Impact Of Point-of-care Testing Research Articles

Analysis and mapping of global research publications on point-of-care testing for infectious diseases.

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

Stakeholders' views and experiences on implementing new diagnostics in primary care to support management of community-acquired acute respiratory tract infections: a qualitative study.

The majority of antibiotics are prescribed in primary care for respiratory tract infections. Point-of-care tests (POCTs) for the management of community-acquired acute respiratory tract infections (CA-ARTI) have been developed to help optimize antibiotic prescribing. While some countries in Europe have adopted these tests in primary care settings, most have not. Stakeholders, such as policy-makers, regulators, the diagnostic industry, and scientific associations, have roles in the implementation of new diagnostics in primary care. The aim of this study is to explore these stakeholders' views and experiences, and identify areas of unmet need relating to POCT implementation. Stakeholders were recruited using purposive sampling and snowballing. Between March 2021 and May 2022, semi-structured interviews were conducted online with stakeholders in Belgium, the UK and from European Union (EU) -level organizations. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed inductively and deductively using thematic analysis. Twenty-six stakeholders participated: eleven from EU-level organizations, seven from Belgium, and eight from the UK. Five themes were identified. Stakeholders felt a balance of top-down and bottom-up approaches were an optimal strategy to the implementation of POCTs. Stakeholders stressed the need to engage with clinicians to act as champions for tests to help raise awareness and generate new evidence on how tests are used. While acknowledging the potential of POCTs for improving patient outcomes and impacting antibiotic prescribing behavior, some raised concerns on how tests would be used in practice and wished to see national data on effectiveness. COVID-19 catalyzed the use of tests, but stakeholders were pessimistic that processes for approving diagnostics during the pandemic would be replicated in the future. Stakeholders provided recommendations for research and practice. Robust reimbursement policies could alleviate financial burden from clinicians and patients, encouraging practices to adopt POCTs. Industry is likely to benefit from engaging as early on as possible with other stakeholders. Due to uncertainty among stakeholders on the impact of POCTs on antibiotic prescribing, further evidence is needed to understand how practices adopt POCTs and the implications for stewardship. Monitoring how POCTs are used can inform future guidelines on successful diagnostic implementation.

The Debate ROTEMs on–the Utility of Point-of-care Testing and Fibrinogen Concentrate in Postpartum Hemorrhage

(Anaesthesia. 2020;75:1247–1251) A 2019 report by McNamara et al revealed 4 years of data from their use of rotational thromboelastometry (ROTEM) to help guide the treatment of major obstetric hemorrhage (PPH; defined as >1500 mL estimated blood loss with continued bleeding or evidence of shock). Their proposed ROTEM-guided strategy for transfusion called for fibrinogen concentrate to treat coagulopathy in place of fresh frozen plasma (FFP) and/or cryoprecipitate. The ROTEM-based protocol was compared to the previous care standard, which included a shock pack containing four units of FFP, four units of packed red cells, and one pooled unit of platelets. The authors of the original report noted that use of the ROTEM-guided transfusion algorithm had a statistically significant reduction in the number of units and total volume of blood products transfused. This, in turn, pushed them to argue that not all women who experience major PPH are coagulopathic suggesting that perhaps goal-directed transfusion guided by point-of-care (POC) testing is more justified than the routine use of transfusion shock packs in these cases. This issue of Clinical Consequences aims to discuss several controversies: use of fibrinogen concentrates in PPH-related coagulopathy, utility of POC testing in obstetrics and impact of POC testing in guidelines for PPH management; and finally the McNamara et al paper’s likely influence on clinical practice.

Point-of-Care PCR Assays for COVID-19 Detection.

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.

In-vitro diagnostic point-of-care tests in paediatric ambulatory care: A systematic review and meta-analysis.

Paediatric consultations form a significant proportion of all consultations in ambulatory care. Point-of-care tests (POCTs) may offer a potential solution to improve clinical outcomes for children by reducing diagnostic uncertainty in acute illness, and streamlining management of chronic diseases. However, their clinical impact in paediatric ambulatory care is unknown. We aimed to describe the clinical impact of all in-vitro diagnostic POCTs on patient outcomes and healthcare processes in paediatric ambulatory care. We searched MEDLINE, EMBASE, Pubmed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science from inception to 29 January 2020 without language restrictions. We included studies of children presenting to ambulatory care settings (general practice, hospital outpatient clinics, or emergency departments, walk-in centres, registered drug shops delivering healthcare) where in-vitro diagnostic POCTs were compared to usual care. We included all quantitative clinical outcome data across all conditions or infection syndromes reporting on the impact of POCTs on clinical care and healthcare processes. Where feasible, we calculated risk ratios (RR) with 95% confidence intervals (CI) by performing meta-analysis using random effects models. We included 35 studies. Data relating to at least one outcome were available for 89,439 children of whom 45,283 had a POCT across six conditions or infection syndromes: malaria (n = 14); non-specific acute fever 'illness' (n = 7); sore throat (n = 5); acute respiratory tract infections (n = 5); HIV (n = 3); and diabetes (n = 1). Outcomes centred around decision-making such as prescription of medications or hospital referral. Pooled estimates showed that malarial-POCTs (Plasmodium falciparum) better targeted antimalarial treatment by reducing over-treatment by a third compared to usual care (RR 0.67; 95% CI [0.58 to 0.77], n = 36,949). HIV-POCTs improved initiating earlier antiretroviral therapy compared to usual care (RR, 3.11; 95% CI [1.55 to 6.25], n = 912). Across the other four conditions, there was limited evidence for the benefit of POCTs in paediatric ambulatory care except for acute respiratory tract infections (RTI) in low-and-middle-income countries (LMICs), where POCT C-Reactive Protein (CRP) may reduce immediate antibiotic prescribing by a third (risk difference, -0.29 [-0.47, -0.11], n = 2,747). This difference was shown in randomised controlled trials in LMICs which included guidance on interpretation of POCT-CRP, specific training or employed a diagnostic algorithm prior to POC testing. Overall, there is a paucity of evidence for the use of POCTs in paediatric ambulatory care. POCTs help to target prescribing for children with malaria and HIV. There is emerging evidence that POCT-CRP may better target antibiotic prescribing for children with acute RTIs in LMIC, but not in high-income countries. Research is urgently needed to understand where POCTs are likely to improve clinical outcomes in paediatric settings worldwide.

Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa

BackgroundMany clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa.MethodsWe used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation.ResultsAmong 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment.ConclusionsThis busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.

Detection of antibiotic resistance is essential for gonorrhoea point-of-care testing: a mathematical modelling study

BackgroundAntibiotic resistance is threatening to make gonorrhoea untreatable. Point-of-care (POC) tests that detect resistance promise individually tailored treatment, but might lead to more treatment and higher levels of resistance. We investigate the impact of POC tests on antibiotic-resistant gonorrhoea.MethodsWe used data about the prevalence and incidence of gonorrhoea in men who have sex with men (MSM) and heterosexual men and women (HMW) to calibrate a mathematical gonorrhoea transmission model. With this model, we simulated four clinical pathways for the diagnosis and treatment of gonorrhoea: POC test with (POC+R) and without (POC−R) resistance detection, culture and nucleic acid amplification tests (NAATs). We calculated the proportion of resistant infections and cases averted after 5 years, and compared how fast resistant infections spread in the populations.ResultsThe proportion of resistant infections after 30 years is lowest for POC+R (median MSM: 0.18%, HMW: 0.12%), and increases for culture (MSM: 1.19%, HMW: 0.13%), NAAT (MSM: 100%, HMW: 99.27%), and POC−R (MSM: 100%, HMW: 99.73%). Per 100 000 persons, NAAT leads to 36 366 (median MSM) and 1228 (median HMW) observed cases after 5 years. Compared with NAAT, POC+R averts more cases after 5 years (median MSM: 3353, HMW: 118). POC tests that detect resistance with intermediate sensitivity slow down resistance spread more than NAAT. POC tests with very high sensitivity for the detection of resistance are needed to slow down resistance spread more than by using culture.ConclusionsPOC with high sensitivity to detect antibiotic resistance can keep gonorrhoea treatable longer than culture or NAAT. POC tests without reliable resistance detection should not be introduced because they can accelerate the spread of antibiotic-resistant gonorrhoea.

La Gestione Ambulatoriale Della Terapia Anticoagulante Orale (TAO) Nelle Cure Primarie: L'esperienza Dell'Associazione “Medicina di Gruppo di Masate”

Oral anticoagulants are used for prophylaxis in thromboembolic conditions. Vitamin K antagonists (VKAs) such as warfarin, are commonly employed. The anticoagulation activity induced by VKAs is monitored by the prothrombin time test to determine the International Normalized Ratio (INR). Point-of-care testing (POCT) devices can be used to monitor anticoagulant therapy improving the quality of oral anticoagulation. This paper aims at describing the relevant experience of the “Medicina di Gruppo di Masate” in general practice. We also put this experience into the general context of the international evidence on the impact of POCT. Both our experience and the international evidence may support anticoagulant therapy management by GPs (General Practitioners).

Point of Care Testing—Current and Emerging Quality Perspectives

The volume and repertoire of point-of-care testing (POCT) is increasing rapidly, and it is now used in a variety of settings, including patient self-testing. Point-of-care testing offers the significant advantage of rapidly available test results, which have the potential to expedite clinical decision making and improve patient outcomes. Modification of traditional patient care pathways may be required to attain the maximum clinical benefit from POCT. Although POCT simplifies the testing process, it may be more prone to error than conventional laboratory testing. Operator-related error has emerged as a significant risk factor. Efforts to minimize POCT-related quality errors should focus on better and more robust instrument design with increased automation, improved training, and assessment of POCToperators and an enhanced regulatory and governance framework. A key quality measure is the impact of POCT on clinical outcomes, but this generally has been less well documented. Evidence on the effect of self-monitoring of blood glucose in diabetes and selfInternational Normalized Ratio testing for patients on long-term anticoagulant therapy in improving clinical outcomes measures highlight the potential for POCT to enhance patient care.

Point-of-Care Testing: Improving Emergency Department Performance through Process Redesign

Hospital emergency departments (EDs) typically rely on central laboratories to analyze patient samples for the purposes of diagnosing and treating patients. Point-of-care testing (POCT) is a process redesign that shifts the analysis of samples from the central lab to the ED. Using a queueing model, we generate hypotheses about how POCT impacts operational performance and then test those hypotheses empirically using data collected from a large, urban, tertiary, academic hospital. Specifically, we analyze how the adoption of POCT impacts service time, defined as the time between patient bed assignment and disposition, and waiting time, defined as the time between patient intake and bed assignment, as well as the quality of care provided to patients, defined by the 72 hour bounceback rate. We find POCT to be associated with statistically significant improvements in nearly all measures of operational performance. Specifically, we find the adoption of POCT to be associated with a 21.6% reduction in service time among test patients during peak hours and a 35.5% reduction in waiting time among all low priority patients presenting during peak hours. Moreover, we find the adoption of POCT to be associated with improved service quality as patients’ predicted probability of bounceback decreased by 0.6% during its usage. We also find system wide spillover effects for patients who do not receive POCT (no-test patients). In other words, the adoption of POCT is associated with a service time reduction among these no-test patients of 4.73% and the observed changes in waiting time are statistically similar across test and no-test patients. By examining the impact of POCT among both the population of patients receiving the test and the population that does not, this research is unique in identifying the system-wide benefits that can be attained through ED process redesign.

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

BackgroundPoint of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT.Design/MethodsThe Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location.DiscussionThe paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided. The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.Trial Registration12612605000272695

Point-of-Care Testing in Diabetes Management: What Role Does It Play?

Diabetes is a multisystem disease requiring complex management provided by a variety health care professionals (HCPs). Comprehensive care of patients with diabetes requires frequent testing of hemoglobin A1c (A1C),and research indicates that use of point-of-care testing (POCT) can affect patients' A1C results in the shortterm. The purpose of this qualitative study was to explore the ideas, opinions, and expectations of HCPs and patients with diabetes about the potential role of POCT, including its impact on patient-provider interactions, patient care, and issues of implementation.In-depth interviews, which were audiotaped and transcribed verbatim, were conducted with key stakeholders. The analysis used immersion and crystalization strategies. Thirty-seven interviews were conducted: seven with endocrinologists and internists, seven with family physicians, eight with diabetes educators, seven with family practice nurses, and eight with patients with diabetes.Two major themes emerged from the data analysis: 1) the impact of POCT on the clinical encounter and the care of patients, and 2) the POCT machine, including accuracy and the cost of incorporating the machine into clinical practice. The analysis revealed strong similarities across all groups of HCPs, and patients also expressed similar concerns.This study illuminates perceptions of HCPs and patients regarding the impact of POCT on diabetes management. POCT was viewed as having many benefits in the clinical care of patients with diabetes, including face-to-face encounters that offer immediate feedback, proactive patient education,increased collaboration between patients and providers, and improved patient adherence. However, logistical issues, such as the machine's accuracy and cost factors, could be significant barriers to implementation

Faster Is Better—It’s Rarely That Simple!

With the enormous popularity of audioconferences, meetings, and special inserts in nonarchived journals regarding point-of-care testing (POCT), it is clear that laboratorians are struggling with questions about implementing and managing POCT. Yet there is a paucity of serious studies in the peer-reviewed literature that address the benefits of POCT. In this issue, Nichols et al. (1) present a study that examined the impact of POCT implementation on patient waiting time for interventional cardiology procedures. This study provides an example of the proper way to address decisions regarding the implementation of POCT. The authors established an hypothesis about the impact of POCT in their setting, implemented POCT, examined a measurable outcome, and then made adjustments to patient management and workflow when simple implementation of POCT did not substantiate their hypothesis. The bottom line from this study is that despite the initial intuition that faster laboratory values would be better, it took more than just fast laboratory data to obtain the desired benefit. These authors found that simply moving the point of testing from the central laboratory to the clinical service did not improve patient waiting time until significant changes in workflow were made. The predictions of the second phase of their study [when the potential time-savings of POCT vs central laboratory turnaround time (TAT) were determined] suggested that 92% of patients requiring either renal function or coagulation tests could meet their scheduled procedure time with POCT. By contrast, at baseline, only 8% and 29% …