scholarly journals Molecular point-of-care testing for SARS-CoV-2 using the ID NOW(TM) System in Emergency Department: Prospective Evaluation and Implementation in the Care Process

2021 ◽  
Author(s):  
Stefan O. Kortuem ◽  
Marina Krause ◽  
Hans-Juergen Ott ◽  
Lisa Kortuem ◽  
Hans-Peter Schlaudt
Keyword(s):  
Point Of Care ◽  
Clinical Care ◽  
Care Process ◽  
Daily Routine ◽  
Rt Pcr ◽  
Essential Information ◽  
Testing Procedures ◽  
Patient Pathways ◽  
The Impact ◽  
Second Wave

Background. The increasing number of cases and hospital admissions due to COVID-19 created an urgent need for rapid, reliable testing procedures for SARS-CoV-2 in Emergency Departments (ED) in order to effectively manage hospital resources, allocate beds and prevent nosocomial spread of infection. The ID NOW(TM) COVID-19 assay is a simple, user-friendly, rapid molecular test run on an instrument with a small footprint enabling point-of-care diagnostics. Methods. In the first wave, outsourced RT-PCR testing regularly required 36-48 hours before results were available. This prospective study was conducted in the second wave (October 2020-April 2021) and evaluated the impact the implementation of the ID NOW(TM) COVID-19 test in the ED had on clinical care processes and patient pathways. 710 patients were recruited upon arrival at the ED which included those presenting clinical symptoms, asymptomatic individuals or persons fulfilling epidemiological criteria. The first anterior nasal swab was taken by trained nurses in the ambulance or a separate consultation room. The ID NOW(TM) COVID-19 test was performed in the ED in strict compliance with the manufacturer's instructions and positive or suspected cases were additionally tested with RT_PCR (cobas SARS-COV-2 RT-PCR, Roche) following collection of a second nasopharyngeal NP specimen. Results. Swabs directly tested with the ID NOW(TM) COVID-19 test showed a diagnostic concordance of 98 % (sensitivity 99.59 %, specificity 94.55 %, PPV 97.6 %, NPV 99.05 %) compared to RT-PCR as reference. The 488 patients that tested positive with the ID NOW(TM) COVID-19 had a Ct range in RT-PCR results between 7.94 to 37.42 (in 23.2 % > 30). Two false negative results (0.28%) were recorded from patients with Ct values > 30. 14 (1.69%) discordant results were reviewed case-by-case and usually associated with either very early or very advanced stages of infection. Furthermore, patients initially negative with the ID NOW(TM) COVID-19 test and admitted to the hospital were tested again on days 5 and 12: no patient became positive. Discussion. The ID NOW(TM) COVID-19 test for detection of SARS-CoV-2 demonstrated excellent diagnostic agreement with RT-PCR under the above-mentioned patients pathways implemented during the second wave. The main advantage of the system was the provision of reliable results within a few minutes. This not only allowed immediate initiative of appropriate therapy and care for COVID-19 (patient benefit) but provided essential information on isolation and thus available beds. This drastically helped the overall finances of the department and additionally allowed more patients to be admitted including those requiring immediate attention; this was not possible during the first wave since beds were blocked waiting for diagnostic confirmation. Our findings also show that when interpreting the results, the clinical condition and epidemiological history of the patient must be taken into account, as with any test procedure. Overall, the ID NOW(TM) COVID-19 test for SARS-CoV-2 provided a rapid and reliable alternative to laboratory-based RT-PCR in the real clinical setting which became an acceptable part of the daily routine within the ED and demonstrated that early patient management can mitigate the impact of the pandemic on the hospital.

scholarly journals Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031674 ◽  
Author(s):  
Kate Beard ◽  
Nathan Brendish ◽  
Ahalya Malachira ◽  
Samuel Mills ◽  
Cathleen Chan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Respiratory Illness ◽  
Acute Respiratory Illness ◽  
National Guidelines ◽  
South Central ◽  
Randomised Controlled ◽  
The Impact

BackgroundInfluenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.Methods and analysisThe FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.Ethics and disseminationPrior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences.Trial registration numberISRCTN17197293

scholarly journals Impact of point-of-care tests in community pharmacies: a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034298 ◽  
Author(s):  
Ali Albasri ◽  
Ann Van den Bruel ◽  
Gail Hayward ◽  
Richard J McManus ◽  
James Peter Sheppard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Point Of Care ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Clinical Care ◽  
Cochrane Central Register ◽  
Upper Respiratory Tract ◽  
Review Team ◽  
Tract Infections ◽  
The Impact

ObjectivesTo summarise the literature regarding the use of point-of-care test (POCT) in pharmacies versus control/usual care.Design and settingSystematic review and random-effects meta-analysis in community pharmacy.Data sourcesMEDLINE, Cochrane Central Register of Controlled Trials, Embase, ClinicalTrial.gov and Web of Science databases were searched.Eligibility criteriaArticles were included if they: involved a POCT conducted by a community pharmacist, member of pharmacy staff or local equivalent; measured a clinically relevant outcome for example, clinical parameter monitoring. No clinical condition or language limits were set.Patient and public involvementNo patient involvement.Data extraction and synthesisData were independently extracted by two members of the review team to capture changes in clinical care that resulted from the use of the POCTs. The methodological quality of included studies was assessed, using the Cochrane Risk of Bias tool and Newcastle-Ottawa scale.ResultsThirteen of the 1584 articles found were included in the meta-analyses. Studies covered four therapeutic areas: targeted anti-malarial therapy (n=3 studies), glycated haemoglobin (HbA1c) in diabetes (n=2 studies), lipid control (n=3 studies) and international normalised ratio (INR) control in patients taking warfarin (n=5 studies). POCT in pharmacies reduced the risk of receiving antimalarial treatment when not clinically indicated (risk ratio 0.34, 95% CI 0.31 to 0.37). Lipid and HbA1c control appeared largely unaffected by pharmacy POCTs, and the impact on INR time-in-therapeutic-range was inconclusive.ConclusionsOnly 4 out of 13 included studies used a gold-standard randomised controlled trial (RCT) design, limiting our ability to conclusively determine the clinical utility of POCT conducted in pharmacies. Further RCTs are needed, particularly in areas such as upper respiratory tract infections, which have gathered momentum among service commissioners in recent years.PROSPERO registration numberCRD42017048578.

scholarly journals 1717. The Impact of Routine Molecular Point-of-care Testing for Gastrointestinal Pathogens in Adults Hospitalized With Suspected Gastroenteritis: Results of a Pragmatic Randomized Controlled Trial (GastroPOC)

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S51-S51
Author(s):  
Ahalya Malachira ◽  
Kate Beard ◽  
Nathan Brendish ◽  
Tristan Clark
Keyword(s):  
Infection Control ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Infection Control Measure ◽  
Group Versus ◽  
Antibiotic Use ◽  
Turnaround Time ◽  
Control Group ◽  
The Impact

Abstract Background Adults hospitalised with diarrhoea are routinely isolated as an infection control measure, but many have non-infectious etiology. Side room facilities are a limited resource in hospitals. Routine laboratory testing takes several days to generate results but rapid molecular platforms can test comprehensively for GI pathogens and generate a result in 1 hour, making them deployable as point-of-care tests (POCT). POCT could reduce unnecessary isolation facility use in addition to other benefits. Methods In this pragmatic, pilot randomised controlled trial, adults hospitalised with suspected gastroenteritis were recruited and randomised 1:1 to receive either POCT (using the FilmArray GI panel) or routine clinical care. Results of POCT were communicated directly to clinical and infection control teams. The primary outcome was duration of time in a side room and secondary outcomes included turnaround time, proportion of patients with a pathogen detected, proportion of patients correctly de-isolated, time to de-isolation, antibiotic use and length of hospital stay. Results 140 patients were recruited. Groups (n = 70) were well matched in terms of baseline characteristics. The median [IQR] turnaround time for results was 1.7 [1.6–2.3] hours in the POCT group and 61 [49–84] hours in the control group, P < 0.0001. Pathogens were detected in 44% of patients in the POCT group and 23% in the control group; P = 0.012. Overall the duration of side room isolation was 1.9 [1.0–2.9] days in the POCT group compared with 2.7 [1.8–5.1] days in the control group; P = 0.001. For those testing negative for pathogens this was 1.3 [0.8–2.5] days in the POCT group versus 2.7 [1.8–5.0] days in the control group, P < 0.0001. 63% of pathogen-negative patients were correctly de-isolated in the POCT group versus 28% in the control group, P = 0.0012. Antibiotic use and length of stay data will be available subsequently. Conclusion POCT using the FilmArray GI panel resulted in a substantially reduced turnaround time for results and an increase in the proportion of patients with pathogens correctly detected. POCT was associated with a reduction in the duration of unnecessary side room use. If these benefits are confirmed in further studies and cost effectiveness is demonstrated, molecular POCT for GI pathogens should replace current diagnostic pathways. Disclosures T. Clark, BioFire LLC: Collaborator, Research support and Speaker honorarium. NIHR: Grant Investigator, Grant recipient.

scholarly journals P122: The use of decision support tools in the implementation of the Prehospital Canadian Triage Acuity Score (Pre-CTAS)

CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S119-S119
Author(s):  
K.E. Smith ◽  
K. Lobay ◽  
M. Bullard
Keyword(s):  
Decision Support ◽  
Point Of Care ◽  
Clinical Care ◽  
Future Research ◽  
Decision Support Tools ◽  
Triage Nurse ◽  
Kappa Score ◽  
Rater Reliability ◽  
Support Tools ◽  
The Impact

Introduction: The Prehospital Canadian Triage and Acuity Scale (Pre-CTAS) is based upon, and is consistent with, the CTAS (Canadian Triage and Acuity Scale). Paramedic-assigned Pre-CTAS scores using memory compared to Triage Nurse CTAS scores have previously demonstrated moderate inter-rater reliability. This is the first study to measure the effect of two different point-of-care decision support tools on the inter-rater reliability of paramedic assigned Pre-CTAS and Triage nurse CTAS scores. Methods: Paramedics were randomized to Pre-CTAS booklet or CTAS smartphone app during the one-year study period. Pre-CTAS scores assigned on arrival at hospital (AH) were compared with Triage Nurse CTAS scores and analyzed using Cohen’s Kappa. Paramedics were then surveyed to assess the perceived utility and satisfaction with the decision support tools. Results: For 1663 patient transports, the weighted kappa score for Paramedic AH vs. Triage Nurse CTAS was fair at 0.38 (95% CI 0.35-0.41). For patients whose initial on-scene and AH Pre-CTAS scores did not change (n= 1405, 85%), Paramedic-Triage Nurse agreement was moderate at 0.43 (95% CI 0.39-0.46). The survey revealed that tools, when employed, helped assign scores; however accessing the additional resource was cumbersome or time consuming, and scores were occasionally assigned post clinical encounter. Conclusion: Point-of-care external decision support tools did not affect Pre-CTAS and ED CTAS agreement. These tools may add complexity or be perceived to add time to documentation within the delivery of clinical care if not implemented with adequate support. Future research needs to evaluate the impact of clinical decision support embedded within an electronic patient care record consistent with many ED information systems.

scholarly journals Qualitative impact assessment of an educational workshop on primary care practitioner attitudes to NICE HIV testing guidelines

BJGP Open ◽  
2018 ◽  
Vol 2 (1) ◽  
pp. bjgpopen18X101433 ◽  
Author(s):  
Rosalie L Allison ◽  
Ellie J Ricketts ◽  
Thomas Hartney ◽  
Anthony Nardone ◽  
Katy Town ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Point Of Care ◽  
Clinical Care ◽  
Qualitative Interviews ◽  
Normalisation Process Theory ◽  
National Guidelines ◽  
Practitioner Attitudes ◽  
Hiv Test ◽  
The Impact ◽  
Educational Workshop

BackgroundIn 2013, Public Health England piloted the ‘3Cs (chlamydia, contraception, condoms) and HIV (human immunodeficiency virus)’ educational intervention in 460 GP surgeries. The educational HIV workshop aimed to improve the ability and confidence of staff to offer HIV testing in line with national guidelines.AimTo qualitatively assess the impact of an educational workshop on GP staff’s attitudes to NICE HIV testing guidelines.Design & settingQualitative interviews with GP staff across England before and after an educational HIV workshop.MethodThirty-two GP staff (15 before and 17 after educational HIV workshop) participated in interviews exploring their views and current practice of HIV testing. Interview transcripts were thematically analysed and examined, using the components of the theory of planned behaviour (TPB) and normalisation process theory (NPT) as a framework.ResultsGPs reported that the educational HIV workshop resulted in increased knowledge of, and confidence to offer, HIV tests based on indicator conditions. However, overall participants felt they needed additional HIV training around clinical care pathways for offering tests, giving positive HIV results, and current treatments and outcomes. Participants did not see a place for point-of-care testing in general practice.ConclusionImplementation of national HIV guidelines will require multiple educational sessions, especially to implement testing guidelines for indicator conditions in areas of low HIV prevalence. Additional role-play or discussions around scripts suggesting how to offer an HIV test may improve participants’ confidence and facilitate increased testing. Healthcare assistants (HCAs) may need specific training to ensure that they are skilled in offering HIV testing within new patient checks.

scholarly journals LAGOS: learning health systems and how they can integrate with patient care

2019 ◽  
Vol 26 (1) ◽  
pp. e100037 ◽  
Author(s):  
Scott McLachlan ◽  
Kudakwashe Dube ◽  
Evangelia Kyrimi ◽  
Norman Fenton
Keyword(s):  
Health Systems ◽  
Medical Practice ◽  
Health Informatics ◽  
Clinical Care ◽  
Care Process ◽  
Daily Routine ◽  
Study Approach ◽  
Correct Analysis ◽  
Conceptual Setting

ProblemLearning health systems (LHS) are an underexplored concept. How LHS will operate in clinical practice is not well understood. This paper investigates the relationships between LHS, clinical care process specifications (CCPS) and the established levels of medical practice to enable LHS integration into daily healthcare practice.MethodsConcept analysis and thematic analysis were used to develop an LHS characterisation. Pathway theory was used to create a framework by relating LHS, CCPS, health information systems and the levels of medical practice. A case study approach evaluates the framework in an established health informatics project.ResultsFive concepts were identified and used to define the LHS learning cycle. A framework was developed with five pathways, each having three levels of practice specificity spanning population to precision medicine. The framework was evaluated through application to case studies not previously understood to be LHS.DiscussionClinicians show limited understanding of LHS, increasing resistance and limiting adoption and integration into care routine. Evaluation of the presented framework demonstrates that its use enables: (1) correct analysis and characterisation of LHS; (2) alignment and integration into the healthcare conceptual setting; (3) identification of the degree and level of patient application; and (4) impact on the overall healthcare system.ConclusionThis paper contributes a theoretical framework for analysis, characterisation and use of LHS. The framework allows clinicians and informaticians to correctly identify, characterise and integrate LHS within their daily routine. The overall contribution improves understanding, practice and evaluation of the LHS application in healthcare.

scholarly journals Point-of-Care PCR Assays for COVID-19 Detection

Biosensors ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 141
Author(s):  
Niharika Gupta ◽  
Shine Augustine ◽  
Tarun Narayan ◽  
Alan O’Riordan ◽  
Asmita Das ◽  
...  
Keyword(s):  
Point Of Care ◽  
Digital Pcr ◽  
Rt Pcr ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Pcr Assays ◽  
Antigen Tests ◽  
Distinct Features ◽  
The Impact ◽  
Higher Sensitivity

Molecular diagnostics has been the front runner in the world’s response to the COVID-19 pandemic. Particularly, reverse transcriptase-polymerase chain reaction (RT-PCR) and the quantitative variant (qRT-PCR) have been the gold standard for COVID-19 diagnosis. However, faster antigen tests and other point-of-care (POC) devices have also played a significant role in containing the spread of SARS-CoV-2 by facilitating mass screening and delivering results in less time. Thus, despite the higher sensitivity and specificity of the RT-PCR assays, the impact of POC tests cannot be ignored. As a consequence, there has been an increased interest in the development of miniaturized, high-throughput, and automated PCR systems, many of which can be used at point-of-care. This review summarizes the recent advances in the development of miniaturized PCR systems with an emphasis on COVID-19 detection. The distinct features of digital PCR and electrochemical PCR are detailed along with the challenges. The potential of CRISPR/Cas technology for POC diagnostics is also highlighted. Commercial RT–PCR POC systems approved by various agencies for COVID-19 detection are discussed.

Particularities of the independent auditor's report on reliability of accounting (financial) statements for 2019: COVID-19 as qualitatively essential information (Part 2)

2020 ◽  
Vol 23 (7) ◽  
pp. 777-799
Author(s):  
O.I. Shvyreva ◽  
Z.I. Kruglyak ◽  
A.V. Petukh
Keyword(s):  
Financial Reporting ◽  
Financial Statements ◽  
Economic Situation ◽  
Risk Disclosure ◽  
Essential Information ◽  
Logical Method ◽  
Annual Reporting ◽  
The Face ◽  
Key Aspects ◽  
The Impact

Subject. This article discusses the issues related to the practice of financial reporting in the face of uncertainties caused by the coronavirus contagion, as well as the specifics of the audit strategy and formation of an audit opinion on this reporting. Objectives. The article aims to identify the quality characteristics of financial reporting prepared in the context of the COVID-19 pandemic and justify the key aspects of assurance engagement completion in an extremely uncertain epidemiological and economic situation. Methods. For the study, we used an abstract-logical method, content analysis techniques, systematization, and classification. Results. Analyzing the impact of the extremely uncertain epidemiological and economic situation on financial statements, the article clarifies aspects of disclosure of events after the reporting date and threats to business continuity in the annual reporting of economic entities. The article identifies possible alternative procedures and algorithms to obtain proper evidence when it is insufficient in the face of the inability to meet certain audit standards requirements in a remote audit environment. The article defines the impact of COVID-19 risk disclosure on the structure of the audit report and opinion. Relevance. The results of the study can be used in the practical activities of economic entities that prepare financial statements in the face of significant uncertainty, as well as auditors and audit organizations.

Sign in / Sign up

Export Citation Format

Share Document