HIV Programmes and Advocacy, International AIDS Society, Geneva, Switzerland.
Board of Directors, MedTech Europe, Brussels, Belgium.
Clin Infect Dis. 2018 Jan 6;66(2):301-305. doi: 10.1093/cid/cix719.
In vitro diagnostic devices (IVDs) help clinicians determine specific conditions, monitor therapeutic efficacy, and prevent drug resistance development. While stringent regulatory authorities (SRAs) regulate IVDs in most high-income countries, regulatory authorities in many low- and middle-income countries (LMICs) are nonexistent or do not enforce rigorous standards. In 2010, the World Health Organization established its Prequalification of In Vitro Diagnostics (PQDx) program to ensure "access to safe, appropriate and affordable" IVDs, especially in LMICs with little or no domestic regulatory frameworks, thereby reaching underserved populations. However, challenges in PQDx policies and procedures include an overloaded pipeline, timelines not publicly available, confusion about which products PQDx focuses on, perceived burden for documenting changes to prequalified products, overlap with SRA approvals, and uncertainty around long-term financing. PQDx can maximize its impact by considering the perspective of IVD manufacturers; similarly, IVD manufacturers should exercise adequate quality control over their submissions and associated processes.
体外诊断设备（IVD）有助于临床医生确定特定的病情、监测治疗效果和预防耐药性的产生。虽然大多数高收入国家都有严格的监管机构（SRA）来监管 IVD，但许多低收入和中等收入国家（LMIC）的监管机构要么不存在，要么没有执行严格的标准。2010 年，世界卫生组织设立了体外诊断产品预认证（PQDx）计划，以确保“获得安全、适当和负担得起的”IVD，特别是在那些几乎没有或没有国内监管框架的 LMIC，从而为服务不足的人群提供服务。然而，PQDx 政策和程序面临的挑战包括：积压的产品过多、时间表不公开、对 PQDx 关注哪些产品存在混淆、认为记录预认证产品变更的负担过重、与 SRA 批准重叠，以及长期融资的不确定性。PQDx 可以通过考虑 IVD 制造商的角度来最大化其影响；同样，IVD 制造商也应该对其提交的产品和相关流程进行充分的质量控制。
