Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Clin Biochem. 2023 Jul;117:75-83. doi: 10.1016/j.clinbiochem.2021.11.003. Epub 2021 Nov 19.
The STI diagnostic landscape of FDA cleared tests for use at point-of-care (POC), as well as those emergency use authorized for COVID-19 are reviewed; some of these COVID-19 diagnostics may have platform potential as STI diagnostics. Finally, process innovation is described with self-collection and hub-and-spoke mail-in to reference lab models. Movement of Clinical Laboratory Improvement Amendments (CLIA)-waived POC tests to over-the-counter formats will make tests more accessible to consumers. Together with public health messaging, these measures could accelerate STI and COVID-19 syndemic diagnostic solutions.
本文回顾了美国食品和药物管理局（FDA）批准在即时护理（POC）点使用的性病诊断测试以及为应对 COVID-19 而授权紧急使用的诊断测试，其中一些 COVID-19 诊断方法可能具有作为性病诊断方法的平台潜力。最后，本文描述了自我采集和枢纽辐射邮件送样至参考实验室模式的流程创新。临床实验室改进修正案（CLIA）豁免的 POC 测试转移到非处方格式将使消费者更容易获得测试。这些措施与公共卫生信息传播相结合，可能会加速性传播感染和 COVID-19 双重流行的诊断解决方案。
