NB公告号对于自测试剂盒产品性能指标的审核要求 临床性能评估要求

accuracy issues

the issue with home tests is accuracy, which is between 85% and95% for detecting covid. that is, they catch about nine of every 10infections, a metric called the test’s “sensitivity.” some peoplehave said that any missed cases are a worry, since a person with afalse negative could go out and infect someone else. but if thealternative is no test at all, then none of those infections wouldbe caught.

准确性问题

家庭测试的一个问题是准确性，对于检测，这些准确性通常在85％到95％之间。也就是说，它们在每10例感染中能检测出9例，该项指标被称为测试的“敏感性”。有人说，任何被遗漏的病例都是令人担心的，因为假阴性的人可能会外出，进而感染他人。但是，如果完全不进行任何测试，那么这些感染都不会被发现。

公告机构对于自测试剂盒产品性能指标的审核要求？ 答：阴性、阳性各 200 例、灵敏度指标≥ 90％、特异性指标≥98％、数据来源须真实有 效，出具数据或报告的机构须具备相关资质，仅提供企业自身编写的总结报告不受认可，还需提供原始数据和报告