Anahtar Melis N, Shaw Bennett M, Slater Damien, Byrne Elizabeth H, Botti-Lodovico Yolanda, Adams Gordon, Schaffner Stephen F, Eversley Jacqueline, McGrath Graham E G, Gogakos Tasos, Lennerz Jochen, Marble Hetal Desai, Ritterhouse Lauren L, Batten Julie M, Georgantas N Zeke, Pellerin Rebecca, Signorelli Sylvia, Thierauf Julia, Kemball Molly, Happi Christian, Grant Donald S, Ndiaye Daouda, Siddle Katherine J, Mehta Samar B, Harris Jason B, Ryan Edward T, Pierce Virginia M, LaRocque Regina C, Lemieux Jacob E, Sabeti Pardis C, Rosenberg Eric S, Branda John A, Turbett Sarah E
Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
Infectious Disease and Microbiome Program, Eli and Edythe L. Broad Institute of Harvard and MIT, Cambridge, Massachusetts, USA.
J Clin Pathol. 2021 Aug;74(8):496-503. doi: 10.1136/jclinpath-2020-207128. Epub 2021 May 28.
Developing and deploying new diagnostic tests are difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important. During a pandemic, laboratories play a key role in helping healthcare providers and public health authorities detect active infection, a task most commonly achieved using nucleic acid-based assays. While the landscape of diagnostics is rapidly evolving, PCR remains the gold-standard of nucleic acid-based diagnostic assays, in part due to its reliability, flexibility and wide deployment. To address a critical local shortage of testing capacity persisting during the COVID-19 outbreak, our hospital set up a molecular-based laboratory developed test (LDT) to accurately and safely diagnose SARS-CoV-2. We describe here the process of developing an emergency-use LDT, in the hope that our experience will be useful to other laboratories in future outbreaks and will help to lower barriers to establishing fast and accurate diagnostic testing in crisis conditions.
开发和部署新的诊断测试很困难，但针对像新冠疫情这样迅速出现的大流行病，这样做至关重要。在大流行期间，实验室在帮助医疗服务提供者和公共卫生当局检测活动性感染方面发挥着关键作用，这一任务通常使用基于核酸的检测方法来完成。虽然诊断领域正在迅速发展，但聚合酶链反应（PCR）仍然是基于核酸的诊断检测的金标准，部分原因在于其可靠性、灵活性和广泛应用。为解决新冠疫情爆发期间持续存在的当地检测能力严重短缺问题，我们医院设立了一个基于分子的实验室自行开发检测方法（LDT），以准确、安全地诊断严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。我们在此描述开发一种紧急使用的LDT的过程，希望我们的经验对未来疫情爆发中的其他实验室有用，并有助于降低在危机情况下建立快速准确诊断检测的障碍。
