[Viscoelasticity-based point of care coagulation diagnostics in the context of resuscitation room management of severely injured and bleeding trauma patients : Diagnostics and treatment of trauma-induced coagulopathy]. / Viskoelastizitätsbasierte "Point-of-care"-Gerinnungsdiagnostik im Kontext des Schockraummanagements von blutenden Traumapatienten : Diagnostik und Therapie der traumainduzierten Koagulopathie.

Uncontrolled bleeding with associated trauma-induced coagulopathy (TIC) remains the leading cause of preventable death after severe trauma. Meanwhile, TIC is recognized as a separate clinical entity with substantial impact on downstream morbidity and mortality. In clinical practice severely injured and bleeding patients are often still being treated according to established damage control surgery (DCS) procedures with surgical bleeding control and empirical transfusion of classical blood products in predefined ratios in the sense of damage control resuscitation (DCR); however, algorithms are also available, which have been constructed from established viscoelasticity-based point of care (POC) diagnostic procedures and target value-oriented treatments. The latter enables a timely qualitative assessment of coagulation function from whole blood at bedside and provides rapid and clinically useful information on the presence, development and dynamics of the coagulation disorder. The early implementation of viscoelasticity-based POC procedures in the context of resuscitation room management of severely injured and bleeding patients was uniformly associated with reductions in potentially harmful blood products, especially overtransfusions, and an overall improvement in outcome including survival. The present article reviews the clinical questions around the use of viscoelasticity-based procedures as well as recommendations for the early and acute management of bleeding trauma patients taking the current literature into account.

Implementation of a Urinary Tract Infection Management Pathway to Evaluate Emergency Department Length of Stay in a Pediatric Emergency Department.

STUDY OBJECTIVE: Point-of-care urine testing is an alternative to urine microscopy in children. However, it remains unclear if utilizing point-of-care urine testing without urine microscopy decreases length of stay in the emergency department (ED). We implemented a point-of-care-driven urinary tract infection management pathway to evaluate effects on length of stay. METHODS: This was an uncontrolled before and after study examining a point-of-care urinalysis pathway in a children's ED. We obtained preliminary data by prospectively evaluating urine microscopy. We then implemented a pathway in which point-of-care urine testing determined treatment and disposition. Outcomes included time from urinalysis order to discharge order, length of stay, and rate of delayed treatment. RESULTS: A total of 118 patients were enrolled before pathway initiation, and 97 patients were enrolled after. Demographics and infection rates were similar between the 2 groups. When urine microscopy was compared to point-of-care urine testing, there were significant reductions in time from urinalysis order to discharge order (median difference of 30 minutes; 95% confidence interval 19 to 42 minutes) and length of stay (median difference of 36 minutes; 95% confidence interval 19 to 55 minutes). There was no treatment delayed because of institution of the point-of-care pathway. CONCLUSION: Using point-of-care urine testing as an alternative to urine microscopy significantly reduced pediatric ED length of stay and time from urinalysis order to discharge order.

The impact of the COVID-19 pandemic on addressing common barriers to pharmacy-based point-of-care testing.

Introduction: Pharmacy-based point-of-care testing has long had the potential to improve patient access to timely care, but adoption has been slowed by financial and regulatory barriers. The COVID-19 pandemic reduced or temporarily eliminated many of the barriers to pharmacy-based testing. This review examines how the changes brought on by may impact pharmacy-based testing after the pandemic.Areas covered: This review searched peer-reviewed, lay, and regulatory literature to explore the implementation of pharmacy-based COVID-19 testing. This includes a review of regulatory and financial changes that removed barriers to testing. Additionally, it reviews the literature related to the growth of pharmacy-based testing.Expert opinion: It is clear that the COVID-19 pandemic created an awareness and opportunity for pharmacy-based point-of-care testing. The changes made in response to the pandemic have the potential to increase the role of pharmacy-based testing, but additional regulatory changes and wider pharmacy adoption are still needed to maximize the value of such services.

The NSEBA Demonstration Project: implementation of a point-of-care platform for early infant diagnosis of HIV in rural Zambia.

OBJECTIVES: To describe the experience and resource requirements of implementing point-of-care testing for early infant diagnosis of HIV in rural Zambia. METHODS: A demonstration project was conducted using a hub-and-spoke model in 2018-2019 at five clinics in rural Zambia. Two testing hubs were established, and all HIV-exposed infants were tested with the GeneXpert system. Data on costs, turnaround times and test results were collected. RESULTS: Seven hundred and eighty six tests were conducted. At the hubs, results were available a median of 2.4 (IQR: 2.1, 2.8) hours after sample collection and most mothers (84%) received same-day results. At the spoke facilities, results were available a median of 9 days (IQR: 7, 12) after sample collection and provided to the mother a median of 16 days (IQR: 10, 28) after sample collection. Eleven children tested positive, and 9 (82%) started treatment a median of 13 days (IQR: 7, 21) after sample collection and on the day mothers received results. In contrast, results from matching samples sent for routine testing were available a median of 38 days (IQR: 27, 61) after sample collection and provided to the mother a median of 91 days (IQR: 47, 135) after sample collection. CONCLUSIONS: Implementing point-of-care testing in a network of rural health centres in Zambia required significant initial and ongoing investment in infrastructure, training and supervision. However, point-of-care testing can rapidly diagnose HIV-infected infants, so they can benefit from early treatment.

Testing telediagnostic obstetric ultrasound in Peru: a new horizon in expanding access to prenatal ultrasound.

BACKGROUND: Ninety-four percent of all maternal deaths occur in low- and middle-income countries, and the majority are preventable. Access to quality Obstetric ultrasound can identify some complications leading to maternal and neonatal/perinatal mortality or morbidity and may allow timely referral to higher-resource centers. However, there are significant global inequalities in access to imaging and many challenges to deploying ultrasound to rural areas. In this study, we tested a novel, innovative Obstetric telediagnostic ultrasound system in which the imaging acquisitions are obtained by an operator without prior ultrasound experience using simple scan protocols based only on external body landmarks and uploaded using low-bandwidth internet for asynchronous remote interpretation by an off-site specialist. METHODS: This is a single-center pilot study. A nurse and care technician underwent 8 h of training on the telediagnostic system. Subsequently, 126 patients (68 second trimester and 58 third trimester) were recruited at a health center in Lima, Peru and scanned by these ultrasound-naïve operators. The imaging acquisitions were uploaded by the telemedicine platform and interpreted remotely in the United States. Comparison of telediagnostic imaging was made to a concurrently performed standard of care ultrasound obtained and interpreted by an experienced attending radiologist. Cohen's Kappa was used to test agreement between categorical variables. Intraclass correlation and Bland-Altman plots were used to test agreement between continuous variables. RESULTS: Obstetric ultrasound telediagnosis showed excellent agreement with standard of care ultrasound allowing the identification of number of fetuses (100% agreement), fetal presentation (95.8% agreement, κ =0.78 (p < 0.0001)), placental location (85.6% agreement, κ =0.74 (p < 0.0001)), and assessment of normal/abnormal amniotic fluid volume (99.2% agreement) with sensitivity and specificity > 95% for all variables. Intraclass correlation was good or excellent for all fetal biometric measurements (0.81-0.95). The majority (88.5%) of second trimester ultrasound exam biometry measurements produced dating within 14 days of standard of care ultrasound. CONCLUSION: This Obstetric ultrasound telediagnostic system is a promising means to increase access to diagnostic Obstetric ultrasound in low-resource settings. The telediagnostic system demonstrated excellent agreement with standard of care ultrasound. Fetal biometric measurements were acceptable for use in the detection of gross discrepancies in fetal size requiring further follow up.

A recombinase polymerase amplification assay for rapid detection of rabies virus.

Rabies is a generally fatal encephalitis caused by a negative-sense single-stranded RNA lyssavirus transmitted to humans mainly from dog bite. Despite the recommendation by WHO and OIE to use the direct immunofluorescence test as standard method, molecular diagnostic assays like reverse transcription quantitative polymerase chain reaction (RT-qPCR) are increasing as a confirmatory method. However, both technologies are inaccessible in resource-limited settings. Moreover, the available point-of-need molecular assay is of poor detection limit for African strains. Herein, we developed a reverse transcription recombinase polymerase amplification (RT-RPA) assay as potential point-of-need diagnostic tool for rapid detection of various strains of rabies virus including locally isolated African strains. The sensitivity and specificity of the method was evaluated using a molecular RNA standard and different Rabies-related viruses belonging to the Rhabdoviridea family, respectively. The RABV-RPA performances were evaluated on isolates representative of the existing diversity and viral dilutions spiked in non-neural clinical specimen. The results were compared with RT-qPCR as a gold standard. The RABV-RPA detected down to 4 RNA molecules per reaction in 95% of the cases in less than 10 min. The RABV-RPA assay is highly specific as various RABV isolates were identified, but no amplification was observed for other member of the Rhabdoviridea family. The sample background did not affect the performance of the RABV-RPA as down to 11 RNA molecules were identified, which is similar to the RT-qPCR results. Our developed assay is suitable for use in low-resource settings as a promising alternative tool for ante-mortem rabies diagnosis in humans for facilitating timely control decisions.

Point-of-care ultrasound during the COVID-19 pandemic: A multidisciplinary approach between intensivists and echocardiographers.

PURPOSE: The coronavirus disease-2019 (COVID-19) led to a large influx of critically ill patients and altered echocardiography laboratory workflow. We developed a point-of-care ultrasound (POCUS) first approach to patients requiring echocardiography and describe our workflow and findings. METHODS: We performed a single-center retrospective analysis of all POCUS studies performed on critically ill patients with COVID-19. Sonography was performed by intensivists, uploaded and archived, and rapidly reviewed by echocardiographers. We evaluated each study based on the number of views obtained. Additionally, we provide a description of the workflow during the COVID-19 surge at a tertiary care hospital in New York City. RESULTS: Fifty patients had POCUS studies performed by intensivists and reviewed by echocardiographers obviating the need for sonographer-performed studies. Of the 48 cardiac POCUS studies, 17% of patients had 4 of 4 standard views available while 53% had 3 of 4 standard views. The parasternal long-axis view was obtained on 81%, subxiphoid view on 79%, apical 4-chamber view on 71%, and parasternal short-axis view on 63% of patients. CONCLUSIONS: Our POCUS workflow allowed intensivists to perform cardiac sonography for rapid bedside diagnosis of pathology with immediate interpretation performed by echocardiographers. At least 3 views were obtained in the majority of cases.

Loop-mediated isothermal amplification (LAMP): An effective molecular point-of-care technique for the rapid diagnosis of coronavirus SARS-CoV-2.

The novel coronavirus disease-2019 (Covid-19) public health emergency has caused enormous loss around the world. This pandemic is a concrete example of the existing gap between availability of advanced diagnostics and current need for cost-effective methodology. The advent of the loop-mediated isothermal amplification (LAMP) assay provided an innovative tool for establishing a rapid diagnostic technique based on the molecular amplification of pathogen RNA or DNA. In this review, we explore the applications, diagnostic effectiveness of LAMP test for molecular diagnosis and surveillance of severe acute respiratory syndrome coronavirus 2. Our results show that LAMP can be considered as an effective point-of-care test for the diagnosis of Covid-19 in endemic areas, especially for low- and middle-income countries.

Rapid response team integration at a quaternary care academic centre: new paradigm for critical care organistions.

BACKGROUND: Decompensating patients require expeditious and focused care at the bedside. This can be particularly challenging when there are multiple layers of providers, each with differing specialisation, experience and autonomy. We examined the impact of our intensivist-driven hospital-wide rapid response team (RRT) at our 1171-bed quaternary care centre. DESIGN: Single-centre retrospective cohort study. METHODS: RRT service was implemented to assess, manage and triage acutely ill patients outside the intensive care unit (ICU). Criteria for consultation and workflow were established. The 24/7 team was led by an intensivist and included nurse practitioners and respiratory therapists. Over 3 years, we reviewed the impact of the RRT on patient outcomes and critical care support beyond the ICU. RESULTS: Over 3 years, the RRT received 31 392 consults for 12 122 individual patients averaging 30 consults over 24 hours. 58.9% of the calls received were for sepsis alerts/risk of decompensation and 41.1% of the consults were for reasons of acute decompensation. Among patients that were seen by the RRT, over the course of their hospital stay, 14% were upgraded to a step-down unit, 18% were upgraded to the ICU and 68% completed care without requiring any escalation. The average mortality rate for patients seen by the RRT service during their hospital stay was 11.3% with an average 30-day readmission rate of 16.5% and average hospital length of stay 16 days without significant variation between the 3 years. CONCLUSIONS: Intensivist-led RRT ensured consistent high value care. Early intervention and consistent supervision enabled timely and efficient delivery of critical care services.

A Novel Approach to Hematology Testing at the Point of Care.

BACKGROUND: The need for rapid point-of-care (POC) diagnostics is now becoming more evident due to the increasing need for timely results and improvement in healthcare service. With the recent COVID-19 pandemic outbreak, POC has become critical in managing the spread of disease. Applicable diagnostics should be readily deployable, easy to use, portable, and accurate so that they fit mobile laboratories, pop-up treatment centers, field hospitals, secluded wards within hospitals, or remote regions, and can be operated by staff with minimal training. Complete blood count (CBC), however, has not been available at the POC in a simple-to-use device until recently. The HemoScreen, which was recently cleared by the FDA for POC use, is a miniature, easy-to-use instrument that uses disposable cartridges and may fill this gap. CONTENT: The HemoScreen's analysis method, in contrast to standard laboratory analyzers, is based on machine vision (image-based analysis) and artificial intelligence (AI). We discuss the different methods currently used and compare their results to the vision-based one. The HemoScreen is found to correlate well to laser and impedance-based methods while emphasis is given to mean cell volume (MCV), mean cell hemoglobin (MCH), and platelets (PLT) that demonstrate better correlation when the vision-based method is compared to itself due to the essential differences between the underlying technologies. SUMMARY: The HemoScreen analyzer demonstrates lab equivalent performance, tested at different clinical settings and sample characteristics, and might outperform standard techniques in the presence of certain interferences. This new approach to hematology testing has great potential to improve quality of care in a variety of settings.

Excessive fibrinolysis detected with thromboelastography in a case of amniotic fluid embolism: fibrinolysis may precede coagulopathy.

Amniotic fluid embolism (AFE) is a catastrophic condition in the peripartum period and still remains as a leading cause of maternal death. Although over 80% of cases of AFE cases are accompanied by coagulopathy, the pathology of disseminated intravascular coagulation is not well understood not only because of its rarity but also because of the limited availability of laboratory testing in emergent clinical settings. We describe a case of AFE whose characteristic data for coagulation and fibrinolysis were timely depicted with sequential thromboelastography. We believe that the point-of-care, which provides information for both coagulopathy and fibrinolysis, may provide crucial data not only for the treatment of postpartum hemorrhage in daily clinical practice but also for the elucidation of AFE pathophysiology.

Clinical impact of a routine, molecular, point-of-care, test-and-treat strategy for influenza in adults admitted to hospital (FluPOC): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Diagnosis of influenza in patients admitted to hospital is delayed due to long turnaround times with laboratory testing, leading to inappropriate and late antiviral treatment and isolation facility use. Molecular point-of-care tests (mPOCTs) are highly accurate, easy to use, and generate results in less than 1 h, but high-quality evidence for their effect on management and clinical outcomes is needed. The aim of this study was to assess the clinical impact of an mPOCT on influenza detection, antiviral use, infection control measures, and clinical outcomes in adults admitted to hospital with acute respiratory illness. METHODS: In this multicentre, pragmatic, open-label, randomised controlled trial (FluPOC), we recruited adults admitted to hospital with acute respiratory illness during influenza seasons from two hospitals in Hampshire, UK. Eligible patients were aged 18 years and older, with acute respiratory illness of 10 days or fewer duration before admission to hospital, who were recruited within 16 h of admission to hospital. Participants were randomly assigned (1:1), using random permuted blocks of varying sizes (4, 6 and 8), to receive mPOCT for influenza or routine clinical care (control group). The primary outcome was the proportion of patients infected with influenza who were treated appropriately with antivirals (neuraminidase inhibitors) within 5 days of admission. Safety was assessed in all patients. Secondary outcomes included time to antivirals, isolation facility use, and clinical outcomes. This study is registered with the ISRCTN registry, ISRCTN17197293, and is now complete. FINDINGS: Between Dec 12, 2017, and May 3, 2019, over two influenza seasons, 613 patients were enrolled, of whom 307 were assigned to the mPOCT group and 306 to the control group, and all were analysed. Median age was 62 years (IQR 45-75) and 332 (54%) of 612 participants with data were female. 100 (33%) of 307 patients in the mPOCT group and 102 (33%) of 306 in the control group had influenza. 100 (100%) of 100 patients with influenza were diagnosed in the mPOCT group and 60 (59%) of 102 were diagnosed though routine clinical care in the control group (relative risk 1·7, 95% CI 1·7-1·7; p<0·0001). 99 (99%) of 100 patients with influenza in the mPOCT group were given antiviral treatment within 5 days of admission versus 63 (62%) 102 in the control group (relative risk 1·6, 95% CI 1·4-1·9; p<0·0001). Median time to antivirals was 1·0 h (IQR 0·0 to 2·0) in the mPOCT group versus 6·0 h (0·0 to 12·0) in the control group (difference of 5·0 h [95% CI 0·0-6·0; p=0·0039]). 70 (70%) of 100 patients with influenza in the mPOCT group were isolated to single-room accommodation versus 39 (38%) of 102 in the control group (relative risk 1·8 [95% CI 1·4-2·4; p<0·0001]). 19 adverse events occurred among patients with influenza in the mPOCT group compared with 34 events in the control group. No patients with influenza died in the mPOCT group and two (2%) died in the control group (p=0·16). INTERPRETATION: Routine mPOCT for influenza was associated with improved influenza detection and improvements in appropriate and timely antiviral and isolation facility use. Routine mPOCT should replace laboratory-based diagnostics for acute admissions to hospital during the influenza season. FUNDING: National Institute for Health Research.

Emerging Telemedicine Tools for Remote COVID-19 Diagnosis, Monitoring, and Management.

The management of the COVID-19 pandemic has relied on cautious contact tracing, quarantine, and sterilization protocols while we await a vaccine to be made widely available. Telemedicine or mobile health (mHealth) is well-positioned during this time to reduce potential disease spread and prevent overloading of the healthcare system through at-home COVID-19 screening, diagnosis, and monitoring. With the rise of mass-fabricated electronics for wearable and portable sensors, emerging telemedicine tools have been developed to address shortcomings in COVID-19 diagnostics, monitoring, and management. In this Perspective, we summarize current implementations of mHealth sensors for COVID-19, highlight recent technological advances, and provide an overview on how these tools may be utilized to better control the COVID-19 pandemic.

Matching Development of Point-of-Care Diagnostic Tests to the Local Context: A Case Study of Visceral Leishmaniasis in Kenya and Uganda.

The rapid growth of point-of-care (POC) diagnostic tests necessitates a clear vision of when, where, and why a new POC diagnostic test needs to be developed and how it can be used in a way that matches a local health care context. Here, we present an innovative approach toward developing a concept target product profile (CTPP), which is a new mapping tool that helps researchers match a new diagnostic test to a specific local health care context early in the research and development process. As a case study, we focus on the diagnosis of visceral leishmaniasis (VL) in rural resource-limited regions of Kenya and Uganda. Our stepwise approach integrates elements of design thinking and uses a combination of literature reviews and field research for a context analysis of local health care systems and practices. We then use visual thinking in the form of Gigamaps and patient journeys to identify use case scenarios and to present our findings from the field research to key stakeholders. The use case scenarios describe the diagnostic scope of a new POC test based on the feasibility of the new test, the local need, and the contextual fit. For our case study of VL, we identify 2 valuable use case scenarios, namely test-of-cure and screening and confirmation, and we formulate a CTPP. We anticipate that a CTPP will enable researchers to match a new POC diagnostic test during the research and development process to the local health care context in which it will be used.

Experience on how to implement a preanalytical and POCT unit in Madrid's IFEMA field hospital during this unprecedented COVID-19 emergency.

To fight the virus SARS-CoV-2 spread to Europe from China and to give support to the collapsed public health system, the Spanish Health Authorities developed a field hospital located in the facilities of Madrid exhibition centre (IFEMA) to admit and treat patients diagnosed with SARS-CoV-2 infectious disease (COVID-19). The Department of Laboratory Medicine of La Paz University Hospital in Madrid (LMD-HULP) was designated to provide laboratory services. Due to the emergency, the IFEMA field hospital had to be prepared for patient admission in less than 1 week and the laboratory professionals had to collaborate in a multidisciplinary group to assure that resources were available to start on time. The LMD-HULP participated together with the managers in the design of the tests portfolio and the integration of the healthcare information systems (IS) (hospital IS, laboratory IS and POCT management system). Laboratorians developed a strategy to quickly train clinicians and nurses on test requests, sample collection procedures and management/handling of the POCT blood gas analyser both by written materials and training videos. The IFEMA´s preanalytical unit managed 3782 requests, and more than 11,000 samples from March 27th to April 30th. Furthermore, 1151 samples were measured by blood gas analysers. In conclusion, laboratory professionals must be resilient and have to respond timely in emergencies as this pandemic. The lab's personnel selection, design and monitoring indicators to maintain and further improve the quality and value of laboratory services is crucial to support medical decision making and provide better patient care.

Hepatitis C Among High-Risk Alabamians: Disease Burden and Screening Effectiveness.

BACKGROUND: The effectiveness of hepatitis C testing and linkage-to-care (LTC) is poorly characterized in low-resource jurisdictions facing gaps in harm reduction, including illegality of syringe exchange services. Effectiveness of a community-based test/LTC program was evaluated in Alabama. METHODS: In 2016-2018, shelters, drug treatment centers (DTCs), AIDS organizations, and Federally Qualified Health Centers (FQHCs) engaged in screening/LTC. A coordinator navigated individuals to confirm viremia and link to substance use treatment or primary care with hepatitis C prescribers. RESULTS: Point-of-care (POC) tested 4293 individuals (10% [427] antibody-positive, 71% [299/419] RNA performed, 80% [241/299] viremia confirmed) and 93% linked to care (225/241). Electronic medical record (EMR)-based reflex strategy screened 4654 (15% [679] antibody positive, 99% [670/679] RNA performed, 64% [433/679] viremia confirmed) and 85% linked to care (368/433). We observed higher odds of RNA confirmation in EMR-based reflex versus POC (OR, 2.07; P < .0001) and higher odds of LTC in EMR-based reflex versus POC (OR, 1.51; P < .0001). Overall, 53% individuals tested were nonbaby boomers. CONCLUSIONS: In Alabama, screening at high-risk settings identified significant hepatitis C burden and reflex testing outperformed point-of-care linkage indicators. Colocating testing in DTCs and treatment in FQHCs provided key LTC venues to at-risk younger groups.