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’.

中文翻译：

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模棱两可的诊断：为消除全球健康做出“良好”的现场护理测试


诊断测试的目的是什么？我们可能假设这个问题的答案很简单。良好的测试将有助于确定某人患有什么疾病，帮助医疗服务提供者确定正确的治疗方案和/或使公共卫生当局能够了解并干预人群的健康状况。在本文中，我们展示了特定诊断测试的用途、它对不同参与者的价值以及它的好坏的原因通常还远未确定。我们讲述了盘尾丝虫病或河盲症快速抗体测试的开发和设计故事，通过盘尾丝虫病框架中的三个配置时刻跟踪设备的多次迭代，并重塑全球健康创新生态系统。建立诊断生态系统的努力通常以这样的理念为前提：公共卫生对诊断的需求是预先给定且稳定的；所面临的挑战是如何激励投资并为资源贫乏地区的诊断寻找客户群。相比之下，我们表明，对于任何疾病，诊断需求都是多种多样且不断变化的，并且不太可能通过单一的独立产品来满足。就盘尾丝虫病 Ov-16 快速检测而言，创新过程中未能认识到并解决诊断需求的多样性和不稳定性，导致开发了一种快速护理点检测，该检测可能会被制造、采购和使用，但不受公共卫生专家和商业制造商的喜爱。我们认为，盘尾丝虫病快速检测的模糊价值揭示了当前全球健康创新生态系统在开发诊断“产品”方面的不足。