Department of Pathology, University of Michigan School of Medicine, Ann Arbor, MI;
Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA.
Clin Chem. 2018 Aug;64(8):1148-1157. doi: 10.1373/clinchem.2017.275339. Epub 2018 Jun 5.
There are numerous barriers to achieving high-quality laboratory diagnostic testing in resource-limited countries. These include inconsistent supply chains, variable quality of diagnostic devices, lack of human and financial resources, the ever-growing list of available tests, and a historical reliance on syndromic treatment algorithms. A list of essential diagnostics based on an accepted standard like the WHO Essential Medicines List (EML) could coordinate stakeholders in the strengthening of laboratory capacity globally.
To aid in the creation of an essential diagnostics list (EDL), we identified laboratory test indications from expert databases for the safe and effective use of WHO EML medicines. In all, 446 EML medicines were included in the study. We identified 279 conditions targeted by these medicines, spanning communicable and noncommunicable diseases (e.g., HIV, diabetes mellitus).
We found 325 unique diagnostic tests, across 2717 indications, associated with the identified conditions or their associated medicines. The indications were divided into 10 categories: toxicity (865), diagnosis (591), monitoring (379), dosing/safety (325), complications (217), pathophysiology (154), differential diagnosis (97), comorbidities (53), drug-susceptibility testing (22), and companion diagnostic testing (14). We also created a sublist of 74 higher-priority tests to help define the core of the EDL.
An EDL such as we describe here could align the global health community to solve the problems impeding equitable access to high-quality diagnostic testing in support of the global health agenda.
在资源有限的国家，实现高质量实验室诊断检测存在诸多障碍。这些障碍包括供应链不一致、诊断设备质量不稳定、缺乏人力和财力资源、不断增长的可用检测清单，以及对基于综合征治疗算法的历史依赖。根据世卫组织基本药物清单（EML）等公认标准列出的基本诊断清单，可以协调全球利益相关者加强实验室能力。
为了帮助创建基本诊断清单（EDL），我们从专家数据库中确定了实验室检测适应症，以安全有效地使用世卫组织 EML 药物。在这项研究中，共有 446 种 EML 药物被纳入研究。我们确定了这些药物针对的 279 种疾病，涵盖了传染病和非传染病（例如 HIV、糖尿病）。
我们发现了 325 种独特的诊断测试，涉及 2717 种适应症，这些测试与确定的疾病或其相关药物有关。这些适应症分为 10 类：毒性（865）、诊断（591）、监测（379）、剂量/安全性（325）、并发症（217）、病理生理学（154）、鉴别诊断（97）、合并症（53）、药物敏感性测试（22）和伴随诊断测试（14）。我们还创建了一个 74 种更高优先级测试的子列表，以帮助定义 EDL 的核心。
我们所描述的这样的 EDL 可以使全球卫生界团结一致，解决阻碍公平获得高质量诊断检测的问题，以支持全球卫生议程。
