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BACKGROUND: Investing in continued medical education strengthens surgical systems. This study assessed the effectiveness of an evidence-based practice (EBP) tutorial and access to UpToDate (UTD) to improve EBP and understand how and why providers practice using evidence. STUDY DESIGN: This is a mixed-methods, implementation study at 9 public hospitals in Peru consisting of a didactic session for surgeons on EBP and Google Translate and support of applications for UTD access. Change in clinical knowledge scores (CKS), access and use of UTD, and impact of language pre-and postintervention were measured. Qualitative interviews uncovered reasons for these changes. RESULTS: Intervention participants had lower CKS at follow-up compared with baseline (odds ratio [OR] of higher score 0.41 [0.18,0.98]; p = 0.044), and this effect was modified (p = 0.003) to the extent that the reverse was true for control participants (OR 2.30 [1.13,4.71]; p = 0.022). Participants with 1 to 20 years of experience had significantly improved CKS compared with students/residents (1 to 10 years: OR 4.5 [1.1,18]; 11 to 20 years: OR 4.9 [1.4,17]); there was no evidence of a different CKS between providers with >20 years of experience compared with students/residents (OR 1.3 [0.5,3.7]). Administrative disconnect, usability, motivation, education, time, resources, and age influenced point-of-care medical information systems impact on knowledge and EBP. Participants reporting low English proficiency translated medical literature mostly used Google Translate. Those with low/no English reading proficiency had higher odds of reporting a negative impact on research than those with working (p = 0.007) or professional (p < 0.001) proficiency. CONCLUSIONS: Providing education on EBP, free UTD access, and translation solutions did not correlate with increased CKS due to complex barriers to using point-of-care medical information systems. Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Surgeons.

Georgia M Parkin,1,2 Elizabeth A Thomas1,2 1Department of Epidemiology, University of California Irvine, Irvine, CA, USA; 2Institute for Interdisciplinary Salivary Bioscience Research, University of California Irvine, Irvine, CA, USACorrespondence: Georgia M Parkin, Department of Epidemiology, University of California, Irvine, Irvine, CA, USA, Tel +1 657 888 3303, Email gparkin@hs.uci.eduPurpose: Despite lithium being a gold standard treatment for bipolar disorder, the percentage of patients with bipolar disorder who are prescribed lithium medication has declined in many parts of the world over the past two decades. The use of lithium is limited by its narrow therapeutic window and adverse side effects, which necessitates frequent serum lithium monitoring; hence, there is a critical need for improved ways to monitor lithium levels in psychiatric patients. We have recently shown that saliva lithium levels are highly correlated with those in blood, thereby presenting an alternative to venipuncture. Saliva sampling could open the door for at-home collections – potential that has been exemplified throughout the COVID-19 pandemic – thereby allowing samples to be collected remotely and delivered to a specific site for testing. In addition, prototype point-of-care devices have been developed by others for serum lithium monitoring, suggesting potential for a saliva lithium monitoring device. Our objective was to query the perspectives of American psychiatrists on lithium treatment practices and obstacles, the potential for at-home saliva collection and point-of-care devices, for lithium monitoring, as an alternative to pathology-based blood testing.Methods: Data was collected through an online, anonymous survey, distributed to American psychiatric societies.Results: Sixty-five respondents from 21 American states completed the survey. The majority of respondents were female, over 65 years of age, and/or had practiced for 30 years or more. The most frequent obstacles encountered with regard to lithium monitoring were adverse drug effects, and the need for monitoring. Overall, respondents believed saliva lithium monitoring and point-of-care devices would be useful, however raised concerns regarding validity and time-delay.Conclusion: Point-of-care devices and saliva lithium monitoring are promising alternatives to blood testing that would be welcomed by psychiatric societies, however, require extensive development and validation before implementation into a clinical setting.Keywords: lithium, saliva, drug monitoring, point-of-care, survey

This thesis presents contributions to the field of point-of-care (POC) testing through the identification of novel biosensing technologies for the detection of stress-related proteins and monitoring of DNA amplification procedures in real-time. The studies presented herein successfully demonstrated proof-of-concept cases using interdigitated microelectrode arrays (IMEAs) and graphene field-effect transistors (GFETs) for POC applications. IMEAs were utilized to fabricate a conductometric biosensor for label-free, time-point, DNA loop-mediated isothermal amplification (LAMP) detection. The incorporation of Au nanoislands between the electrodes resulted in a notable increase in sensor sensitivity (51.3%, 200%, and 48.5% enhancement for acidic, neutral, and basic solutions, respectively). Moreover, the presence of these nanoislands substantially improved sensor sensitivity during LAMP time-point detection, resulting in a near doubling of current outputs at 200 mV. These findings suggest that IMEA biosensors equipped with nanoislands offer a viable approach for pH sensing applications and end-point detection of LAMP amplification, using label-free, cost- effective, and readily scalable POC testing devices. Secondly, a flexible GFET biosensor was developed for detecting the neuropeptide Y (NPY) biomarker in artificial sweat with high sensitivity and specificity. The biosensor utilized a polyimide flexible substrate and graphene functionalized with NPY-specific antibodies. NPY is an important biomarker associated with stress levels. The developed biosensor was capable of detecting NPY concentrations as low as 1 pM and exhibited a linear response within the concentration range of 1 pM to 1 μM, with a correlation coefficient of approximately 0.99. This proof-of-concept device represents a potential breakthrough for the development of flexible POC devices for real-time consumer stress monitoring. The final part of this research was focused on developing GFET-based biosensors for real-time monitoring of LAMP reactions, with an ultimate goal of integrating these biosensors into LAMP-based POC diagnostics. The development of a pH-dependent LAMP master mix was necessary to overcome the challenge of detecting pH changes during the amplification process. The successful development of this master mix provided the foundation for the subsequent assay design and optimization for the detection of the N-acetyltransferase 2 (NAT2) gene. The GFET biosensors were evaluated for their ability to detect changes in the amplification process with a shift in the Dirac point of 150 mV for the 30 min reaction, indicating production of amplified products from the NAT2 template. The biosensors were further evaluated for real-time monitoring of LAMP reaction progress and were capable of detecting amplified products in real-time through detection of changes in pH values, as evidenced by a decrease of about 20% in drain current. This research highlights the potential of GFET-based biosensors for the real-time monitoring of LAMP reactions, which could have significant implications for the development of more efficient and accurate POC diagnostic tools.

Background The current COVID-19 pandemic is causing significant morbidity and death worldwide and produces significant socio-economic losses. Objective To assess the cost–benefit relation of implementing point-of-care COVID-19 antigen testing (POCT) in emergency rooms (ER) of German hospitals. Methods A deterministic decision-analytic model simulated the incremental costs of using the Sofia® SARS Antigen FIA test compared to those of using clinical judgement alone to confirm or exclude COVID-19 in adult patients in German ER, prior to hospitalization. Direct and indirect costs, with and without subsequent RT-PCR confirmation, were evaluated from the hospital perspective. Results With respect to ER patients, in base-case analysis, considering a COVID-19 prevalence of 15.6% and a hospitalization rate among COVID-19 suspects of 10.1%, POCT testing reduces average costs of hospitalized patients by €213 per tested patient if nasopharyngeal swabs of patients suspected to have COVID-19 are also sent to external labs for RT-PCR testing. In probabilistic sensitivity analysis, under all reasonable assumptions, implementing the Sofia® SARS Antigen FIA saves on average about €210 as compared to applying the clinical-judgement-only strategy. The major part of cost savings, €159 or 75.9%, is due to the POC test´s high specificity resulting in a 21-fold lower proportion of unnecessary bed blocking at the first day of hospitalization. Conclusions Using highly specific rapid COVID-19 tests in COVID-19 suspects at German ER, despite of their sub-optimal sensitivity, may significantly reduce hospital expenditure.

The prevalence of soil-transmitted helminths (STH) is high in communities within the Peruvian Amazon despite repeated mass-drug administration, demanding alternative strategies of control. Smartphone-attached microscopy (SAM) permits visualization of STH from a small portable microscope through a smartphone screen, potentially providing an inexpensive and rapid method of STH visualization in communities where diagnostic laboratories with microscopes are inaccessible. In this study, a total of 45 community health workers who work within the health systems of Loreto, Peru, attended a 1-day training session with lectures and practicums on STH and SAM. Participants received a pre- and post-intervention questionnaire. Post-intervention, participants were significantly more confident using SAM and identifying parasite images, symptoms, transmission, and treatment (P ≤ 0.0045). Post-intervention, participants correctly labeled a median of five of seven SAM apparatus components and five of eight steps of Kato–Katz technique, were less likely to choose taking medicine to prevent parasite infection (P = 0.0075), and were more likely to select Kato–Katz technique as a type of diagnostic test (P < 0.0001). Most participants felt ready to use SAM in their communities and stated that it could help rural communities far from health centers or laboratories (24%); provide faster identification, results, diagnosis (19%); permit at-home or on-the-spot visualization (14%); and save money (14%). Results show that community health workers show a high level of willingness and competency to learn about both STH and SAM and may be a yet-unexplored practical method of augmenting STH visualization, bringing healthcare to communities in Loreto with poor access to diagnostic laboratories and clinics.

BackgroundBreakthrough cases of SARS-CoV-2 infection correlate with decreased antibody immunity following mRNA vaccination. Measuring kinetics of vaccine efficacy using traditional laboratory approaches is more expensive and can be impractical. In this study, we evaluated the diagnostic performance of a validated COVID-19 point-of-care lateral flow assay (LFA) kit in detecting post-vaccination antibody response.MethodsWe conducted a prospective cohort study of whole blood and plasma samples to evaluate the performance of a LFA in detecting SARS-CoV-2-specific antibodies following mRNA vaccination compared to enzyme-linked immunosorbent assays (ELISAs). Health care workers at 2 tertiary centers who completed an initial BNT162b2 (n=103) or mRNA-1273 (n=35) vaccine series were enrolled between June and August of 2021. We performed an exploratory analysis to correlate band strength and antibody concentration of LFAs and ELISAs respectively.ResultsWhen compared to the ELISA, LFA results showed similar test positivity for plasma samples (P=0.55), but not for whole blood samples (P&nbsp

No abstract available

Syndromes encountered in critical care medicine have significant underlying biological heterogeneity. Researchers are increasingly using enrichment methods to identify putative treatment responsive subphenotypes of critical illness syndromes. The methods used to identify these subphenotypes often rely on assays for the quantification of plasma proteins (usually inflammatory cytokines) that are technically challenging and time consuming, limiting their utility in a clinical setting. In order to use critical illness subphenotypes to guide treatment decisions, automated platforms that can reliably quantify plasma proteins in a clinically-actionable timeframe are needed. This protocol outlines the procedure for a scoping review that aims to identify such platforms. The review will follow the Joanna Briggs Institute methodology framework for scoping reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. This protocol defines the review questions, defines eligibility criteria, identifies concepts of interest, outlines the search strategy and study selection process, and provides a procedure for data extraction and analysis. Searches will be conducted on PubMed and Embase for published scientific literature, on OpenGrey to review the grey literature, and on Espacenet to review patent registries. Search results will be supplemented with personal company correspondences.

Background Point-of-care testing (POCT) has applications across medical specialties and holds promise to improve patient care. While cardiovascular medicine has been attractive for POCT applications in recent years, little is known about how cardiovascular health professionals perceive them. Objective The objective of our study was to examine differences in perceptions and attitudes towards POCTs between cardiovascular health professionals compared to other healthcare professionals. Methods We surveyed healthcare professionals to assess perceptions of POCT usage and their benefits and concerns between October 2019 and March 2020. Questions regarding POCT perceptions were assessed on a 5-point Likert scale. Results We received a total of 148 survey responses; of the responders, 52% were male, 59% were physicians, and 50% worked in a hospital setting. We found that cardiology professionals were less likely, compared to other specialties, to view POCTs as improving patient management or reducing errors. These cardiology professionals were not constrained by resources or a lack of investment opportunities to implement these technologies. Conclusion This study provides a better understanding of perceptions about POCTs among healthcare specialists. To improve patient outcomes through the adoption and usage of POCTs, greater collaboration is advised among key industry and healthcare stakeholders.

Study objective Rapid point-of-care (POC) SARS-CoV-2 detection with Abbott ID NOW™ COVID-19 test has been implemented in our Emergency Department (ED) for several months. We aimed to evaluate the operational impact and potential benefits of this innovative clinical pathway. Methods We conducted a prospective, descriptive, interventional, non-randomized study, before-after trial with the comparison of patient cohorts from two consecutive periods of seven weeks (observational pre-POC period vs interventional POC period). Results In 2020, throughout weeks 37 to 50, 3333 patients were assessed for eligibility and among them 331 (9.9%) were positive for SARS-CoV-2 infections. Among the included patients, 136 (9.2%) were positive for SARS-CoV-2 infection in the pre-POC period and 195 (10.5%) in the POC period. Among positive patients for SARS-CoV-2 related infection in-hospital mortality rate was similar between the two groups but the hospitalization rate was higher in the POC group (81.6% vs. 65.4%; p

The coronavirus disease 2019 (COVID-19) pandemic has created an urgent need for accurate early diagnosis and monitoring. A label-free rapid electrochemical point-of-care (POC) biosensor for SARS-CoV-2 detection in human saliva is reported here to help address the shortcomings of traditional nucleic acid amplification methods and give a quantitative assessment of the viral load to track infection status anywhere, using disposable electrochemical sensor chips. A new chemical construct of gold nanoparticles (GNp) and thionine (Th) are immobilized on carboxylic acid functionalized carbon nanotubes (SWCNT-COOH) for high-performance biosensing. The sensor uses saliva with a one-step pretreatment and simple testing procedure as an analytical medium due to the user-friendly and non-invasive nature of its procurement from patients. The sensor has a response time of 5 min with a limit of detection (LOD) reaching 200 and 500 pM for the freely suspended spike (S) protein in phosphate buffer saline (PBS) and human saliva, respectively. The sensor’s performance was also proven for detecting a COVID-19 pseudovirus in an electrolyte solution with a LOD of 106 copies/mL. The results demonstrate that the optimized POC sensor developed in this work is a promising device for the label-free electrochemical biosensing detection of SARS-CoV-2 and different species of viruses.

Objectives Real-world evaluation of the performance of the Innova lateral flow immunoassay antigen device (LFD) for regular COVID-19 testing of hospital workers. Methods This prospective cohort analysis took place at a London NHS Trust. 5076 secondary care healthcare staff participated in LFD testing from 18 November 2020 to21 January 2021. Staff members submitted results and symptoms via an online portal twice weekly. Individuals with positive LFD results were invited for confirmatory SARS CoV-2 PCR testing. The positive predictive value (PPV) of the LFD was measured. Secondary outcome measures included time from LFD result to PCR test and staff symptom profiles. Results 284/5076 individuals reported a valid positive LFD result, and a paired PCR result was obtained in 259/284 (91.2%). 244 were PCR positive yielding a PPV of 94.21% (244/259, 95% CI 90.73% to 96.43%). 204/259 (78.8%) staff members had the PCR within 36 hours of the LFD test. Symptom profiles were confirmed for 132/244 staff members (54.1%) with positive PCR results (true positives) and 13/15 (86.6%) with negative PCR results (false positives). 91/132 true positives (68.9%) were symptomatic at the time of LFD testing: 65/91 (71.4%) had symptoms meeting the PHE case definition of COVID-19, whilst 26/91 (28.6%) had atypical symptoms. 18/41 (43.9%) staff members who were asymptomatic at the time of positive LFD developed symptoms in the subsequent four days. 9/13 (76.9%) false positives were asymptomatic, 1/13 (7.7%) had atypical symptoms and 3/13 (23.1%) had symptoms matching the PHE case definition. Conclusions The PPV of the Innova LFD is high when used amongst hospital staff during periods of high prevalence of COVID-19, yet we find frequent use by symptomatic staff rather than as a purely asymptomatic screening tool. LFD testing does allow earlier isolation of infected workers and facilitates detection of individuals whose symptoms do not qualify for PCR testing.

Purpose To determine the utility, diagnostic accuracy, sensitivity, specificity, and negative predictive value of the laboratory based Covid-19 antigen detection test (Coris Bio- Concept, Gembloux, Belgium) for the diagnosis of SARS-CoV-2 in a tertiary care hospital among symptomatic and asymptomatic patients. Methods The nasopharyngeal swab samples were collected from the symptomatic patients and their contacts. The diagnostic accuracy of this antigen kit was determined in comparison to SARS-CoV-2 real-time reverse transcriptase (RT-PCR). Results A total of 825 patients fulfilling the inclusion criteria were included in the study; RT-PCR and antigen detection was performed simultaneously for 484 samples to determine the sensitivity and specificity of the test. The overall specificity and sensitivity was 99.32% and 71.96% respectively. Also, 3.7% of the asymptomatic patients who were negative by RAT were detected positive by RT-PCR. Conclusion This rapid antigen test (RAT) was sensitive in the symptomatic patients presenting during the initial phase of the illness. Since, majority of the SARS-CoV-2 patients are asymptomatic and considering the huge population, the testing strategy formulated by Indian Council of Medical Research (ICMR) at the national level was cost effective. Thus, Ag-RDTs could play a pivotal role in early diagnosis, policy making and surveillance of the SARS-CoV-2.

Fast and precise diagnosis of infectious and non-infectious animal diseases and their targeted treatments are of utmost importance for their clinical management. The existing biochemical, serological and molecular methods of disease diagnosis need improvement in their specificity, sensitivity and cost and, are generally not amenable for being used as points-of-care (POC) device. Further, with dramatic changes in environment and farm management practices, one should also arm ourselves and prepare for emerging and re-emerging animal diseases such as cancer, prion diseases, COVID-19, influenza etc. Aptamer – oligonucleotide or short peptides that can specifically bind to target molecules – have increasingly become popular in developing biosensors for sensitive detection of analytes, pathogens (bacteria, virus, fungus, prions), drug residues, toxins and, cancerous cells. They have also been proven successful in the cellular delivery of drugs and targeted therapy of infectious diseases and physiological disorders. However, the in vivo application of aptamer-mediated biosensing and therapy in animals has been limited. This paper reviews the existing reports on the application of aptamer-based biosensors and targeted therapy in animals. It also dissects the various modifications to aptamers that were found to be successful in in vivo application of the aptamers in diagnostics and therapeutics. Finally, it also highlights major challenges and future directions in the application of aptamers in the field of veterinary medicine.

Electrochemical sensors embedded in hydrogel-based contact lenses provide valuable health-related information, enabling non-invasive and real-time continuous monitoring. Recently, considerable progress has been made in tear based electrochemical sensors. The scope of reported analytes is continuously expanding. This review identifies key chemical biomarkers (including metabolites, ions, proteins) that can be electrochemically detected in tears. The working principles of i) amperometric enzymatic biosensors, ii) ion-selective sensors for pH and ions, iii) voltammetric sensors and iv) affinity sensors are summarized. This review provides guidelines for the future development of contact lens based electrochemical sensors.

[Background] Management of the coronavirus disease 2019 (COVID-19) pandemic caused by a novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) requires rapid and simple methods to detect COVID-19 patients and identify potential infectors. This study aimed to evaluate the utility of a point-of-care (PoC) rapid antigen diagnostic test (Ag-RDT) in these settings., [Patients and methods] Individuals who consecutively presented for SARS-CoV-2 testing at a tertiary care center in Buenos Aires, Argentina, underwent PoC Ag-RDT testing and real-time RT-PCR (qRT-PCR) on the same day during June 2021., [Results] Of 584 included subjects, 108 (18.5%) were symptomatic for COVID-19 while the remaining presented for miscellaneous reasons unrelated to possible or confirmed contact with a SARS-CoV-2-infected individual. A positive Ag-RDT result was obtained in 26 (24.1%) symptomatic and 7 (1.5%) asymptomatic persons (p < 0.001), which was concordant with qRT-PCR in 105/108 [97.2%, Cohen's kappa coefficient (κ) = 0.927] symptomatic and 467/476 (98.1% κ = 0.563) asymptomatic participants, with a positive percentage agreement (PPA; 95% confidence interval) of 89.7% (71.5–97.3%) and 42.9% (18.8–70.4%), respectively. None of the 11 false-negative diagnoses showed a Ct-value ≤20. Considering only failures with a Ct-value below 31 as hypothetical infectivity threshold of 105 SARS-CoV-2 RNA copies/mL, concordance was observed in 98.1% (κ = 0.746) in the asymptomatic population, accounting for a PPA of 66.7% (30.9–91%)., [Conclusions] PoC Ag-RDT accurately detected active SARS-CoV-2 infection and showed acceptable diagnostic performance in asymptomatic persons potentially spreading infectious virus. Ag-RDT may therefore be useful to slow down or stop transmission by enabling adequate decisions on isolation at a public health level., This work was supported by the Instituto de Salud Carlos III, co-financed by the European Development Regional Fund (A way to achieve Europe), Subprograma Miguel Servet (grant numbers CP19/00159 to AG-V and CPII18/00033 to KN). FD is a member of the National Research Council (CONICET) Research Career Program. KN is the recipient of a Senior Researcher Contract by the Office for Families and Health of the Andalusian Council (RH-0019-2021).

Throughout the pandemic, serological assays have been revealed as crucial for detecting previous exposures to the virus and determining the timing of antibody maintenance after vaccination or natural infection. This study aimed to develop an optimized enzyme-linked immunosorbent assay (ELISA)-based serology, which could be used in case of reagent shortages, such as that occurred in the beginning of this health emergency. As a result, we present a high-sensitive immunoassay for the determination of IgG levels in venous serum samples, using 2 μg/mL antigen (receptor-binding domain of the spike protein S1) for coating the plate and utilizing human samples at a dilution 1:1000. This method showed non-inferiority features versus a commercial kit, is less expensive, and has a higher spectrophotometric range that allows for a better quantification of the antibody titers. The optical density values before and after heating venous serum samples at 56 °C during 30 min was quite similar, showing that heat inactivation can be used to reduce the biohazardous risks while handling samples. Furthermore, we show that finger-stick capillary blood samples can also serve as a suitable source for IgG detection, bypassing the need for serum isolation and being suitable for point-of-care application (Pearson’s coefficient correlation with capillary serum was 0.95, being statistically significant).

To reduce high mortality and morbidity rates, timely and proper treatment of methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infection is required. A multiplex polymerase reaction (mPCR)-based DNA lateral flow assay (MBDLFA) was developed as a point-of-care diagnostic for simultaneous identification of S. aureus, methicillin resistance, and vancomycin resistance directly from blood or blood cultures. A mPCR was developed to detect nuc, mecA, and vanA/B; its sensitivity, specificity, and limit of detection (LOD) were determined. The developed reaction was further modified for use in MBDLFA and its sensitivity for detection of target genes from artificially inoculated blood samples was checked. The optimized mPCR successfully detected nuc, mecA, and vanA/B from genomic DNA of bacterial colonies with LODs of 107, 107, and 105 CFU/mL, respectively. The reaction was sensitive and specific. The optimized mPCR was used in MBDLFA that detected nuc, mecA, and vanA/B with LODs of 107, 108, and 104 CFU/mL, respectively, directly from artificially inoculated blood. The developed MBDLFA can be used as a rapid, cheap point-of-care diagnostic for detecting S. aureus, MRSA, and vancomycin resistance directly from blood and blood cultures in ~2 h with the naked eye. This will reduce morbidity, mortality, and treatment cost in S. aureus bacteremia.

Reliable point-of-care (POC) rapid tests are crucial to detect infection and contain the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The emergence of several variants of concern (VOC) can reduce binding affinity to diagnostic antibodies, limiting the efficacy of the currently adopted tests, while showing unaltered or increased affinity for the host receptor, angiotensin converting enzyme 2 (ACE2). We present a graphene field-effect transistor (gFET) biosensor design, which exploits the Spike-ACE2 interaction, the crucial step for SARS-CoV-2 infection. Extensive computational analyses show that a chimeric ACE2-Fragment crystallizable (ACE2-Fc) construct mimics the native receptor dimeric conformation. ACE2-Fc functionalized gFET allows in vitro detection of the trimeric Spike protein, outperforming functionalization with a diagnostic antibody or with the soluble ACE2 portion, resulting in a sensitivity of 20 pg/mL. Our miniaturized POC biosensor successfully detects B.1.610 (pre-VOC), Alpha, Beta, Gamma, Delta, Omicron (i.e., BA.1, BA.2, BA.4, BA.5, BA.2.75 and BQ.1) variants in isolated viruses and patient's clinical nasopharyngeal swabs. The biosensor reached a Limit Of Detection (LOD) of 65 cps/mL in swab specimens of Omicron BA.5. Our approach paves the way for a new and reusable class of highly sensitive, rapid and variant-robust SARS-CoV-2 detection systems.

BACKGROUND: The erythrocyte sedimentation rate (ESR) test is commonly used in clinical practice for monitoring, screening and diagnosing pathological conditions and diseases related to the inflammatory response of the immune system. Several ESR techniques have been developed over the years improving the reliability, the precision and the duration of the measurement. OBJECTIVE: In the present study a new low cost micro-ESR technique is described providing the major advantage of reducing the measurement time and the blood sample volume by multiple times compared to the commercial methods. METHODS: Blood samples were obtained from healthy donors within the age group of 24–28 years and the haematocrit was adjusted to 30%, 40% and 50%. The ESR of the samples was measured utilizing a surface tension driven (STD) microfluidic chip and a monitoring device. RESULTS: The evaluation of the method showed a high correlation (0.94, p

Data from External Quality Assessment schemes for glucose measurements in Germany. Please be aware of commutability issues (EQA samples do not behave exactly as patient samples) when analysing the data. Feel free to contact me (Andreas Bietenbeck) if you have any questions.

This work studies the feasibility of using a battery-less Near-Field Communication (NFC) potentiostat for the next generation of electrochemical point-of-care sensors. A design based on an NFC microchip, a microcontroller, and a custom potentiostat based on an operational amplifier is presented. A proof-of-concept prototype has been designed and used to quantify glucose concentration using commercial glucose test strips from chronoamperometry measurements. The device is harvested and the sensor is read using a mobile phone. The prototype uses an antenna loop covered with ferrite sheets to ensure stable operation of the electronics when the mobile phone is used as reader. The use of ferrite reduces the detuning caused by the proximity of the metal parts of the mobile phone. A comparison with a commercial glucometer device is provided. Results obtained using a commercial glucometer and those provided by the proposed potentiostat show an excellent agreement.

Microfluidic droplet generation typically entails an initial stabilization period on the order of minutes, exhibiting higher variation in droplet volume until the system reaches monodisperse production. The material lost during this period can be problematic when preparing droplets from limited samples such as patient biopsies. Active droplet generation strategies such as antiphase peristaltic pumping effectively reduce stabilization time but have required off-chip control hardware that reduces system accessibility. We present a fully integrated device that employs on-chip pneumatic logic to control phase-optimized peristaltic pumping. Droplet generation stabilizes in about a second, with only one or two non-uniform droplets produced initially.

Rapid and accurate detection and identification of pathogens in clinical samples is essential for all infection diseases. However, in the case of epidemics, it plays a key role not only in the implementation of effective therapy but also in limiting the spread of the epidemic. In this study, we present the application of two nucleic acid isothermal amplification methods—reverse transcription helicase dependent amplification (RT-HDA) and reverse transcription loop-mediated amplification (RT-LAMP)—combined with lateral flow assay as the tools for the rapid detection of SARS-CoV-2, the etiological agent of COVID-19, which caused the ongoing global pandemic. In order to optimize the RT-had, the LOD was 3 genome copies per reaction for amplification conducted for 10–20 min, whereas for RT-LAMP, the LOD was 30–300 genome copies per reaction for a reaction conducted for 40 min. No false-positive results were detected for RT-HDA conducted for 10 to 90 min, but false-positive results occurred when RT-LAMP was conducted for longer than 40 min. We concluded that RT-HDA combined with LFA is more sensitive than RT-LAMP, and it is a good alternative for the development of point-of-care tests for SARS-CoV-2 detection as this method is simple, inexpensive, practical, and does not require qualified personnel to perform the test and interpret its results.

With rising healthcare costs and the rapid increase in remote physiologic monitoring and care delivery, there is an increasing need for economical, accurate, and non-invasive continuous measures of blood analytes. Based on radio frequency identification (RFID), a novel electromagnetic technology (the Bio-RFID sensor) was developed to non-invasively penetrate inanimate surfaces, capture data from individual radio frequencies, and convert those data into physiologically meaningful information and insights. Here, we describe groundbreaking proof-of-principle studies using Bio-RFID to accurately measure various concentrations of analytes in deionized water. In particular, we tested the hypothesis that the Bio-RFID sensor is able to precisely and non-invasively measure and identify a variety of analytes in vitro. For this assessment, varying solutions of (1) water in isopropyl alcohol; (2) salt in water, and (3) commercial bleach in water were tested, using a randomized double-blind trial design, as proxies for biochemical solutions in general. The Bio-RFID technology was able to detect concentrations of 2000 parts per million (ppm), with evidence suggesting the ability to detect considerably smaller concentration differences.

Background Monitoring blood glucose concentrations is common in critically ill neonatal foals, especially septic foals and those receiving naso-esophageal feedings or IV parenteral nutrition. Glucose typically is measured using a point-of-care (POC) glucometer but requires repeated restraint and blood collections, which may cause irritation at venipuncture sites and increased demands on nursing staff. Continuous glucose monitoring systems (CGMS) may provide an accurate alternative for monitoring blood glucose concentration. Objectives To determine the correlation and accuracy of a CGMS to monitor neonatal foals' blood glucose concentrations as compared to a POC glucometer and laboratory chemistry analysis (CHEM). Animals Samples from 4 healthy and 4 ill neonatal foals. Methods A CGMS was placed on each foal, and glucose measurements acquired from this device were compared to simultaneous measurements of blood glucose concentration using a POC glucometer and CHEM. Results Two-hundred matched glucose measurements were collected from 8 neonatal foals. The mean bias (95% limits of agreement) between CGMS and CHEM, CGMS and POC glucometer, and POC glucometer and CHEM was 3.97 mg/dL (-32.5 to 40.4), 18.2 mg/dL (-28.8 to 65.2), and 22.18 mg/dL (-9.3 to 53.67), respectively. The Pearson's correlation coefficient (r) was significantly correlated among all devices: GCMS and CHEM (r = 0.81), CGMS and POC glucometer (r = 0.77) and POC glucometer-CHEM (r = 0.92). Conclusions and clinical importance Within the blood glucose concentration ranges in this study (78-212 mg/dL), CGMS measurements were significantly correlated with CHEM, suggesting that it is an acceptable method to provide meaningful, immediate, and continuous glucose concentration measurements in neonatal foals while eliminating the need for repeated restraint and blood collection.

Background Quantitative PCR (qPCR) aims to measure the DNA or RNA concentration in diagnostic and biological samples based on the quantification cycle (Cq) value observed in the amplification curves. Results of qPCR experiments are regularly calculated as if all assays are 100% efficient or reported as just Cq, ΔCq, or ΔΔCq values. Contents When the reaction shows specific amplification, it should be deemed to be positive, regardless of the observed Cq. Because the Cq is highly dependent on amplification efficiency that can vary among targets and samples, accurate calculation of the target quantity and relative gene expression requires that the actual amplification efficiency be taken into account in the analysis and reports. PCR efficiency is frequently derived from standard curves, but this approach is affected by dilution errors and hampered by properties of the standard and the diluent. These factors affect accurate quantification of clinical and biological samples used in diagnostic applications and collected in challenging conditions. PCR efficiencies determined from individual amplification curves avoid these confounders. To obtain unbiased efficiency-corrected results, we recommend absolute quantification with a single undiluted calibrator with a known target concentration and efficiency values derived from the amplification curves of the calibrator and the unknown samples. Summary For meaningful diagnostics or biological interpretation, the reported results of qPCR experiments should be efficiency corrected. To avoid ambiguity, the Minimal Information for Publications on Quantitative Real-Time PCR Experiments (MIQE) guidelines checklist should be extended to require the methods that were used (1) to determine the PCR efficiency and (2) to calculate the reported target quantity and relative gene expression value.

Point-of-care (POC) diagnostics is a discipline focused on using instrumentation or analytical techniques to detect and identify target analytes at or near a patient in need of treatment, whereby the patient is properly diagnosed and provided the necessary medical care. In the past few years, there has been an increased focus on the development and implementation of POC devices to rapidly detect infectious diseases. Microfluidics has assisted in bridging the technology gap to produce inexpensive, portable, and easy to use POC diagnostic devices. An introduction into POC devices and microfluidics is described in Chapter 1, as well as the relevant literature surrounding their design and method of detection. Additionally, a thorough description of the types of paper-based immunoassays and their integration into microfluidic devices are presented. The work described in Chapter 2 focused on the development of a novel centrifugally-driven orthogonal flow immunoassay (cOFI) disc with a long microfluidic channel which allows for a constant flow rate throughout the duration of the assay. Additionally, the work presented proof-of-concept to detect an infectious disease, Yersinia pestis, on disc. Chapter 3 builds on the cOFI disc design to increase the assay’s sensitivity by increasing the overall sample volume that can be analyzed; by leveraging 3D-printed technology, a large volume sample chamber was developed allowing up to 12 mL of sample to be handled on disc. Therefore, increasing the sensitivity ten times compared to the original disc design in Chapter 2. To further improve on the cOFI device, an automated cOFI system was presented in Chapter 4 that could perform all of the assay steps and the image analysis of the membranes without requiring user input, simplifying the diagnostic testing and meeting the requirements of a POC system. The work presented in Chapter 5 was focused on the design and characterization of a multiplexed flow through assay (FTA). The FTA chip has the potential to detect up to six different target analytes on one membrane from a single sample, without requiring any off-chip sample preparation or external instrumentation. Finally, Chapter 6 highlights the potential applications and impacts the POC devices described in the previous chapters will have on medical diagnostics, as well as current challenges that need to overcome and future research that needs to be performed.

Visual complications represent common deficits following surgical or endovascular repair of paraclinoid aneurysms. Different etiologies should be investigated to prevent devastating consequences. Herein we present a point-of-care evaluation to investigate sudden visual loss after coiling of paraclinoid aneurysms. A 20-year-old male was admitted for a sudden headache. Head computed tomography showed a subarachnoid hemorrhage and subsequent angiography revealed a 9-mm left supraclinoid aneurysm of the internal carotid artery treated with endovascular coil embolization. Thirty minutes after intensive care unit admission, the patient reported a left amaurosis. To exclude secondary etiologies, an immediate evaluation with point-of-care devices (color-doppler and B-mode ultrasound and automated pupillometry) was performed. Sonographic evaluations were negative for ischemic/thrombotic events and neurologic pupil index within physiological ranges provide evidence of third cranial nerve responsiveness. The symptomatology resolved progressively over 120 minutes with low-dose steroid therapy, 30° head-of-bed elevation, and blood pressure management. Visual deficits can occur after endovascular procedure and should be investigated. Suspected visual loss is a neurological emergency that deserves a prompt evaluation. Ultrasound and automated pupillometry have proved to be an effective, rapid, reliable, and non-invasive combination for a clinical decision-making strategy in the management of post-procedural acute visual deficits.

Weight loss through dietary and exercise intervention is commonly prescribed but is not effective for all individuals. Recent studies have demonstrated that circulating microRNA (miR) biomarkers could potentially be used to identify individuals who will likely lose weight through diet and exercise and attain a healthy body weight. However, accurate detection of miRs in clinical samples is difficult, error-prone, and expensive. To address this issue, we recently developed iLluminate—a low-cost and highly sensitive miR sensor suitable for point-of-care testing. To investigate if miR testing and iLluminate can be used in real-world obesity applications, we developed a pilot diet and exercise intervention and utilized iLluminate to evaluate miR biomarkers. We evaluated the expression of miRs-140, -935, -let-7b, and -99a, which are biomarkers for fat loss, energy metabolism, and adipogenic differentiation. Responders lost more total mass, tissue mass, and fat mass than non-responders. miRs-140, -935, -let-7b, and -99a, collectively accounted for 6.9% and 8.8% of the explained variability in fat and lean mass, respectively. At the level of the individual coefficients, miRs-140 and -935 were significantly associated with fat loss. Collectively, miRs-140 and -935 provide an additional degree of predictive capability in body mass and fat mass alternations.

Metabolic syndrome (MS) is a cluster of conditions that increases the probability of heart disease, stroke, and diabetes, and is very common worldwide. While the exact cause of MS has yet to be understood, there is evidence indicating the relationship between MS and the dysregulation of the immune system. The resultant biomarkers that are expressed in the process are gaining relevance in the early detection of related MS. However, sensing only a single analyte has its limitations because one analyte can be involved with various conditions. Thus, for MS, which generally results from the co-existence of multiple complications, a multi-analyte sensing platform is necessary for precise diagnosis. In this review, we summarize various types of biomarkers related to MS and the non-invasively accessible biofluids that are available for sensing. Then two types of widely used sensing platform, the electrochemical and optical, are discussed in terms of multimodal biosensing, figure-of-merit (FOM), sensitivity, and specificity for early diagnosis of MS. This provides a thorough insight into the current status of the available platforms and how the electrochemical and optical modalities can complement each other for a more reliable sensing platform for MS.

Personalized and point-of-care (POC) diagnoses are critical for ocular physiology and disease diagnosis. Real-time monitoring and continuous sampling abilities of tear fluid and user-friendliness have become the key characteristics for the applied ophthalmic techniques. Fluorescence technologies, as one of the most popular methods that can fulfill the requirements of clinical ophthalmic applications for optical sensing, have been raised and applied for tear sensing and diagnostic platforms in recent decades. Wearable sensors in this case have been increasingly developed for ocular diagnosis. Contact lenses, as one of the commercialized and popular tools for ocular dysfunction, have been developed as a platform for fluorescence sensing in tears diagnostics and real-time monitoring. Numbers of biochemical analytes have been examined through developed fluorescent contact lens sensors, including pH values, electrolytes, glucose, and enzymes. These sensors have been proven for monitoring ocular conditions, enhancing and detecting medical treatments, and tracking efficiency of related ophthalmic surgeries at POC settings. This review summarizes the applied ophthalmic fluorescence sensing technologies in tears for ocular diagnosis and monitoring. In addition, the cooperation of fabricated fluorescent sensor with mobile phone readout devices for diagnosing ocular diseases with specific biomarkers continuously is also discussed. Further perspectives for the developments and applications of fluorescent ocular sensing and diagnosing technologies are also provided.

Funding Information: The authors acknowledge funding through project TecniCov ( POCI-01-02B7-FEDER-069745 ), co-funded by FEDER through COMPETE2020 and Lisboa2020 and CY-Sensors ( POCI-01-0145-FEDER-032359 ) through Fundação para a Ciência e a Tecnologia (FCT) , Portugal. ARC acknowledge funding to National Foundation for Science and Technology , I.P., Portugal ( FCT ) through the PhD. Grant, reference SFRH/BD/130107/2017 . Publisher Copyright: © 2022 The Authors This work presents an innovative ultra-sensitive biosensor having the Spike protein on carbon-based screen-printed electrodes (SPEs), for monitoring in point-of-care antibodies against SARS-CoV-2, a very important tool for epidemiological monitoring of COVID-19 infection and establishing vaccination schemes. In an innovative and simple approach, a highly conductive support is combined with the direct adsorption of Spike protein to enable an extensive antibody capture. The high conductivity was ensured by using carboxylated carbon nanotubes on the carbon electrode, by means of a simple and quick approach, which also increased the surface area. These were then modified with EDC/NHS chemistry to produce an amine layer and undergo Spike protein adsorption, to generate a stable layer capable of capturing the antibodies against SARS-CoV-2 in serum with great sensitivity. Electrochemical impedance spectroscopy was used to evaluate the analytical performance of this biosensor in serum. It displayed a linear response between 1.0 ​pg/mL and 10 ​ng/mL, with a detection limit of ∼0.7 ​pg/mL. The analysis of human positive sera containing antibody in a wide range of concentrations yielded accurate data, correlating well with the reference method. It also offered the unique ability of discriminating antibody concentrations in sera below 2.3 ​μg/mL, the lowest value detected by the commercial method. In addition, a proof-of-concept study was performed by labelling anti-IgG antibodies with quantum dots to explore a new electrochemical readout based on the signal generated upon binding to the anti-S protein antibodies recognised on the surface of the biosensor. Overall, the alternative serologic assay presented is a promising tool for assessing protective immunity to SARS-CoV-2 and a potential guide for revaccination. publishersversion published

Purpose Vitamin D (VitD) is a pleiotropic hormone with effects on a multitude of systems and metabolic pathways. Consequently, the relevance of a sufficiently high VitD serum level becomes self-evident. Methods A rapid immunofluorescence assay designed for the point-of-care measurement of serum VitD3 solely was tested. Inter- and intra-assay validation, double testing and result comparison with a standardized laboratory method were performed. Results An overall linear correlation of r = 0.89 (Pearson, 95% CI 0.88–0.92, p r = 0.91, 95% CI 0.86–0.94, p r = 0.86, 0.82–0.89, p Conclusion This novel, innovative, and controlled study indicates that the evaluated rapid point of care VitD assay is reliable, accurate, and suited for clinical practice.

Objectives The aim of this study was to optimize the diagnosis of feline panleukopenia virus (FPV) infection in a shelter setting by: (1) comparing the results of the canine parvovirus IDEXX SNAP Parvo (SNAP) point-of-care ELISA with a commercial FPV quantitative real-time PCR (qPCR) test; (2) assessing whether vomit and anal/rectal swabs could be used for early diagnosis; and (3) clarifying the interpretation of weak-positive SNAP test results. Methods The study included shelter cats and kittens with incomplete or unknown vaccination history that had clinical signs suspicious for feline panleukopenia and fecal SNAP and PCR tests performed within 24 h of onset. Feces, anal/rectal swabs and vomit were tested using SNAP and PCR, with fecal PCR utilized as the reference standard. Results One hundred and forty-five cats were included. Seventeen were diagnosed with FPV infection and 62 were negative; 66 could not be individually designated because they were co-housed. Sensitivity was as follows: fecal SNAP 55% (n = 102; 95% confidence interval [CI] 32–77); swab SNAP 30% (n = 55; 95% CI 7–65); swab PCR 77% (n = 55; 95% CI 46–95); and vomit PCR 100% (n = 17; 95% CI 16–100). Specificity was high (96–100%) for all sample and test types. For PCR-positive fecal samples, true-positive SNAP tests (including weak positives) had significantly higher DNA viral copy numbers than false-negative SNAP tests ( P = 0.0031). Conclusions and relevance The SNAP ELISA should be viewed as an initial diagnostic test to rule in feline panleukopenia. Positive fecal SNAP test results, including weak positives, are highly likely to be true positives in clinically affected animals. Negative results in clinically affected animals are unreliable and should be followed up with PCR testing.

Josie Acuna, Adrienne Yarnish, Elaine Situ-LaCasse, Richard Amini, Srikar Adhikari Department of Emergency Medicine, University of Arizona, Tucson, AZ, USACorrespondence: Josie AcunaDepartment of Emergency Medicine, The University of Arizona Medical Center, PO Box 245057, Tucson, AZ, 85724-5057, USATel +1 760 485-1330Email jacuna@aemrc.arizona.eduIntroduction: The objective of this study is to determine if EM resident physicians are able to successfully utilize POCUS to perform an arthrocentesis in the ED. This is a retrospective review of ED patients who received an ultrasound-guided or ultrasound-assisted arthrocentesis performed in the ED over a 6-year period by an EM resident physician.Methods: This was a retrospective review of ED patients who received an ultrasound-guided or ultrasound-assisted arthrocentesis performed in the ED over a 6-year period by an EM resident physician. An ED POCUS database was reviewed for POCUS examinations where an arthrocentesis was performed. Electronic medical records were then reviewed for demographic characteristics, history, physical examination findings, ED course, additional imaging studies, and the impact of the POCUS study on patient care and disposition.Results: A total of 101 POCUS examinations of patients were included in the final analysis. The POCUS examinations and procedures were performed by 59 different EM residents at various levels of training. Overall, 92.1% (93/101) of the procedures were successful. When assessing for image quality, 98/101 (97%) had recognizable structures at minimum. The majority of the patients (84/101, 83.2%) received additional imaging of the affected joint. In the minority of cases (23/101, 22.8%), the ultrasound-assisted approach was utilized, while 78/100 (77.2%) utilized the ultrasound-guided approach. For the studies that utilized the ultrasound-guided approach, the quality of needle visualization was determined to be “good” 40/78 (51.3%).Conclusion: EM resident physicians are able to utilize POCUS to perform an arthrocentesis in the ED. Further research is encouraged to determine whether having residents utilize POCUS to perform an arthrocentesis has a significant impact on outcomes and patient care.Keywords: ultrasound, ultrasonography, emergency medicine, arthrocentesis, education, point-of-care

To assess the practicability (usability and satisfaction) and analytical performances of the VitaPCR™ SARS‐CoV‐2 Assay (Credo Diagnostics Biomedical Pte. Ltd.), a rapid point‐of‐care nucleic acid amplification test (NAAT), by reference to real‐time reverse‐transcription polymerase chain reaction (rRT‐PCR) for respiratory viruses. The practicability of the VitaPCR™ Assay and Instrument was assessed from usability evaluation and a satisfaction questionnaire. Nasopharyngeal swabs were collected from 239 patients with coronavirus disease 2019 (COVID‐19)‐like illness during the second epidemic wave, in Paris, France. Overall, the usability of the VitaPCR™ Instrument was high. The satisfaction questionnaire indicated a high appreciation of the VitaPCR™ NAAT mainly for the short duration of analysis in only 20 min. A total of 140 and 99 samples were positive and negative for SARS‐CoV‐2 RNA by rRT‐PCR, respectively. In the event of significant viral load (i.e., N gene C t values 33), the platform's analytical performances dropped significantly, with lower sensitivity, concordance, and accuracy, while its specificity remained high. The VitaPCR™ SARS‐CoV‐2 Assay is an accurate rapid point‐of‐care NAAT, suitable for clinical practice for the rapid diagnosis of COVID‐19, especially in patients with COVID‐19‐suspected symptoms.

Background Rapid point-of-care (POC) detection of Streptococcus equi subsp. equi (S. equi) would theoretically reduce the spread of strangles by identifying index and carrier horses. Hypothesis That the eqbE isothermal amplification (LAMP) assay, and the same eqbE LAMP assay tested in a microfluidic device format, are comparable to a triplex real-time quantitative polymerase chain reaction (qPCR) assay that is commonly used in diagnostic labs. Samples Sixty-eight guttural pouch lavage (GPL) specimens from horses recovering from strangles. Methods Guttural pouch lavage specimens were tested for S. equi retrospectively using the benchtop eqbE LAMP, the eqbE LAMP microfluidic device, and compared to the triplex qPCR, that detects 2 S. equi-specific genes, eqbE and SEQ2190, as the reference standard using the receiver operating characteristic area under the curve (ROC). Results The 27/68 specimens were positive by benchtop eqbE LAMP, 31/64 by eqbE LAMP microfluidic device, and 12/67 by triplex qPCR. Using the triplex PCR as the reference, the benchtop eqbE LAMP showed excellent discrimination (ROC Area = 0.813, 95% confidence interval [CI] = 0.711-0.915) as did the LAMP microfluidic device (ROC Area = 0.811, 95% CI = 0.529-0.782). There was no significant difference between the benchtop LAMP and LAMP microfluidic device (ROC Area 0.813 ± 0.055 vs 0.811 ± 0.034, P = .97). Conclusions The eqbE LAMP microfluidic device detected S. equi in GPL specimens from convalescent horses. This assay shows potential for development as a POC device for rapid, sensitive, accurate, and cost-efficient detection of S. equi.

The COVID-19 global pandemic of 2019–2020 pointedly revealed the lack of diagnostic solutions that are able to keep pace with the rapid spread of the virus. Despite the promise of decades of lab-on-a-chip research, no commercial products were available to deliver rapid results or enable testing in the field at the onset of the pandemic. In this critical review, we assess the current state of progress on the development of point-of-care technologies for the diagnosis of viral diseases that cause pandemics. While many previous reviews have reported on progress in various lab-on-a-chip technologies, here we address the literature from the perspective of the testing needs of a rapidly expanding pandemic. First, we recommend a set of requirements to heed when designing point-of-care diagnostic technologies to address the testing needs of a pandemic. We then review the current state of assay technologies with a focus on isothermal amplification and lateral-flow immunoassays. Though there is much progress on assay development, we argue that the largest roadblock to deployment exists in sample preparation. We summarize current approaches to automate sample preparation and discuss both the progress and shortcomings of these developments. Finally, we provide our recommendations to the field of specific challenges to address in order to prepare for the next pandemic., Graphical abstract Image 1, Highlights • Despite decades of research, no products can to meet the testing needs of a pandemic. • We propose new guidelines for the design of point-of-care tests for pandemics. • We summarize the literature on point-of-care diagnostics for pandemics. • We find that sample preparation steps are the primary hindrance to deployment. • We provide a list of recommended research topics to prepare for future pandemics.

Quick and reliable mass testing of infected people is an effective tool for the contingency of SARS-CoV-2. During the COVID-19 pandemic, Point-of-Care (POC) tests using Loop-Mediated Isothermal Amplification (LAMP) arose as a useful diagnostic tool. LAMP tests are a robust and fast alternative to Polymerase Chain Reaction (PCR), and their isothermal property allows easy incorporation into POC platforms. The main drawback of using colorimetric LAMP is the reported short-term stability of the pre-mixed reagents, as well as the relatively high rate of false-positive results. Also, low-magnitude amplification can produce a subtle color change, making it difficult to discern a positive reaction. This paper presents Hilab Molecular, a portable device that uses the Internet of Things and Artificial Intelligence to pre-analyze colorimetric data. In addition, we established manufacturing procedures to increase the stability of colorimetric RT-LAMP tests. We show that ready-to-use reactions can be stored for up to 120 days at −20 °C. Furthermore, we validated both the Hilab Molecular device and the Hilab RT-LAMP test for SARS-CoV-2 using 581 patient samples without any purification steps. We achieved a sensitivity of 92.93% and specificity of 99.42% (samples with CT ≤ 30) when compared to RT-qPCR.

We propose a protocol suitable for point-of-care diagnosis of malaria utilizing a simple and purification-free DNA extraction method with the combination of loop-mediated isothermal amplification assay and lateral flow (LAMP-LF). The multiplex LAMP-LF platform developed here can simultaneously detect Plasmodium knowlesi, P. vivax, P. falciparum, and Plasmodium genus (for P. malariae and P. ovale). Through the capillary effect, the results can be observed by the red band signal on the test and control lines within 5 min. The developed multiplex LAMP-LF was tested with 86 clinical blood samples on-site at Hospital Kapit, Sarawak, Malaysia. By using microscopy as the reference method, the multiplex LAMP-LF showed 100% sensitivity (95% confidence interval (CI): 91.4 to 100.00%) and 97.8% specificity (95% CI: 88.2% to 99.9%). The high sensitivity and specificity of multiplex LAMP-LF make it ideal for use as a point-of-care diagnostic tool. The simple and purification-free DNA extraction protocol can be employed as an alternative DNA extraction method for malaria diagnosis in resource-limited settings. By combining the simple DNA extraction protocol and multiplex LAMP-LF approach, we aim to develop a simple-to-handle and easy-to-read molecular diagnostic tool for malaria in both laboratory and on-site settings.

There is increasing recognition that point-of-care ultrasound (POCUS), performed by the clinician at the bedside, can be a natural extension of the clinical examination—the modern abdominal “stethoscope” and provides an opportunity to expedite the care pathway for patients with acute gallbladder disease. The primary aims of this study were to benchmark the accuracy of surgeon-performed POCUS in suspected acute gallbladder disease against standard radiology or pathology reports and to compare time to POCUS diagnosis with time to definitive imaging. This prospective single-arm observational cohort study was conducted in four hospitals in Ireland, Italy, and Portugal to assess the accuracy of POCUS against standard radiology in patients with suspected acute biliary disease (ClinicalTrials.govIdentifier: NCT02682368). The findings of surgeon-performed POCUS were compared with those on definitive imaging or surgery. Of 100 patients recruited, 89 were suitable for comparative analysis, comparing POCUS with radiological findings in 84 patients and with surgical/histological findings in five. The overall global accuracy of POCUS was 88.7% (95% CI, 80.3–94.4%), with a sensitivity of 94.7% (95% CI, 85.3–98.9%), a specificity of 78.1% (95% CI, 60.03–90.7%), a positive likelihood ratio (LR+) of 4.33 and negative likelihood ratio (LR) of 0.07. The mean time from POCUS to the final radiological report was 11.9 h (range 0.06–54.9). In five patients admitted directly to surgery, the mean time between POCUS and incision was 2.30 h (range 1.5–5), which was significantly shorter than the mean time to formal radiology report. Sixteen patients were discharged from the emergency department, of whom nine did not need follow-up. Our study is one of the very few to demonstrate a high concordance between surgeon-performed POCUS of patients without a priori radiologic diagnosis of gallstone disease and shows that the expedited diagnosis afforded by POCUS can be reliably leveraged to deliver earlier definitive care for patients with acute gallbladder pathology, as the general surgeon skilled in POCUS is uniquely positioned to integrate it into their bedside assessment.

Interpreting blood gas analysis results can be challenging for the clinician, especially in stressful situations under time pressure. To foster fast and correct interpretation of blood gas results, we developed Visual Blood. This computer-based, multicentre, noninferiority study compared Visual Blood and conventional arterial blood gas (ABG) printouts. We presented six scenarios to anaesthesiologists, once with Visual Blood and once with the conventional ABG printout. The primary outcome was ABG parameter perception. The secondary outcomes included correct clinical diagnoses, perceived diagnostic confidence, and perceived workload. To analyse the results, we used mixed models and matched odds ratios. Analysing 300 within-subject cases, we showed noninferiority of Visual Blood compared to ABG printouts concerning the rate of correctly perceived ABG parameters (rate ratio, 0.96; 95% CI, 0.92–1.00; p = 0.06). Additionally, the study revealed two times higher odds of making the correct clinical diagnosis using Visual Blood (OR, 2.16; 95% CI, 1.42–3.29; p < 0.001) than using ABG printouts. There was no or, respectively, weak evidence for a difference in diagnostic confidence (OR, 0.84; 95% CI, 0.58–1.21; p = 0.34) and perceived workload (Coefficient, 2.44; 95% CI, −0.09–4.98; p = 0.06). This study showed that participants did not perceive the ABG parameters better, but using Visual Blood resulted in more correct clinical diagnoses than using conventional ABG printouts. This suggests that Visual Blood allows for a higher level of situation awareness beyond individual parameters’ perception. However, the study also highlighted the limitations of today’s virtual reality headsets and Visual Blood.

Xylella fastidiosa subsp. pauca (Xfp) infects olive trees and other hosts in Southern Apulia (Italy), devastating agriculture and landscape. A containment strategy of the disease requires quick and sensitive detection tools. Therefore, a colorimetric LAMP protocol was developed using as a template a crude alkaline sap obtained from incubation of 50–60 mg of thin slices of olive twigs in a NaOH-containing buffer. This rapid molecular assay can be performed directly in the field, as it needs only a portable isothermal block. Tissues of the same olive trees analysed by this technique were also compared to qPCR (using purified total plant DNA as template) as well as digital droplet PCR (on the same crude alkaline extracts used in cLAMP). A titration of the cLAMP reaction with healthy olive sap, spiked with dilutions of in vitro cultivated Xfp cells and plasmid DNA containing the target sequence, gave positive detection results as low as 102 CFU/mL and up to 169.2 target copies/µL, equivalent to about 0.9 pg of the genomic DNA. A portable, sensitive and target-specific Xfp field test was developed, which has a 40 min sample-to-answer time and does not require any DNA isolation procedure or laboratory equipment. The application of this detection assay could help the monitoring and containment of the disease spread.

Objectives Performing lung ultrasound during the clinical assessment of patients with suspicion of noncritical COVID‐19 may increase the diagnostic rate of pulmonary involvement over other diagnostic techniques used in routine clinical practice. This study aims to compare complications (readmissions, emergency department [ED] visits, and length of outpatient follow‐up) in the first 30 days after ED discharge in patients with confirmed COVID‐19 who were managed with versus without lung ultrasound. Materials and Methods Prospective, observational, analytical study in noncritical patients with confirmed respiratory disease due to SARS‐CoV‐2, assessed in the ED of a tertiary Spanish hospital in March and April 2020. We compared 2 cohorts, differentiated by the use of lung ultrasound as a diagnostic tool. Complications were assessed (hospital admissions, ED revisits and days of outpatient follow‐up) at 30 days postdischarge. Results Of the 88 included patients, 31% (n = 27) underwent an initial lung ultrasound, while 61 (68%) did not. In 82.5% of the patients evaluated with ultrasound, the most predominant areas affected were the posterobasal regions, in the form of focalized and confluent B‐lines; 70.4% showed pleural irregularity in these same areas. Use of the lung ultrasound was associated with a greater probability of hospital admission (odds ratio 5.63, 95% confidence interval 3.31 to 9.57; p

Optical immunoassays require measurement systems capable of distinguishing the light from the laser source, used to illuminate the assay, from the light generated by the particles contained within the assay itself (fluorescence). The main challenge is that the light used to excite the sample is several orders of magnitude more intense than that generated by fluorescence. Usually, single junction photodiodes and optical filters are used. The sensitivity of these schemes is limited by the filter performance. In this work, the design of a CMOS integrated circuit including buried double junction photodiodes (BDJ) is presented. This approach allows the measurement of both light sources simultaneously. From simulations, it is shown that this integrated circuit with BDJ would achieve a better detection limit than the scheme based on single-junction photodiodes of equivalent silicon area. Furthermore, integrating the photodetectors and the reading circuit on the same chip would make the system suitable to be used in biomedical applications such as Point-of-Care (POC) devices., Los inmunoensayos ópticos requieren de sistemas de medición capaces de distinguir la luz de la fuente láser, utilizada para iluminar el ensayo, de aquella generada por las partículas contenidas en el mismo (fluorescencia). El principal desafío es que la luz usada para excitar la muestra es varios órdenes de magnitud más intensa que la generada por fluorescencia. Usualmente, se utilizan filtros ópticos y fotodiodos de juntura simple. La sensibilidad de estos esquemas se encuentra limitada por el desempeño del filtro. En este trabajo se presenta el diseño de un circuito integrado de lectura que incorpora fotodiodos de doble juntura, lo que permite la medición de ambas fuentes de luz en simultáneo. A partir de simulaciones, se demuestra que este enfoque lograría un mejor límite de detección que el esquema basado en fotodiodos de juntura simple de igual área. Además, la integración del circuito de lectura y los fotoreceptores en un mismo chip, favorecería la miniaturización y portabilidad del sistema para aplicaciones biomédicas como en dispositivos Point-of-Care (POC).

The growing importance of nanomaterials toward the detection of neurotransmitter molecules has been chronicled in this review. Neurotransmitters (NTs) are chemicals that serve as messengers in synaptic transmission and are key players in brain functions. Abnormal levels of NTs are associated with numerous psychotic and neurodegenerative diseases. Therefore, their sensitive and robust detection is of great significance in clinical diagnostics. For more than three decades, electrochemical sensors have made a mark toward clinical detection of NTs. The superiority of these electrochemical sensors lies in their ability to enable sensitive, simple, rapid, and selective determination of analyte molecules while remaining relatively inexpensive. Additionally, these sensors are capable of being integrated in robust, portable, and miniaturized devices to establish point-of-care diagnostic platforms. Nanomaterials have emerged as promising materials with significant implications for electrochemical sensing due to their inherent capability to achieve high surface coverage, superior sensitivity, and rapid response in addition to simple device architecture and miniaturization. Considering the enormous significance of the levels of NTs in biological systems and the advances in sensing ushered in with the integration of nanotechnology in electrochemistry, the analysis of NTs by employing nanomaterials as interface materials in various matrices has emerged as an active area of research. This review explores the advancements made in the field of electrochemical sensors for the sensitive and selective determination of NTs which have been described in the past two decades with a distinctive focus on extremely innovative attribut,es introduced by nanotechnology.

Background Point‐of‐care lung ultrasound (LUS) is an effective tool to diagnose left‐sided congestive heart failure (L‐CHF) in dogs via detection of ultrasound artifacts (B‐lines) caused by increased lung water. Hypothesis/Objectives To determine whether LUS can be used to monitor resolution of cardiogenic pulmonary edema in dogs, and to compare LUS to other indicators of L‐CHF control. Animals Twenty‐five client‐owned dogs hospitalized for treatment of first‐onset L‐CHF. Methods Protocolized LUS, thoracic radiographs (TXR), and plasma N‐terminal pro‐B‐type natriuretic peptide were performed at hospital admission, hospital discharge, and recheck examinations. Lung ultrasound findings were compared between timepoints and to other clinical measures of L‐CHF. Results From time of hospital admission to discharge (mean 19.6 hours), median number of LUS sites strongly positive for B‐lines (>3 B‐lines per site) decreased from 5 (range, 1‐8) to 1 (range, 0‐5; P

ObjectivesTo evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test.Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation.MethodsThe Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set.ResultsThe Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%.ConclusionsThe Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.