Laboratory-Generated DNA Can Cause Anomalous Pathogen Diagnostic Test Results

• DOI: 10.1128/spectrum.00313-21
• Publication Date: 2021-09-15T14:35:53Z
• Authors: Lindsey R. Robins...; Alexander J. Mijalis; Gabriel T. Filsinger; Helena de Puig; Nina M. Donghia; Thomas E. Schaus; Robert A. Rasmussen; Raphael Ferreira; Jeantine E. Lunshof; George Chao; Dmitry Ter-Ovanesyan; Oliver Dodd; Erkin Kuru; Adama M. Sesay; Joshua Rainbow; Andrew C. Pawlowski; Timothy M. Wannier; Nicolaas M. Angen...; Devora Najjar; Peng Yin; Donald E. Ingber; Jenny M. Tam; George M. Church
• Keywords: Pandemic; Nucleic acid test; Nucleic acid detection

The coronavirus disease 2019 (COVID-19) pandemic has brought about the unprecedented expansion of highly sensitive molecular diagnostics as a primary infection control strategy. At same time, many laboratories have shifted focus to severe acute respiratory syndrome 2 (SARS-CoV-2) research and diagnostic development, leading large-scale production SARS-CoV-2 nucleic acids that can interfere with these tests. We identified multiple instances, in independent laboratories, which generated settings are suspected caused researchers test positive for surveillance testing. In some cases, affected individuals did not work directly but were exposed via contaminated surface or object. Though long been vigilant DNA contaminants, transfer contaminants testing samples result anomalous results. impact incidents stretches into public sphere, placing additional burdens on health resources, their contacts isolation quarantine, removing them from pool 3 months, carrying potential trigger shutdowns classrooms workplaces. report our observations call increased stewardship over both use development diagnostics. IMPORTANCE To meet challenges imposed by COVID-19 pandemic, clinical developed utilized new assays. Nucleic acid-based became widespread and, first was used prophylactic measure. 15 cases at two institutes routine tests, absence any symptoms transmission. These likely nonhazardous laboratory course developing contaminating persistent throughout laboratory. findings cautionary tale those working careful diagnostically relevant molecules. Our conclusions especially at-home gains traction marketplace amplicons may general public.