The social lives of point-of-care tests in low- and middle-income countries: A meta-ethnography.

Point-of-care tests (POCTs) have become technological solutions for many global health challenges. This meta-ethnography examines what in-depth qualitative research reveals about the "social lives" of POCTs from, highlighting key social considerations for policymakers, funders, developers and users in the design, development and deployment of POCTs. We screened qualitative research examining POCTs in low- and middle-income countries (LMICs) and selected 13 papers for synthesis. Findings illuminate five value-based logics-technological autonomy, care, scalability, rapidity and certainty-shaping global health innovation ecosystems and their entanglement with health systems. Our meta-ethnography suggests POCTs never achieve the technological autonomy often anticipated during design and development processes. Instead, they are both embedded in and constitutive of the dynamic relationships that make up health systems in practice. POCTs are often imagined as caring commodities; however, in use, notions of care inscribed in these devices are constantly negotiated and transformed in relation to multiple understandings of care. POCTs promise to standardize care across scale, yet our analysis indicates non-standard processes, diagnoses and treatment pathways as essential to "fluid technologies" rather than dangerous aberrations. The rapidity of POCTs is constructed and negotiated within multiple distinct temporal registers and POCTs operate as temporal objects that can either speed up or slow down experiences of diagnosis and innovation. Finally, while often valued as epistemic tools that can dispel diagnostic uncertainty, these papers demonstrate that POCTs contribute to new forms of uncertainty. Together, these papers point to knowledge practices as multiple, and POCTs as contributing to, rather than reducing, multiplicity. The values embedded in POCTs are fluid and contested, with important implications for the kind of care these tools can deliver. These findings can contribute to more reflexive approaches to global health innovation, which take into account limitations of established global health logics, and recognise the socio-technical complexity of health systems.

Invisible and undervalued: A qualitative study of laboratory workers' experiences and perceptions of laboratory strengthening in Sierra Leone.

Background: The 2013-2016 West Africa Ebola outbreak highlighted the importance of laboratory capacity to outbreak response while also revealing its long-standing neglect. The outbreak prompted massive international investment into strengthening laboratory services across multiple healthcare settings. Objective: In this article, we explore hospital-based clinical laboratory workers' experiences and perceptions of their everyday working environment in Sierra Leone, and how recent investments in laboratory strengthening have shaped these. Methods: This qualitative study draws on in-depth interviews with eight laboratory workers and participant observation of laboratory practices at a tertiary referral hospital in Freetown between April 2019 and December 2019. Interview and observational data were coded and analysed using a reflexive thematic approach. Results: The Ebola outbreak prompted international investments in automated devices, biosafety training, and a new dedicated infectious diseases laboratory. However, little investment was made in the infrastructure and supply systems needed to sustain routine laboratory work or keep machines functioning. Laboratory workers perceived their work to be under-recognised and undervalued by the government, hospital managers and clinical staff, a perception compounded by under-use of the hospital's laboratory services by clinicians. Conclusion: Understanding laboratory technicians' views, experiences, and priorities is essential to any sustainable laboratory-strengthening effort. Investments in personnel should match investments in technologies and infrastructure for outbreak response. What this study adds: This study contributes to an understanding of how clinical laboratory personnel in Sierra Leone view and experience their work, and introduces the concept of social invisibility to explain these experiences.

Who We Test For: Aligning Relational and Public Health Responsibilities in COVID-19 Testing in Scotland.

COVID-19 testing programs in the UK often called on people to test to "protect others." In this article we explore motivations to test and the relationships to "others" involved in an asymptomatic testing program at a Scottish university. We show that participants engaged with testing as a relational technology, through which they navigated multiple overlapping responsibilities to kin, colleagues, flatmates, strangers, and to more diffuse publics. We argue that the success of testing as a technique of governance depends not only on the production of disciplined selves, but also on the program's capacity to align interpersonal and public scales of responsibility.

Equivocal diagnostics: Making a 'good' point-of-care test for elimination in global health.

What is a diagnostic test for? We might assume the answer to this question is straightforward. A good test would help identify what disease someone suffers from, assist health providers to determine the correct course of treatment and/or enable public health authorities to know and intervene in health at the level of the population. In this article, we show that what a specific diagnostic test is for, the value it holds for different actors, and what makes it good, or not, is often far from settled. We tell the story of the development and design of a rapid antibody test for onchocerciasis, or river blindness, tracking multiple iterations of the device through three configurational moments in the framing of onchocerciasis disease and reshaping of the global health innovation ecosystem. Efforts to build that ecosystem for diagnostics are often premised on the notion that public health needs for diagnostics are pre-given and stable; the challenge is seen to be how to incentivize investment and find a customer base for diagnostics in under-resourced settings. By contrast, we show that for any disease, diagnostic needs are both multiple and constantly in flux, and are unlikely to be met by a single, stand-alone product. In the case of the onchocerciasis Ov-16 rapid test, the failure to recognize and address the multiplicity and instability of diagnostic needs in the innovation process resulted in the development of a rapid point of care test that might be manufactured, procured and used, but is unloved by public health experts and commercial manufacturers alike. The equivocal value of the onchocerciasis rapid test, we suggest, reveals the inadequacy of the current global health innovation ecosystem for developing diagnostic 'goods'.

Is qualitative social research in global health fulfilling its potential?: a systematic evidence mapping of research on point-of-care testing in low- and middle-income contexts.

BACKGROUND: Qualitative social research has made valuable contributions to understanding technology-based interventions in global health. However, we have little evidence of who is carrying out this research, where, how, for what purpose, or the overall scope of this body of work. To address these questions, we undertook a systematic evidence mapping of one area of technology-focused research in global health, related to the development, deployment and use of point-of-care tests (POCTs) for low-and middle-income countries (LMICs). METHODS: We conducted an exhaustive search to identify papers reporting on primary qualitative studies that explore the development, deployment, and use of POCTs in LMICs and screened results to identify studies meeting the inclusion criteria. Data were extracted from included studies and descriptive analyses were conducted. RESULTS: One hundred thirty-eight studies met our inclusion criteria, with numbers increasing year by year. Funding of studies was primarily credited to high income country (HIC)-based institutions (95%) and 64% of first authors were affiliated with HIC-based institutions. Study sites, in contrast, were concentrated in a small number of LMICs. Relatively few studies examined social phenomena related to POCTs that take place in HICs. Seventy-one percent of papers reported on studies conducted within the context of a trial or intervention. Eighty percent reported on studies considering POCTs for HIV and/or malaria. Studies overwhelmingly reported on POCT use (91%) within primary-level health facilities (60%) or in hospitals (30%) and explored the perspectives of the health workforce (70%). CONCLUSIONS: A reflexive approach to the role, status, and contribution of qualitative and social science research is crucial to identifying the contributions it can make to the production of global health knowledge and understanding the roles technology can play in achieving global health goals. The body of qualitative social research on POCTs for LMICs is highly concentrated in scope, overwhelmingly focuses on testing in the context of a narrow number of donor-supported initiatives and is driven by HIC resources and expertise. To optimise the full potential of qualitative social research requires the promotion of open and just research ecosystems that broaden the scope of inquiry beyond established public health paradigms and build social science capacity in LMICs.

Students' and staffs' views and experiences of asymptomatic testing on a university campus during the COVID-19 pandemic in Scotland: a mixed methods study.

OBJECTIVES: To explore the acceptability of regular asymptomatic testing for SARS-CoV-2 on a university campus using saliva sampling for PCR analysis and the barriers and facilitators to participation. DESIGN: Cross-sectional surveys and qualitative semistructured interviews. SETTING: Edinburgh, Scotland. PARTICIPANTS: University staff and students who had registered for the testing programme (TestEd) and provided at least one sample. RESULTS: 522 participants completed a pilot survey in April 2021 and 1750 completed the main survey (November 2021). 48 staff and students who consented to be contacted for interview took part in the qualitative research. Participants were positive about their experience with TestEd with 94% describing it as 'excellent' or 'good'. Facilitators to participation included multiple testing sites on campus, ease of providing saliva samples compared with nasopharyngeal swabs, perceived accuracy compared with lateral flow devices (LFDs) and reassurance of test availability while working or studying on campus. Barriers included concerns about privacy while testing, time to and methods of receiving results compared with LFDs and concerns about insufficient uptake in the university community. There was little evidence that the availability of testing on campus changed the behaviour of participants during a period when COVID-19 restrictions were in place. CONCLUSIONS: The provision of free asymptomatic testing for COVID-19 on a university campus was welcomed by participants and the use of saliva-based PCR testing was regarded as more comfortable and accurate than LFDs. Convenience is a key facilitator of participation in regular asymptomatic testing programmes. Availability of testing did not appear to undermine engagement with public health guidelines.

The "ready-to-hand" test: Diagnostic availability and usability in primary health care settings in Sierra Leone.

This article assesses the availability of essential diagnostic tests in primary health care facilities in two districts in Sierra Leone. In addition to evaluating whether a test is physically present at a facility, it extends the concept of availability to include whether equipment is functional and whether infrastructure, systems, personnel and resources are in place to allow a particular test to be "ready to hand", that is, available for immediate use when needed. Between February 2019 and September 2019, a cross-sectional mixed-methods survey was conducted in all 40 Community Health Centres (CHCs) in Western Area, one of five principal divisions in Sierra Leone. The number of rapid diagnostic tests (RDTs) available ranged from 1-12, with 75% of facilities having 9 or less RDTs available out of a possible 17. While RDTs were overall more widely present than manual assays, there was wide variation between tests. The presence of RDTs at individual facilities was associated with having a permanent laboratory technician on staff. Despite CHCs being formally designated as providing laboratory services, no CHC fulfilled standard World Health Organisation (WHO) criteria for a laboratory. Only 9/40 (22.5%) CHCs had a designated laboratory space and a permanently employed laboratory technician. There was low availability of essential equipment and infrastructure. Supply chains were fragmented and unreliable, including a high dependency (>50%) on informal private sources for the majority of the available RDTs, consumables, and reagents. We conclude that the readiness of diagnostic services, including RDTs, depends on the presence and functionality of essential infrastructure, human resources, equipment and systems and that RDTs are not on their own a solution to infrastructural failings. Efforts to strengthen laboratory systems at the primary care level should take a holistic approach and focus on whether tests are "ready-to-hand" in addition to whether they are physically present.

The hidden burden of medical testing: public views and experiences of COVID-19 testing as a social and ethical process.

BACKGROUND: In May 2020, the Scottish Government launched Test and Protect, a test, trace and isolate programme for COVID-19 that includes a PCR testing component. The programme's success depended on the willingness of members of the public to seek out testing when they experienced symptoms and to comply with guidelines on isolation should they test positive. Drawing on qualitative interview-based research, this paper analyses public understandings, expectations, and experiences of COVID-19 testing during the early stages of the programme. Through anthropological and sociological analysis of the findings we aim to contribute to social understandings of COVID-19 testing practices; and to inform the design of population level testing programmes for future pandemics. METHODS: Between 7 July and 24 September 2020, 70 semi-structured interviews were conducted with members of the general public (aged 19-85) living in the Lothian region of Scotland. Interviews were held online or by telephone, were transcribed verbatim and analysed using thematic analysis informed by anthropological and sociological theories of medical testing. FINDINGS: Social relationships and ethical considerations shape testing practices at every stage of the testing process. Members of the public viewed testing as a civic duty to society and moral duty to friends, family, and colleagues. However, the testing process also placed a significant social, economic, and practical burden on the individual and sometimes generated competing obligations. Many participants experienced a disconnect between the government's portrayal of testing as easy and the everyday burden of testing. CONCLUSIONS: COVID-19 testing is experienced as a social process shaped by multiple relationships and ethical considerations. The full burden of testing should be considered in the design of future testing programmes.

Human preparedness: Relational infrastructures and medical countermeasures in Sierra Leone.

This paper examines health worker experiences in two areas of post-epidemic preparedness in Sierra Leone - vaccine trials and laboratory strengthening - to reflect on the place of people in current models of epidemic response. Drawing on ethnographic research and interviews with health workers in the aftermath of Ebola, it explores the hopes and expectations that interventions foster for frontline workers in under-resourced health systems, and describes the unseen work involved in sustaining robust response infrastructures. Our analysis focuses on what it means for the people who sustain health systems in an emergency to be 'prepared' for an epidemic. Human preparedness entails more than the presence of a labour force; it involves building and maintaining 'relational infrastructures', often fragile social and moral relationships between health workers, publics, governments, and international organisations. The COVID-19 pandemic has underscored the value of rethinking human resources from an anthropological perspective, and investing in the safety and support of people at the forefront of response. In describing the labour, personal losses, and social risks undertaken by frontline workers for protocols and practicality to meet in an emergency context, we describe the social process of preparedness; that is, the contextual engineering and investment that make response systems work.

Engineering a sustainable future for point-of-care diagnostics and single-use microfluidic devices.

Single-use, disposable, point-of-care diagnostic devices carry great promise for global health, including meeting urgent needs for testing and diagnosis in places with limited laboratory facilities. Unfortunately, the production and disposal of single-use devices, whether in lateral flow assay, cartridges, cassettes, or lab-on-chip microfluidic format, also poses significant challenges for environmental and human health. Point-of-care devices are commonly manufactured from unsustainable polymeric materials derived from fossil sources. Their disposal often necessitates incineration to reduce infection risk, thereby creating additional release of CO2. Many devices also contain toxic chemicals, such as cyanide derivatives, that are damaging to environmental and human health if not disposed of safely. Yet, in the absence of government regulatory frameworks, safe and sustainable waste management for these novel medical devices is often left unaddressed. There is an urgent need to find novel solutions to avert environmental and human harm from these devices, especially in low- and middle-income countries where waste management infrastructure is often weak and where the use of point-of-care tests is projected to rise in coming years. We review here common materials used in the manufacture of single-use point-of-care diagnostic tests, examine the risks they pose to environmental and human health, and investigate replacement materials that can potentially reduce the impact of microfluidic devices on the production of harmful waste. We propose solutions available to point-of-care test developers to start embedding sustainability at an early stage in their design, and to reduce their non-renewable plastic consumption in research and product development.

Diagnostic waste: whose responsibility?

Waste management is notably absent from current discussions about efforts to improve access to diagnostics in low-and middle-income Countries (LMICs). Yet an increase in testing will inevitably lead to an increase in diagnostic waste, especially since many of the diagnostic tests designed for use in LMICs are single-use point-of-care tests. Diagnostic waste poses a threat to both human and environmental health. In this commentary we draw on our experience of diagnostic waste management in Sierra Leone and review current evidence on: the volume and impact of diagnostic waste in LMICs, existing health-care waste management capacity in LMICs, established national and international policies for improving health-care waste management, and opportunities for strengthening policy in this area. We argue that questions of safe disposal for diagnostics should not be an afterthought, only posed once questions of access have already been addressed. Moreover, responsibility for safe disposal of diagnostic waste should not fall solely on national health systems by default. Instead, consideration of the end-life of diagnostic products must be fully integrated into the diagnostic access agenda and greater pressure should be placed on manufacturers to take responsibility for the full life-cycle of their products.

Responsibility, repair and care in Sierra Leone's health system.

Central to the workings of a hospital are the technical and bureaucratic systems that ensure the effective coordination of information and biological materials of patients across time and space. In this paper, which is based on ethnographic research in a public referral hospital in Freetown, Sierra Leone, conducted between October 2018 and September 2019, we adopt a patient pathway approach to examine moments of breakdown and repair in the coordination of patient care. Through the in-depth analysis of a single patient pathway through the hospital, we show how coordination work depends on frequent small acts of intervention and improvisation by multiple people across the pathway, including doctors, managers, nurses, patients and their relatives. We argue that such interventions depend on the individualisation of responsibility for 'making the system work' and are best conceptualised as acts of temporary repair and care for the health system itself. Examining how responsibility for the repair of the system is distributed and valued, both within the hospital and in terms of broader structures of health funding and policy, we argue, is essential to developing more sustainable systems for repair.

Knowledge, Attitudes, and Behavior Related to COVID-19 Testing: A Rapid Scoping Review.

Testing programs for COVID-19 depend on the voluntary actions of members of the public for their success. Understanding people's knowledge, attitudes, and behavior related to COVID-19 testing is, therefore, key to the design of effective testing programs worldwide. This paper reports on the findings of a rapid scoping review to map the extent, characteristics, and scope of social science research on COVID-19 testing and identifies key themes from the literature. Main findings include the discoveries that people are largely accepting of testing technologies and guidelines and that a sense of social solidarity is a key motivator of testing uptake. The main barriers to accessing and undertaking testing include uncertainty about eligibility and how to access tests, difficulty interpreting symptoms, logistical issues including transport to and from test sites and the discomfort of sample extraction, and concerns about the consequences of a positive result. The review found that existing research was limited in depth and scope. More research employing longitudinal and qualitative methods based in under-resourced settings and examining intersections between testing and experiences of social, political, and economic vulnerability is needed. Last, the findings of this review suggest that testing should be understood as a social process that is inseparable from processes of contact tracing and isolation and is embedded in people's everyday routines, livelihoods and relationships.

Acceptability and perceived utility of different diagnostic tests and sample types for trachoma surveillance in the Bijagos Islands, Guinea Bissau.

BACKGROUND: Trachoma is the leading infectious cause of blindness worldwide and is nearing elimination as a public health problem in Guinea Bissau. It is imperative that elimination is followed by a successful postvalidation surveillance programme. The aim of this study was to determine the acceptability and perceived utility of different diagnostic tests and sample types that could be used for postvalidation trachoma surveillance in the Bijagos Islands, Guinea Bissau. METHODS: Semistructured interviews with community members and stakeholders involved in trachoma elimination were followed by focus group discussions with community members, covering experiences with trachoma and views on trachoma diagnostic methods and sample types. RESULTS: In this setting, all diagnostic tests and sample types used for trachoma surveillance were generally considered acceptable by communities. A preference for laboratory-based testing and finger-prick blood samples was expressed as these results were considered more accurate and applicable to a range of diseases beyond trachoma. CONCLUSIONS: Appropriate community and stakeholder engagement and communication regarding the purpose and processes around diagnostic practice prior to trachoma programme implementation are crucial for long-term successful disease-elimination efforts.

A cross-sectional survey of practices and knowledge among antibiotic retailers in Nairobi, Kenya.

BACKGROUND: Antimicrobial resistance (AMR) driven by antibiotic consumption is a growing global health threat. However, data on antimicrobial consumption patterns in low- and middle-income countries (LMICs) is sparse. Here, we investigate the patterns of antibiotic sales in humans and livestock in urban Nairobi, Kenya, and evaluate the level of awareness and common behaviours related to antibiotic use and AMR amongst human and veterinary pharmacists. METHODS: A total of 40 human and 19 veterinary drug store pharmacists were interviewed in Nairobi in 2018 using a standard questionnaire. Data recorded included demographic variables, types of antibiotics sold, antibiotic customers, antibiotic prescribing practices and knowledge of antibiotic use and AMR. RESULTS: Our study shows that at the retail level, there is a considerable overlap between antibiotic classes (10/15) sold for use in both human and veterinary medicine. Whilst in our study, clinical training significantly influenced knowledge on issues related to antibiotic use and AMR and respondents had a relatively adequate level of knowledge about AMR, several inappropriate prescribing practices were identified. For example, we found that most veterinary and human drug stores (100% and 52% respectively) sold antibiotics without a prescription and noted that customer preference was an important factor when prescribing antibiotics in half of the drug stores. CONCLUSION: Although more research is needed to understand the drivers of antibiotic consumption in both human and animal populations, these findings highlight the need for immediate strategies to improve prescribing practices across the pharmacists in Nairobi and by extension other low- and middle-income country settings.

The hospital and the hospital: Infrastructure, human tissue, labour and the scientific production of relational value.

How does science make a home for itself in a public hospital? This article explores how scientists working in 'resource poor' contexts of global health negotiate relationships with their hosts, in this case the doctors, nurses and patients who already inhabit a provincial-level hospital. Taking its lead from recent works on science, ethics and development, this article seeks to 'provincialize the laboratory' by focussing on the scientific tropics as a space of productive encounter and engagement. A view from the hospital reveals the tenuous process of 'setting up' a place for science, in a world that does not immediately recognize its value. The article examines the material exchanges of infrastructure, bodily tissues and labour that enable one young scientist to establish a scientific life for himself. The success of those transactions, it argues, ultimately derives from their objectification of scientific vulnerability and their enactment of relationships of mutual recognition. As opposed to asking how scientific knowledge is produced in the tropics, the view from the hospital challenges us to focus on the establishment of relationships between scientists and their hosts as a productive endeavour in its own right.

Food as pharma: marketing nutraceuticals to India's rural poor.

This commentary sketches out the politics of the expansion of affordable, fast-moving nutraceutical products into rural India, with a focus on fortified foods and beverages. It examines the relationships between industry, government and humanitarian organisations that are being forged alongside the development of markets for nutraceuticals; the production of evidence and the harnessing of science to support nutraceutical companies' claims; the ways in which nutraceuticals are being marketed and distributed in rural areas; and the concepts of health and well-being that are being promulgated through those marketing campaigns. Lastly, it asks what kinds of impact fast-moving nutraceuticals are likely to have on the lives of India's rural poor. It concludes by questioning how smooth a transition to nutraceutical consumption Big Food marketing strategies can really facilitate and how readily low-income families seeking to feed their families and safeguard health will actually adopt concepts of wellness and internalise micro-nutrient associated risks.