a roadmap for next-generation decentralized, high-precision diagnostics. Full article

On-site nucleic acid analysis for infectious diseases can be rapidly achieved through molecular point-of-care testing (molecular POCT), which plays an indispensable role in early pathogen identification, timely clinical intervention, and public health emergency response. Performance improvements in such systems are largely driven by innovations in functional materials that refine nucleic acid extraction, amplification, and signal output. This article reviews recent developments in functional materials deployed in molecular POCT, with emphasis on nucleic acid capture matrices, amplification-promoting agents, and signal transduction components. From a medical device regulatory standpoint, we examine how material characteristics shape key analytical indicators, including sensitivity and specificity, and discuss critical risks such as off-target amplification and batch inconsistency. Finally, we outline future directions, highlighting cross-disciplinary cooperation to reconcile technological innovation with risk control for translating advanced materials into high-performance molecular POCT products. Full article

External quality assessment (EQA) using fresh blood from companion animals has not yet been conducted worldwide. This study investigated storage temperature, duration, and anticoagulant conditions to identify more stable sample preparation methods for fresh canine blood stored for more than 24 h, as required for distributed surveys. Blood samples from five healthy dogs containing CPDA-1 supplemented with EDTA-2K at final concentrations of 1, 2, and 3 mg/mL were stored at room temperature (RT group) and refrigerated temperature (RE group). Complete blood count measurements were performed at 2, 5, 8, 24, 48, and 72 h after blood collection using the Microsemi LC-662, a point-of-care testing (POCT) automated hematology analyzer. White blood cell and platelet counts were more stable over time in the RT group compared with the RE group. In contrast, red blood cell parameters were more stable in the RE group. Variability in measured values increased with storage time but decreased with higher EDTA-2K concentration (3 mg/mL). Anticoagulation using CPDA-1 supplemented with EDTA-2K may be appropriate for future EQA programs using fresh canine blood. Full article

Feline panleukopenia is an acute, highly contagious, and fatal infectious disease, posing a serious threat to the health and conservation of felids. It is necessary to develop diagnostic tools suitable for point-of-care testing (POCT). Herein, a colorimetric loop-mediated isothermal amplification (LAMP) assay targeting the FPV VP2 gene was developed using cresol red as a colorimetric indicator. The colorimetric LAMP enables result interpretation by visual observation of a color change from violet to yellow after amplification at 64 °C for 40 min. The limit of detection was 18.38 copies/µL for pMD-VP2 plasmid and 10^1.62 TCID₅₀/mL for crudely extracted nucleic acids. This method exhibits no cross-reactivity with other common feline pathogens, and shows good repeatability. Nevertheless, this method is unable to differentiate FPV from canine parvovirus (CPV) owing to their high genetic similarity. Testing of 153 clinical samples revealed a 40.52% (62/153) positive rate, with 98.04% agreement compared to a commercial qPCR kit (42.48% positive rate). Collectively, the developed colorimetric LAMP assay offers a specific, sensitive, simple and visual approach for FPV detection, demonstrating great potential for field point-of-care applications. Full article

The Enterobacteriaceae family is a significant source of foodborne pathogens and represents a severe threat to human and animal health. These bacteria can penetrate the dairy supply chain through direct contact with cattle and the livestock environment and can survive production processes. Escherichia coli (E. coli), one of the most diffuse bacteria in raw and processed milk, exposes consumers to the risk of contaminated milk. As a result of this exposition, several milk-borne illness outbreaks have been reported worldwide, underscoring the urgent need for effective detection and prevention measures. Conventional analysis methods are effective but have significant limitations, including the requirement of pre-treatment and pre-enrichment steps. Thus, the need for advanced detection techniques that can accurately identify these pathogens without pre-treatment steps is critical. In this work, a proof-of-concept biosensor based on a spoon-shaped optical biochip was developed to detect E. coli via surface plasmon resonance (SPR) phenomena and was combined with a polyclonal antibody layer against E. coli as a molecular recognition element (MRE). The proposed label-free biosensing strategy, achieved by exploiting simple SPR spoon-shaped biochips, exhibits a remarkable detection limit (6.8 colony-forming units, CFU/mL) and high specificity towards other interfering bacteria belonging to the Enterobacteriaceae family. In addition, tests on commercial milk samples were carried out, achieving recovery values of 95% and 102% for whole milk and infant milk, respectively. The proposed spoon-shaped biosensor enables label-free biosensing without the need for microfluidic systems. It provides a rapid response (10 min), paving the way for its use as a point-of-care test (POCT) in real-world settings. Full article

Necrotising enterocolitis (NEC) remains an important disease for neonatologists, with diagnostic and management challenges and impacts on mortality and neurodisability. NEC can present in a non-specific way, and differentiating from late-onset sepsis (LOS), focal perforation (FIP) and feed intolerance can be difficult. Biomarkers have been extensively explored as a way to help more definitively identify NEC or rule it out. Many biomarkers that have been studied are blood biomarkers, and several other extensive reviews of biomarkers in NEC exist. In this narrative review, we focus on non-invasive samples, namely stool, urine and saliva, and on tests that are already available as point-of-care tests (POCTs) or are likely to be available as POCTs soon given current technologies. Faecal calprotectin and urinary intestinal fatty acid-binding protein (IFABP) have the most data to currently support their use in larger multi-centre studies and appear most likely to achieve translation into clinical practice. Saliva appears the most under-researched potential source of a non-invasive POCT for a biomarker for NEC. For faecal calprotectin and urinary IFABP, data that are most lacking relate to specificity, particularly the performance of these tests to differentiate NEC from FIP or LOS (occurring in the absence of NEC). We suggest a study design to facilitate moving towards the clinical use of non-invasive biomarkers in NEC. Full article

Driven by the rising demand for point-of-care testing (POCT) in aging societies, accurate temperature regulation of reaction solutions has become a core technical bottleneck for miniaturized chemiluminescence immunoassay systems, since conventional indirect control strategies inevitably produce systematic deviations. To tackle this challenge, we present an integrated solution that couples multiphysics simulation, data-driven temperature estimation modeling, and embedded hardware design. We constructed a COMSOL heat transfer model to analyze the thermal performance of the microfluidic chip. Meanwhile, a grey wolf optimization (GWO) enhanced long short-term memory (LSTM) network was developed to infer the unmeasured actual reaction solution temperature based on accessible parameters, including heating voltage, ambient temperature and substrate temperature. The obtained temperature estimation was then fed back to a fuzzy PID controller for closed-loop regulation. Experimental results demonstrated that the GWO-LSTM model limited the estimation error within 0.3 °C, and the steady-state temperature control accuracy reached ±0.2 °C or higher under fluctuating ambient conditions and diverse initial states. For cardiac troponin I (cTnI) detection, the proposed system shortened the incubation duration and reduced the coefficient of variation from 10.77% to 2.69%. This work addresses the key bottleneck restricting precise temperature control in microfluidic chemiluminescence analyzers, which provides robust technical support for the development of next-generation high-performance POCT instruments. Full article

The co-circulation of respiratory viruses, including SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV), represents a significant global health challenge that requires rapid, accurate, and differential diagnosis to support infection control and appropriate clinical decision-making. This narrative review summarizes emerging multimodal point-of-care testing (POCT) strategies for the detection and management of these respiratory viruses. Relevant studies were identified through literature searches of major scientific databases, including PubMed, Scopus, and Web of Science, focusing on recent advances in molecular diagnostics, biosensors, microfluidics, and digital health technologies. To improve clinical interpretation and comparative assessment, current POCT platforms were organized into four operational tiers based on infrastructure dependence, degree of portability, and level of decentralization of testing. Tier 1 (Professional Clinical Systems) includes fully integrated automated molecular diagnostic platforms designed for use in hospital and emergency care settings. Tier 2 (Field-Deployable Systems) comprises portable molecular and isothermal amplification technologies designed for use in decentralized or resource-limited environments. Tier 3 (Hardware-Lite Assays) includes simplified diagnostic approaches that minimize instrument requirements and are suitable for near-patient or low-infrastructure settings. Tier 4 (Consumer-Digital Diagnostics) encompasses emerging smartphone- and IoT-integrated diagnostic platforms that support user-driven testing and digital health connectivity. This tier-based framework reflects a proposed stratification of POCT technologies along a decentralization continuum and aims to facilitate comparison and selection of diagnostic strategies across diverse healthcare settings. Full article

Background: The 75 g oral glucose tolerance test (OGTT) is the gold standard for diagnosing gestational diabetes mellitus (GDM) and, according to current guidelines, is recommended for postpartum testing. German guidelines recommend a two-step screening approach, which can delay treatment initiation. In order to prevent complications for mother and child, treatment of GDM should be started as early as possible. To expedite clinical decisions, point-of-care testing (POCT) is often used alongside venous laboratory analysis. For historical reasons, capillary blood was used for POCT at our competence center. This analysis evaluates the diagnostic accuracy of capillary POCT compared to the venous reference standard analyzed in our department of clinical chemistry. Methods: We retrospectively analyzed 401 OGTTs (260 during pregnancy, 141 postpartum) with simultaneous capillary POCT and venous laboratory glucose measurements and investigated the agreement between the two methods. Optimal capillary cut-offs were determined using ROC analysis. Results: In pregnant women (n = 260), capillary POCT showed 80.8% sensitivity and 73.4% specificity. Regarding the diagnostic classification, the initial agreement with the reference standard at fasting was 71.9% (8.9% false positives, 19.2% false negatives). Optimized capillary cut-offs—fasting ≥95 mg/dL (5.3 mmol/L), 1-h ≥203 mg/dL (11.3 mmol/L), and 2-h ≥174 mg/dL (9.7 mmol/L)—increased the proportion of correctly classified cases to 85.5% (fasting), 97.0% (1-h), and 94.4% (2-h), respectively, and effectively eliminated false negatives. Conclusions: While capillary POCT offers >80% sensitivity, its false-positive rate of more than 20% must be managed. Utilizing optimized cut-off values can mitigate this uncertainty. If at least one of these cut-offs is exceeded, capillary POCT via StatStrip^® (Nova Biomedical Corporation, Waltham, MA, USA) provides a sufficient basis for treatment initiation. Full article

Routine monitoring of ortho-phthalaldehyde (OPA) disinfectants is critical for endoscope reprocessing, yet commercial test strips suffer from subjective visual ambiguity, strict manual timing, and susceptibility to sample matrix dilution. This study proposes a portable multi-spectral colorimetric sensing platform paired with structurally engineered microfluidic plastic strips for quantitative OPA monitoring. The strips utilize a confined microfluidic geometry to achieve capillary-driven volumetric self-metering (5.4 μL), while cross-hatched micro-structures eliminate edge pooling, yielding uniform colorimetric responses. Analytically, the system integrates a matrix-matched reagent formulation, an interference-free indicator, and an automated steady-state ratiometric readout algorithm to counteract physical dilution and spectral interference. Cross-validation against a capillary electrophoresis benchmark confirmed quantitative accuracy (R² = 0.9684) under physical dilution of real-world CIDEX OPA solutions. This correlation facilitated a matrix-compensated 0.32% diagnostic threshold for unambiguous, automated “[PASS]” or “[FAIL]” alerts. Ultimately, this scalable, cost-effective microfluidic architecture provides an objective point-of-care diagnostic solution, demonstrating translational potential for broad dry chemistry optical detection. Full article

Acid phosphatase (ACP) is a clinically important enzyme whose early-stage detection is hindered by its extremely low abundance, nonspecific tissue distribution, and rapid loss of activity under conventional analytical conditions. Herein, we present a target-driven in situ nanozyme synthesis strategy that enables rapid and ultrasensitive point-of-care testing (POCT) of ACP. In this approach, ACP catalyzes the hydrolysis of L-ascorbic acid 2-phosphate sesquimagnesium (AAPS), producing ascorbic acid (AA). The generated AA partially reduces Fe³⁺ ions to Fe²⁺, thereby initiating alkaline co-precipitation and in situ formation of Fe₃O₄ nanoparticles. Polyvinylpyrrolidone (PVP) stabilizes the nanoparticles and preserves catalytic accessibility, while their intrinsic magnetism allows for efficient magnetic separation to eliminate matrix interference. The resulting Fe₃O₄@PVP nanozymes display pronounced peroxidase-like activity, catalyzing hydrogen-peroxide-mediated oxidation of 3,3′,5,5′-tetramethylbenzidine (TMB). Quantitative readout can be achieved using either spectrophotometric analysis or smartphone imaging. The sensing platform achieves a detection limit of 0.021 U/L within 40 min and demonstrates excellent sensitivity, selectivity, and operational robustness. Successful validation in human serum confirms its clinical feasibility, while smartphone-based imaging enables portable and low-cost quantification suitable for decentralized diagnostics. Collectively, this work establishes a generalizable paradigm for target-triggered nanozyme generation aimed at detecting low-abundance and labile biomarkers. Full article