New recommended policies for pathogen surveillance testing of researchers and improved stewardship of diagnostic DNA

Author:

Robinson-McCarthy LindseyORCID,Mijalis Alexander J.,Filsinger Gabriel T,de Puig Helena,Donghia Nina M.,Schaus Thomas E.,Rasmussen Robert A.,Ferreira Raphael,Lunshof Jeantine E.,Chao George,Ter-Ovanesyan Dmitry,Dodd Oliver,Kuru Erkin,Sesay Adama M.,Rainbow Joshua,Pawlowski Andrew C.,Wannier Timothy M.,Yin Peng,Collins James J.,Ingber Donald,Tam JennyORCID,Church George M.

Abstract

The SARS-CoV-2 pandemic has brought about the unprecedented expansion of highly sensitive molecular diagnostics as a primary infection control strategy. At the same time, many laboratories have shifted focus to SARS-CoV-2 research and diagnostic development, leading to large-scale production of nucleic acids that can interfere with these tests. We have identified multiple instances, in independent laboratories, in which nucleic acids generated in research settings are suspected to have caused researchers to test positive for SARS-CoV-2 in surveillance testing. In some cases, the affected individuals did not work directly with these nucleic acids, but were exposed via a contaminated surface or object. Though researchers have long been vigilant of DNA contaminants, the transfer of these contaminants in SARS-CoV-2 testing samples results in anomalous test results. The impact of these stretches into the public sphere, placing additional burdens on public health resources, placing affected researchers and their contacts in quarantine, and carrying the potential to trigger shutdowns of classrooms and workplaces. We report our observations as a call for increased stewardship over nucleic acids with the potential to impact both use and development of diagnostics. These experiences highlight a neglected aspect of the test, trace, isolate public health strategy for managing COVID-19: we cannot easily identify and diagnose an erroneous test result. To prevent undue personal and economic strain and maintain faith in the testing process, we propose: a test, isolate, verify, and trace approach to COVID-19 diagnosis in research and clinical diagnostic workplaces.

Publisher

Center for Open Science

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