Which Septic Shock Patients With Non-Overt DIC Progress to DIC After Admission? Point-of-Care Thromboelastography Testing.

BACKGROUND: Disseminated intravascular coagulation (DIC) is a life-threatening complication of septic shock; however, risk factors for its development after admission are unknown. Thromboelastography (TEG) can reflect coagulation disturbances in early non-overt DIC that are not detected by standard coagulation tests. This study investigated the risk factors including TEG findings as early predictors for DIC development after admission in septic shock patients with non-overt DIC. METHODS: This retrospective observation study included 295 consecutive septic shock patients with non-overt DIC at admission between January 2016 and December 2019. DIC was defined as an International Society on Thrombosis and Hemostasis (ISTH) score ≥ 5. The primary outcome was non-overt DIC at admission that met the ISTH DIC criteria within 3 days after admission. RESULTS: Of the 295 patients with non-overt DIC, 89 (30.2%) developed DIC after admission. The DIC group showed a higher ISTH score and 28-day mortality rate than the non-DIC group (2 vs. 3, P < 0.001; 13.6% vs. 27.0%, P = 0.008, respectively). The DIC rate increased with the ISTH score (7.7%, 13.3%, 15.8%, 36.5%, and 61.4% for scores of 0, 1, 2, 3, and 4, respectively). Among TEG values, the maximum amplitude (MA) was higher in the non-DIC group (P < 0.001). On multivariate analysis, an MA < 64 mm was independently associated with DIC development (odds ratio, 2.311; 95% confidence interval, 1.298-4.115). CONCLUSIONS: DIC more often developed among those with admission ISTH scores ≥ 3 and was associated with higher mortality rates. An MA < 64 mm was independently associated with DIC development in septic shock patients.

The Use of Antigenic SARS-CoV-2 Point-of-Care Test: The Italian Pediatric Real-Life Experience.

In Italy, during the second epidemic wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rapid antigenic (Ag) test at point-of-care (POCT) station were employed to quickly evaluate large numbers of swabs. We collected data of all children who underwent the Ag test in our hospital. All positive patients were recalled to perform reverse transcription polymerase chain reaction. A total of 2133 tests were collected over 1 month. Clinical data of 1941 children (median age = 3.7 years) were analyzed: 1343 (69.2%) patients complained of symptoms, 594 (30.6%) had a history of close contact with SARS-CoV-2-positive individuals. Among symptoms reported, acute rhinitis was the most frequent (67.9%), followed by cough (42.6%) and fever (31.5%). Among all tests, 95.8% resulted negative, 4.2% positive: 37/89 were confirmed. In confirmed cases, fever (56.2% vs 32.2%; P = .041) and gastrointestinal symptoms (18.8% vs 6.25%; P = .041) were significantly more frequent compared with negative children. The use of POCT for Ag test seems appropriate for SARS-CoV-2 screening in the pediatric population. In children, fever and gastrointestinal symptoms may constitute red flags of SARS-CoV-2.

Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial.

BACKGROUND: HIV counselling and testing are essential to control the HIV epidemic. However, HIV testing uptake is low in sub-Saharan Africa, where many people use informal health-care resources such as traditional healers. We hypothesised that uptake of HIV tests would increase if provided by traditional healers. We aimed to determine the effectiveness of traditional healers delivering HIV testing at point of care compared with referral to local clinics for HIV testing in rural southwestern Uganda. METHODS: We did a mixed-methods study that included a cluster-randomised trial followed by individual qualitative interviews among a sample of participants in Mbarara, Uganda. Traditional healers aged 18 years or older who were located within 8 km of the Mbarara District HIV clinic, were identified in the 2018 population-level census of traditional healers in Mbarara District, and delivered care to at least seven clients per week were randomly assigned (1:1) as clusters to an intervention or a control group. Healers screened their clients for eligibility, and research assistants confirmed eligibility and enrolled clients who were aged 18 years or older, were receiving care from a participating healer, were sexually active (ever had intercourse), self-reported not having received an HIV test in the previous 12 months (and therefore considered to be of unknown serostatus), and had not previously been diagnosed with HIV infection. Intervention group healers provided counselling and offered point-of-care HIV tests to adult clients. Control group healers provided referral for HIV testing at nearby clinics. The primary outcome was the individual receipt of an HIV test within 90 days of study enrolment. Safety and adverse events were recorded and defined on the basis of prespecified criteria. This study is registered with ClinicalTrials.gov, NCT03718871. FINDINGS: Between Aug 2, 2019, and Feb 7, 2020, 17 traditional healers were randomly assigned as clusters (nine to intervention and eight to control), with 500 clients of unknown HIV serostatus enrolled (250 per group). In the intervention group, 250 clients (100%) received an HIV test compared with 57 (23%) in the control group, a 77% (95% CI 73-82) increase in testing uptake, after adjusting for the effect of clustering (p<0·0001). Ten (4%) of 250 clients in the intervention group tested HIV positive, seven of whom self-reported linkage to HIV care. No new HIV cases were identified in the control group. Qualitative interviews revealed that HIV testing delivered by traditional healers was highly acceptable among both providers and clients. No safety or adverse events were reported. INTERPRETATION: Delivery of point-of-care HIV tests by traditional healers to adults of unknown serostatus significantly increased rates of HIV testing in rural Uganda. Given the ubiquity of healers in Africa, this approach holds promise as a new pathway to provide community-based HIV testing, and could have a dramatic effect on uptake of HIV testing in sub-Saharan Africa. FUNDING: US National Institute of Mental Health, National Institutes of Health.

A Comparison of the Performance of SARS-CoV-2 Antibody Assays in Healthcare Workers with COVID-19.

Aims Since its emergence, significant interest surrounds the use of SARS-CoV-2 serological tests as an alternative or as an adjunct to molecular testing. However, given the speed of this pandemic, paralleled with the pressure to develop and provide serological tests in an expediated manner, not every assay has undergone the rigorous evaluation that is usually associated with medical diagnostic assays. We aimed to examine the performance of several commercially available SARS-CoV-2 IgG antibody assays among participants with confirmed COVID-19 disease and negative controls. Methods Serum taken between day 17 and day 40 post onset of symptoms from 41 healthcare workers with RT-PCR confirmed COVID-19 disease, and pre-pandemic serum from 20 negative controls, were tested for the presence of SARS-CoV-2 IgG using 7 different assays including point-of-care (POC) and laboratory-based assays. Results Assay performance varied. The lab-based Abbott diagnostics SARS-CoV-2 IgG assay proved to be the assay with the best positive and negative predictive value, and overall accuracy. The POC Nal von Minden GmbH and Biozek assays also performed well. Conclusion Our research demonstrates the variations in performance of several commercially available SARS-CoV-2 antibody assays. These findings identify the limitations of some serological tests for SARS-CoV-2. This information will help inform test selection and may have particular relevance to providers operating beyond accredited laboratories.

WHotLAMP: A simple, inexpensive, and sensitive molecular test for the detection of SARS-CoV-2 in saliva.

Despite the development of effective vaccines against SARS-CoV-2, epidemiological control of the virus is still challenging due to slow vaccine rollouts, incomplete vaccine protection to current and emerging variants, and unwillingness to get vaccinated. Therefore, frequent testing of individuals to identify early SARS-CoV-2 infections, contact-tracing and isolation strategies remain crucial to mitigate viral spread. Here, we describe WHotLAMP, a rapid molecular test to detect SARS-CoV-2 in saliva. WHotLAMP is simple to use, highly sensitive (~4 viral particles per microliter of saliva) and specific, as well as inexpensive, making it ideal for frequent screening. Moreover, WHotLAMP does not require toxic chemicals or specialized equipment and thus can be performed in point-of-care settings, and may also be adapted for resource-limited environments or home use. While applied here to SARS-CoV-2, WHotLAMP can be modified to detect other pathogens, making it adaptable for other diagnostic assays, including for use in future outbreaks.

Can family physicians accurately screen for AAA with point-of-care ultrasound?

Likely yes. Point-of-care ultrasound (POCUS) screening for abdominal aortic aneurysm (AAA) by nonradiologist physicians is 98% sensitive and 99% specific, compared with imaging performed by radiologists (strength of recommendation [SOR]: B, meta-analysis of diagnostic accuracy studies mostly involving emergency medicine physicians). European family physicians demonstrated 100% concordance with radiologist readings (SOR: C, very small subsequent diagnostic accuracy studies).

Impact of an epic-integrated point-of-care ultrasound workflow on ultrasound performance, compliance, and potential revenue.

OBJECTIVES: The purpose of this study was to describe the design and impact of a point-of-care ultrasound (PoCUS) workflow integrated into the electronic medical record (EMR) on PoCUS utilization, documentation compliance, and resultant revenue potential. METHODS: This was a single-center retrospective study at an academic center. The study period spanned from December 1, 2018 to June 30, 2019 (pre-implementation) to August 1, 2019 to February 29, 2020 (post-implementation). The implementation date was July 11, 2019 at which time a PoCUS workflow was integrated into the EMR in the emergency department without the purchase of middleware. Prior to this new workflow, a non-automated workflow was in place. PoCUS scan data were extracted from the EMR and archived examinations. The mean number of PoCUS examinations performed per month per 100 ED visits before and after implementation of the new workflow were compared using an unpaired t-test, stratified by all health care professionals, and attending physicians alone. The rate of documentation compliance before and after implementation of the new workflow were compared using a chi square contingency test. Potential revenue was calculated for each period by multiplying the number of eligible examinations by the respective 2020 Medicare conversion factor Relative Value Units. RESULTS: Utilization of PoCUS from pre-implementation to post-implementation increased 28.7% from 5.01 to 6.45 mean examinations per month per 100 ED visits by all health care professionals (p = 0.063), and 75.1% from 2.01 to 3.52 by attending physicians (p = 0.0001). Examinations in compliance with workflow requirements increased from 153 (14.7%) to 1307 (94.0%). The rate of workflow compliance improved from 14.7% to 94.0% of examinations (p < 0.0001). Potential revenue increased from $546.01 to $22,014.47. CONCLUSIONS: The implementation of a middleware-free PoCUS workflow at our institution was associated with increased PoCUS utilization, documentation compliance, and potential revenue.

Comparison of glucose concentrations in canine whole blood, plasma, and serum measured with a veterinary point-of-care glucometer.

Previous studies have determined that, compared to whole blood, serum or plasma used in a portable blood glucometer (PBG) may provide more accurate results. We investigated the accuracy of a veterinary PBG (AlphaTRAK 2; Zoetis) for the measurement of glucose concentrations in serum, plasma, and whole blood compared to plasma glucose concentration measured by a biochemical analyzer. Blood samples from 53 client-owned dogs were collected. Lin concordance correlation coefficient (ρc) and Bland-Altman plots were used to determine correlation and agreement between the results obtained for the different sample types. Glucose concentration in whole blood measured by the veterinary PBG was more strongly correlated with the glucose concentration measured by the biochemical analyzer (ρc = 0.92) compared to plasma and serum glucose concentrations (ρc = 0.59 and 0.57, respectively). The mean differences between the glucose concentrations in whole blood, plasma, and serum measured by the veterinary PBG and the glucose concentration determined by the biochemical analyzer were 1.0, 6.3, and 6.7 mmol/L (18, 113, and 121 mg/dL), respectively. Our findings suggest that, when using this veterinary PBG, the accuracy of a glucose measurement obtained is higher when using whole blood compared to plasma or serum. Use of whole blood allows for more correct assessment and diagnosis, which are necessary for appropriate therapeutic intervention.

The Use of Point-of-care Ultrasound in Emergency Medical Centers in Korea: a National Cross-sectional Survey.

BACKGROUND: Point-of-care ultrasound (POCUS) is an essential tool in emergency medicine (EM). We aimed to investigate the current status and perception of POCUS use in emergency medical centers in Korea. METHODS: A cross-sectional, nationwide survey was conducted using a mobile survey of physicians at emergency medical centers in Korea. The first message was sent on November 27, 2020, and the second message was sent on December 3, 2020 to the non-responders. The questionnaire comprised 6 categories and 24 questionnaires on demographics, current practice, education, perception, and barriers to the use of POCUS. RESULTS: A total of 467 physicians participated in the survey (a response rate of 32% among 1,458 target physicians), of which 43% were residents and 57% were EM specialists. Most of the respondents (96%) answered that they use POCUS, of which 89% reported using it at least once a week. The most frequently used types of POCUS were focused assessment with sonography for trauma (68%) and echocardiography (66%). Musculoskeletal, male genital, and pediatric scans were rarely performed tests but ranked as of the scans physicians most wanted to learn. About 73% of the respondents received ultrasound education, and 41% received ultrasound education at their own institutions. Nevertheless, education-related barriers are still the biggest deterrent to POCUS use (60%). In addition, multivariate multinomial logistic regression analysis revealed that the greater the number of ultrasound devices and the total number of physicians in the emergency center, the more likely they were to use POCUS every day. CONCLUSION: This study found that most physicians currently working in emergency medical centers in Korea more frequently perform various types of ultrasound scans compared to those 10 years prior. To further promote the use of POCUS, it is important to have an appropriate number of ultrasound devices and physicians in the emergency center along with systematic POCUS education.

Accuracy of a point-of-care major crossmatch test and risk factors for major crossmatch incompatibility in cats.

Major crossmatch testing can help identify immunologic incompatibilities between blood donors and recipients; however, there are limited studies describing the accuracy of point-of-care crossmatch tests. The first aim of this study was to determine if a gel-based, point-of-care major crossmatch method (GEL-CM), without antiglobulin-enhancement, could accurately detect compatible and incompatible donor-recipient pairings, using an antiglobulin-enhanced laboratory-based major crossmatch method (LAB-CM) as the reference standard. The second aim was to describe the incidence of, and risk factors for, major crossmatch incompatibility in cats. Nineteen previously-transfused cats and 32 transfusion-naïve cats, representing 132 unique donor-recipient pairings, were included in this study. Both LAB-CM and GEL-CM tests were performed for most parings. There was poor agreement between the LAB-CM and GEL-CM results (kappa = 0.111; 95% confidence interval [CI], -0.093 to 0.314). Transfusion-naïve cats had incompatibility rates of 3% and 6% using LAB-CM and GEL-CM, respectively; previously-transfused cats had incompatibility rates of 32% and 26% using LAB-CM and GEL-CM, respectively. History of previous transfusion was the only identified cat risk factor for an incompatible LAB-CM (odds ratio [OR], 31.0; 95% CI, 3.77-254.98; P = 0.0019) and GEL-CM (OR, 5.7; 95% CI, 1.72-19.20; P = 0.0054). Further studies are needed to determine if GEL-CM can detect clinically-relevant immunologic incompatibilities that would result in transfusion reactions. Major crossmatch testing is of greater importance in cats that have previously received a transfusion.

ADR databases for on-site clinical use: Potentials of summary of products characteristics.

Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs or American Structured Product Labels and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section in the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content have to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.

Fluorescence polarization system for rapid COVID-19 diagnosis.

Prompt diagnosis, patient isolation, and contact tracing are key measures to contain the coronavirus disease 2019 (COVID-19). Molecular tests are the current gold standard for COVID-19 detection, but are carried out at central laboratories, delaying treatment and control decisions. Here we describe a portable assay system for rapid, onsite COVID-19 diagnosis. Termed CODA (CRISPR Optical Detection of Anisotropy), the method combined isothermal nucleic acid amplification, activation of CRISPR/Cas12a, and signal generation in a single assay, eliminating extra manual steps. Importantly, signal detection was based on the ratiometric measurement of fluorescent anisotropy, which allowed CODA to achieve a high signal-to-noise ratio. For point-of-care operation, we built a compact, standalone CODA device integrating optoelectronics, an embedded heater, and a microcontroller for data processing. The developed system completed SARS-CoV-2 RNA detection within 20 min of sample loading; the limit of detection reached 3 copy/µL. When applied to clinical samples (10 confirmed COVID-19 patients; 10 controls), the rapid CODA test accurately classified COVID-19 status, in concordance with gold-standard clinical diagnostics.

Sequence-specific and multiplex detection of COVID-19 virus (SARS-CoV-2) using proofreading enzyme-mediated probe cleavage coupled with isothermal amplification.

The outbreak of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been challenging human health worldwide. Loop-mediated isothermal amplification (LAMP) has been promptly applied to the detection of SARS-CoV-2 owing to its high amplification efficacy and less requirement of the thermal cycler. However, the vast majority of these LAMP-based assays depend on the non-specific detection of LAMP products, which can not discern the undesirable amplificons, likely to yield unreliable results. Herein, a sequence-specific LAMP assay was reported to detect SARS-CoV-2 using proofreading enzyme-mediated probe cleavage (named Proofman), which could realize real-time and visual detection without uncapping. This assay, introducing a proofreading enzyme and the fluorogenic probe to reverse-transcription LAMP (RT-Proofman-LAMP), can specifically detect the SARS-CoV-2 RNA with a detection limit of 100 copies. In addition to the real-time analysis, the assay is capable of endpoint visualization under a transilluminator within 50 min, providing a convenient reporting manner under the setting of point-of-care testing (POCT). In combination with different fluorophores, the one-pot multiplex assay was successfully achieved to detect multiple targets of SARS-CoV-2 and inner control simultaneously. In summary, the development of RT-Proofman-LAMP offers a versatile and highly-specific method for fast field screening and laboratory testing of SARS-CoV-2, making it a promising platform in COVID-19 diagnosis.

Bedside POCUS during ward emergencies is associated with improved diagnosis and outcome: an observational, prospective, controlled study.

BACKGROUND: Rapid response teams are intended to improve early diagnosis and intervention in ward patients who develop acute respiratory or circulatory failure. A management protocol including the use of a handheld ultrasound device for immediate point-of-care ultrasound (POCUS) examination at the bedside may improve team performance. The main objective of the study was to assess the impact of implementing such a POCUS-guided management on the proportion of adequate immediate diagnoses in two groups. Secondary endpoints included time to treatment and patient outcomes. METHODS: A prospective, observational, controlled study was conducted in a single university hospital. Two teams alternated every other day for managing in-hospital ward patients developing acute respiratory and/or circulatory failures. Only one of the team used an ultrasound device (POCUS group). RESULTS: We included 165 patients (POCUS group 83, control group 82). Proportion of adequate immediate diagnoses was 94% in the POCUS group and 80% in the control group (p = 0.009). Time to first treatment/intervention was shorter in the POCUS group (15 [10-25] min vs. 34 [15-40] min, p < 0.001). In-hospital mortality rates were 17% in the POCUS group and 35% in the control group (p = 0.007), but this difference was not confirmed in the propensity score sample (29% vs. 34%, p = 0.53). CONCLUSION: Our study suggests that protocolized use of a handheld POCUS device at the bedside in the ward may improve the proportion of adequate diagnosis, the time to initial treatment and perhaps also survival of ward patients developing acute respiratory or circulatory failure. Clinical Trial Registration NCT02967809. Registered 18 November 2016, https://clinicaltrials.gov/ct2/show/NCT02967809 .

Individual point-of-care trials: a new approach to incorporate patient's preferences into personalized pragmatic clinical trials.

Although Evidence-based medicine (EBM) and Patient-centered medicine (PCM) are often perceived as two conflicting paradigms that speak the language of populations and the language of individuals, respectively, both share the common objective of improving the care of individual patients. As physicians should not practice an EBM that is away from the individual patient nor a PCM that is not based on the best available evidence, it is crucial to connect and combine both movements, promoting the fruitful and natural interaction between research and care. Achieving such interaction requires developing new individual-patient centric research methods. In this commentary, we propose an innovative clinical research design oriented to personalize point-of-care trials-integrating clinical research and medical care-through the incorporation of individual patients' preferences to build personalized research protocols. Building on the framework of N-of-1 studies, in "individual point-of-care trials," each protocol could be personalized for each patient so that the therapeutic objectives, the outcome variables analyzed, and the (operationalization of the) compared interventions would be based not only on the clinical and biological characteristics of each patient but also on their individual preferences, goals, and values. If patient preferences are being progressively integrated into medical practice, it makes sense that they also are incorporated into clinical trials embedded in care delivery. The proposal to perform individual point of care trials may be an optimal way to combine EBM and PCM while preserving their foundational principles, and to ensure the connection between "personalized" and "personal" care.