Abstract

Point-of-care testing promises laboratory-based precision in settings that do not have easy access to laboratories or where processing tests takes too long or is too costly. Developers and global health actors stress values and norms such as simplicity, rapidity and accuracy for realizing diagnostic innovations that work at point of care and are aligned to the specific requirements of point-of-care settings. This paper uses fieldwork among diagnostic manufacturers, scientists, donors, members of civil society, industry consultants, international organizations, regulators, policymakers, programme officers, lab technicians, and clinicians involved in development and implementation of tuberculosis and HIV diagnostics, to examine how norms and values of what constitutes a good point-of-care diagnostic are operating in practice through both top-down and bottom-up dynamics. It draws the link between design, evidence and adoption of diagnostics and how the different actors interpret the values underpinning the new practice. The analysis draws on literature on valuation practices, evidence-making and technology design in science and technology studies and medical sociology. The findings reveal how these values constitute innovation, implementation, and evaluation practices across global and local (India) sites, with important consequences for funding of health infrastructure, capacity, and training resources for addressing some of the existing structural inequalities. Dominant values currently defining point of care diagnostics risk exacerbating health inequalities between those who do and do not have the necessary social and financial resources to access better equipped and functioning healthcare facilities, especially in resource constrained settings.

Highlights

  • What is a good point-of-care (POC) diagnostic? The idea of diagnosing at point of care has gained much enthusiasm and attention among researchers, policymakers and funders in the last decades

  • How do norms and values of what constitutes a good POC diagnostic operate in practice? Through fieldwork and interviews with global diagnostic developers, donors, members of civil society, industry consultants, international organizations, regulators, and researchers involved in innovating POC diagnostics for tuberculosis (TB) and HIV, as well as local implementers, developers, and users in India, we found that simplicity remains a prominent value when developing more sophisticated technologies for POC

  • Our results reveal how donor groups such as Bill and Melinda Gates Foundation, USAID, Foundation for Innovative New Diagnostics (FIND) or UNITAID have considerable influence in defining what is good in relation to the register of simplicity; especially in their role as funders of research and development activities of diagnostic developers and through publication of design standards

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Summary

Introduction

What is a good point-of-care (POC) diagnostic? The idea of diagnosing at point of care (i.e., where patients encounter the healthcare system, for instance in communities and clinics) has gained much enthusiasm and attention among researchers, policymakers and funders in the last decades. By allowing healthcare workers to diagnose without relying on laboratories and laboratory technicians, POC diagnostics change when and where the boundary between the normal and the pathological is drawn and who has the power to make these decisions. More nuanced understandings emphasize the rapid completion of test and treat cycle within one patient encounter (“while the patient waits”) This latter perspective acknowledges that in order to complete processes of diagnosing at POC successfully, POC diagnostics will occupy a spectrum of technologies (from dipsticks to automated molecular tests, portable analysers, and imaging systems), users (lay persons to highly trained), and settings (homes, communities, clinics, to peripheral labs and hospital wards) (Pant Pai et al, 2012)

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