Search Results (124)

Integrating three-dimensional printing (3DP) in healthcare has modernized medical diagnostics and therapies by presenting various accurate, efficient, and patient-specific tailored solutions. This review critically examines the integration of 3DP in the development of miniaturized devices specifically tailored for point-of-care testing (PoCT) applications in healthcare. Focusing on progressive additive manufacturing techniques, such as material extrusion, vat photopolymerization, and powder bed fusion, the review classifies and evaluates their contributions toward designing compact, portable, and patient-specific diagnostic devices. Unlike previous reviews that treat 3DP or PoCT generically, this work uniquely bridges the technical innovations of 3DP with clinical applications by analyzing wearable sensors, biosensors, lab-on-chip systems, and microfluidic platforms. It highlights recent case studies, performance metrics, and the role of 3DP in enhancing diagnostic speed, accessibility, and personalization. The review also explores challenges such as material standardization and regulatory hurdles while outlining future directions involving artificial intelligence (AI), the Internet of Things (IoT), and multifunctional integration. This focused assessment establishes 3DP as a transformative force in decentralized and precision healthcare. Full article

Vitamins are crucial micro-nutrients for overall well-being, making continuous monitoring essential. There are demands to provide an alternative detection, especially using a portable detection or a point-of-care-testing (POCT) device. One promising approach is employing an in situ electro-polymerised MIP (eMIP), which offers a straightforward polymerisation technique on screen-printed electrodes (SPEs). Here, we report a review based on three databases (PubMed, Scopus, and Web of Science) from 2014 to 2024 using medical subject heading (MeSH) terms “electrochemical polymerisation” OR “electropolymerisation” crossed with the terms “molecularly imprinted polymer” AND “vitamin A” OR “vitamin D” OR “vitamin E” OR “vitamin K” OR “fat soluble vitamin” OR “vitamin B” OR “vitamin C” OR “water soluble vitamin”. The resulting 12 articles covered the detection of vitamins in ascorbic acid, riboflavin, cholecalciferol, calcifediol, and menadione using monomers of catechol (CAT), 3,4-ethylenedioxythiophene (EDOT), o-aminophenol (oAP), o-phenylenediamine (oPD), pyrrole, p-aminophenol (pAP), p-phenylenediamine (pPD), or resorcinol (RES), using common bare electrodes including graphite rod electrode (GRE), glassy carbon electrode (GCE), gold electrode (GE), and screen-printed carbon electrode (SPCE). The most common electrochemical detections were differential pulse voltammetry (DPV) and linear sweep voltammetry (LSV). The imprinting factor (IF) of the eMIP-modified electrodes were from 1.6 to 21.0, whereas the cross-reactivity was from 0.0% to 29.9%. Several types of food and biological samples were tested, such as supplement tablets, poultry and pharmaceutical drugs, soft drinks, beverages, milk, infant formula, human and calf serum, and human plasma. However, more discoveries and development of detection methods needs to be performed, especially for the vitamins that have not been studied yet. This will allow the improvement in the application of eMIPs on portable-based detection and POCT devices. Full article

We present a compact and cost-effective real-time PCR system designed for point-of-care testing (POCT), utilizing a PCB-based disposable chip and an open-platform CMOS camera. The system integrates precise thermal cycling with software-synchronized fluorescence detection and provides real-time analysis through a dedicated user interface. To minimize cost and complexity, a polycarbonate reaction chamber was integrated with a PCB-based heater and thermistor. A slanted LED illumination setup and an open-platform USB camera were employed for fluorescence imaging. Signal alignment was enhanced using device-specific region-of-interest (ROI) tracking based on copper pad corner detection. Thermal cycling performance achieved a heating rate of 8.0 °C/s and a cooling rate of −9.3 °C/s, with steady-state accuracy within ±0.1 °C. Fluorescence images exhibited high dynamic range without saturation, and the 3σ-based ROI correction method improved signal reliability. System performance was validated using Chlamydia trachomatis DNA standard (10³ copies), yielding consistent amplification curves with a Ct standard deviation below 0.3 cycles. These results demonstrate that the proposed system enables rapid, accurate, and reproducible nucleic acid detection, making it a strong candidate for field-deployable molecular diagnostics. Full article

The growing demand for real-time, non-invasive, and cost-effective health monitoring has driven significant advancements in portable point-of-care testing (POCT) devices. Among these, optical biosensors have emerged as promising tools for the detection of critical biomarkers such as uric acid (UA) and blood glucose. Different optical transduction methods, like fluorescence, surface plasmon resonance (SPR), and colorimetric approaches, are talked about, with a focus on how sensitive, specific, and portable they are. Despite considerable advancements, several challenges persist, including sensor stability, miniaturization, interference effects, and the need for calibration-free operation. This review also explores issues related to cost-effectiveness, data integration, and wireless connectivity for remote monitoring. The review further examines regulatory considerations and commercialization aspects of optical biosensors, addressing the gap between research developments and clinical implementation. Future perspectives emphasize the integration of artificial intelligence (AI) and healthcare for improved diagnostics, alongside the development of wearable and implantable biosensors for continuous monitoring. Innovative optical biosensors have the potential to change the way people manage their health by quickly and accurately measuring uric acid and glucose levels. This is especially true as the need for decentralized healthcare solutions grows. By critically evaluating existing work and exploring the limitations and opportunities in the field, this review will help guide the development of more efficient, accessible, and reliable POCT devices that can improve patient outcomes and quality of life. Full article

The technology of digital polymerase chain reaction (dPCR) is rapidly evolving, yet current devices often suffer from bulkiness and cumbersome sample-loading procedures. Moreover, challenges such as droplet merging and partition size limitations impede efficiency. In this study, we present a super-hydrophilic microarray chip specifically designed for dPCR, featuring streamlined loading methods compatible with micro-electro-mechanical systems (MEMS) technology. Utilizing hydrodynamic principles, our platform enables the formation of a uniform array of 120-pL independent reaction units within a closed channel. The setup allows for rapid reactions facilitated by an efficient thermal cycler and real-time imaging. We achieved absolute quantitative detection of hepatitis B virus (HBV) plasmids at varying concentrations, alongside multiple targets, including cancer mutation gene fragments and reference genes. This work highlights the chip’s versatility and potential applications in point-of-care testing (POCT) for cancer diagnostics. Full article

Mycoplasma pneumoniae (MP) is the main culprit of community-acquired pneumonia. Commonly used laboratory testing methods have many shortcomings. Serological diagnosis has low sensitivity, causing false negatives, while a quantitative real-time polymerase chain reaction (qPCR) requires large equipment and professional staff. To make up for these shortcomings, we proposed a label-free, low-cost, and small-sized ion-sensitive field-effect transistor (ISFET) array based on a low-buffered loop-mediated isothermal amplification (LAMP) assay. A complementary metal oxide semiconductor (CMOS)-based ISFET array with 512 × 512 sensors was used in this system, which responds specifically to H⁺ with a sensitivity of 365.7 mV/pH. For on-chip amplification, a low-buffered LAMP system designed for the conserved sequences of two genes, CARDS and gyrB, was applied. The rapid release of large amounts of H⁺ in the low-buffered LAMP solution led to a speedy increase in electrical signals captured by the ISFET array, eliminating the need for a sophisticated temperature cycling and optical system. The on-chip results showed that the device can accurately complete MP detection with a detection limit of about 10³ copies/mL (approximately 1 copy per reaction). In the final clinical validation, the detection results of eight throat swab samples using the ISFET sensors were fully consistent with the clinical laboratory diagnostic outcomes, confirming the accuracy and reliability of the ISFET sensors for use in clinical settings. And the entire process from sample lysis to result interpretation takes about 60 min. This platform has potential to be used for the point-of-care testing (POCT) of pathogen infections, providing a basis for the timely adjustment of diagnosis and treatment plans. Full article

High-sensitivity and high-specificity biodetection is critical for advancing applications in life sciences, biosafety, food safety, and environmental monitoring. CRISPR/Cas systems have emerged as transformative tools in biosensing due to their unparalleled specificity, programmability, and unique enzymatic activities. They exhibit two key cleavage behaviors: precise ON-target cleavage guided by specific protospacers, which ensures accurate target recognition, and bystander cleavage activity triggered upon target binding, which enables robust signal amplification. These properties make CRISPR/Cas systems highly versatile for designing biosensors for ultra-sensitive detection. This review comprehensively explores recent advancements in CRISPR/Cas system-based biosensors, highlighting their impact on improving biosensing performance. We discuss the integration of CRISPR/Cas systems with diverse signal readout mechanisms, including electrochemical, fluorescent, colorimetric, surface-enhanced Raman scattering (SERS), and so on. Additionally, we examine the development of integrated biosensing systems, such as microfluidic devices and portable biosensors, which leverage CRISPR/Cas technology for point-of-care testing (POCT) and high-throughput analysis. Furthermore, we identify unresolved challenges, aiming to inspire innovative solutions and accelerate the translation of these technologies into practical applications for diagnostics, food, and environment safety. Full article

Pathogens and their metabolites in food present significant risks to both human health and economic development. Rising living standards and increasing awareness of food safety have driven the demand for sensitive and rapid detection methods. Lanthanide-doped upconversion nanoparticles (UCNPs), with their exceptional optical properties, have emerged as a promising platform for developing biosensors to detect pathogenic bacteria and their metabolites. The integration of UCNPs with point-of-care testing (POCT) has garnered considerable attention for its portability and immediacy, highlighting a promising future for biosensing, particularly in applications requiring quick and accurate diagnostics. This review explores the recognition elements and design principles commonly used in UCNP-based biosensors and examines various applications, including lateral flow assays, microfluidic systems, photoelectrochemical devices, and smartphone-integrated platforms. Despite significant advancements, challenges remain in the applicability and commercialization of UCNP-based biosensing technology. Future research should focus on enhancing sensitivity and specificity, developing scalable and cost-effective production methods, and integrating with advanced digital technologies to enable broader adoption. Addressing these challenges, establishing regulatory frameworks, and considering sustainability will be crucial to fully realizing the potential of UCNP-based biosensors. Full article

The quantitative analysis of nucleic acid markers is extensively utilized in cancer detection. However, it faces significant challenges, such as the need for specialized detection devices and the inherent complexity of testing procedures. To address these issues, this study proposes a simplified, rapid, and user-friendly platform for cancer nucleic acid marker detection. We firstly designed a polydimethylsiloxane (PDMS) device for the isothermal amplification reaction of nucleic acid biomarkers based on reverse-transcription recombinase-aided amplification (RT-RAA) technology. Specifically, three potential cancer nucleic acid biomarkers, carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and prostate cancer antigen 3 (PCA3) were amplified from human serum or urine samples in the PDMS device at body temperature. The reaction chamber was directly integrated with nucleic acid test strips labeled with colloidal gold nanoparticles, allowing for the visual observation of the detection results for the amplification products. The optimal reaction conditions, such as pH, reaction time, antibody, and streptavidin concentration, were defined after a series of optimization studies. The findings demonstrated that the optimal RT-RAA reaction time was 20 min, the primary antibodies were labeled with colloidal gold to the greatest extent at pH 8.5, and the optimal concentrations of secondary antibody and streptavidin were 1.0 mg/mL and 0.5 mg/mL, respectively. Furthermore, this novel detection approach could not only exhibit excellent sensitivity and specificity but also show high accuracy for the analysis of nucleic acid biomarkers in both clinical serum and urine samples. Therefore, the simplified and more convenient operation platform provides a new insight for the semi-quantitative analysis of cancer nucleic acid biomarkers and the rapid screening of early cancer, thereby offering a promising alternative to oncological point-of-care testing (POCT) diagnostics. Full article

Background: Point-of-care (POC) diagnostics is an innovative approach to healthcare analysis that brings the diagnostic process closer to the patient’s immediate care setting. This study was conducted to assess POC testing devices’ use in diagnosing cancer and detecting the main challenges facing laboratory specialists. Method: A cross-sectional study was conducted on conveniently selected laboratory specialists working in the Prince Mohammed bin Abdulaziz Hospital in Riyadh for six weeks. Result: A total of 187 study participants (51% males and 49% females) were enrolled. Around one-half of them (96, 51%) were less than 30 years old, and 85% had 1–5 years of experience, with 61% (124) having no previous cancer diagnosis devices training. Most of this study’s cohort was using ABL 90 Radio meter/blood gases (45, 24%), followed by ABL 800 Radio meter/blood gases (39, 20.9%), as the main cancer diagnostic devices. Several challenges were faced by this study’s participants during their work with cancer diagnosis devices. The participants shared that some time was needed to use most of the devices, and learning how to use them was a significantly steep learning curve (2.99 ± 0.07 of participants). Most participants (113, 60.4%) carried out all the control testing, and their results were compared completely (100%) with the central laboratory. They took special precautions to keep the instruments safe (162, 86.6%). Conclusion: The correlation between type of devices used and the challenges faced during the use of POCT cancer diagnosis devices showed that there is a significant correlation between all challenges facing the participants and the type of devices (p = 0.001), except for the need for time to use these devices (p = 0.53). There are many challenges facing workers who operate point-of-care cancer diagnosis devices to a high degree. Full article

A plastic optical fiber (POF)-based device for biosensing strategies has been developed to monitor several protein–protein interactions at ultra-low concentrations without functionalization processes, exploiting plasmonic phenomena. In this work, novel tests were applied to different kinds of analyte–receptor interactions, such as interleukins, where the bioreceptor’s (protein antibody) molecular weight is roughly ten times that of the analyte (protein interleukin), while intracellular bioreceptors and small molecules at low molecular weight interactions have already been demonstrated via the same point-of-care test (POCT). The POCT was implemented by a white light source and a spectrometer connected via two POF-based chips connected in series: an innovative microcuvette chip and a D-shaped POF surface plasmon resonance (SPR) probe. In particular, the POF microcuvette chip was achieved by drilling three micro holes in the core of a modified POF. Instead of performing a functionalization step, the micro holes were filled with a specific receptor solution for the analyte (one microliter at the femtomolar level), which selectively captured the target (e.g., cytokine) when the samples were dropped over the filled micro holes (twenty microliters at the attomolar level). Three interleukins, IL-1β, IL-17A, and IL-18, were detected in the attomolar concentrations range by monitoring the resonance wavelength shift over time due to the cytokine/antibody (protein–protein) interaction. The POF-based device was proven to be effective for detecting several interleukins at the attomolar level in a few minutes and without functionalization processes. Full article

Background: Thanks to the evolution of laboratory medicine, point-of-care testing (POCT) for troponin levels in the blood (hs-cTn) has been greatly improved in order to quickly diagnose acute myocardial infarction (AMI) with an accuracy similar to standard laboratory tests. The rationale of the HEART POCT study is to propose the application of the 0/1 h European Society of Cardiology (ESC) algorithm in the pre-hospital setting using a POCT device (Atellica VTLi). Methods: This is a prospective study comparing patients who underwent pre-hospital point-of-care troponin testing (Atellica VTLi) with a control group that underwent standard hospital-based troponin testing (Elecsys). The primary objectives were to determine if the 0/1 h algorithm of the Atellica VTLi is non-inferior to the standard laboratory method for diagnosing AMI and to analyze rule-out/rule-in times and emergency department (ED) stay times. The secondary objective was to evaluate the feasibility of pre-hospital troponin testing. Results: The Atellica VTLi demonstrated reasonable sensitivity for detecting AMI, with sensitivity increasing from 60% at the first measurement (time 0) to 80% at the second measurement (time 1 h). Both the Atellica VTLi and the Elecsys method showed high negative predictive value (NPV), indicating that a negative troponin result effectively ruled out AMI in most cases. Patients in the Atellica VTLi group experienced significantly shorter times to diagnosis and discharge from the emergency department compared to the control group (Elecsys). This highlights a potential benefit of point-of-care testing: streamlining the diagnostic and treatment processes. Conclusions: POCT allows for rapid troponin measurement, leading to a faster diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI). This enables earlier initiation of appropriate treatment, potentially improving patient outcomes and the efficiency of emergency department operations. POCT could be particularly beneficial in pre-hospital settings, enabling faster triage and transportation of patients to appropriate care centers. Full article

Small intestinal bacterial overgrowth (SIBO) is a disorder characterized by the excessive growth of bacteria in the small intestine. Bacterial overgrowth disrupts the bacterial balance and can lead to abdominal pain, weight loss, and gastrointestinal symptoms, including bloating, diarrhea, and malabsorption. SIBO is widespread in the population. There are two main methods for diagnosing SIBO: breath tests and bacterial culture. The most commonly used method is a breath test, which enables the division of SIBO into the following three types: hydrogen-dominant (H-SIBO), methane-dominant (CH₄-SIBO), and hydrogen/methane-dominant (H/CH₄-SIBO). This comprehensive review aims to present the current knowledge on the use of prebiotics, probiotics, and postbiotics in the context of SIBO. For this purpose, medical databases such as MEDLINE (PubMed) and Scopus were analyzed using specific keywords and their combinations. This review is based on research studies no older than 10 years old and those using only human models. In summary, clinical studies have shown that the efficacy of SIBO therapy can be increased by combining antibiotics with probiotics, especially in vulnerable patients such as children and pregnant women. The further development of diagnostic methods, such as point of care testing (POCT) and portable devices, and a better understanding of the mechanisms of biotics action are needed to treat SIBO more effectively and improve the quality of life of patients. Full article

Accurate fluid management in microfluidic-based point-of-care testing (POCT) devices is critical. Fluids must be gated and directed in precise sequences to facilitate desired biochemical reactions and signal detection. Pneumatic valves are widely utilized for fluid gating due to their flexibility and simplicity. However, the development of reliable normally closed pneumatic valves remains challenging, despite their increasing demand in advanced POCT applications to prevent uncontrolled fluid flow. Existing normally closed valves often suffer from poor reliability and lack precise control over fluid opening pressure, due to the uncontrolled stretching of the elastomer during assembly. In this study, we propose and develop a robust method for normally closed valves. By precisely controlling the pre-stretching of the elastomer, we achieve reliable valve closure and accurate control of the opening pressure. A robust normally closed valve was designed and fabricated, and its pneumatic opening pressure was systematically studied. Experimental validations were conducted to demonstrate the reliability and effectiveness of the proposed design. Full article

Diagnostics often require specialized equipment and trained personnel in laboratory settings, creating a growing need for point-of-care tests (POCTs). Among the genetic testing methods available, Loop-mediated Isothermal Amplification (LAMP) offers a viable solution for developing genetic POCT due to its compatibility with simplified devices. This study aimed to create a genetic test that integrates all steps from sample processing to analyzing results while minimizing the complexity, handling, equipment, and time required. Several challenges were addressed to achieve this goal: (1) the development of a buffer for bacterial DNA extraction that is compatible with both LAMP and immunochromatographic tests; (2) the adaption of the LAMP protocol for use with the SPID device; and (3) the optimization of the detection protocol for specific test conditions, with a lateral flow immunoassay format selected for its POCT compatibility. Following these developments, the test was validated using Escherichia coli (E. coli) and non-E. coli strains. A portable heating station was also developed to enable amplification without costly equipment. The resulting genetic POCT achieved 100% sensitivity and 85% specificity, with results available in 60 to 75 min. This study demonstrated that our POCT efficiently performs DNA extraction, amplification, and detection for bacterial identification. The test’s simplicity and cost-effectiveness will support its implementation in various settings. Full article