美国FDA授予NOWDiagnostics在家中使用的梅毒抗体测试的营销许可. US FDA grants marketing authorization for NOWDiagnostics' at-home syphilis antibody test.
美国FDA已授予NOWDiagnostics首个在家,非处方测试的营销许可,用于检测人类血液中的梅毒抗体. The US FDA has granted marketing authorisation to NOWDiagnostics for the first at-home, over-the-counter test to detect syphilis antibodies in human blood. 这标志着家庭健康检测方面的一个重大发展,使个人能够在自己家中的隐私中方便地对性传播感染进行检测。 This marks a significant development in home health testing, allowing individuals to conveniently test for the sexually transmitted infection in the privacy of their own homes. 虽然仅凭这一测试的结果不足以诊断梅毒感染,但它们有助于说明确证检测的必要性。 While results from this test alone are not sufficient to diagnose syphilis infection, they can help inform the need for confirmatory testing. 美国食品和药物管理局已经制定了特别的控制措施来规范此项测试,定义标签和性能要求,此次授权创建了一个新的监管分类,允许对未来同类型的设备进行更简化的流程. The FDA has established special controls to regulate this test, defining labeling and performance requirements, and this authorization creates a new regulatory classification that allows for a more streamlined process for future devices of the same type.