Search

Point-of-care serological and direct antigen testing offers actionable insights for diagnosing challenging illnesses, empowering distributed health systems. Here, we report a POC-compatible serologic test for Lyme disease (LD), leveraging synthetic peptides specific to LD antibodies and a paper-based platform for rapid, and cost-effective diagnosis. Antigenic epitopes conserved across Borrelia burgdorferi genospecies, targeted by IgG and IgM antibodies, are selected to develop a multiplexed panel for detection of LD antibodies from patient sera. Multiple peptide epitopes, when combined synergistically with a machine learning-based diagnostic model achieve high sensitivity without sacrificing specificity. Blinded validation with 15 LD-positive and 15 negative samples shows 95.5% sensitivity and 100% specificity. Blind testing with the CDCs LD repository samples confirms the test accuracy, matching lab-based two-tier results, correctly differentiating between LD and look-alike diseases. This LD diagnostic test could potentially replace the cumbersome two-tier testing, improving diagnosis and enabling earlier treatment while facilitating immune monitoring and surveillance.

Context: The purpose of this study was to compare short-term clinical outcomes between meniscus procedures performed with anterior cruciate ligament reconstruction (ACLR), ACLR (ACLR-only), ACLR with meniscectomy/resection (ACLR-resect), and ACLR with meniscal repair (ACLR-repair) for bone patellar tendon bone grafts (BPTB) and hamstring tendon grafts, separately. Design: This was a cross-sectional study conducted in a controlled laboratory setting as part of a large point-of-care collaborative research program. Methods: This study included 314 participants (168 females; mean [SD]: age, 19.7 [4.8]) with primary unilateral ACLR with a BPTB or hamstring tendon. Patients were divided into 3 groups depending on meniscal procedure (ACLR-only, ACLR-resect, and ACLR-repair). Postsurgical testing included: isokinetic assessment of knee extension and flexion, single-leg hop tests, and patient-reported outcomes. Multivariate analysis of covariance compared differences between meniscal procedures on the battery of tests, and for each statistically significant variable an analysis of covariance assessed the effect of meniscal procedure within each graft type. Chi-square analysis assessed the influence of meniscal procedure on tests' pass rates defined as 90% of limb symmetry index. Results: BPTB: ACLR-only had greater hamstring strength than ACLR-resect (P = .05) and ACLR-repair (P = .005). ACLR-only had the highest proportion of participants to pass the hamstring strength test (P=.02). amstring tendon: ACLR-only (P=.03) and ACLR-resect (P=.003) had higher International Knee Documentation Committee scale scores than ACLR-repair. There was a significant difference in the proportion of participants who scored >90% limb symmetry index on the timed hop test (P = .05). Conclusions: The influence of meniscal repair on clinical outcomes is dependent on the graft choice. Following an ACLR with BPTB and a meniscal procedure, hamstring function should be more closely monitored for optimal short-term recovery. [ABSTRACT FROM AUTHOR]

BackgroundHousehold contact investigations are effective for finding tuberculosis (TB) cases but are hindered by low referral uptake for clinic-based evaluation and testing. We assessed the acceptability and feasibility of in-home testing of household contacts (HHC) using the GeneXpert Edge platform.MethodsWe conducted a 2-arm, randomized study in Eastern Cape, South Africa. HHCs were verbally assessed using the World Health Organization-recommended 4-symptom screen. Households with ≥1 eligible symptomatic contact were randomized. Intervention households received in-home GeneXpert MTB/RIF molecular testing. GeneXpert-positive HHCs were referred for clinic-based treatment. Standard-of-care households were referred for clinic-based sputum collection and testing. We defined acceptability as agreeing to in-home testing and feasibility as generation of valid Xpert MTB/RIF results. The proportion and timeliness of test results received was compared between groups.ResultsEighty-four households were randomized (n = 42 per arm). Of 100 eligible HHCs identified, 98/100 (98%) provided consent. Of 51 HHCs allocated to the intervention arm, all accepted in-home testing; of those, 24/51 (47%) were sputum productive and 23/24 (96%) received their test results. Of 47 HCCs allocated to standard-of-care, 7 (15%) presented for clinic-based TB evaluation, 6/47 (13%) were tested, and 4/6 (67%) returned for their results. The median (interquartile range) number of days from screening to receiving test results was 0 (0) and 16.5 (11-15) in the intervention and standard-of-care arms, respectively.ConclusionsIn-home testing for TB was acceptable, feasible, and increased HHCs with a molecular test result. In-home testing mitigates a major limitation of household contact investigations (dependency on clinic-based referral), revealing new strategies for enhancing early case detection.

ObjectivePregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa.MethodsThe STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for Chlamydia trachomatis, Neisseria gonorhoeae and Trichomonas vaginalis (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes.ResultsWe enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age.ConclusionsPOC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW.Trial registration numberNCT03902418; Clinical Trials.gov; 1 April 2019.

Hydrolytic enzymes play crucial roles in cellular processes, and dysregulation of their activities is implicated in various physiological and pathological conditions. These enzymes cleave substrates such as peptide bonds, phosphodiester bonds, glycosidic bonds, and other esters. Detecting aberrant hydrolase activity is vital for understanding disease mechanisms and developing targeted therapeutic interventions. This study introduces a novel approach to measuring hydrolase activity using giant magnetoresistive (GMR) spin valve sensors. These sensors change resistance in response to magnetic fields, and here, they are functionalized with specific substrates for hydrolases conjugated to magnetic nanoparticles (MNPs). When a hydrolase cleaves its substrate, the tethered magnetic nanoparticle detaches, causing a measurable shift in the sensor's resistance. This design translates hydrolase activity into a real-time, activity-dependent signal. The assay is simple, rapid, and requires no washing steps, making it ideal for point-of-care settings. Unlike fluorescent methods, it avoids issues like autofluorescence and photobleaching, broadening its applicability to diverse biofluids. Furthermore, the sensor array contains 80 individually addressable sensors, allowing for the simultaneous measurement of multiple hydrolases in a single reaction. The versatility of this method is demonstrated with substrates for nucleases, Bcu I and DNase I, and the peptidase, human neutrophil elastase. To demonstrate a clinical application, we show that neutrophil elastase in sputum from cystic fibrosis patients hydrolyze the peptide-GMR substrate, and the cleavage rate strongly correlates with a traditional fluorogenic substrate. This innovative assay addresses challenges associated with traditional enzyme measurement techniques, providing a promising tool for real-time quantification of hydrolase activities in diverse biological contexts.

Objective Administering surfactant timely and appropriately is important to minimize lung injury but remains challenging in preterm neonates with respiratory distress syndrome. The published literature supports that lung ultrasound (LUS) score can predict surfactant need. Neonatal LUS scanning specification and parameter setting guidelines have been recently published for standardization. However, variations in scanning protocols and machine settings hinder its clinical implementation widely. This observational study aims to internally validate the suggested LUS protocol in a neonatal intensive care unit to establish a correlation between LUS scores and surfactant need as the first step of integrating LUS in the clinical practice. Study Design LUS was performed on 40 eligible preterm neonates within 3 hours after birth or before surfactant administration between May 2020 and March 2021. The neonates were between 27 and 32 weeks' gestational age, and all had respiratory distress. Neonates with known congenital anomalies were excluded. A high-frequency linear probe was used to obtain LUS images from six lung zones which were scored using a 0 to 3 system, yielding a maximum of 18 points. Treating physicians were blinded to the LUS score. Receiver operating characteristic analysis determined the optimal LUS score cut-off for predicting surfactant need. Results Fifteen of the 40 neonates (38%) required higher oxygen fraction and received surfactant. In our cohort, an LUS score ≥10 was identified as the optimal cut-off for predicting surfactant need, with a sensitivity of 80% and specificity of 84%. The area under the curve was 0.8 (p = 0.0003). LUS predicted surfactant need at a median of 3.5 hours earlier than traditional clinical decision (p < 0.0037). Conclusion LUS is a helpful adjunct for predicting surfactant need in preterm neonates. This study describes an approach to implement the LUS protocol and score for clinical decision-making in the clinical practice. Key Points LUS is a helpful adjunct for predicting surfactant need in preterm neonates. Machine setting variation and probe selection may affect LUS image and score. LUS score should be validated at the local unit before clinical implementation. [ABSTRACT FROM AUTHOR]

Background: Although the number of point-of-care ultrasound devices available in Hungarian primary care practices are increasing due to government funding, their use in day-to-day patient care is limited and unregulated. Our study aimed to evaluate the attitudes and needs of general practitioners (GPs) and patients in Hungary regarding the introduction of bedside ultrasonography in primary care practices. Methods: As a part of a cross-sectional study, an anonymous, self-administered questionnaire was distributed to GPs and patients on a social media platform. Data collection was carried out from August 2023 to October 2023. Chi-square test was used to determine the associations between categorical variables. Results: The survey was completed by 415 GPs (mean age 53.8 ± 11.1 years, 54.9% female, mean 19.5 ± 11.9 years of practice) and 693 patients (mean age 45.5 ± 12.3 years, 95.2% female). There was a statistically significant increase in interest in PoCUS among young and middle-aged GPs (age 28–59; p = 0.02). In addition, this population of GPs was also more likely to undertake training in PoCUS than their older colleagues (p < 0.0001). An inverse relationship was found between the duration of practice and training willingness (p = 0.0011). Even with the government's financial support, only 8.2% of GPs currently use PoCUS in a daily basis, and 59.5% of GPs are unfamiliar with the indications and the ways of using it. Patients would even pay to have the examination done in a primary care setting, even though only 45.9% of patients would pay a GP who is not certified in PoCUS, but the willingness to pay increased to 99.4% for those with formal training (p = 0.024). Conclusion: Our findings indicate a significant interest in adapting PoCUS in primary care from both GPs and patients. Based on the fact that a significant proportion of Hungarian GPs are unaware of PoCUS and its indications, it is particularly important to develop educational frameworks, and practical guidelines for the effective incorporation of PoCUS in Hungary. [ABSTRACT FROM AUTHOR]

This article discusses a new method for diagnosing brain lymphoma using nanopore sequencing of cerebrospinal fluid (CSF). The study demonstrates the clinical application of this method in two cases of CNS lymphoma. The researchers adapted their fast-track unsupervised machine learning approach for cases with a differential diagnosis of lymphoma and other malignant brain tumors. The results showed that nanopore sequencing-derived methylation patterns can be used for next-day diagnosis and treatment initiation. This point-of-care protocol has the potential to significantly reduce neurological impairment through timely and non-invasive testing. [Extracted from the article]

Objective: Point-of-Care Ultrasound (POCUS) refers to the use of portable ultrasound machines to perform quick and focused ultrasound examinations at a patient's bedside or point-of-care. POCUS can be performed by all health workers with specific training to use POCUS. The aim of this study was to investigate the radiological performance and feasibility of POCUS using a handheld ultrasound device (HHUSD) in children for examining the thyroid gland. Methods: A pediatric endocrinologist performed thyroid imaging in children referred to our hospital with suspected thyroid disease using an HHUSD. The same children underwent ultrasonography (US) imaging using the same device by the first radiologist, and a second radiologist performed thyroid US using an advanced high-range ultrasound device (AHUSD) (defined as the gold-standard method) within two hours. The data obtained by the three researchers were compared with each other. Results: This study included 105 patients [68.6% girls (n=72)] with a mean age 12.8±3.6 years. When the thyroid volume was evaluated, a strong correlation was found between the measurements of the three researchers (AA vs. MG: r=0.963, AA vs. GT: r=0.969, MG vs. GT: r=0.963, p<0.001). According to the Bland-Altman analysis for total thyroid volume, AA measured 0.43 cc [95% confidence interval (CI): -0.89-0.03] smaller than MG, and 0.11 cc (95% CI: -0.30-0.52) larger than GT, whereas MG measured 0.52 cc (95% CI: 0.09-0.94) larger than GT. When evaluated for the presence of goiter and nodules, a near-perfect agreement was found between the results of the three researchers (AA vs. GT; κ=0.863, MG vs. GT; κ=0.887, p<0.001, and AA vs. GT; κ=1.000, MG vs. GT; κ=0.972, p<0.001, respectively). When evaluated in terms of the longest axis of nodules, a high correlation was found between the measurements of the three researchers (AA vs. MG; r=0.993, AA vs. GT; r=0.996, MG vs. GT; r=0.996, p<0.001). When evaluated in terms of the final diagnosis, the evaluations of the three researchers showed excellent agreement with each other (AA vs. GT; κ=0.893, MG vs. GT; κ=0.863, p<0.001, accuracy rate AA vs. GT: 93.3%; MG vs. GT: 91.4%). Conclusion: A pediatric endocrinologist, equipped with sufficient training in thyroid US evaluation, incorporated HHUSD examination as a routine clinical tool in an outpatient setting. It was shown that, they could effectively assess normal thyroid tissue in pediatric patients. Moreover, the HHUSD proved to be useful in detecting thyroid pathologies. However, it is important to note that for a more comprehensive evaluation of thyroid nodules, including detailed assessment and Thyroid Imaging Reporting and Data System (TIRADS) classification, patients should be referred to radiology departments equipped with AHUSD systems. These specialized devices, along with the expertise of radiologists, are essential for in-depth evaluations and accurate classification of thyroid nodules. [ABSTRACT FROM AUTHOR]

Background Despite stewardship efforts, laboratory testing overuse persists across medicine. Objectives To understand laboratory stewardship perceptions and testing patterns at a tertiary care pediatric hospital so that we could identify potential improvement opportunities. Methods An electronic survey exploring laboratory stewardship was sent to all pediatric medicine resident and staff physicians. Laboratory testing data were also assessed for patterns of testing and overuse. Results The survey response rate was 54% (43/80). The results indicated good familiarity with stewardship but poor familiarity with testing specifics (eg, cost). A mobile reference application was the most preferred quality improvement intervention, and online modules were the least desired. Overuse was apparent, with as many as 53% of laboratory tests being repeated within 7 days and only half of repeated tests subsequently yielding abnormal results. Conclusions Altogether, the data we collated demonstrated poor understanding of laboratory stewardship and substantial repeat testing with few abnormal results. These study findings suggest that laboratory stewardship is lacking at our center, and that multiple improvement opportunities exist. [ABSTRACT FROM AUTHOR]

Why you should read this article: • To refresh your knowledge of the aims of and processes involved in triage • To enhance your understanding of the strategies you can use to make triage as safe and effective as possible for patients and staff • To contribute towards revalidation as part of your 35 hours of CPD (UK readers) • To contribute towards your professional development and local registration renewal requirements (non-UK readers). Triage is the first stage of a patient’s journey through the emergency department and is used to determine patient acuity. There is no single quantifiable metric for determining acuity, which amalgamates different factors that are more or less relevant depending on the patient’s presentation. This article explains the aim and process of triage and how nurses can ensure the process is effective and safe. The author discusses strategies nurses can use to mitigate uncertainty and to make their acuity assessments rapid, targeted and comprehensive. The author also highlights triage safety considerations, including infection prevention and control and the physical and emotional safety of patients and staff. [ABSTRACT FROM AUTHOR]

Sexually transmitted infections (STIs) continue to be a health concern in the United States, particularly in rural settings. Point‐of‐care (POC) STI testing is useful in overcoming access barriers in these settings. The purpose of this project was to implement POC STI testing to increase access to care in rural settings and test the feasibility of this model. Six mobile health clinics were implemented by a nurse‐led team in three rural communities in the Blackbelt region of Alabama utilizing the Binx IO® to test for chlamydia and gonorrhea. Mobile clinic volunteers participated in focus groups to determine provider satisfaction with clinic workflow. The mobile health clinics were a feasible way to increase access to STI testing in rural settings with reported provider and client satisfaction in work flow. [ABSTRACT FROM AUTHOR]

During 2018–2021, eight septic transfusion reactions occurred from transfusion of platelet units contaminated with Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecarboxylata, or a combination of those environmental organisms. Whether biofilm formation contributed to evasion of bacterial risk mitigations, including bacterial culture, point-of-care testing, or pathogen-reduction technology, is unclear. We designed a 12-well plate-based method to evaluate environmental determinants of single-species and multispecies biofilm formation in platelets. We evaluated bacteria isolated from septic transfusion reactions for biofilm formation by using crystal violet staining and enumeration of adherent bacteria. Most combinations of bacteria had enhanced biofilm production compared with single bacteria. Combinations involving L. adecarboxylata had increased crystal violet biofilm production and adherent bacteria. This study demonstrates that transfusion-relevant bacteria can produce biofilms well together. More work is needed to clarify the effect of biofilms on platelet bacterial risk control strategies, but US Food and Drug Administration– recommended strategies remain acceptable. [ABSTRACT FROM AUTHOR]

Background: There has been a notable decrease in antibiotic prescribing in the last thirty years in Sweden. Little is known about factors influencing antibiotic prescribing over several years. Objective: To compare primary care physicians who, over time, reduced their antibiotic prescribing for respiratory tract infections with those who remained either high or low prescribers regarding potentially influencing factors. Design and setting: A register-based study including all RTI visits in primary care in Region Kronoberg, Sweden 2006–2014. The data were divided into three 3-year periods. Subjects: The data comprised all physicians who had diagnosed at least one RTI for each of the three-year periods. The antibiotic prescribing rate adjusted for the patients' sex and age group was calculated for each physician and period, and based on the change between the first and the third period, the physicians were divided into three prescriber groups: The High Prescribing Group, the Decreasing Prescribing Group, and the Low Prescribing Group. Main outcome measures: For the three prescriber groups, we compared factors influencing antibiotic prescribing such as the characteristics of the physicians, their use of point-of-care tests, their choice of diagnoses, and whether the patients returned and received antibiotics. Results: The High Prescribing Group ordered more point-of-care tests, registered more potential bacterial diagnoses, prescribed antibiotics at lower C-reactive protein levels, and prescribed antibiotics more often despite negative group A Streptococci test than in the Low Prescribing Group. The Decreasing Prescribing Group was between the High Prescribing Group and the Low Prescribing Group regarding these variables. The lower prescription rate in the Low Prescribing Group did not result in more return visits or new antibiotic prescriptions within 30 days. Conclusion: Point-of-care testing and its interpretation differed between the prescriber groups. Focus on interpreting point-of-care test results could be a way forward in antibiotic stewardship. KEY POINTS: High prescribers used antibiotics at lower CRP levels and were more likely to identify a potential bacterial diagnosis. Many physicians reduced their antibiotic prescribing during the study period. Nine out of ten low prescribers remained low prescribers. Seeing a low-prescribing physician did not lead to more return visits or antibiotic changes. [ABSTRACT FROM AUTHOR]

Rationale: This study presents the first comprehensive analysis and mapping of scientific research on point‐of‐care testing (POCT) in infectious diseases, filling a gap in understanding the evolving landscape of this field. The identification of research themes and global contributions offers valuable insights. Aims and Objectives: This manuscript aims to analyse and map scientific research on POCT in the context of infectious diseases. Methods: The study employed a comprehensive search strategy using terms related to POCT and infectious diseases. The search was conducted on the Scopus database, refining results based on inclusion and exclusion criteria. The dataset of 1719 research articles was then subjected to descriptive analysis and mapping using VOSviewer. Results: The research findings indicate an exponential growth in POCT‐related publications, with 46.8% published post the COVID‐19 pandemic. Plos One journal led in publication frequency, and Biosensors and Bioelectronics received the highest citations per article. North America and Western Europe dominated contributions, with notable participation from China, South Africa, and India. The research landscape revealed the following research themes: detection technologies, human immunodeficiency virus (HIV)/sexually transmitted infection (STI) diagnosis, antibiotic optimisation, and schistosomiasis. Clinical trials focused on antibiotic prescribing, HIV, STIs, and specific infections. The findings suggest a shifting landscape towards POCT, emphasising the need for future planning and investment in healthcare systems. The research identifies areas for future exploration, such as the impact of POCT on antibiotic prescribing and its role in combating infectious diseases in low‐ and middle‐income countries. Conclusion: Implementation of POCT has the potential to revolutionise infectious disease management, improve patient outcomes, and reduce the global burden of diseases. Better public awareness, healthcare team management, and planning for POCT at entry points are crucial for societal benefit. Results demonstrated the evolving role of POCT in infectious disease management and prevention. [ABSTRACT FROM AUTHOR]

Lung cancer remains a major global health problem with high mortality rates. Early diagnosis can significantly improve prognosis. Hence alternative diagnostic platforms facilitating rapid, noninvasive, point-of-care screening are needed. Nanomaterial-assisted electrochemical biosensors present a promising technology. Unique properties of nanomaterials like high electrical conductivity, catalytic activity, and large surface area enhance achieved detection limits and kinetics. Recent works have combined nanomaterials like graphene, metal nanoparticles and conducting polymers with recognition elements like antibodies and aptamers. Considerable progress has focused on improving analytical parameters including sensitivity, linear ranges, reproducibility and response times. Initial embodiments also demonstrate multiplexed detection, microfluidic integration and smartphone connectivity towards viable clinical practice. However considerable efforts on large sample size validation, standardization of testing protocols and viable commercialization pathways integrating regulatory guidelines and reimbursement ecosystem partnerships remain before such lab-on-chip platforms can enter mainstream and guide therapeutic interventions through affordable decentralized personalized monitoring. [ABSTRACT FROM AUTHOR]

Microfluidic-based point-of-care diagnostics offer several unique advantages over existing bioanalytical solutions, such as automation, miniaturisation, and integration of sensors to rapidly detect on-site specific biomarkers. It is important to highlight that a microfluidic POC system needs to perform a number of steps, including sample preparation, nucleic acid extraction, amplification, and detection. Each of these stages involves mixing and elution to go from sample to result. To address these complex sample preparation procedures, a vast number of different approaches have been developed to solve the problem of reagent storage and delivery. However, to date, no universal method has been proposed that can be applied as a working solution for all cases. Herein, both current self-contained (stored within the chip) and off-chip (stored in a separate device and brought together at the point of use) are reviewed, and their merits and limitations are discussed. This review focuses on reagent storage devices that could be integrated with microfluidic devices, discussing further issues or merits of these storage solutions in two different sections: direct on-chip storage and external storage with their application devices. Furthermore, the different microvalves and micropumps are considered to provide guidelines for designing appropriate integrated microfluidic point-of-care devices. [ABSTRACT FROM AUTHOR]

AbstractIn this dual-center study, we assessed the BioHermes A1C EXP M13 system for point-of-care (POC) HbA1c testing against two NGSP-certified HPLC instruments, the Bio-Rad D100 and Tosoh G8. Analyzing 605 samples, we evaluated the A1C EXP's reproducibility, sensitivity, specificity and impact of anemia on HbA1c measurements. The device showed excellent reproducibility with CVs under 2.4% and high sensitivity and specificity for diabetes diagnosis—98.1% and 96.8% against D100, and 97.1% and 96.7% against G8. Passing-Bablok regression confirmed a close correlation between A1C EXP and the HPLC instruments, with equations y = 0.10625 + 0.9688x (D100) and y = 0.0000 + 0.1000x (G8), and Bland–Altman plots indicated mean relative differences of −1.4% (D100) and −0.4% (G8). However, in anemic samples, A1C EXP showed a negative bias compared to HPLC devices, suggesting that anemia may affect the accuracy of HbA1c results. The study indicates that A1C EXP is a reliable POC alternative to laboratory assays, albeit with considerations for anemic patients. [ABSTRACT FROM AUTHOR]

Background: While mobile-linked point-of-care diagnostics may circumvent geographical and temporal barriers to efficient communication, the use of such technology in community settings will depend on user experience. We conducted a scoping review to systematically map evidence on user experiences of mobile-linked point-of-care diagnostics in community healthcare settings published from the year 2016 up to the year 2022. Methodology: We conducted a comprehensive search of the following electronic databases: Scopus, Web of Science, and EBSCOhost (Medline, CINAHL, Africa-wide, Academic Search Complete). The inter-reviewer agreement was determined using Cohen's kappa statistic. Data quality was appraised using the mixed method appraisal tool version 2018, and the results were reported according to the preferred reporting items for systematic reviews and meta-analyses for scoping reviews (PRISMA-ScR). Results: Following the abstract and full article screening, nine articles were found eligible for inclusion in data extraction. Following the quality appraisal, one study scored 72.5%, one study scored 95%, and the remaining seven studies scored 100%. Inter-rater agreement was 83.54% (Kappa statistic = 0.51, p < 0.05). Three themes emerged from the articles: approaches to implementing mobile-linked point-of-care diagnostics, user engagement in community-based healthcare settings, and limited user experiences in mobile-linked point-of-care diagnostics. User experiences are key to the sustainable implementation of mobile-linked point-of-care diagnostics. User experiences have been evaluated in small community healthcare settings. There is limited evidence of research aimed at evaluating the usability of mobile-linked diagnostics at the community level. Conclusion: More studies are needed to assess the user experience of mobile-linked diagnostics in larger communities. This scoping review revealed gaps that need to be addressed to improve user experiences of mobile-linked diagnostics, including language barriers, privacy issues, and clear instructions. [ABSTRACT FROM AUTHOR]

The sensitivity of cardiac troponin testing for diagnosing acute myocardial infarction （AMI） varies over time from chest pain onset. This study aimed to determine the diagnostic performance of point-of-care testing cardiac troponin T （POCT-cTnT） at different time intervals post-symptom onset to refine rapid rule-out approaches for AMI. Methods This retrospective study included 6，024 patients presenting with chest pain from January 2018 to December 2022. POCT-cTnT and central lab cTnI levels were measured on admission. Receiver operating characteristics analysis stratified by time windows assessed the accuracy of POCT-cTnT for diagnosing AMI. Results The overall AUC of POCT-cTnT for diagnosing AMI was 0.826 （95% CI:0.816 ~ 0.836）， with a sensitivity of 72.81% and a specificity of 86.26%. According to the time intervals of chest pain onset （< 3 hours， 3 ~ 6 hours， 6 ~ 12 hours， 12 ~ 24 hours， 24 ~ 72 hours， and ≥ 72 hours）， the AUC values for groups after 6 ~ 12 hours were 0.918， 0.928， 0.920 and 0.908， respectively， with no statistically significant difference （P > 0.05）， but all were higher than the groups within 6 hours （P < 0.001）. According to the time of chest pain onset， the AUC for the ≥8h group was 0.921， with a negative predictive value （NPV） of 98.1% and a negative likelihood ratio （-LR） of 0.11. Its AUC was higher than those of the ≥ 3 h， ≥ 2 h， ≥ 1 h， and overall groups （P < 0.05）， but there was no statistically significant difference compared with the groups after ≥ 4 h（ P > 0.05）. Conclusions Chest pain onset time has a certain impact on the performance of a single POCT-cTnT test for diagnosing AMI. The duration from chest pain onset to hospital admission combined with POCT-cTnT test may improve the reliability in diagnosing AMI. Specifically， a single POCT-cTnT test at four hours after chest pain onset， especially eight hours after chest pain onset， can diagnose or exclude AMI. [ABSTRACT FROM AUTHOR]

Current diagnostic tests for high sensitivity detection of protein biomarkers involve long incubation times or require bulky/expensive instrumentation, hindering their use for point-of-care testing. Here, we report a microfluidic electrochemical immunosensor that employs a unique finger-actuated mixer for rapid, ultrasensitive measurements of protein biomarkers. Mixing was implemented during the incubation steps, which accelerated biomolecular transport and promoted immunocomplex formation, leading to enhanced analytical sensitivity and a shortened detection time. Electrochemical measurements were performed using a handheld diagnostic device consisting of a smartphone and miniature potentiostat. Proof of principle was demonstrated by using this platform for quantitative measurements of C–X–C motif chemokine ligand 9 (CXCL9), a serological biomarker for autoimmune and inflammatory diseases, which could be detected in human plasma at concentrations as low as 4.7 pg mL−1 in <25 min. The ability to rapidly detect protein biomarkers with high sensitivity in a point-of-care format makes this device a promising tool for diagnostic testing, particularly in resource-limited settings. [ABSTRACT FROM AUTHOR]

AbstractIntroductionMaterial and methodsResultsConclusionUrinary symptoms constitute the primary reason for female patients to consult their general practitioner. The urinary dipstick test serves as a cornerstone for diagnosing urinary tract infections (UTIs), yet traditional visual interpretation may be subject to variability. Automated devices for dipstick urinalysis are routinely used as alternatives, yet the evidence regarding their accuracy remains limited. Therefore we aimed to compare concordance between visual and automated urinary dipstick interpretation and determine their test characteristics for the prediction of bacteriuria.We conducted a prospective validation study including urine samples originating from adult patients in general practice that were sent to the Maastricht Medical Centre + for urinary culture. Urinary dipstick tests were performed on each sample, which were interpreted visually and automatically. We calculated Cohen’s κ and percentage agreement and used 2 × 2 tables to calculate test characteristics.We included 302 urine samples. Visual and automated analysis showed almost perfect agreement (κ = 0.82 and κ = 0.86, respectively) for both nitrite and leukocyte esterase, but moderate agreement for erythrocytes (κ = 0.51). Interpretation of clinically relevant (nitrite and/or leukocyte esterase positive) samples showed almost perfect agreement (κ = 0.88). Urinary dipsticks show similar test characteristics with urinary culture as gold standard, with sensitivities of 0.92 and 0.91 and specificities of 0.37 and 0.41 for visual and automated interpretation respectively.Automated and visual dipstick analysis show near perfect agreement and perform similarly in predicting bacteriuria. However, automated analysis requires maintenance and occasionally measurement errors can occur. [ABSTRACT FROM AUTHOR]

Since two‐dimensionalal (2D) materials have distinct chemical and physical properties, they are widely used in various sectors of modern technologies. In the domain of diagnostic biodevices, particularly for point‐of‐care (PoC) biomedical diagnostics, 2D‐based field‐effect transistor biosensors (bio‐FETs) demonstrate substantial potential. Here, in this review article, the operational mechanisms and detection capabilities of biosensing devices utilizing graphene, transition metal dichalcogenides (TMDCs), black phosphorus, and other 2D materials are addressed in detail. The incorporation of these materials into FET‐based biosensors offers significant advantages, including low detection limits (LOD), real‐time monitoring, label‐free diagnosis, and exceptional selectivity. The review also highlights the diverse applications of these biosensors, ranging from conventional to wearable devices, underscoring the versatility of 2D material‐based FET devices. Additionally, the review provides a comprehensive assessment of the limitations and challenges faced by these devices, along with insights into future prospects and advancements. Notably, a detailed comparison of FET‐based biosensors is tabulated along with various other biosensing platforms and their working mechanisms. Ultimately, this review aims to stimulate further research and innovation in this field while educating the scientific community about the latest advancements in 2D materials‐based biosensors. [ABSTRACT FROM AUTHOR]

The rapid and sensitive detection of chemical compounds in body fluids and tissues is important for diagnosis of diseases and assessment of the effectiveness of treatment programs. Point-of-care (POC) sensors based on fluorescence signals have been widely used in the rapid detection of various infectious diseases. However, the aggregation-caused quenching phenomenon of conventional fluorescent probes limits the sensitivity and accuracy of fluorescent POC sensors. In this review, we first focus on aggregation-induced emission (AIE)-based POC detection for early diagnosis of diseases and then describe how to use mechanisms of AIE to improve the sensitivity of POC testing. This review gives a summary of the design mechanisms of AIE probes in AIE-based biosensors. Subsequently, it summarizes the design strategies of AIE-based POC sensors in the detection of ions, small molecules, nucleic acids, proteins, and whole entity (cells, bacteria, viruses, and exosomes), placing an emphasis on signal amplification. Finally, it gives an overview of AIE-based POC biosensors, including probes, instruments, and applications. We hope that this review will provide valuable guidance for further expanding the application of AIE luminogens in POC biosensors. [ABSTRACT FROM AUTHOR]

Mycoplasma pneumoniae is a significant pathogen responsible for communityacquired pneumonia, predominantly affecting children and adolescents. Here, we devised a rapid method for M. pneumoniae that combined multiple cross displacement amplification (MCDA) with real-time fluorescence technology. A set of ten primers, which were specifically designed for M. pneumoniae detection, were employed in a real-time fluorescence MCDA reaction. Of these, one primer incorporated a restriction endonuclease recognition sequence, a fluorophore, and a quencher, facilitating real-time fluorescence detection. The real-time (RT)-MCDA reactions were monitored in a simple realtime fluorescence instrument and conducted under optimised conditions (64°C for 40 min). The detection limit of the M. pneumoniae RT-MCDA assay for genomic DNA extracted from M. pneumoniae culture was down to 43 fg/μl. This assay accurately identified M. pneumoniae strains without cross-reacting with other bacteria. To validate its practical application, we tested the M. pneumoniae RT-MCDA assay using genomic DNA extracted from clinical samples. The assay's detection capability proved comparable with real-time PCR, MCDA-based biosensor detection, and visual inspection under blue light. The entire process, including rapid DNA extraction and real-time MCDA detection, was completed within 1 h. Overall, the M. pneumoniae RT-MCDA assay reported here is a simple and effective diagnostic tool for rapid M. pneumoniae detection, which holds significant potential for point-of-care testing and in resource-limited regions. [ABSTRACT FROM AUTHOR]

Background: There is little to no data evaluating long term usage of point of care ultrasound (POCUS) after a training intervention for medical students. The purpose of this study was to examine the impact of an intensive POCUS training program on medical student's usage at 9-months post-program. Methods: This was a prospective cross-sectional study of rising second year medical students who participated in a 2-week summer POCUS training program. Instruction consisted of 8 h of asynchronous online didactic material, 2–4 h of daily hands-on instructor-led and independent scanning, and instruction on how to teach POCUS. Students were assessed pre- and post-program, and again at 9 months post-program to evaluate POCUS usage. Results: A total of 56 students participated in the program over 2 summers; 52 (92.9%) responded to the 9-month post-program survey. At 9 months, 49 (94.2%) of students taught POCUS after the program to peers or faculty. Students reported serving as a POCUS instructor in 283 subsequent teaching sessions accounting for 849 h of POCUS instruction time. Six (11.5%) students were involved in the creation of a POCUS interest group on their regional campus, 7 (13%) created a POCUS curriculum for their student interest group, and 4 (7.7%) created an opt-in co-curricular POCUS program for students at their regional campus. Three (5.8%) students did not serve as educators after the program and only one student reported not using POCUS again after the program. Conclusion: After a 2-week intensive POCUS training program for medical students, the majority of students demonstrated continued involvement in POCUS learning and education at 9-month follow-up including serving as peer instructors and assisting with limitations in financial resources and trained faculty. [ABSTRACT FROM AUTHOR]

Molecularly imprinted membranes (MIMs) have been a focal research interest since 1990, representing a breakthrough in the integration of target molecules into membrane structures for cutting-edge sensing applications. This paper traces the developmental history of MIMs, elucidating the diverse methodologies employed in their preparation and characterization on two-dimensional solid-supported substrates. We then explore the principles and diverse applications of MIMs, particularly in the context of emerging technologies encompassing electrochemistry, surface-enhanced Raman scattering (SERS), surface plasmon resonance (SPR), and the quartz crystal microbalance (QCM). Furthermore, we shed light on the unique features of ion-sensitive field-effect transistor (ISFET) biosensors that rely on MIMs, with the notable advancements and challenges of point-of-care biochemical sensors highlighted. By providing a comprehensive overview of the latest innovations and future trajectories, this paper aims to inspire further exploration and progress in the field of MIM-driven sensing technologies. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is a progressive condition that affects more than 10% of the world's population. Monitoring urine albumin-to-creatinine ratio (uACR) has become the gold standard for nephropathy diagnosis and control. The objective of the present study was to develop a simple, accurate, sensitive, and rapid point-of-care test (PoCT) device, MyACR, for uACR measurement, intended for use in community healthcare to screen for the risk and monitor the progress of CKD. Albumin and creatinine concentrations in urine samples were determined using spectrophotometric dye (tetrabromophenol blue)-binding and colorimetric Jaffe assay, respectively. Urine samples were diluted with distilled water (1:80) and mixed separately with albumin and creatinine reaction mixture. The creatinine reaction was incubated at room temperature (25 °C) for 30 min before analysis. Optical density (OD) was measured at the wavelengths of 625 nm (albumin) and 515 nm (creatinine). All calibration curves (0–60 mg/L and 0–2 mg/dL for albumin and creatinine) yielded linear relationships with correlation coefficients (R2) of >0.997. Good accuracy (% deviation of mean value (DMV) ≤ 5.42%) and precision (% coefficients of variation (CV) ≤ 12.69%) were observed from both the intra- and inter-day assays for the determination of albumin and creatinine using MyACR. The limit of quantification (LOQ) of albumin and creatinine in urine samples determined using MyACR and a laboratory spectrophotometer were 5 mg/L and 0.25 mg/dL, respectively, using 37.5 μL urine spiked samples (n = 5). The device was well-applied with clinical samples from 20 CKD patients. The median (range) of %DMV of the central (hospital) laboratory method (immune-based assay) was 3.48 (−17.05 to 21.64)%, with a high correlation coefficient (R2 > 0.98). In conclusion, MyACR showed satisfactory test performance in terms of accuracy, reproducibility, and sensitivity. Cost-effectiveness and improvement in clinical decision making need to be proven in future multisite community and home studies. [ABSTRACT FROM AUTHOR]

Point-of-care ultrasound (POCUS) is a safe, noninvasive technique performed at the patient's bedside, providing immediate results to the operator. It complements physical examination and facilitates clinical decision-making. In infectious diseases, POCUS is particularly valuable, offering an initial assessment in cases of suspected infection. It often leads to an early tentative diagnosis enabling the prompt initiation of antimicrobial treatment without the delay associated with traditional radiology. POCUS provides direct visualization of affected organs, assists in evaluating fluid balance, and facilitates various interventions, all while reducing patient discomfort. For infectious disease specialists, becoming proficient in POCUS is a critical future challenge, requiring dedicated training for effective utilization. [ABSTRACT FROM AUTHOR]

Urine analysis stands as a critical diagnostic tool, offering insights into health and disease. However, current techniques demand sophisticated equipment or significant sample processing for urine examination, reducing their suitability for regular point‐of‐care assessments. This study introduces a novel multi‐component sensing platform to address these constraints. The proposed sensor array can detect sodium (Na+), potassium (K+), ammonium (NH4+), calcium (Ca++), chloride (Cl−), and pH levels, thus, enabling real‐time urine analysis. This sensing platform utilizes an extended gate (EG)‐field effect transistor (FET) design employing EG electrodes made of LASER engraved graphene on flexible Kapton substrates. These experimental findings from individual sensors demonstrate consistent linear responses to ion levels, discrimination of specific ions among interferences, and operational stability over time. Additionally, the six‐channel sensor array exhibits notable sensitivity and selectivity in a urine environment, effectively discerning various ions and pH, illustrating its efficacy for urine analysis and validating its potential for reliable point‐of‐care diagnostics. [ABSTRACT FROM AUTHOR]

Background: Globally, around 7 to 20 million people are believed to be suffering from coinfection with both hepatitis B virus (HBV) and hepatitis C virus (HCV). The loop-mediated isothermal amplification (LAMP) approach, introduced by Notomi and colleagues, has undergone substantial advancements as an effective molecular tool that enables the simultaneous analysis of multiple samples in a single tube. Methods: The present study examined the simultaneous detection of HBV and HCV in a single tube using melt curve analysis multiplex LAMP (mLAMP), which is based on the identification of unique melting peak temperatures. Selected regions for primer design including the S gene of HBV and the UTR gene of HCV. Primer optimization is initially performed through individual HBV and HCV LAMP analysis. Following the optimization process, the mLAMP assay was evaluated by optimizing the multiplex reaction mixture, determining the reaction time, and analyzing the limit of detection (LOD). The results are also analyzed using lateral flow dipsticks (LFD), which enable the visual detection of HBV and HCV by adding 20 pmol FITC-labeled LF primers into the reaction mixture prior the mLAMP. Results: The LOD for the mLAMP assay was determined as 10 copies/µl, and no cross-reactivity with other microorganisms was detected. The detection results obtained from patient plasma were also visually demonstrated using LFD, and displayed significant concordance with those obtained from Real-Time Polymerase Chain Assay. The mLAMP assay revealed a diagnostic sensitivity of 95% for detecting the HBV, and LOD is 90% for HCV. The overall diagnostic sensitivity of the mLAMP assay for both viruses was 85%. The assay confirmed a specificity of 100%. Conclusion: The mLAMP assay displays significant promise for analyzing coinfected samples by simultaneously detecting the dual targets HBV and HCV within a set temperature of 62 °C, all within a time frame of 1 h. Additionally, when paired with disposable LFD, the mLAMP assay enables rapid visual detection of assay results in a matter of minutes. The result contributes to the mLAMP assay being highly suitable for coinfection screening, particularly in field conditions. [ABSTRACT FROM AUTHOR]

Human respiratory syncytial virus (HRSV) is the most prevalent pathogen contributing to acute respiratory tract infections (ARTI) in infants and young children and can lead to significant financial and medical costs. Here, we developed a simultaneous, dual-gene and ultrasensitive detection system for typing HRSV within 60minutes that needs only minimum laboratory support. Briefly, multiplex integrating reverse transcriptionrecombinase polymerase amplification (RT-RPA) was performed with viral RNA extracted from nasopharyngeal swabs as a template for the amplification of the specific regions of subtypes A (HRSVA) and B (HRSVB) of HRSV. Next, the Pyrococcus furiosus Argonaute (PfAgo) protein utilizes small 5'-phosphorylated DNA guides to cleave target sequences and produce fluorophore signals (FAM and ROX). Compared with the traditional gold standard (RT-qPCR) and direct immunofluorescence assay (DFA), this method has the additional advantages of easy operation, efficiency and sensitivity, with a limit of detection (LOD) of 1 copy/mL. In terms of clinical sample validation, the diagnostic accuracy of the method for determining the HRSVA and HRSVB infectionwas greater than 95%. This technique provides a reliable point-of-care (POC) testing for the diagnosis of HRSV-induced ARTI in children and for outbreak management, especially in resource-limited settings. [ABSTRACT FROM AUTHOR]

Paper-based rapid diagnostic tests (RDTs) are an essential component of modern healthcare, particularly for the management of infectious diseases. Despite their utility, these capillary-driven RDTs are compromised by high failure rates, primarily caused by user error. This limits their utility in complex assays that require multiple user operations. Here, we demonstrate how this issue can be directly addressed through continuous electrochemical monitoring of reagent flow inside an RDT using embedded graphenized electrodes. Our method relies on applying short voltage pulses and measuring variations in capacitive discharge currents to precisely determine the flow times of injected samples and reagents. This information is reported to the user, guiding them through the testing process, highlighting failure cases and ultimately decreasing errors. Significantly, the same electrodes can be used to quantify electrochemical signals from immunoassays, providing an integrated solution for both monitoring assays and reporting results. We demonstrate the applicability of this approach in a serology test for the detection of anti-SARS-CoV-2 IgG in clinical serum samples. This method paves the way towards "smart" RDTs able to continuously monitor the testing process and improve the robustness of point-of-care diagnostics. [ABSTRACT FROM AUTHOR]

Timely and accurate diagnosis is critical for effective healthcare, yet nearly half the global population lacks access to basic diagnostics. Point-of-care (POC) testing offers partial solutions by enabling low-cost, rapid diagnosis at the patient's location. At-home POC devices have the potential to advance preventive care and early disease detection. Nevertheless, effective sample preparation and detection methods are essential for accurate results. This review surveys recent advances in sample preparation and detection methods at POC. The goal is to provide an in-depth understanding of how these technologies can enhance at-home POC devices. Lateral flow assays, nucleic acid tests, and virus detection methods are at the forefront of POC diagnostic technology, offering rapid and sensitive tools for identifying and measuring pathogens, biomarkers, and viral infections. By illuminating cutting-edge research on assay development for POC diagnostics, this review aims to accelerate progress towards widely available, user-friendly, at-home health monitoring tools that empower individuals in personalized healthcare in the future. [ABSTRACT FROM AUTHOR]

Sexually Transmitted Infections (STIs) are a critical global health concern, with low- and middle-income countries carrying the highest burden. The development of rapid point-of-care STI tests has enabled screening in settings without laboratory access. Yet, high-need settings face unique challenges that may influence the implementation and uptake of STI screening. This piece discusses lessons learned from the implementation of STI screening in a rural, low-resource setting in Chiapas, Mexico. Despite minimal privacy and a low staff-to-patient ratio, a streamlined approach was developed to destigmatize and maximize STI screening. The clinic team developed strategies through practice, including incorporating screening into triage procedures and offering screening to family members. This protocol led to an average screening rate of 37% within three months and acceptance of screening by family units. It was observed that access to treatment was necessary to alleviate patient hesitation to screening due to fears of a positive result. As STI screening increases globally, healthcare systems must develop robust access to treatment to effectively prevent and treat STIs worldwide. [ABSTRACT FROM AUTHOR]

Background Pharmacies are popular first points of contact for mild infections in the community. Pharmacy services in many countries have expanded to include vaccines and point-of-care tests. In low- and middle-income countries such as Vietnam, poor enforcement of regulations results in substantial volumes of over-the-counter antibiotic sales. Point-of-care tests could provide an economically viable way to reduce antibiotic sales, while still satisfying customer demand for convenient healthcare. C-reactive protein point-of-care testing (CRP-POCT) can reduce antibiotic prescribing for respiratory illness in primary care. Here, we explore the acceptability and feasibility of implementing CRP-POCT in pharmacies in Vietnam. Methods We conducted a mixed-methods study between April and June 2021. A customer exit survey with 520 participants seeking acute respiratory infection treatment at 25 pharmacies evaluated acceptability and willingness-to-pay (WTP) for CRP-POCT and post-service satisfaction. Factors driving customers" acceptance and WTP were explored through mixed-effects multivariable regression. Three focus group discussions with customers (20 participants) and 12 in-depth interviews with pharmacists and other stakeholders were conducted and analyzed thematically. Results Antibiotics were sold to 81.4% of patients with CRP levels <10 mg/L (antibiotics not recommended). A total of 96.5% of customers who experienced CRP-POCT supported its future introduction at pharmacies. Patients with antibiotic transactions (adjusted odds ratio [aOR], 2.25; 95% confidence interval [CI], 1.13–4.48) and those suffering acute respiratory infection symptoms for more than 3 days (aOR, 2.10; 95% CI, 1.08–4.08) were more likely to accept CRP-POCT, whereas customers visiting for children (aOR, 0.20; 95% CI,.10–.54) and those with preference for antibiotic treatment (aOR, 0.45; 95% CI, 0.23–0.89) were less likely to accept CRP-POCT. A total of 78.3% (95% CI, 74.8–81.7) of customers were willing to pay for CRP-POCT, with a mean cost of US$2.4 (±1.1). Customer's income and cost of total drug treatment were associated with increased WTP. Enablers for implementing CRP-POCT included customers' and pharmacists' perceived benefits of CRP-POCT, and the impact of COVID-19 on perceptions of POCT. Perceived challenges for implementation included the additional burden of service provision, lack of an enabling policy environment, and potential risks for customers. Conclusions Implementing CRP-POCT at pharmacies is a feasible and well-accepted strategy to tackle the overuse of antibiotics in the community, with appeal for both supply and demand sides. Creating an enabling policy environment for its implementation, and transparent discussion of values and risks would be key for its successful implementation. [ABSTRACT FROM AUTHOR]

Purpose: Post-operative hyperglycemia is a known risk factor for post-surgical complications. The predictive value of pre-operative blood glucose levels, however, is less understood. This study aimed to determine if pre-operative screening blood glucose levels affect the rate of post-operative infection or wound complications. We also investigated if case urgency or anatomic location alters this relationship. Methods: A single-institution retrospective chart review was performed to evaluate patients treated between 2018 and 2021. Subjects ≥ 18 years with closed, non-infected orthopaedic diagnoses requiring surgery were included. Case urgency, demographics, comorbidities, blood glucose level within twelve h prior to surgery, and hemoglobin A1c level within 3 months of surgery, were collected. Infections and wound complications were recorded as outcomes. Results: A total of 775 subjects with a mean age of 61 (range 18–96) were identified, including 543 elective and 232 trauma patients, with a mean pre-operative fasting glucose value of 127.7 mg/dL (range, 49–388 mg/dL) and average HbA1c of 6.9%. The odds of infectious complications were increased by a factor of 1.01 for every 1-point increase in blood glucose (95% CI 1.01–1.02; p < 0.01). Conclusions: Pre-operative blood glucose levels greater than 137 mg/dL were associated with an increase in wound complications, but not deep infections. Infection rates stratified by anatomic site and case urgency were not impacted by pre-operative glucose levels. The increased risk of poor wound healing in patients with pre-operative hyperglycemia demonstrates that day of surgery point-of-care blood glucose screening can be a useful risk stratification tool. [ABSTRACT FROM AUTHOR]

[Display omitted] • This is the first known application of CRISPR/Cas12a in the diagnosis of East Coast fever. • We have designed a simple flow cytometry-based assay to test trans -cleavage of a FAM-biotin DNA probe. • The CRISPR/Cas12a assay allows for specific, universal, and sensitive detection of Theileria parva strains in cattle. Theileria parva causes East Coast fever (ECF), one of the most important and lethal tick-borne diseases of cattle in sub-Saharan Africa. ECF is a considerable burden to the livestock industry, causing annual losses exceeding US $300 million. Currently, diagnosis of T. parva infections relies mainly on clinical signs, serology, and microscopic identification of parasites in either blood or lymph fluid samples. However, some of these tests might not indicate ongoing infection and they all lack the sensitivity to detect low-level infections. Molecular tests such as nested and quantitative PCR assays offer high sensitivity for detection of T. parva. However, these tests remain highly complex technologies that are impractical to use in resource-limited settings where economic losses due to the disease have the most significant impact. A field-deployable, point-of-care test will be of significant value in the treatment and control of ECF in endemic areas. For this purpose, we have developed a CRISPR-Cas12a-based pen-side tool that can sensitively and specifically detect T. parva based on the p104 gene. We describe a streamlined, field-applicable diagnostic tool comprising a 20 min recombinase polymerase amplification (RPA) reaction followed by a 60 min CRISPR-Cas12a reaction using a FAM/Biotin lateral flow strip readout. We tested two different RPA primer pairs and four different CRISPR-RNAs (crRNAs). The p104-based assay displayed high sensitivity, detecting as low as one infected lymphocyte per three microliters of blood and universally detecting eight different T. parva strains without detecting DNA from other Theileria spp. such as Theileria mutans and Theileria lestoquardi. This work opens the way for a field-applicable diagnostic tool for the sensitive point-of-care early diagnosis of T. parva infections in cattle. [ABSTRACT FROM AUTHOR]

Background: Point‐of‐care cardiovascular left ventricle ejection fraction (LVEF) quantification is established, but automatic tablet‐based stroke volume (SV) quantification with handheld ultrasound (HAND) devices is unexplored. We evaluated a tablet‐based monoplane LVEF and LV volume quantification tool (AutoEF) against a computer‐based tool (Tomtec) for LVEF and SV quantification. Methods: Patients underwent HAND scans, and LVEF and SV were quantified using AutoEF and computer‐based software that utilized either apical four‐chamber views (Auto Strain‐monoplane [AS‐mono]) or both apical four‐chamber and apical two‐chamber views (Auto Strain‐biplane [AS‐bi]). Correlation and Bland–Altman analysis were used to compare AutoEF with AS‐mono and AS‐bi. Results: Out of 43 participants, eight were excluded. AutoEF showed a correlation of.83 [.69:.91] with AS‐mono for LVEF and.68 [.44:.82] for SV. The correlation with AS‐bi was.79 [.62:.89] for LVEF and.66 [.42:.81] for SV. The bias between AutoEF and AS‐mono was 4.88% [3.15:6.61] for LVEF and 17.46 mL [12.99:21.92] for SV. The limits of agreement (LOA) were [−5.50:15.26]% for LVEF and [−8.02:42.94] mL for SV. The bias between AutoEF and AS‐bi was 6.63% [5.31:7.94] for LVEF and 20.62 mL [16.18:25.05] for SV, with LOA of [−1.20:14.47]% for LVEF and [−4.71:45.94] mL for SV. Conclusion: LVEF quantification with AutoEF software was accurate and reliable, but SV quantification showed limitations, indicating non‐interchangeability with neither AS‐mono nor AS‐bi. Further refinement of AutoEF is needed for reliable SV quantification at the point of care. [ABSTRACT FROM AUTHOR]

The novel coronavirus SARS-CoV-2 was first isolated in late 2019; it has spread to all continents, infected over 700 million people, and caused over 7 million deaths worldwide to date. The high transmissibility of the virus and the emergence of novel strains with altered pathogenicity and potential resistance to therapeutics and vaccines are major challenges in the study and treatment of the virus. Ongoing screening efforts aim to identify new cases to monitor the spread of the virus and help determine the danger connected to the emergence of new variants. Given its sensitivity and specificity, nucleic acid amplification tests (NAATs) such as RT-qPCR are the gold standard for SARS-CoV-2 detection. However, due to high costs, complexity, and unavailability in low-resource and point-of-care (POC) settings, the available RT-qPCR assays cannot match global testing demands. An alternative NAAT, RT-LAMP-based SARS-CoV-2 detection offers scalable, low-cost, and rapid testing capabilities. We have developed an automated RT-LAMP-based microfluidic chip that combines the RNA isolation, purification, and amplification steps on the same device and enables the visual detection of SARS-CoV-2 within 40 min from saliva and nasopharyngeal samples. The entire assay is executed inside a uniquely designed, inexpensive disposable microfluidic chip, where assay components and reagents have been optimized to provide precise and qualitative results and can be effectively deployed in POC settings. Furthermore, this technology could be easily adapted for other novel emerging viruses. [ABSTRACT FROM AUTHOR]

Objective: To determine the relationship between point‐of‐care β‐hydroxybutyrate (BHB) concentration and outcomes in adult patients without diabetes admitted through ED. Methods: This was a prospective study from 10 March to 2 July 2021. Admitted patients without diabetes had capillary BHB sampled in ED. Outcomes of length‐of‐stay (LOS), composite mortality/ICU admission rates and clinical severity scores (Quick Sepsis Organ Failure Assessment score/National Early Warning Score [qSOFA/NEWS]) were measured. BHB was assessed as a continuous variable and between those with BHB above and equal to 1.0 mmol/L and those below 1.0 mmol/L. Results: A total of 311 patients were included from 2377 admissions. Median length‐of‐stay was 4.1 days (IQR 2.1–9.8), 18 (5.8%) died and 37 (11.8%) were admitted to ICU. Median BHB was 0.2 mmol/L (IQR 0.1–0.4). Twenty‐five patients had BHB ≥1.0 mmol/L and five were >3.0 mmol/L. There was no significant difference in median LOS for patients with BHB ≥1.0 mmol/L compared to non‐ketotic patients, 5.3 days (IQR 2.2–7.5) versus 4.1 days, respectively (IQR 2.0–9.8) (P = 0.69). BHB did not correlate with LOS (Spearman ρ = 0.116, 95% confidence interval: 0.006–0.223). qSOFA and NEWS also did not differ between these cohorts. For those 25 patients with BHB ≥1.0 mmol/L, an infective/inflammatory diagnosis was present in 11 (44%), at least 2 days of fasting in 10 (40%) and ethanol intake >40 g within 48 h in 4 (16%). Conclusions: Routine BHB measurement in patients without diabetes does not add to clinical bedside assessment and use should be limited to when required to confirm a clinical impression. [ABSTRACT FROM AUTHOR]

Small, portable hand-held ultrasound devices nowadays enable a widespread use of prehospital point-of-care ultrasound (pPOCUS), which has so far only been used hesitantly, especially in ground-based emergency services. Many critical or even life-threatening conditions or internal injuries can often be better diagnosed or ruled out using pPOCUS, which can enable faster and more suitable goal-directed treatment and hospital transport. This article critically discusses relevant data, clinical benefits, limitations and challenges to be overcome when using pPOCUS for the most important life-threatening situations and aims to call for intensifying training and the extensive use of pPOCUS. [ABSTRACT FROM AUTHOR]

High‐quality, low‐cost, and rapid detection is essential for the society to reopen the economy during the critical period of transition from Coronavirus Disease 2019 (COVID‐19) pandemic response to pandemic control. In addition to performing sustainable and target‐driven tracking of SARS‐CoV‐2, conducting comprehensive surveillance of variants and multiple respiratory pathogens is also critical due to the frequency of reinfections, mutation immune escape, and the growing prevalence of the cocirculation of multiple viruses. By utilizing a 0.05 cents wax interface, a Stable Interface assisted Multiplex Pathogenesis Locating Estimation in Onepot (SIMPLEone) using nested RPA and CRISPR/Cas12a enzymatic reporting system is successfully developed. This smartphone‐based SIMPLEone system achieves highly sensitive one‐pot detection of SARS‐CoV‐2 and its variants, or multiple respiratory viruses, in 40 min. A total of 89 clinical samples, 14 environmental samples, and 20 cat swab samples are analyzed by SIMPLEone, demonstrating its excellent sensitivity (3–6 copies/reaction for non‐extraction detection of swab and 100–150 copies/mL for RNA extraction‐based assay), accuracy (>97.7%), and specificity (100%). Furthermore, a high percentage (44.2%) of co‐infection cases are detected in SARS‐CoV‐2‐infected patients using SIMPLEone's multiplex detection capability. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical utility of point‐of‐care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). Design: Prospective cohort study. Setting: Antenatal clinics at King's College Hospital. Population: Women screened for GDM between March and June 2020. Methods: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse‐It 5.40.2. Main outcome measures: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. Results: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%–99%) and 97% (93%–98%) at fasting and 97% (91%–99%) and 79% (71%–84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. Conclusions: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h. [ABSTRACT FROM AUTHOR]

In the United States, the scope of practice of pharmacists is determined primarily at the state level. Not all state laws expressly permit or prohibit pharmacists from providing certain services; in between is a grey area of legal silence. Does legal silence permit pharmacists to perform a service that is not specifically permitted, but not expressly prohibited? Point-of-care testing provides a useful case study in legal silence: there are 1536 pharmacies currently holding a CLIA-waiver to administer tests in states reporting that pharmacists are not expressly permitted to administer tests. Legal silence may even provide a better framework for pharmacy based testing as it is naturally inclusive of any point-of-care test and no laws need updated when a new test comes to the market. Other health professions navigate this legal silence by governing according to a "standard of care." Rather than specifying a list of services a health professional can or cannot provide in law, it provides a flexible framework for the health professional to provide any service that other similarly situated health professionals would provide in the same or similar situation. A standard of care regulatory framework should thus be the target of the pharmacy profession in order to advance patient care. [ABSTRACT FROM AUTHOR]

Background and Objectives: This study evaluated the efficacy of the TrueLab™ Real Time mini-PCR system in providing rapid and accurate diagnostic results for tuberculosis (TB) detection in India. The goal is to improve case detection and accelerate treatment in settings with limited resources. Materials and Methods: This prospective study was conducted by the Department of Microbiology on 120 patients, age ranging from >=15 years with at least two clinical symptoms of pulmonary TB. Molbio and Universal Cartridge Based Sample Prep were the 2 methods used for processing sputum samples. The diagnosis was based on the MTB Real Time PCR test, which has a detection limit of 100 CFU/mL. Patients under 15 years, samples lacking clinical background, saliva specimens or extra-pulmonary TB cases were excluded from the study. Results: A total of 44.17% samples were positive for TB with maximum positivity in the age group 31-45 years. Positivity rate was found to be higher in females. In 4.17% of cases there was rifampicin resistance, which was significantly high in previously treated cases. Comparison of Truenat with Ziehl-Neelsen and fluorescent method revealed that it was more sensitive and less time consuming. Conclusion: Truenat MTB/RIF is a sensitive detection system for TB with rapid results, which serves as an important tool in the early management of tuberculosis patients and drug-resistant-TB cases. [ABSTRACT FROM AUTHOR]

The rapid and accurate diagnosis of meningitis is critical for preventing severe complications and fatalities. This study addresses the need for accessible diagnostics in the absence of specialized equipment by developing a novel diagnostic assay. The assay utilizes dual-priming isothermal amplification (DAMP) with unique internal primers to significantly reduce non-specificity. For fluorescence detection, the dye was selected among Brilliant Green, Thioflavin T, and dsGreen. Brilliant Green is preferred for this assay due to its availability, high fluorescence level, and optimal sample-to-background (S/B) ratio. The assay was developed for the detection of the primary causative agents of meningitis (Haemophilus influenzae, Neisseria meningitidis, and Streptococcus pneumoniae), and tested on clinical samples. The developed method demonstrated high specificity, no false positives, sensitivity comparable to that of loop-mediated isothermal amplification (LAMP), and a high S/B ratio. This versatile assay can be utilized as a standalone test or an integrated assay into point-of-care systems for rapid and reliable pathogen detection. [ABSTRACT FROM AUTHOR]