美国食品药品管理局 11月10日定版紧急诊断检测验证指引：新发病原体应急授权检测通常需 30 份阳性与 30 份阴性样本
华盛顿 — 美国食品药品管理局 11月10日定版一份指引，说明在卫生与公众服务部长宣布符合紧急使用授权条件后，厂商应如何验证针对新发病原体的体外诊断检测。该指引草案于 2025年1月7日发布，定版文件案卷编号为 FDA-2024-D-2707，意见可随时提交。
管理局称，指引适用于在预授权或紧急使用授权申请中提交的检测数据，以及依据适用执法裁量政策提供的检测，涵盖用于检出病原体的分子与抗原检测，可用于临床实验室、床旁场景或家庭。血清学与抗体检测不在其范围内。与全部管理局指引一样，其中建议不具约束力。
在临床性能方面，管理局称，对于建立在成熟高灵敏技术上的病毒核酸检测，在疫情阶段已可获得样本与对照时，通常 30 份阳性与 30 份阴性预期使用人群样本即已足够。管理局同时举例称，一项仅用 12 份阳性样本验证且表现完美的新冠分子检测申请，在追加 12 份样本后累计阳性符合率降至 71%，该申请随后被撤回。
指引还就居家检测写明，说明书应限一至两页，阅读难度不高于七年级水平，并应只采用无需专门培训的非侵入式采集方式。管理局称，该指引回应了两份评估其新冠应对的独立报告所提建议，目的在于帮助厂商为未来疫情做准备。
FDA Finalized Emergency Diagnostic Test Validation Guidance on November 10, 2026: Typically 30 Positive and 30 Negative Specimens for Emergency Use Tests for Emerging Pathogens
Washington, D.C. — The U.S. Food and Drug Administration finalized guidance on November 10, 2026, on how manufacturers should validate in vitro diagnostic tests for emerging pathogens when the Secretary of Health and Human Services has declared that circumstances justify emergency use authorizations under section 564 of the Federal Food, Drug, and Cosmetic Act. The document followed a draft released January 7, 2025, and comments may be submitted at any time under docket number FDA-2024-D-2707.
The FDA states that the recommendations apply to test data submitted in a pre-EUA or an EUA request, or to tests offered under an applicable enforcement discretion policy. The guidance covers molecular and antigen tests intended to detect a pathogen, designed for use in CLIA certified laboratories, at point of care sites, or at home. Serology and antibody tests are outside its scope. As with all FDA guidance, the recommendations are nonbinding.
On clinical performance, the FDA states that for a viral nucleic acid test built on established, highly sensitive technology, at a stage of an outbreak when samples and comparators are available, at least 30 positive and 30 negative specimens from the intended use population are typically adequate. The agency cites an EUA request for a COVID-19 molecular test validated with only 12 positive samples that showed perfect performance. After 12 more samples were evaluated, cumulative positive percent agreement fell to 71 percent, and the request was withdrawn.
For home use tests, the guidance states that instructions should be limited to one to two pages at no higher than a seventh grade reading level, using only noninvasive collection methods that require no specialized training. The FDA states that the document responds to two independent assessments of its COVID-19 response and is meant to help manufacturers prepare for future outbreaks.
来源链接： https://clpmag.com/lab-management/compliance/fda-finalizes-emergency-diagnostic-test-validation-guidance/
发布：GSM·美国（发布链接）
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