Search Results (579)

The global spread of Mpox virus (MPXV) underscores the urgent need for rapid, field-deployable diagnostic tools, especially in low-resource settings. We evaluated a loop-mediated isothermal amplification (LAMP) assay, termed LAMPOX, developed by Coris BioConcept. The assay was tested in three formats—two liquid versions and a dried, ready-to-use version—targeting only the ORF F3L (Liquid V1) or both the ORF F3L and N4R (Liquid V2 and dried) genomic regions. Analytical sensitivity and specificity were assessed using 60 clinical samples from confirmed MPXV-positive patients. Sensitivity on clinical samples was 81.7% for Liquid V1 and 88.3% for Liquid V2. The dried LAMPOX assay demonstrated a sensitivity of 88.3% and a specificity of 100% in a panel of 112 negative controls, with most positive samples detected in under 7 min. Additionally, a simplified sample lysis protocol was developed to facilitate point-of-care use. While this method showed slightly reduced sensitivity compared to standard DNA extraction, it proved effective for samples with higher viral loads. The dried format offers key advantages, including ambient-temperature stability and minimal equipment needs, making it suitable for point-of-care testing. These findings support LAMPOX as a promising tool for rapid MPXV detection during outbreaks, especially in resource-limited settings where traditional PCR is impractical. Full article

Infectious diseases poses a growing public health challenge. The COVID-19 pandemic has further emphasized the urgent need for rapid, accessible diagnostics. This study presents the development of an integrated, flexible point-of-care (POC) diagnostic system for the rapid detection of Corynebacterium diphtheriae, the pathogen responsible for diphtheria. The system comprises a microfluidic polymerase chain reaction (micro-PCR) device and an electrochemical DNA biosensor, both fabricated on flexible substrates. The micro-PCR platform offers rapid DNA amplification overcoming the time limitations of conventional thermocyclers. The biosensor utilizes specific molecular recognition and an electrochemical transducer to detect the amplified DNA fragment, providing a clear and direct indication of the pathogen’s presence. The combined system demonstrates the effective amplification and detection of a gene fragment from a toxic strain of C. diphtheriae, chosen due to its increasing incidence. The design leverages lab-on-a-chip (LOC) and microfluidic technologies to minimize reagent use, reduce cost, and support portability. Key challenges in microsystem design—such as flow control, material selection, and reagent compatibility—were addressed through optimized fabrication techniques and system integration. This work highlights the feasibility of using flexible, integrated microfluidic and biosensor platforms for the rapid, on-site detection of infectious agents. The modular and scalable nature of the system suggests potential for adaptation to a wide range of pathogens, supporting broader applications in global health diagnostics. The approach provides a promising foundation for next-generation POC diagnostic tools. Full article

Background/Objective: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has affected more than 1700 women with textured breast implants. About 80% of patients present with fluid (seroma) around their implant. BIA-ALCL can be cured by surgery alone when confined to the seroma and lining of the peri-implant capsule. To address the need for early detection, we developed a rapid point of care (POC) lateral flow assay (LFA) to identify lymphoma in seromas. Methods: We compared 28 malignant seromas to 23 benign seromas using both ELISA and LFA. LFA test lines (TL) and control lines (CL) were visualized and measured with imaging software and the TL/CL ratio for each sample was calculated. Results: By visual exam, the sensitivity for detection of CA9 was 93% and specificity 78%, while the positive predictive value was 84% and negative predictive value 90%. Quantitative image analysis increased the positive predictive value to 96% while the negative predictive value reduced to 79%. Conclusions: We conclude that CA9 is a sensitive biomarker for detection and screening of patients for BIA-ALCL in patients who present with seromas of unknown etiology. The CA9 LFA can potentially replace ELISA, flow cytometry and other tests requiring specialized equipment, highly trained personnel, larger amounts of fluid and delay in diagnosis of BIA-ALCL. Full article

Point-of-care (POC) diagnostic technologies have become essential for the real-time monitoring and management of chronic wounds, where maintaining a moist environment and controlling pH levels are critical for effective healing. In this study, a flexible pH sensor based on a graphene/molybdenum disulfide (graphene/MoS₂) composite interdigitated electrode (IDE) structure was fabricated using pulsed laser ablation. The pH sensor, with an active area of 30 mm × 30 mm, exhibited good adhesion to the polyethylene terephthalate (PET) substrate and maintained structural integrity under repeated bending cycles. Precise ablation was achieved under optimized conditions of 4.35 J/cm² laser fluence, a repetition rate of 300 kHz, and a scanning speed of 500 mm/s, enabling the formation of defect-free IDE arrays without substrate damage. The influence of laser processing parameters on the surface morphology, electrical conductivity, and wettability of the composite thin films was systematically characterized. The fabricated pH sensor exhibited high sensitivity (~4.7% change in current per pH unit) across the pH 2–10 range, rapid response within ~5.2 s, and excellent mechanical stability under 100 bending cycles with negligible performance degradation. Moreover, the sensor retained > 95% of its stable sensitivity after 7 days of ambient storage. Furthermore, the pH response behavior was evaluated for electrode structures with different pitches, demonstrating that structural design parameters critically impact sensing performance. These results offer valuable insights into the scalable fabrication of flexible, wearable pH sensors, with promising applications in wound monitoring and personalized healthcare systems. Full article

The Internet of Medical Things (IoMT) is revolutionizing healthcare by integrating smart diagnostic devices with cloud computing and real-time data analytics. The emergence of infectious diseases, including COVID-19, underscores the need for rapid and decentralized diagnostics to facilitate early intervention. Traditional centralized laboratory testing introduces delays, limiting timely medical responses. While point-of-care molecular diagnostic (POC-MD) systems offer an alternative, challenges remain in cost, accessibility, and network inefficiencies. This study proposes an IoMT-based architecture for fully automated POC-MD devices, leveraging WebSockets for optimized communication, enhancing microfluidic cartridge efficiency, and integrating a hardware-based emulator for real-time validation. The system incorporates DNA extraction and real-time polymerase chain reaction functionalities into modular, networked components, improving flexibility and scalability. Although the system itself has not yet undergone clinical validation, it builds upon the core cartridge and detection architecture of a previously validated cartridge-based platform for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). These pathogens were selected due to their global prevalence, high asymptomatic transmission rates, and clinical importance in reproductive health. In a previous clinical study involving 510 patient specimens, the system demonstrated high concordance with a commercial assay with limits of detection below 10 copies/μL, supporting the feasibility of this architecture for point-of-care molecular diagnostics. By addressing existing limitations, this system establishes a new standard for next-generation diagnostics, ensuring rapid, reliable, and accessible disease detection. Full article

Precision nutrition is an emerging approach that tailors dietary recommendations based on an individual’s unique genetic, metabolic, microbiome, and lifestyle factors. β-hydroxybutyrate (β-HB) is a key ketone body produced during fat metabolism, especially in states of fasting, low-carbohydrate intake, or prolonged exercise. Therefore, monitoring β-HB levels provides valuable insights into an individual’s metabolic state, making it an essential biomarker for precision and personalized nutrition. A smartphone-connected electrochemical biosensor for single-use, rapid, low-cost, accurate, and selective detection of β-HB in whole blood and saliva at the Point-of-Care (POC) is reported. A graphite screen-printed carbon electrode modified with potassium ferricyanide (Fe(III)GSPE) was used as an electrode platform for the deposition of β-hydroxybutyrate dehydrogenase (HBDH), nicotinamide adenine dinucleotide oxidized form (NAD⁺), and chitosan nanoparticles (ChitNPs). An outer poly(vinyl) chloride (PVC) diffusion-limiting membrane was used to protect the modified electrode. The biosensor showed a linear range in the clinically relevant range, between 0.4 and 8 mM, with a detection limit (LOD) of 0.1 mM. The biosensor was tested on human blood and saliva samples, and the results were compared to those obtained with a commercial ketone meter, showing excellent agreement. Full article

Chronic kidney disease (CKD) is associated with heart failure and neurological disorders. Therefore, point-of-care (POC) detection of CKD is essential, allowing disease monitoring from home and alleviating healthcare professionals’ workload. Lateral flow immunoassays (LFIAs) facilitate POC testing for a renal function biomarker, serum Cystatin C (CysC). LF devices were fabricated and optimised by varying the diluted sample volume, the nitrocellulose (NC) membrane, bed volume, AuNPs’ OD value and volume, and assay formats of partial or full LF systems. Notably, 310 samples were analysed to satisfy the minimum sample size for statistical calculations. This allowed for a comparison between the LFIAs’ results and the general Roche standard assay results from the Southern Health and Social Care Trust. Bland–Altman plots indicated the LFIAs measured 0.51 mg/L lower than the Roche assays. With the 95% confidence interval, the Roche method might be 0.24 mg/L below the LFIAs’ results or 1.27 mg/L above the LFIAs’ results. In summary, the developed non-fluorescent LFIAs could detect clinical CysC values in agreement with Roche assays. Even though the developed LFIA had an increased bias in low CysC concentration (below 2 mg/L) detection, the developed LFIA can still alert patients at the early stages of renal function impairment. Full article

The COVID-19 pandemic and recent viral outbreaks have highlighted the need for viral diagnostics that balance accuracy with accessibility. While traditional laboratory methods remain essential, point-of-care solutions are critical for decentralized testing at the population level. However, a gap persists between academic proof-of-concept studies and clinically viable tools, with novel technologies remaining inaccessible to clinics due to cost, complexity, training, and logistical constraints. Recent advances in surface functionalization, assay simplification, multiplexing, and performance in complex media have improved the feasibility of both optical and non-optical sensing techniques. These innovations, coupled with scalable manufacturing methods such as 3D printing and streamlined hardware production, pave the way for practical deployment in real-world settings. Additionally, software-assisted data interpretation, through simplified readouts, smartphone integration, and machine learning, enables the broader use of diagnostics once limited to experts. This review explores improvements in viral diagnostic approaches, including colorimetric, optical, and electrochemical assays, showcasing their potential for democratization efforts targeting the clinic. We also examine trends such as open-source hardware, modular assay design, and standardized reporting, which collectively reduce barriers to clinical adoption and the public dissemination of information. By analyzing these interdisciplinary advances, we demonstrate how emerging technologies can mature into accessible, low-cost diagnostic tools for widespread testing. Full article

Accurate, rapid and inexpensive diagnosis of poultry respiratory pathogens remains a challenge, especially in many developing countries. Meanwhile, poultry respiratory pathogens are a major threat to poultry production worldwide, accounting for billions of dollars in economic loss to the sector. Early and accurate diagnosis of these diseases is critical for economic poultry production. Molecular diagnostic methods, including PCR-based techniques, have been developed and used to fill this gap, but unfortunately, these techniques require skilled technicians, relatively costly equipment and reagents and can only be performed in a laboratory setting. This warrants the development of other diagnostic tools, which can be used in the field even by unskilled personnel. In this review, we discussed the genesis, challenges, advances and prospects of loop-mediated isothermal amplification (LAMP) for the detection of poultry respiratory pathogens at the flock side, especially in resource-constrained countries. We highlighted the application of LAMP in routine poultry disease surveillance and early outbreak detection, underscoring its value as a transformative diagnostic tool in poultry production. The development and use of a point-of-care (POC) LAMP assay that can be used to screen for these poultry respiratory pathogens simultaneously enhance disease surveillance and diagnosis. Full article

Escherichia coli (E. coli) remains a major concern in poultry production due to its ability to incite foodborne illness and public health crisis, zoonotic potential, and the increasing prevalence of antibiotic-resistant strains. The contamination of poultry products with pathogenic E. coli, including avian pathogenic E. coli (APEC) and Shiga toxin-producing E. coli (STEC), presents risks at multiple stages of the poultry production cycle. The stages affected by E. coli range from, but are not limited to, the hatcheries to grow-out operations, slaughterhouses, and retail markets. While traditional detection methods such as culture-based assays and polymerase chain reaction (PCR) are well-established for E. coli detection in the food supply chain, their time, cost, and high infrastructure demands limit their suitability for rapid and field-based surveillance—hindering the ability for effective cessation and handling of outbreaks. Biosensors have emerged as powerful diagnostic tools that offer rapid, sensitive, and cost-effective alternatives for E. coli detection across various stages of poultry development and processing where detection is needed. This review examines current biosensor technologies designed to detect bacterial biomarkers, toxins, antibiotic resistance genes, and host immune response indicators for E. coli. Emphasis is placed on field-deployable and point-of-care (POC) platforms capable of integrating into poultry production environments. In addition to enhancing early pathogen detection, biosensors support antimicrobial resistance monitoring, facilitate integration into Hazard Analysis Critical Control Points (HACCP) systems, and align with the One Health framework by improving both animal and public health outcomes. Their strategic implementation in slaughterhouse quality control and marketplace testing can significantly reduce contamination risk and strengthen traceability in the poultry value chain. As biosensor technology continues to evolve, its application in E. coli surveillance is poised to play a transformative role in sustainable poultry production and global food safety. Full article

Ammonia (NH₃) detection in liquids and biological fluids is essential for monitoring environmental contamination and industrial processes, ensuring food safety, and diagnosing health conditions. Existing detection techniques are often unsuitable for point-of-care (POC) use due to limitations including complex sample handling, lack of portability, and poor compatibility with miniaturized systems. This study introduces a proof-of-concept for a compact, portable device tailored for POC detection of gaseous ammonia released from liquid samples. The device combines a polyaniline (PANI)-based chemoresistive sensor with interdigitated electrodes and a resistance readout circuit, enclosed in a gas-permeable hydrophobic membrane that permits ammonia in the vapor phase only to reach the sensing layer, ensuring selectivity and protection from liquid interference. The ink formulation was optimized. PANI nanoparticle suspension exhibited a monomodal, narrow particle size distribution with an average size of 120 nm and no evidence of larger aggregates. A key advancement of this device is its ability to limit the impact of water vapor, a known source of interference in PANI-based sensors, while maintaining a simple sensor design. A tailored signal processing strategy was implemented, extracting the slope of resistance variation over time as a robust metric for ammonia quantification. The sensor demonstrated reliable performance across a concentration range of 1.7 to 170 ppm with strong logarithmic correlation (R² = 0.99), and very good linear correlations in low (R² = 0.96) and high (R² = 0.97) subranges. These findings validate the feasibility of this POC platform for sensitive, selective, and practical ammonia detection in clinical and environmental applications. Full article

Sepsis remains a global health emergency, demanding timely and accurate diagnostics to reduce morbidity and mortality. This review critically assesses the recent progress (2020–2025) in the development of electrochemical aptamer-based biosensors for sepsis detection. These biosensors combine aptamers’ high specificity and modifiability with the sensitivity and miniaturization potential of electrochemical platforms. The analysis highlights notable advances in detecting key sepsis biomarkers, such as C-reactive protein (CRP), procalcitonin (PCT), interleukins (e.g., interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)), lipopolysaccharides (LPSs), and microRNAs using diverse sensor configurations, including a field-effect transistor (FET), impedance spectroscopy, voltammetry, and hybrid nanomaterial-based systems. A comparative evaluation reveals promising analytical performance in terms of the limit of detection (LOD), rapid response time, and point-of-care (POC) potential. However, critical limitations remain, including variability in validation protocols, limited testing in real clinical matrices, and challenges in achieving multiplexed detection. This review underscores translational barriers and recommends future directions focused on clinical validation, integration with portable diagnostics, and interdisciplinary collaboration. By consolidating current developments and gaps, this work provides a foundation for guiding next-generation biosensor innovations aimed at effective sepsis diagnosis and monitoring. Full article

Microalbuminemia, characterized by a urinary albumin concentration between 20 and 200 mg/L, is a critical marker in assessing the risk of chronic kidney disease (CKD), diabetic nephropathy, and various other chronic conditions. Previously, we developed and validated the MyACR point-of-care (PoC) device, which facilitates the monitoring of CKD progression through real-time data transmission, thus enhancing patient management. This device utilizes a spectrophotometric dye-binding assay to measure albumin and creatinine concentrations in urine samples, providing an albumin-to-creatinine ratio (ACR) result. In the present study, we introduced a refined version of the PoC device, MyμAlbumin, designed to offer a simple, accurate, specific, sensitive, and rapid method for detecting microalbumin in urine as an early indicator of CKD and related diseases. The measurement is based on a specific immunoturbidimetric assay in a microcuvette, using a total solution volume of 125 µL (n = 5 for each validation test). The MyμAlbumin device demonstrated excellent performance, achieving high accuracy (%DMV ≤ 4.67) and precision (%CV < 5) and a strong correlation (R² > 0.995) with laboratory spectrophotometry (dye-binding assay) and reference hospital-based immunoturbidimetric assay. Its high sensitivity (LOQ = 5 mg/L) positions MyμAlbumin as a highly viable and cost-effective tool for clinical use. Additionally, the device supports real-time, seamless data transmission, making it ideal for integration into remote healthcare settings. Full article

Point-of-care (POC) tests for blood ammonia (BA) measurement have not been well evaluated in veterinary species. This cross-sectional study sought to establish an inferred reference interval for BA using a POC analyser in dogs and cats. Blood ammonia was measured in 175 dogs and 63 cats for which relevant clinical history and laboratory data was available. Reference values were inferred based on comparisons between patients with and without disease pathologies reported to cause BA elevation. Descriptive statistics, Pearson Chi², and Mann–Whitney U testing were used to assess for associations between clinical parameters and BA concentration. Seventy-one percent (124/175) of dogs and forty-six percent (29/63) of cats had undetectable BA. Following the exclusion of dogs with potential causes of hyperammonaemia, all remaining dogs had BA < 30 µg/dL. With one exception, all dogs with BA > 30 µg/dL had liver disease. All dogs with a clinical suspicion of hepatic encephalopathy (HE) had BA > 40 µg/dL. Following the exclusion of cats with potential causes of hyperammonaemia, all remaining cats had BA < 25 µg/dL. Only 50% of cats with BA > 25 µg/dL had liver disease. All cats with a clinical suspicion of HE had BA > 30 µg/dL. Based on this study population, BA < 30 µg/dL and <25 µg/dL should be considered normal in dogs and cats, respectively. Additionally, dogs with BA > 30 µg/dL are likely to have liver disease, while cats with BA > 25 µg/dL appear to exhibit a wider variety of disease pathologies. Full article

Background/Objectives: Syphilis remains a significant public health challenge worldwide. Accurate and efficient diagnostic tools are essential to controlling the spread of the disease. Current diagnostic approaches primarily rely on serologic treponemal tests (TTs) and nontreponemal tests (NTTs). The aim of this study was to evaluate the diagnostic properties of various serological methods for syphilis diagnosis. Methods: Samples were collected from participants of the Health, Information, and Sexually Transmitted Infection Monitoring (SIM study) between March 2020 and May 2023, using convenience sampling at a mobile health unit in Porto Alegre, Brazil. A total of 250 individuals were tested using the point-of-care (POC) lateral flow treponemal test, Venereal Disease Research Laboratory (VDRL) test, Rapid Plasma Reagin (RPR) test, Enzyme-Linked Immunosorbent Assay (ELISA), and Treponema pallidum hemagglutination assay (TPHA). Of these, 125 participants tested positive for syphilis in the POC screening. Diagnostic properties such as sensitivity, specificity, and predictive values were assessed for the POC test, ELISA, and VDRL test. The TPHA was used as the reference standard for the TT, and the RPR test as the reference standard for the NTT. Results: Among individuals with positive POC test results, 97.6% (122/125) were also positive by the ELISA, and 85.6% (107/125) were positive by the TPHA. Additionally, 48.0% (60/125) and 42.4% (53/125) tested positive by the VDRL and RPR tests, respectively. Using the TPHA as a reference, TT tests showed sensitivities of 97–98% and specificities of 93–95% for detecting anti-Treponema pallidum antibodies using the ELISA and POC test, respectively. For the NTT, the VDRL test demonstrated a sensitivity of 98% and a specificity of 95% compared to the RPR test. The kappa coefficients were 0.85 for the POC test vs. the TPHA, 0.81 for the ELISA vs. the TPHA, and 0.89 for the VDRL vs. the RPR tests, indicating substantial agreement. Conclusions: This study highlights a good diagnostic performance and high agreement levels among the evaluated serological tests for syphilis, reinforcing their utility in clinical and public health settings, as well as epidemiological studies. Full article