The NIH Rapid Acceleration of Diagnostics (RADx ^SM ) Tech Program was created to speed the development, validation, and commercialization of innovative point-of-care (POC) and home-based tests, and to improve clinical laboratory tests, that can directly detect SARS-CoV-2. Leveraging the experience of the Point-of-Care Technologies Research Network, a Clinical Review Committee (CRC) composed of clinicians, bioengineers, regulatory experts, and laboratorians was created to provide structured feedback to SARS-CoV-2 diagnostic innovators. The CRC convened 53 meetings with 49 companies offering SARS-CoV-2 tests in POC and reference laboratory formats as well as collection materials. The CRC identified common barriers to device design finalization including biosafety, workflow, result reporting, regulatory requirements, sample type, supply chain, limit of detection, lack of relevant validation data, and price-performance-use mismatch. Feedback from companies participating was positive.

中文翻译：

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临床审查委员会：在 RADx Tech 内开发 SARS-CoV-2 体外诊断测试的影响

NIH 快速加速诊断 (RADx ^SM ) 创建技术计划的目的是加快创新床旁 (POC) 和家庭测试的开发、验证和商业化，并改进可以直接检测 SARS-CoV-2 的临床实验室测试。利用即时技术研究网络的经验，成立了一个由临床医生、生物工程师、监管专家和实验室人员组成的临床审查委员会 (CRC)，为 SARS-CoV-2 诊断创新者提供结构化反馈。CRC 与 49 家公司召开了 53 次会议，提供 POC 和参考实验室格式的 SARS-CoV-2 测试以及收集材料。CRC 确定了设备设计最终确定的常见障碍，包括生物安全、工作流程、结果报告、监管要求、样本类型、供应链、检测限、缺乏相关验证数据、和性价比使用不匹配。参与公司的反馈是积极的。