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For the detection of ferritin, this work engineered an electrochemical immunosensor by functionalizing multi-walled carbon nanotubes (MWCNTs) and integrating them into a screen-printed carbon electrode (SPCE) platform. Under optimal conditions (pH 7.4, antibody concentration 10 μg/mL, incubation time 30 min), the developed immunosensor exhibited a linear relationship between the electrochemical signal and ferritin concentrations spanning 1–500 ng/mL. Notably, it demonstrated an impressive ability to detect ferritin at exceptionally low levels, with a limit of detection reaching 0.3 ng/mL. The immunosensor demonstrated high selectivity, good reproducibility (RSD = 3.2 %, n = 5), and stability (87.3 % of initial response after 14 days at 4°C). The immunosensor was used to sensing ferritin in serum and good agreement with the commercial ELISA method (relative error < 5 %). The proposed sensor shows promise as a analytical approach for early diagnosis of lymphoma and point-of-care testing.

The excessive presence of Cu2+ could be harmful to human health. Therefore, a ratiometric fluorescence sensor based on multicolor fluorescent carbon dots (CDs) was developed for Cu2+ detection. The blue and yellow carbon dots (B-CDs/Y-CDs) were synthesized by one-step hydrothermal method. After adding Cu2+, it is captured by the amino groups of B-CDs to form complexes, resulting in a strong fluorescence quenching via photoinduced electron transfer (PET). Meanwhile, the amino groups from Y-CDs also binds with Cu2+ that inhibit the internal PET thus enhancing the fluorescence of Y-CDs. The sensor has the merits in rapid, visual, and selective with a low limit of detection (LOD) at 2.29 nM. Furthermore, an intelligent device composed of portable optical detector and smartphone is constructed, which realizes the visual point-of-care testing (POCT) of Cu2+ with a LOD of 7.51 nM. The strategy provides an accessible approach for monitoring heavy metal pollution and food safety.

Accurately measuring interleukin-6 (IL-6) levels is crucial in both clinical medicine and research due to its role in various physiological and pathological processes. We present proof-of-concept of a novel three-dimensional (3D) spatial amplification method for developing highly sensitive and miniaturized IL-6 biosensors. We designed an IL-6 immunosensor platform utilizing a unique 3D microfluidic structure fabricated with femtosecond-pulsed laser processing. This design features a porous transducer element with over 4500 microcavities, thereby increasing the reaction area by 13-fold compared to traditional 2D designs while maintaining transparency. By combining this 3D structure with a competitive antigen-antibody reaction, the sensor achieved an exceptional limit of detection of 0.27 pg/mL for IL-6 in human blood samples. Additionally, we demonstrated effective control of liquid flow within the porous element using a reduction of pressure and centrifugation speeds. This 3D spatial amplification method offers a promising approach for developing highly sensitive and compact IL-6 biosensors. Such miniaturized sensors hold potential for point-of-care testing devices, enabling convenient and timely IL-6 analysis.

Point-of-care testing (POCT) of pathogenic bacteria at low concentrations is vital to early warning of bacterial contaminations. A disposable centrifuge tube was reconstructed in this study for sensitive Salmonella detection in large-volume samples, where the entire bacterial detection progress from separation to detection, was performed within the tube. The bottom of this centrifuge tube was assembled with a flexible stirrer containing a pair of circular magnets, which was rapidly rotated using a DC motor to produce the vortex for simultaneous mixing and capture of target bacteria. Besides, immune manganese dioxide nanoflowers were synthesized and used to label target bacteria, followed by mimicking catalyze colorless TMB substrate into blue TMBox product. The product image was captured and analyzed by a smartphone App to quantitatively determine the target bacteria. This POCT centrifuge tube effectively achieved a separation efficiency of approximately 80 % for target bacteria from a 10 mL sample, enabling the detection of target bacteria within the range of 1.3 × 101 to 1.3 × 104 CFU/mL in 1 h, with a low detection limit of 13 CFU/mL. More importantly, this reconstructed centrifuge tube demonstrated its potential as a laboratory consumable for bacterial detection in routine screening owing to the features of low cost, easy operation and high integration.

Liver cancer is a highly prevalent and lethal form of cancer worldwide. In the absence of early diagnosis, treatment options for this disease are severely restricted. Recent advancements in genomics and bioinformatics have facilitated the discovery of a multitude of novel biomarkers that accurately depict an individual's disease diagnosis, progression, and treatment response. Leveraging these breakthroughs, personalized medicine employs an individual's biomarker profile to enable early detection of liver cancer and inform decisions regarding treatment selection, dosage determination, and prognosis assessment. The current lack of readily applicable, timely, and economically viable tools for biomarker analysis has hindered the incorporation of personalized medicine into regular clinical procedures. Over the past decade, significant advancements have been achieved in the field of molecular point-of-care testing (POCT) and amplification techniques, leading to substantial improvements in the diagnosis of liver cancer and the implementation of precision medicine. Instrument-free PCR technology or plasma PCR technology can shorten the complex procedure of in vitro detection of nucleic acid-based biomarkers. Also, compared to traditional ELISA, various nanomaterials modified with monoclonal antibodies to target proteins for recognition, capture, and detection have improved the efficiency of protein-based biomarker detection. These advances have reduced the time and cost of clinical detection of early-stage hepatocellular carcinoma and improved the efficiency of timely diagnosis and survival of suspected patients while reducing unnecessary testing costs and procedures. This review aims to provide a comprehensive overview of the current and emerging biomarkers employed in the early detection of liver cancer, as well as the advancements in point-of-care molecular testing technology and platforms. The primary objective is to assess their potential in facilitating the implementation of personalized medicine. This review ultimately revealed that the diagnosis of early-stage hepatocellular carcinoma not only requires sensitive biomarkers, but its various modifications and changes during the progression of cirrhosis to early-stage hepatocellular carcinoma will be a greater focus of our attention in the future. The rapid development of POCT has facilitated the opportunity to readily detect liver cancer in the general population in the future, and the integration of multi-pathway multiplexing and intelligent algorithms has improved the sensitivity and accuracy of early liver cancer biomarker detection. It is expected that the integration of point-of-care technology will be instrumental in the widespread adoption of personalized medicine in the foreseeable future.

The overuse of antibiotics has led to the severe contamination of water bodies, posing a considerable hazard to human health. Therefore, the development of an accurate and rapid point-of-care testing (POCT) platform for the quantitative detection of antibiotics is necessary. In this study, Cerium oxide (CeO2) and Ferrosoferric oxide (Fe3O4) nanoparticles were simultaneously encapsulated into N-doped nanofibrous carbon microspheres to form of a novel nanozyme (CeFe-NCMzyme) with a porous structure, high surface area, and N-doped carbon material properties, leading to a considerable enhancement of the peroxidase (POD)-like activity compared with that of the CeO2 or Fe3O4 nanoparticles alone. The POD-like activity of CeFe-NCMzyme can be quenched using L-Cysteine (Cys) and subsequently restored by the addition of a quinolone antibiotic (norfloxacin, NOR). Therefore, CeFe-NCMzyme was used as a colorimetric sensor to detect NOR via an “On-Off” model of POD-like activity. The sensor possessed a wide linear range of 0.05–20.0 μM (R2 = 0.9910) with a detection limit of 35.70 nM. Furthermore, a smartphone-assisted POCT platform with CeFe-NCMzyme was fabricated for quantitative detection of NOR based on RGB analysis. With the use of the POCT platform, a linear range of 0.1–20.0 μM and a detection limit of 54.10 nM were obtained. The spiked recoveries in the water samples were ranged from 97.73% to 102.01%, and the sensor exhibited good accuracy and acceptable reliability. This study provides a portable POCT platform for the on-site and quantitative monitoring of quinolone antibiotics in real samples, particularly in resource-constrained settings.

Background and aim: This study applied Six Sigma metrics to facilitate the quality control (QC) review for hospital glucose meters. Materials and methods: QC data from a period of six months on all hospital glucose meters were extracted from the data management system. Sigma values for each meter at two QC levels were calculated and evaluated each month by combining the imprecision, the absolute bias between the meter mean and all-meter mean, and the standards from ISO 15179:2013. The effectiveness of using Sigma values in identifying meters with possible quality problems for further Levey-Jennings QC chart review was assessed. Results: More than 80 % of the meter's Sigma values within the six months were greater than 4 at either QC level. At the high QC level, twice as many Sigma values were below 4 than the low QC level. Including Sigma values 4, 3.5 or 3 in the criteria for the QC review reduced the number of chart review to 32.8 %, 11.2 % or 3.5 %, respectively. Conclusions: The majority of the glucose meters examined in this study demonstrated optimal Sigma values. The Sigma metrics-based approach could be a valuable tool to guide an effective QC review of glucose meters for quality improvement.

Objectives: We aimed to rapidly predict the prognosis of patients who present to the emergency department (ED) with acute gastrointestinal bleeding (AGIB) using point-of-care (POC) lactate testing. Methods: This single-center retrospective observational study included 327 patients (survival group, 287; non-survival group, 40) who presented to the ED with AGIB between March 2021 and February 2022. We compared POC-measured lactate levels with laboratory-measured lactate levels using Pearson's correlation. Multivariate logistic regression analysis was used to identify early predictors of in-hospital mortality and correlated clinical outcomes. Receiver operating characteristic (ROC) curves were used to determine the optimal cutoff for POC-measured lactate levels for predicting in-hospital mortality, and the ROC curves for POC-measured lactate levels and AIMS65 scores were compared using the DeLong test. Results: POC-measured lactate levels strongly correlated with laboratory-measured lactate levels (R2 = 0.82). Patients in the non-survival group had higher POC-measured lactate levels than did those in the survival group (2.6 mmol/L vs. 1.4 mmol/L, p

Aims: This study aimed to assess the use of glucometers by patients and the analytical performance of glucometers provided by the primary care services. Methods: The analytical performance of 48 glucometers Accu-Chek® Active, was assessed through quintuplicate analyses of one Roche and one PNCQ (National Quality Control Program) control sample at different concentrations; 31 were also evaluated by a single proficiency testing sample. The evaluation metrics included imprecision, bias, and total error and were measured according to quality specifications based on biological variation (QSBV). Glucometer users answered a questionnaire regarding their experience. Results: Among the 48 glucometers evaluated with internal control samples, 17 met precision criteria at both control levels according to QSBV, while 24 met the criteria at only one control level. Of the 31 glucometers further evaluated through proficiency test, 11 met accuracy criteria according to QSBV, and only one device showed an unacceptable result. Out of these 31, only 15 demonstrated a total error within the acceptable maximum limits based on QSBV. Conclusions: Overall, our findings showed that patients had a good understanding of glucometer usage and suggested that some glucometers should be replaced, as they sometimes failed to meet even the manufacturer’s acceptable variation limits, and/or did not meet QSBV.

Summary: Background: Simplified hepatitis C virus (HCV) testing integrated into existing HIV services has the potential to improve HCV diagnoses and treatment. We evaluated the cost-effectiveness of integrating different simplified HCV testing strategies into existing HIV pre-exposure prophylaxis (PrEP) and treatment services among men who have sex with men (MSM) in Taiwan. Methods: Mathematical modeling was used to assess the cost-effectiveness of integrating simplified HCV tests (point-of-care antibody, reflex RNA, or immediate point-of-care RNA) with HCV treatment into existing HIV prevention and care for MSM from a healthcare perspective. The impact of increasing PrEP and HIV treatment coverage among MSM in combination with these HCV testing strategies was also considered. We reported lifetime costs (2022 US dollars) and quality-adjusted life years (QALYs) and calculated incremental cost-effectiveness ratios (ICERs) with a 3% annual discounting rate. Findings: Point-of-care HCV antibody and reflex RNA testing are cost-effective compared to current HCV testing in all PrEP and HIV treatment coverage scenarios (ICERs

Objectives: Sub-Saharan African (SSA) countries are severely impacted by antimicrobial resistance (AMR). Due to gaps in access to diagnostics in SSA, the true extent of AMR remains unknown. This diagnostic gap affects patient management and leads to significant antimicrobial overuse. This review explores how point-of-care (POC) testing for pathogen identification and AMR may be used to close the diagnostic gap in SSA countries. Methods: A narrative review exploring current clinical practice and novel developments in the field of POC testing for infectious diseases and AMR. Results: POC assays for identification of various pathogens have been successfully rolled out in SSA countries. While implementation studies have mostly highlighted impressive test performance of POC assays, there is limited data on the impact of implementation on clinical outcomes and cost-effectiveness. We did not encounter local studies of host-directed POC assays relevant to AMR. Novel POC assays using real-time polymerase chain reaction, isothermal amplification, microfluidics, and other technologies are in various stages of development. Conclusions: Available literature shows that POC testing for AMR applications is implementable in SSA and holds the potential to reduce the diagnostic gap. Implementation will require effective regulatory pathways, incorporation of POC testing in clinical and laboratory guidelines, and adequate value capture in existing health financing models.

Introduction: Sexually transmitted infections (STIs) are among the most common infectious diseases worldwide, often leading to coinfections. Timely detection of genital tract pathogens in at-risk populations is crucial for preventing STIs. We evaluated the NAP-Fluo Cycler System, an innovative microfluidic nucleic acid detection platform, for its ability to simultaneously identify Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Ureaplasma urealyticum (UU), Mycoplasma genitalium (MG), and Mycoplasma hominis (MH) in urethral or cervical secretions. Materials and methods: The limits of detection (LODs), repeatability, specificity, and interference resistance of the system were evaluated using standard strains, a panel of 24 pathogens, and seven interferents. We used the system to analyze 302 clinical samples and compared the results with those of five approved commercial reference kits. Results: The system achieved LODs of 500 IFU/mL, 500 CFU/mL, and 500 CCU/mL for CT, NG, and UU/MG/MH, respectively, demonstrating high stability (coefficient of variation

Background: Early detection of pathogen-associated diseases are critical for effective treatment. Rapid, specific, sensitive, and cost-effective diagnostic technologies continue to be challenging to develop. The current gold standard for pathogen detection, polymerase chain reaction technology, has limitations such as long operational cycles, high cost, and high technician and instrumentation requirements. Aim of review: This review examines and highlights the technical advancements of CRISPR-Cas in pathogen detection and provides an outlook for future development, multi-application scenarios, and clinical translation. Key scientific concepts of review: Approaches enabling clinical detection of pathogen nucleic acids that are highly sensitive, specific, cheap, and portable are necessary. CRISPR-Cas9 specificity in targeting nucleic acids and “collateral cleavage” activity of CRISPR-Cas12/Cas13/Cas14 show significant promise in nucleic acid detection technology. These methods have a high specificity, versatility, and rapid detection cycle. In this paper, CRISPR-Cas-based detection methods are discussed in depth. Although CRISPR-Cas-mediated pathogen diagnostic solutions face challenges, their powerful capabilities will pave the way for ideal diagnostic tools.

Digital microfluidics (DMF) has found great applications in vitro diagnostics (IVD). Compared to the microfabrication-based DMF, printed circuit board (PCB)-based DMF is more economical and compatible with existing IVD instruments. Despite that, current PCB-based DMF is oftentimes limited by the available droplets that can be controlled simultaneously, compromising their throughput and applications as point-of-care tools. In this work, a platform that simultaneously controls multiple PCB-based DMF plates was constructed. The software and hardware were first developed, followed by the reliability tests. Colorimetric analysis of glucose was applied to the PCB-based DMF, demonstrating the capability of this platform. With the high throughput enabled by simultaneous operations of multiple plates, this PCB-based DMF can potentially allow point-of-care testing with low cost for resource-limited settings.

Summary: Background: Malaria, a widespread parasitic disease caused by Plasmodium species, remains a significant global health concern. Rapid and accurate detection, as well as species genotyping, are critical for effective malaria control. Methods: We have developed a Flexible, Robust, Equipment-free Microfluidic (FREM) platform, which integrates recombinase polymerase amplification (RPA) and clustered regularly interspaced short palindromic repeats (CRISPR)-based detection, enabling simultaneous malaria infection screening and Plasmodium species genotyping. The microfluidic chip enabled the parallel detection of multiple Plasmodium species, each amplified by universal RPA primers and genotyped by specific crRNAs. The inclusion of a sucrose solution effectively created spatial separation between the RPA and CRISPR assays within a one-pot system, effectively resolving compatibility issues. Findings: Clinical assessment of DNA extracts from patients with suspected malaria demonstrates the FREM platform's superior sensitivity (98.41%) and specificity (92.86%), yielding consistent results with PCR-sequencing for malaria detection, which achieved a positive predictive agreement of 98.41% and a negative predictive agreement of 92.86%. Additionally, the accuracy of species genotyping was validated through concordance rates of 90.91% between the FREM platform and PCR-sequencing. Interpretation: The FREM platform offers a promising solution for point-of-care malaria screening and Plasmodium species genotyping. It highlights the possibility of improving malaria control efforts and expanding its applicability to address other infectious diseases. Funding: This work was financially supported by International Joint Laboratory on Tropical Diseases Control in Greater Mekong Subregion, National Natural Science Foundation of China, the Natural Science Foundation of Shanghai, Bill & Melinda Gates Foundation and National Research and Development Plan of China.

Rapid Diagnostic Tests (RDT) are useful to identify syphilis cases, particularly for hard-to-reach populations and if laboratory services are scarce. However, RDT performance may be suboptimal. We aimed to assess the sensitivity and specificity of a syphilis RDT using well-characterized blood donors’ samples. We categorized samples from 811 blood donors into five groups: 1 - Samples with reactive Chemiluminescence (QML), FTA-Abs, and VDRL; 2 - Samples with reactive QML and FTA-Abs, and nonreactive VDRL; 3 - Samples with reactive QML, and nonreactive for other markers (false-positives); 4 - Controls with nonreactive QML; and 5 - Samples reactive for HIV, with nonreactive QML. Sensitivity was tested in groups 1 (overall and according to VDRL titers) and 2; specificity was tested in groups 3‒5. The RDT had high specificity, even in samples reactive for HIV. The sensitivity was high (91.9%) in samples with reactive VDRL but varied between 75.0%‒100% according to VDRL titers. The overall sensitivity was lower (81.3%) in samples with reactive FTA-Abs and nonreactive VDRL. The RDT is a useful tool to detect active syphilis but may be more limited for cases with very early or remote infection, or those with prior treatment. When higher sensitivity is needed, additional strategies including recurrent testing or laboratory-based tests may be required.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus's worldwide pandemic has highlighted the urgent need for reliable, quick, and affordable diagnostic tests for comprehending and controlling the epidemic by tracking the world population. Given how crucial it is to monitor and manage the pandemic, researchers have recently concentrated on creating quick detection techniques. Although PCR is still the preferred clinical diagnostic test, there is a pressing need for substitutes that are sufficiently rapid and cost-effective to provide a diagnosis at the time of use. The creation of a quick and simple POC equipment is necessary for home testing. Our review's goal is to provide an overview of the many methods utilized to identify SARS-CoV 2 in various samples utilizing portable devices, as well as any potential applications for smartphones in epidemiological research and detection. The point of care (POC) employs a range of microfluidic biosensors based on smartphones, including molecular sensors, immunological biosensors, hybrid biosensors, and imaging biosensors. For example, a number of tools have been created for the diagnosis of COVID-19, based on various theories. Integrated portable devices can be created using loop-mediated isothermal amplification, which combines isothermal amplification methods with colorimetric detection. Electrochemical approaches have been regarded as a potential substitute for optical sensing techniques that utilize fluorescence for detection and as being more beneficial to the Minimizing and simplicity of the tools used for detection, together with techniques that can amplify DNA or RNA under constant temperature conditions, without the need for repeated heating and cooling cycles. Many research have used smartphones for virus detection and data visualization, making these techniques more user-friendly and broadly distributed throughout nations. Overall, our research provides a review of different novel, non-invasive, affordable, and efficient methods for identifying COVID-19 contagious infected people and halting the disease's transmission.

Objectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. Results: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. Conclusion: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2’s N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments.

Phenylketonuria is an inborn error of phenylalanine metabolism caused by a phenylalanine hydroxylase deficiency. To prevent the occurrence of neurological symptoms and maternal complications resulting from phenylketonuria, patients must adhere to a strict diet therapy, tetrahydrobiopterin supplementation, or pegvaliase injection to maintain blood phenylalanine levels within a recommended range throughout their lives. Therefore, monitoring blood phenylalanine levels is necessary to determine the recent metabolic status of phenylalanine in patients with PKU; however, there are no available instruments for individuals to monitor their own blood phenylalanine levels using whole fingertip blood. We developed a phenylalanine monitoring system (designated as PheCheck) that included a pre-existing portable ammonia detection device and phenylalanine ammonia-lyase, which converts phenylalanine to trans-cinnamic acid and ammonia. This system was able to remove 86.7% ± 0.03% of the ammonia contained in fingertip blood and successfully reduce background ammonia levels. A good correlation was found between the estimated plasma phenylalanine levels detected by PheCheck and plasma phenylalanine levels detected by high-performance liquid chromatography (R2 0.97). The entire PheCheck process for measuring blood phenylalanine takes only 20 min. PheCheck can lay the foundation for home phenylalanine monitoring with high feasibility because all the components are easily accessible. Further studies with a more user-friendly PheCheck optimized for practice are needed to improve blood phenylalanine control, reduce the burden on patients and/or caregivers, and prevent the sequelae associated with phenylketonuria.

Objective: to evaluate the accuracy of an antibody point-of-care lateral flow immunoassay (LFI - Wondfo Biotech Co., Guangzhou, China) in a pediatric population. Methods: children and adolescents (2 months to 18 years) with signs and symptoms suggestive of acute SARS-CoV-2 infection were prospectively investigated with nasopharyngeal RT-PCR and LFI at the emergency room. RT-PCR was performed at baseline, and LFI at the same time or scheduled for those with less than 7 days of the clinical picture. Overall accuracy, sensitivity and specificity were assessed, as well as according to the onset of symptoms (7-13 or ≥14 days) at the time of the LFI test. Results: In 175 children included, RT-PCR and LFI were positive in 51 (29.14%) and 36 (20.57%), respectively. The overall sensitivity, specificity, positive and negative predictive value was 70.6% (95%CI 56.2-82.5), 96.8% (95%CI 91.9-99.1), 90.0% (95%CI 77.2-96.0), and 88.9% (95%CI 83.9-92.5), respectively. At 7-13 and ≥14 days after the onset of symptoms, sensitivity was 60.0% (95%CI 26.2-87.8) and 73.2% (95%CI 57.1-85.8) and specificity was 97.9% (95%CI 88.7-99.9) and 96.1% (95%CI 89.0-99.2), respectively. Conclusion: Despite its high specificity, in the present study the sensitivity of LFI in children was lower (around 70%) than most reports in adults. Although a positive result is informative, a negative LFI test cannot rule out COVID-19 in children.

Point-of-care testing is widely used in a variety of clinical settings. While this testing provides immediate and actionable clinical information, it is prone to error in both the interpretation and reporting of results. Point-of-care urinalysis presents unique opportunities for errors, ranging from variation in visual interpretation to input of results. The data included here represent the results from 63,279 urinalyses from 36,780 unique patients performed over a span of three years at an academic medical center and its associated clinics. The data include the patient age/legal sex, methodology (instrument and test strip used), and the available test results (color, clarity, glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocyte esterase). Additionally, we include the method of interface between the testing instrumentation and our electronic medical record (EMR). These fell into one of three broad categories: “Interfaced” (results directly transmitted from the urinalysis instrument to the EMR via specialized data interface), “Manual” (results input by selecting from a drop-down menu in the laboratory information system), and “Enter/Edit” (results typed freely into a text field in the EMR). Analysis of this data was primarily a direct comparison of detectable errors (typos, uninterpretable results, and results outside the reportable range) as a function of the method of entry into the EMR. Secondary analysis comparing the impact of restricting drop-down menu options for urine color and clarity was also performed. These data are of use to others as they are diverse in terms of the test performed and the method of interface. Others may wish to analyze these data when making decisions as to how to perform and report these tests and when estimating risks of error with various methods of data entry.

The lack of equipped healthcare infrastructure in isolated hard-to-reach zones exposes their population to a higher risk of complications in common diseases. With a timely diagnosis setting a life-altering difference, worldwide efforts have been conducted for the development of point-of-care testing (PoCT) with cost-effective devices. Among the most common interests in PoCT is the analysis of blood smear samples, as they can help to detect, diagnose, and monitor a wide range of diseases and disorders. With microscopy being the traditional tool for these analyses, a significative advance has been the development of cost-effective digital holographic microscopy systems, driven in part by its label-free imaging capabilities that waive the need for any sample preprocessing. Here, a robust and portable digital lensless holographic microscope, functionalized for the analysis of non-preprocessed blood smear samples in PoCT environments, is presented, and its viability is tested in the observation of red blood cells. The device uses an optical fiber with a cone-shaped tip instead of a pinhole, which ensures the sturdiness of the system and eliminates the need for challenging alignment. While the distances of the microscope can be tuned before fabrication, the herein-reported operational parameters are functionalized for the specific analysis of blood samples.

Objectives: Rapid and accurate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are crucial for controlling the spread of infections in emergency settings. This study evaluated the diagnostic accuracy of a point-of-care (POC) test based on loop-mediated isothermal amplification (LAMP) that produces rapid results within 30 min. Methods: We prospectively included adult patients (age >19 years) who were diagnosed with SARS-CoV-2 infection within the last 3 days and symptomatic patients who had visited the emergency room. Posterior nasopharyngeal (PNP) swabs and throat swabs collected by physicians were used to test the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and Cohen's Kappa coefficient (k) of the POC index and reference reverse transcription quantitative polymerase chain reaction (RT-qPCR) test devices. Results: Of the 352 participants, 102 (29.0%) tested positive via the RT-PCR-based reference test device; the RT-LAMP-based POC test had a sensitivity of 70.6% and specificity of 98.0%, with 93.5% PPV, 89.1% NPV, 35.5% PLR, and 3.4% NLR. Cohen's k correlation of results from the two devices was 0.74. The cycle threshold value between the positive and negative POC test results differed (17.6 vs. 24.6, p

Introduction: In 2019, there were over 1.1 million people living with human immunodeficiency virus (HIV) and 2.4 million people living with hepatitis C virus (HCV) in the United States. One in seven (14%) are unaware of their HIV infection and almost half of all HCV infections are undiagnosed. People with unstable housing are disproportionately affected by HIV and HCV. The present study will evaluate interventions by community pharmacists that may reduce HIV and HCV transmission and promote linkage to care. Methods: This study was conducted in an independent community pharmacy in Spokane, Washington. Eligible study participants were walk-in patients of the pharmacy, over the age of 18, and experiencing homelessness. Pharmacy patients were excluded if they had a history of HIV or HCV diagnosis, received a screening for HIV or HCV in the last six months or were unable to give informed consent. The intervention included administration of HIV and HCV point-of-care testing (POCT) using a blood sample, risk determination interview, comprehensive HIV and HCV education, and personalized post-test and risk mitigation counseling followed by referral to partnering health clinics. Results: Fifty participants were included in the final data analysis. Twenty-two participants (44%) had a reactive HCV POCT, and one participant had a reactive HIV POCT. Of the 94% of participants who reported illicit drug use, 74% reported injection drug use. Seventy-six percent (n = 38) qualified for PrEP. Pharmacist referrals were made for 28 participants and 71% were confirmed to have established care. Conclusion: Individuals experiencing homelessness are at an increased risk for acquiring HIV and HCV due to risky sexual behaviors and substance misuse. PrEP is underutilized in the U.S. and pharmacist involvement in the HIV and HCV care continuum may have a significant impact in improving linkage and retention in care of difficult to treat populations.

Background: MicroRNA (miRNA) has gradually become an emerging biomarker for early diagnosis and prognosis of various diseases due to its specific gene expression and high stability. With the development of molecular diagnosis and point-of-care testing (POCT) technology, developing simple, fast, sensitive, efficient, and low-cost miRNA sensors is of great significance for clinical applications and emergency rapid diagnosis. At present, entropy-driven toehold mediated chain displacement reaction, as a promising enzyme free isothermal amplification technique, is an important tool for ultra-sensitive biosensing applications., Results: In this study, we used gold nanoparticles (AuNPs) as carriers and quenchers, modified them using self-assembled triple chain composite substrates AuNPs@A@B1/B2, and used dual reporter molecules for cascade cyclic amplification to amplify fluorescence signals, which proposed a fluorescent biosensor based on this reaction and build an intelligent fluorescence sensing platform for rapid detection of miRNA. We designed a highly specific self-programmable sensor using the acute ischemic stroke (AIS) biomarker miRNA-125a-5p as a sample, and achieved sensitive detection of miRNA in the range of 0.01 μM∼10 μ M under optimal conditions. It broke through the traditional detection limitations of weak signals and liberated the fluorescence detection environment., Significance: In summary, this creative miRNA biosensor combined with POCT has demonstrated extraordinary detection potential, broad application prospects in the early diagnosis and prognosis monitoring of AIS, provides a novel miRNA universal detection strategy for the fields of biological and life sciences., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Infectious diseases significantly impact global health, necessitating prompt diagnosis to mitigate life-threatening sepsis risk. Identifying patients at risk of severe neurological complications from enterovirus infections is challenging due to nonspecific initial presentations. Point-of-care testing (POCT) has emerged as a transformative tool, with low-cost lateral-flow colorimetric assays showing promise in deployable POCT devices. We developed a PCT/IL-6 rapid diagnostic system integrating lateral flow assay (LFA) test strips and a portable optical spectrum reader, allowing simultaneous semi-quantitative measurement of serum PCT and IL-6 within 30 min at the point of care. The system demonstrated a strong correlation with traditional ELISA and effectively differentiated severe pediatric enterovirus cases using serum samples. IL-6 showed superior discriminatory ability over PCT in identifying patients with severe neurological complications. This novel diagnostic platform holds great potential for early sepsis recognition and infectious disease management, especially in resource-limited settings., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Thrombin, a key factor in the coagulation cascade, is a valuable biomarker of great importance for the prognosis, diagnosis, and monitoring of various diseases, including cancer and heart disease. Due to the increasing attention to the development of point-of-care testing (POCT) options, various types of biosensors have been invented to enhance the accuracy and speed of detection of important biomarkers such as thrombin. Implementation of aptamers in biosensors (aptasensors) improves the target recognition capacity due to the high-affinity binding nature of aptamers. Herein, this review presents recent studies of aptasensors for thrombin detection based on different detection mechanisms encompassing optical biosensors, surface-enhanced Raman spectroscopy (SERS), electrochemical detection, piezoelectric detection, and lateral flow assay., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Respiratory syncytial virus (RSV) is a major cause of acute respiratory tract infections in infants and elderly individuals, leading to hospitalisation and potentially fatal outcomes, posing a serious threat to global health and economy. This study proposes a smartphone-based mobile digital pressure sensor (smartphone-MDPS) for the quantitative detection of the RSV fusion protein (RSV-F) in clinical nasopharyngeal samples. The smartphone-MDPS utilized two monoclonal antibodies (mAbs) specific to the F protein, of which mAb1 was conjugated with Au@PtNPs (Au@PtNPs-mAb1) as the detection antibody and mAb2 was coupled with magnetic beads (MB-mAb2) as a coating antibody to establish a novel sandwich immunoassay. During the immune reaction, the substrate H 2 O 2 was catalyzed to release O 2 gas by the Au@PtNPs nanozyme within the Au@PtNPs-mAb1-RSV-F-mAb2-MB immunocomplexes. The pressure intensity of O 2 was measured using a mobile digital pressure sensor and transmitted wirelessly to a smartphone application for analysis. The programming codes for the sensor module and Android app were developed considering the performance requirements of the smartphone-MDPS. With a quantitation range of 0.09-1.953 ng/mL, the system had a limit of quantitation (LOQ) of 0.09 ng/mL and a limit of detection (LOD) of 0.03 ng/mL. When nasopharyngeal samples from 27 patients with RSV infection and 46 healthy individuals were tested, the smartphone-MDPS and enzyme-linked immunosorbent assays (ELISA) exhibited 100 % positivity and specificity as well as a strong correlation coefficient (R 2  = 0.991) for quantitative measurements between these two assays. In conclusion, the smartphone-MDPS has high portability, affordability, efficiency, sensitivity, and specificity, making it a promising immunoassay for quantitative point-of-care testing of RSV infection., Competing Interests: Declaration of competing interest All authors declare no conflict of interest., (Copyright © 2025 Elsevier B.V. All rights reserved.)

The excessive use of cobalt in various chemical industries and arbitrary discharge of industrial wastewater have led to increased cobalt pollution in soil and water resources, increasing the risk of human exposure to high concentrations of cobalt and necessitating an urgent need for on-site monitoring platform for cobalt pollution. In this study, the terminal deoxynucleotidyl transferase (TdT)-CRISPR platform has been developed. In this platform, cobalt as a cofactor of TdT, can significantly improve the tailing efficiency of TdT-mediated extension. Therefore, when cobalt is present, the detection probe can be extended with poly(T) tails through the TdT-mediated extension, which can be subsequently served as the DNA activator for Cas12a, leading to the cleavage of fluorescence reporter molecules and triggering turn-on fluorescence signals. Consequently, this dual amplification sensing strategy of TdT-CRISPR platform demonstrated exceptional sensitivity (0.83 nM) and high specificity for cobalt over other ions. Furthermore, the method was successfully employed for the detection of cobalt in tap water and river samples. CRISPR-lateral flow assays (CRISPR-LFAs) were evaluated in this study for the simple and point-of-care detection of cobalt pollution. The assays are capable of detecting cobalt concentrations as low as 50 nM, which is significantly lower than the environmental standards of 16.9 μM, through strip analysis with the naked eye. These results commonly suggest that the TdT-CRISPR platform holds significant promise for monitoring cobalt pollution, providing a robust and sensitive solution for on-site detection and contributing to the mitigation of cobalt contamination risks in environmental matrices., Competing Interests: Declaration of competing interest All authors have given approval of this manuscript. The authors declared that they have no financial or other contractual agreements that might cause conflicts of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Activated clotting time (ACT) measurements are frequently used to monitor unfractionated heparin activity during noncardiac arterial procedures (NCAP). Accuracy of ACT-guided heparinization is mandatory to prevent heparin under and overdosing, thereby minimizing thrombo-embolic complications (TECs) and bleeding risk. The main objective of this study was to investigate accuracy of ACT to monitor heparin activity during NCAP using the Hemostasis Management System Plus (HMS) with high-range (HR) cartridges. ACT values were compared with anti-Xa measurements, regarded as the standard test to measure active heparin., Methods: This was a single-center, prospective, observational cohort study. Perioperative blood samples of patients undergoing NCAP between December 2022 and September 2023 were used to perform bedside ACT measurements and anti-Xa assays in the clinical laboratory. Primary outcome was the association between ACT and anti-Xa measurements. TEC, mortality, and bleeding complications within 30 days postoperatively or during primary admission were also scored., Results: 196 pairs of ACT and anti-Xa measurements were performed in 34 patients. Strong correlation was observed between anti-Xa and ACT measurements (Pearson's correlation coefficient = 0.84, 95% CI = 0.79-0.87, P < 0.001). Apart from anti-Xa, no additional variables were associated with ACT in multivariate linear regression analyses (regression coefficient β = 36.7, 95% CI = 33.3-40.1, P < 0.001). Bleeding complications occurred in 29% of the patients, while both TEC and mortality were observed in one patient., Conclusions: Strong correlation and an independent association were observed between heparin activity measured by anti-Xa and ACT using the HMS Plus., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Developing a fluorescence sensing platform for point-of-care detection of low abundance biomarkers is highly valuable for early diagnosis of disease. Herein, a biomimetic fluorescence-enhanced platform based on photonic crystals and DNAzyme walker was constructed and further applied to visualize and quantify the miRNA-21 in biological samples. The DNAzyme walker was orthogonally activated by the target miRNA-21, which enabled the unlocking of the DNAzyme walker strand and the subsequently repeated substrate cleavage, thus generating enhanced fluorescence signals. Meanwhile, a biomimetic photonic crystals substrate was employed to physically boost the emitted fluorescence signals again, enabling visual detection by naked eyes and quantitative analysis by smartphone. A limit of detection as low as 84.8 pM was obtained and the single base variation in miRNA-21 could also be discriminated. Furthermore, the potential application of this platform was demonstrated in spiked-urine sample and total RNA extracts, showing good agreement with RT-qPCR results. Therefore, the multiple signal amplification strategy-based fluorescent platform has the advantages of high sensitivity, good specificity, good portability and high-throughput analysis, providing a powerful tool for convenient disease diagnosis and health assessment., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Paper-based microfluidic analytical devices (μPADs) have become promising alternatives to clinical laboratory-based methods for point-of-care testing (POCT) of biomarkers in family care and resource-limited communities. Here, Co-doped carbon dots (Co-CDs) nanozyme with outstanding oxidase-mimicking catalytic activity and red fluorescent emission were prepared, and combined adhered-3D μPAD (A-3D μPAD) to monitor facilely alkaline phosphatase (ALP) level in whole blood samples. Co-CDs catalyzed the oxidization of nonfluorescent o-phenylenediamine (OPD) into 2,3-diaminophenazine (oxOPD) with yellow fluorescent emission due to the generation of tremendous O 2 •- species. With addition of ALP, ALP hydrolyzed l-ascorbic acid 2-phosphate into ascorbic acid, and the latter was oxidized by Co-CDs, then reacted with OPD to form blue fluorescent emission 3-(dihydroxyethyl)furo [3,4-b]quinoxaline-1-one (DFQ). Both DFQ and oxOPD quenched the fluorescence intensity of Co-CDs via inner-filter effect. The cascade reaction of ALP/Co-CDs was incorporated into A-3D μPAD based on above sensing principles. A-3D μPAD enabled sample pretreatment, cascade reaction and signal output, and integrated portable minimized device and smartphone for visual ALP detection. The linear range and limit of detection for ALP were 0.5-150 U L -1 and 0.1 U L -1 , respectively, and the color varied from red, yellow to blue. The detection results for whole blood samples were consistent with biochemical detector. The efficiency, disposability, practicality and low-cost of A-3D μPAD can be extended to determine various biomarkers, and provided technical support for nanozyme applications in POCT environments., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Azodicarbonamide (ADA) in flour products is easily converted to semicarbazide which greatly threatens human health. Herein, a long-lasting chemiluminescence (CL)-based biosensor was developed for quantitative point-of-care testing (POCT) of ADA. The threonine (Thr)-functionalized Cu-hemin MOFs (Cu-hemin@Thr) could induce persistent CL of luminol with excellent stability. The CL intensity was related to the competition reaction among ADA and a composite of glutathione-silver ions (GSH-Ag + ). In the presence of ADA, GSH is oxidized to glutathione disulfide (GSSG), which breaks the coordination between Ag + and GSH. The CL of the sensing system is then decreased which is expected to be used for ADA detection. By combining a homemade portable device as a detector and a smartphone as an analyzer, quantitative POCT of ADA was successfully achieved. The limit of detection was 0.562 μM (0.065 ppm), which is much lower than the maximum permissible concentration of ADA (45 ppm) in flour extract. The developed strategy demonstrated quantitative POCT capabilities along with advantages of low cost, excellent selectivity, and repeatability, presenting great potential application in food safety and environment monitoring., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objectives: The value of C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescriptions in adults has previously been emphasized. The aim of this study was to assess the impact of CRP POCT on antibiotic prescriptions by general practitioners (GPs) for suspected lower respiratory tract infections in children ≥3 years old and in adults., Methods: This was an open-label randomized trial (NCT03540706) conducted in 26 GPs in France between October 2019 and March 2023. Of the 404 participating patients, 207 (51.2%) were randomized to the CRP POCT group and 197 (48.8%) to the control group (i.e. no CRP POCT). During consultations, GPs measured CRP levels in patients randomized to the CRP POCT group. The primary endpoint was the proportion of patients in each group who were prescribed antibiotics by their GP during the consultation. Z-tests were used for comparisons., Results: The overall proportion of patients treated with antibiotics was similar in the CRP POCT (n = 89/207, 43% CI: 36.2, 50.0) and in the control group (n = 94/197, 47.7% CI: 40.6, 54.9), difference: -4.7 CI: -14.4, 5.0; p 0.3. Overall, 75% of the GPs followed CRP-based antibiotic prescription recommendations in the CRP POCT group., Discussion: CRP POCT did not reduce antibiotic prescriptions in this trial., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Point-of-care testing of multiple chronic disease biomarkers is crucial for timely intervention and management of chronic diseases. Here, a "sample-to-answer" microfluidic chip was developed for simultaneous detection of multiple chronic disease biomarkers in whole blood by integrating a plasma separation module. The whole detection process is very convenient, i.e., just add whole blood and get the results. The chip successfully achieved the simultaneous detection of total cholesterol, triglycerides, uric acid, and glucose in undiluted whole blood within 21 min, including 6 min for plasma separation and 15 min for enzymatic chromogenic reactions. Moreover, the sensitivity levels of on-chip detection of chronic disease biomarkers can also meet clinically relevant thresholds. The chip is easy to use and has significant potential to improve home self-management of chronic diseases and enhance healthcare outcomes., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Aims: Early detection of type 2 diabetes mellitus is key to reducing micro and macrovascular complications associated with this disease. However, a lab-based process for diagnosis entails the risk of loss-to-follow-up. The objective of this study was to demonstrate if performing a point-of-care test of HbA1c immediately after a screening questionnaire will increase the proportion of individuals showing up for a lab-based confirmatory test as Point-of-care (POC) provides immediate availability, which is expected to reduce loss-to-follow-up., Research Design and Methods: This trial was a two-arm, randomized controlled, open-label study. Participants were recruited using the FINDRISC Score in a primary care and community setting. All 902 eligible participants were randomized into the intervention (n=511) and control (n=391) group. The intervention group was given information on healthy lifestyles, and a Point-of-care POC-HbA1c test was performed during the same visit. The control group was only given information on healthy lifestyles. Participants in both groups received a written prescription to have an oral glucose tolerance test (OGTT) performed within the next 30 days. Follow-up phone calls were made at 30 and 90 days to check if participant had undergone the test. The total duration of the intervention was 8 months. The posterior data analysis was made by using the Kolmogorov-Smirnoff test for the quantitative variables, and the descriptive statistics were expressed as means and standard deviation, or median and interquartile range 25 %-75 %, as appropriate., Results: At 30 days, 28 % of participants in the intervention group and 26.1 % in the control group undertook the OGTT (RD 1.90 %; 95 % CI -3.94; 7.73). At 90 days, 35.8 % of participants in the intervention group and 37.1 % in the control group undertook the OGTT. There was no statistically significant difference (RD - 3.17 %; 95 % CI -7.04; 0.70) between both groups., Conclusions: The data suggest that performing a POC-HbA1c test after the FINDRISC did not increase the percentage of individuals showing up for the OGTT., Competing Interests: Declaration of Competig Interest The author Ramon A. Castaño indicates that he received consultancy fees on issues related to diabetes from Abbot Diagnostics, Novo Nordisk and Sanofi. The rest of the authors declare that they have no conflict of interest., (Copyright © 2024 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

Abnormal levels of catecholamines can indicate underlying health issues, such as Parkinson's disease, hypertension, and pheochromocytoma. However, it is difficult to accurately differentiate multiple catecholamines using traditional detection methods due to their highly similar structures. Herein, we proposed a carbon-based fluorescent probe with adaptability named spermine that can react with multiple catecholamines to generate polymer carbon dots with distinct fluorescence colors, enabling visual differentiation and quantitative detection of epinephrine, norepinephrine and levodopa. Spermine does not requires synthesis and exhibits excellent biocompatibility, as it naturally exists in bacteria and most animal cells. Additionally, ratiometric fluorescent probes with high sensitivity was constructed to eliminate nonspecific factors in the sample detection process. Furthermore, due to the simplicity of the designed fluorescence detection steps, a convenient paper-based biosensor for visual detection of multiple catecholamines was formed by pre-dropping the probe on the detection layer, which can be integrated into the portable platform and the detection value can directly display on the smartphone. Therefore, the integrated portable platform of the biosensor can differentiate catecholamines types through fluorescent color and intelligently detect the content of catecholamine in the sample., Competing Interests: Declaration of competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Carcinoembryonic Antigen (CEA) and 4-nitroquinoline-N-oxide (4-NQO) are cancer markers that play a crucial role in tumor risk assessment and early cancer diagnosis. Therefore, it is in demand to develop a fast, accurate, simple, and cost-effective method to detect these cancer markers for quick and early stage-cancer diagnosis and treatment., Results: Herein, we report a dual signaling approach for direct and indirect signal transduction of cancer biomarker binding on molecularly imprinted-electrodes integrated on an ePAD, enabling sensitive and selective quantitative analysis of 4-NQO and CEA. Multiple test zones on a single device based on artificial recognition sites using core-shell Cu-MOF@MIP were developed to create a selective "Dual-signal-ePAD". An effective and facile imprinting method on a Cu-MOF surface based on the synthesized of 4-VPBA/MAA/TRIM polymer. It resulted in a novel MIP useable as a high-performance sensing tool for the ultrasensitive and specific quantification of the target cancer biomarkers. Multiple tests consisted of voltammetric analysis of 4-NQO via oxidation of the analyte on a WE 1 , and impedance analysis of CEA via the molecular interaction with the imprinted WE 2 ., Significance: The proposed device provides enhanced electrochemical signal amplification due to its high conductivity, electrocatalytic activity, and the target-specific recognition sites for accurate determination of 4-NQO and CEA targets. The Dual-signal-ePAD exhibits good voltammetric and EIS response, oxidation currents of 4-NQO at -0.06 V and R CT of CEA, resulting in high selectivity and sensitivity with a linear response range covering the concentration range of clinical interest for both analytes. Dual-signal ePAD is a good candidate for clinical screening and POCT., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Despite the uncertainty raised by several studies regarding the practicality of Point-of-Care Testing (POCT) in hospital settings, the urgency prompted by the COVID-19 pandemic led many hospitals to invest in these rapid diagnostics. As the COVID-19 pandemic showcased the potential of POCT in emergency situations, an urgent call arises to leverage the successes and lessons learned for the long-term benefit of healthcare systems, particularly in preparation for the next pandemic of viral respiratory nature., Methods: We conducted semi-structured interviews with nine emergency care and hospital laboratory stakeholders with expertise and responsibility over POCT operations within hospital systems during the COVID-19 pandemic in Maryland, USA. The grounded theory approach was utilized, and the transcripts were thematically analyzed through an iterative process., Results: Three distinct themes were identified as barriers to POCT implementation: Regulatory barriers encompassed inconsistencies between the federal and state regulations and a regulatory structure that lags technological advancements. Staffing and operational barriers comprised a shortage of POCT workforce including nurses and Point of Care coordinators. Economic barriers were linked to the overall cost of integrating new POCT devices into the existing testing menu at emergency departments., Conclusion: We conclude with strategies, including policy considerations, to enable and sustain decentralized POCT programs within hospitals. Some of these strategies include expanding the workforce trained in the regulatory procedures required to support POCT; harmonizing state and federal regulations for diagnostic testing, especially for FDA-waived POCT; and sustained funding for POCT development and use for public health preparedness., Competing Interests: Conflict of interest None declared., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Rapid and quantitative detection of malachite green (MG) in aquaculture products is very important for safety assurance in food supply. Here, we develop a point-of-care testing (POCT) platform that combines a flexible and transparent surface-enhanced Raman scattering (SERS) substrate with deep learning network for achieving rapid and quantitative detection of MG in fish. The flexible and transparent SERS substrate was prepared by depositing silver (Ag) film on the polydimethylsiloxane (PDMS) film using laser molecular beam epitaxy (LMBE) technique. The wrinkled Ag NPs@PDMS film exhibits high SERS activity, excellent reproducibility and good mechanical stability. Additionally, the fast in situ detection of MG residues onfishscales was achieved by using the wrinkled Ag NPs/PDMS film and a portable Raman spectrometer, with a minimum detectable concentration of 10 -6 M. Subsequently, a one-dimensional convolutional neural network (1D CNN) model was constructed for rapid quantification of MG concentration. The results demonstrated that the 1D CNN quantitative analysis model possessed superior predictive performance, with a coefficient of determination (R 2 ) of 0.9947 and a mean squared error (MSE) of 0.0104. The proposed POCT platform, integrating a transparent flexible SERS substrate, a portable Raman spectrometer and a 1D CNN model, provides an efficient strategy for rapid identification and quantitative analysis of MG in fish., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The first magnetic ligand-based electrochemical assay aimed at the determination of BRD4 was developed and validated. BRD4 is an epigenetic regulator of great interest in oncology in relation to its overexpression observed in the pathogenesis of several cancer diseases. BRD4 also represents a major target for the development of innovative treatments aimed at protein inhibition or degradation. Despite the relevance of BRD4 both for diagnostics and therapeutic purposes, current methodologies for its determination are limited to commercial ELISA kits. We present a novel magnetic ligand-based assay for the electrochemical determination of BRD4. The developed assay is based on the use of a small synthetic fragment of the natural protein ligand for BRD4 as receptor, thus exploiting the intrinsic biological protein-protein recognition mechanism. In addition, the assay features the use of magnetic beads as immobilization platforms and peroxidase-conjugated monoclonal anti-BRD4 antibody for the generation of the electrochemical signal. The ligand-based assay shows outstanding performance in terms of rapidity, with results achievable in less than 20 min, no matrix effect when applied to human plasma or cell lysate samples, and excellent specificity. The proposed method exhibits a limit of detection of 2.66 nM and a response range tunable as a function of the amount of immobilized receptor. The developed ligand-based assay was successfully applied to the accurate determination of BRD4 in untreated cell lysates, as proven by the ELISA reference method. The good performance of the proposed bioassay for determination of BRD4 showed potential application of this strategy in convenient point-of-care testing., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the seasonal influenza virus are spreading among humans concurrently, especially with the ongoing replacement of mutant strains. It is challenging to differentiate between symptoms for therapy due to the comparable symptoms following infection with the SARS-CoV-2 variants and influenza viruses. Meanwhile, in order to achieve rapid point-of-care testing (POCT) to manage the spread of the disease, we developed a dual lateral flow strip based on colloidal gold-labeled monoclonal antibodies that can perform differential detection of SARS-CoV-2 variants and influenza A viruses (IAV) in this study. High-affinity monoclonal antibodies (mAbs) targeting SARS-CoV-2 and IAV were prepared to capture antigens and labeled with colloidal gold nanoparticles (AuNPs). Based on high-affinity mAbs, two targets were immobilized on one nitrocellulose (NC) membrane to establish the lateral flow strip (LFS) for differential diagnosis of SARS-CoV-2 and IAV. With no reactivity to other viruses, this LFS is extremely specific and can only identify SARS-CoV-2 and IAV. The LFS showed a limit of detection (LOD) of 4.88 ng/mL for the Omicron BA.2 RBD protein and 2.44 ng/mL for the nucleoprotein (NP) protein of H1N1. When analyzing 16 SARS-CoV-2 positive clinical samples, eight IAV positive clinical samples, and six negative samples that had already been pre-confirmed by commercial kits, its clinical application is effectively and accurately proven. These results demonstrated that the LFS integrated with AuNPs has great potential to facilitate quick, easy, and reliable POCT diagnosis for promoting the control of infectious diseases., Competing Interests: Declaration of competing interest The authors declare no competing interests., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Fluorescent probes have been reported for monitoring urinary albumin (u-ALB) to enable early diagnosis of kidney diseases and facilitate regular point-of-care testing (POCT) for chronic kidney disease (CKD) patients. However, the albumin can bind hydrophobic drugs through host-guest interactions, which may result in decreased accuracy of probes at regular drug sites and hamper POCT of albuminuria since CKD patients often need to take medications routinely. Herein, we reported a novel fluorescent probe (NC-2) by molecular engineering of a reported AIEgen (NC-1). The introduction of a non-conjugated ring moiety to the molecular rotor granted the NC-2 enhanced sensitivity with a limit of detection in urine of 8.7 mg/L, which is below l the threshold of microalbuminuria (30 mg/L). Moreover, the NC-2 was found to preferentially bind to the FA1 site of ALB, conferring it with excellent anti-interference capacities against exogenous drug molecules and metabolites. Simulation experiments using lab-spiked urine samples containing common drugs taken by CKD patients demonstrated that the probe could provide satisfied detecting accuracy (80-90 %). Furthermore, a paper-based device was constructed and achieved on-site detection of u-ALB in qualitative and semi-quantitative manners. Findings in this work were of great significance to the development of fluorescent probes for accurate detection of ALB in complex urine samples and the further achievement of fluorescence-based POCT for CKD., Competing Interests: Declaration of competing interest The authors declared that there were no competing financial interests nor personal relationship that could influence the work in this paper., (Copyright © 2024. Published by Elsevier B.V.)

ABSTRACT: Introduction: The rapid increase of extended-spectrum beta-lactamase (ESBL)-producing pathogens makes it difficult to choose appropriate antimicrobials in patients with Gram-negative bacterial infection. The Cica-beta reagent (Kanto Chemical, Tokyo, Japan) is a chromogenic test that detects ESBLs from bacterial colonies. This study aimed to reveal whether Cica-beta reagent could detect ESBLs directly from urine samples to facilitate rapid diagnosis of antibiotic susceptibility. Methods: A prospective study was conducted from July 2019 to November 2019. Patients in whom urine culture tests were performed were eligible. Each urine sample was centrifuged, and the pellet was mixed with Cica-beta reagent. The test was considered positive when the enzymatic reaction turned from yellow to red or orange. Results: In total, 350 urine samples were analysed. Urinary tract infection (UTI) was diagnosed in 214 patients. ESBL-producing Enterobacterales were isolated from 79 samples. The Cica-beta test showed sensitivity of 79.8% and specificity of 99.3% in patients with Gram-negative bacteriuria. Sensitivity and specificity improved to 90.2% and 100%, respectively, in patients with UTI. Conclusion: The Cica-beta test could be an efficient test for the detection of ESBL-producing pathogens in urine. By providing immediate information about ESBLs, it might be a useful point-of-care test to guide appropriate antimicrobial use in patients with UTI.

Objectives: Shigella flexneri (S. flexneri) is prevalent worldwide and the most common Shigella in many countries, causing highly contagious diarrhea, which seriously threatens public health. This study aimed to develop a colorimetric loop-mediated isothermal amplification (LAMP) for the rapid, accurate, and visualization detection of S. flexneri. Methods: According to the screened specific genes of S. flexneri, three groups of LAMP primers were designed and evaluated, and the colorimetric LAMP reaction volume was optimized. The specificity of the colorimetric LAMP was validated by 20 S. flexneri and 96 non-S. flexneri clinical isolates. In addition, the sensitivity of the developed assay was evaluated by the serial 10-fold dilutions of plasmid DNA. Results: A colorimetric LAMP assay was developed based on the specific S. flexneri hypothetical protein gene (Accession: AE014073 Region: 4170556.4171068). The colorimetric LAMP method had good specificity for detecting S. flexneri and enabled detection of S. flexneri within 30 minutes, with a plasmid detection limit of 7*10° copies/μL. The results of amplification could be easily identified by color. Conclusions: This colorimetric LAMP assay could be used for rapid and accurate diagnosis of S. flexneri infection, especially in remote hospitals and laboratories with under-equipped medical facilities, and in situations where an urgent diagnosis is needed.

Elevated levels of the aliphatic biogenic amine spemine in human urine and plasma has been considered as a biomarker for different types of cancers particularly, prostate cancer (PCa). Rapid measurement of spermine in human body fluids with high sensitivity is of great significance for the early clinical diagnosis of PCa. However, accurate estimation of the change in spermine concentration in the order of sub micromolar level is required for point-of-care testing (POCT) drive. Herein, a spermine specific receptor has been successfully attached onto the surface of a home-made gold modified plastic chip electrode (PCE). This electrosensor showed good repeatability and reproducibility in the electrochemical measurement of spermine when tested via impedance spectroscopy over a wide concentration range 10-3-10-11 M. Attachment of the receptor using gold thiol chemistry has been confirmed by SEM-EDX as well as Raman spectroscopy. The biosensor (i.e. boronic acid fabricated PCE) demonstrated good linearity over a wide concentration window (10−3-10−11 M) with R2 = 0.983, 0.9388, and 0.9454 for aqueous, urine, and blood plasma samples, respectively. The interference studies have also been performed with other biogenic polyamines, which revealed remarkable specificity of the electrosensor for spermine. The ultralow limit of detection (10 pM) undoubtedly reveals the potential of the electrochemical biosensing platform to be useful for POCT applications targeted towards the early diagnosis of PCa.

The recent COVID-19 infection outbreak has raised the demand for rapid, highly sensitive POC biosensing technology for intelligent health and wellness. In this direction, efforts are being made to explore high-performance nano-systems for developing novel sensing technologies capable of functioning at point-of-care (POC) applications for quick diagnosis, data acquisition, and disease management. A combination of nanostructures [i.e., 0D (nanoparticles & quantum dots), 1D (nanorods, nanofibers, nanopillars, & nanowires), 2D (nanosheets, nanoplates, nanopores) & 3D nanomaterials (nanocomposites and complex hierarchical structures)], biosensing prototype, and micro-electronics makes biosensing suitable for early diagnosis, detection & prevention of life-threatening diseases. However, a knowledge gap associated with the potential of 0D, 1D, 2D, and 3D nanostructures for the design and development of efficient POC sensing is yet to be explored carefully and critically. With this focus, this review highlights the latest engineered 0D, 1D, 2D, and 3D nanomaterials for developing next-generation miniaturized, portable POC biosensors development to achieve high sensitivity with potential integration with the internet of medical things (IoMT, for miniaturization and data collection, security, and sharing), artificial intelligence (AI, for desired analytics), etc. for better diagnosis and disease management at the personalized level.

A novel paper-based analytical device (PAD) was prepared and applied to determine the xanthine oxidase (XOD) inhibitory activity of Salvia miltiorrhiza extracts (SME). First, polycaprolactone was 3D printed on filter paper and heated to form hydrophobic barriers. Then the modified paper was cut according to the specific design. Necessary reagents including XOD for the colorimetric assay were immobilized on two separate pieces of paper. By simply adding phosphate buffer, the reaction was performed on the double-layer PAD. Quantitative results were obtained by analyzing the color intensity with the specialized device system (consisting of a smartphone, a detection box and sandwich plates). The 3D-printed detection box was small, with a size of 9.0 cm × 7.0 cm × 11.5 cm. Color component G performed well in terms of linearity and detection limits and thus was identified as the index. The reaction conditions were optimized using a definitive screening design. Moreover, a 10% glycerol solution was found to be a suitable stabilizer. When the stabilizer was added, the activity of XOD could be maintained for at least 15 days under 4 °C or −20 °C storage conditions. The inhibitory activity of SME was investigated and compared to that of allopurinol. The results obtained with the PAD showed agreement with those obtained with the microplate method. In conclusion, the proposed PAD method is simple, accurate and has a potential for point-of-care testing. It also holds promise for use in rapid quality testing of medicinal herbs, intermediate products, and preparations of traditional Chinese medicines.

In vitro diagnostic (IVD) is indispensable for early identification, prevention, and follow-up treatment of many diseases, therefore developing efficient IVD methods is of significant importance and highly demanded. However, traditional clinical diagnostic methods, which often rely on bulky, complex and expensive instruments with sophisticated operations and tedious procedures, are costly and time-consuming, unsuitable for on-site diagnosis at the point of need, anytime and anywhere. Motivated by the widespread distribution and international connectivity of smartphones, as well as their powerful computing capability and built-in sensors, smartphone-based biosensors have attracted extensive attention and showed great potential as portable and affordable analytical platforms for point-of-care diagnostics. Colorimetric method is of particular interest due to its advantages of simplicity, rapidity and high universality. In this minireview, we briefly summarize the principles, characteristics and advantages of smartphone-based colorimetric biosensors, and highlight their recent advances in applications from biomedical analysis to medical diagnosis, environment monitoring and food safety.

Objectives: Measurement comparability between blood gas analyzers within a laboratory is of utmost importance. This study analyzed the data obtained from a three-year period. Design and methods: For quality monitoring one blood sample was tested on two identical blood gas analyzers at each of three shifts/day for three years. Deming regression analysis was used to determine result correlation and statistical identity between the two analyzers for pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, and lactate. Failures in the two-analyzer comparison were determined by the performance limits from the Institute of Quality Management in Healthcare (IQMH) and from the manufacturer respectively. Results: Correlation coefficients were greater than 0.96 (0.9622–0.9975) for all tested analytes. The measurements of every analyte on both analyzers were statistically identical. In the two-analyzer comparison failure numbers/1000 tests for pO2 and glucose varied with the performance limits (IQMH: 0.6 and 49.2; the manufacturer: 19.3 and 4.4, respectively). In addition, persistent glucose failures (>5/week) between the two analyzers occurred occasionally. Conclusions: Results of all tested analytes between the two blood gas analyzers were interchangeable. Recurring glucose discrepancies might be a result of different lots of cartridges used on each analyzer, which were not identified during the initial installation.