Point-of-Care Testing in Community Pharmacies: A Mixed-Methods Study on Users and Pharmacists’ Facilitators and Barriers

Background Point-of-care tests can contribute to earlier diagnosis and treatment of infectious diseases with the potential to prevent chronic stages. As part of the Fast-Track Cities initiative, a pilot was initiated in community pharmacies in Portugal. Aim To characterize the individuals using point-of-care screening tests for human immunodeficiency virus, hepatitis C and hepatitis B virus infections in community pharmacies, their behaviours and motivations to perform the tests, as well as understand the facilitators and barriers from the perspectives of pharmacists. Method A mixed-methods study was conducted. A survey was applied to test users in pharmacies between May and December 2019, and three focus groups were conducted with pharmacists involved in the initiative. Qualitative data were analysed according to thematic content analysis. Results A total of 210 questionnaires were collected. Point-of-care tests users were predominantly male, mean age of 35 years, the majority were foreign-born and had higher education level. Almost half of the users were first time tested and the main reason for screening was unprotected intercourse. Pharmacists identified speed, confidentiality, counselling provided to users, pharmacists’ initial training to perform the tests and trust in the pharmacist as facilitators of these tests. Stigma associated with infections, the procedure, logistical conditions and the referral process were considered as barriers. Conclusion Pharmacies are an effective screening site, with particular relevance for individuals who are first tested, heterosexuals and some migrants. Nevertheless, it is necessary to understand and reduce barriers and increase the support of specific groups.

Modulating the catalytic activity of gold nanoparticles using amine-terminated ligands

Nanozymes have broad applications in theranostics and point-of-care tests. To enhance the catalytic activity of nanozymes, the conventional strategy is doping metals to form high active nanoalloys. However, high-quality and...

RECENT DEVELOPMENTS IN LABORATORY DIAGNOSIS OF COVID-19 INFECTION- AN UPDATE

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This new virus and disease were unknown before the outbreak began in Wuhan, Hubei Province of China, in December 2019. The World Health Organization (WHO) initially declared COVID19 as the global public health emergency on 30th January 2020 and subsequently a pandemic on March 11, 2020. Besides availability of RT-PCR there is need for development of rapid point of care tests with better sensitivity and specicity which helps in early and accurate diagnosis and also aids in containing the spread . This review summarizes various molecular diagnostics methods, technical guidelines, and advanced testing strategies adopted in India for laboratory diagnosis of COVID-19.

An Overview of Emerging Point-of-Care Tests for Differentiating Bacterial and Viral Infections

Antimicrobial resistance is an important health concern in Canada and around the world. Although resistance arises naturally, the overuse of antibiotics, among many other behavioural, social, and economic drivers, contributes to the emergence of resistance patterns. Within health care settings, diagnostic uncertainty, a situation in which it is uncertain whether a suspected infection is due to a bacterial, viral, or other microorganism, is a regarded as a key driver that contributes to overuse of antibiotics. In these situations, antibiotics may be prescribed although the infection is viral. Emerging health technologies that can help reduce diagnostic uncertainty of acute infections at the point of care may help reduce the unnecessary use of antibiotics. If these point-of-care diagnostic devices demonstrate clinical benefit and cost-effectiveness for health systems, they may complement other interventions as part of antibiotic stewardship programs. This Horizon Scan provides an overview of new and emerging point-of-care tests that help differentiate bacterial and viral infections. Although rapid tests for identifying specific pathogens have existed for decades, these emerging tests aim to assess a wider range of possible pathogens and help inform treatment decisions. Different types of emerging devices, such as rapid molecular tests and immunoassays, are described including how they work and information about their capabilities that may influence their potential use. The report also describes the evidence about the diagnostic accuracy of certain tests and their effect on reducing antibiotic prescribing. Considerations are provided about where tests might be beneficial, such as primary care settings, and the emerging evidence base for their feasibility and acceptability. The emerging evidence suggests that point-of-care tests could be effective tools as part of antibiotic stewardship programs, but further studies assessing specific devices in randomized controlled trials are recommended by researchers and health technology assessment agencies. Monitoring the continued development of devices and the testing landscape, especially in post-pandemic health care, will be important for decision-makers.

Amplified parallel antigen rapid test for point-of-care salivary detection of SARS-CoV-2 with improved sensitivity

In the ongoing COVID-19 pandemic, simple, rapid, point-of-care tests not requiring trained personnel for primary care testing are essential. Saliva-based antigen rapid tests (ARTs) can fulfil this need, but these tests require overnight-fasted samples; without which independent studies have demonstrated sensitivities of only 11.7 to 23.1%. Herein, we report an Amplified Parallel ART (AP-ART) with sensitivity above 90%, even with non-fasted samples. The virus was captured multimodally, using both anti-spike protein antibodies and Angiotensin Converting Enzyme 2 (ACE2) protein. It also featured two parallel flow channels. The first contained spike protein binding gold nanoparticles which produced a visible red line upon encountering the virus. The second contained signal amplifying nanoparticles that complex with the former and amplify the signal without any linker. Compared to existing dual gold amplification techniques, a limit of detection of one order of magnitude lower was achieved (0.0064 ng·mL–1). AP-ART performance in detecting SARS-CoV-2 in saliva of COVID-19 patients was investigated using a case–control study (139 participants enrolled and 162 saliva samples tested). Unlike commercially available ARTs, the sensitivity of AP-ART was maintained even when non-fasting saliva was used. Compared to the gold standard reverse transcription-polymerase chain reaction testing on nasopharyngeal samples, non-fasting saliva tested on AP-ART showed a sensitivity of 97.0% (95% CI: 84.7–99.8); without amplification, the sensitivity was 72.7% (95% CI: 83.7–94.8). Thus, AP-ART has the potential to be developed for point-of-care testing, which may be particularly important in resource-limited settings, and for early diagnosis to initiate newly approved therapies to reduce COVID-19 severity. Graphical abstract

Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation

Introduction Successful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of the contextual and usability factors that affect test results and minimise biosafety risks. This paper presents a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes. Methods A mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was conducted to explore biosafety issues. Results The agreement analysis was conducted on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI:1.3%−98.7%) positive agreement and 96% (95% CI: 92.5%−98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857−0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%−99.6%) positive agreement and 100% (95% CI: 63.1%−100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549−1). The dry run highlighted four main sources of contamination that led to the modification of the standard operating procedures. Simulation post-modification showed no further evidence of contamination. Conclusion Careful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

Exploring Primary Care Clinicians’ Views about How Best to Implement a Potential Trial around Point-of-Care Tests for Common Infections in South Africa

Optimisation of antibiotic prescribing is critical to combat antimicrobial resistance. Point-of-care tests (POCTs) for common infections could be a valuable tool to achieve this in primary care. Currently, their use has primarily been studied in high-income countries. Trials in low-and-middle-income countries face challenges unique to their setting. This study aims to explore the barriers and facilitators for a future trial of POCTs for common infections in South Africa. Twenty-three primary care clinicians in the Western Cape Metropole were interviewed. Interview transcripts were analysed using thematic analysis. We identified three key themes. These themes focused on clinicians’ views about proposed trial design and novel POCTs, clinicians’ perspectives about trial set-up, and specific trial procedures. Participants were overall positive about the proposed trial and POCTs. Potential issues centred around the limited space and technology available and participant retention to follow-up. Additionally, impact on clinic workload was an important consideration. These insights will be invaluable in informing the design of a feasibility trial of POCTs in this setting.

Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

Background Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods We reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA). Results Pooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area. Conclusion Continuous monitoring of clinical performance within more clearly defined target populations is needed.

Molecular chlamydia and gonorrhoea point of care tests implemented into routine practice: Systematic review and value proposition development

Background Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings. Methods We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings. Findings The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a “bridge” between the two. Conclusions Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.