TY - JOUR
T1 - Laboratory-generated dna can cause anomalous pathogen diagnostic test results
AU - Robinson-McCarthy, Lindsey R.
AU - Mijalis, Alexander J.
AU - Filsinger, Gabriel T.
AU - De Puig, Helena
AU - Donghia, Nina M.
AU - Schaus, Thomas E.
AU - Rasmussen, Robert A.
AU - Ferreira, Raphael
AU - Lunshof, Jeantine E.
AU - Chao, George
AU - Ter-Ovanesyan, Dmitry
AU - Dodd, Oliver
AU - Kuru, Erkin
AU - Sesay, Adama M.
AU - Rainbow, Joshua
AU - Pawlowski, Andrew C.
AU - Wannier, Timothy M.
AU - Angenent-Mari, Nicolaas M.
AU - Najjar, Devora
AU - Yin, Peng
AU - Ingber, Donald E.
AU - Tam, Jenny M.
AU - Church, George M.
N1 - Funding Information:
We thank Angela Reid, Jennifer Etter, and James Collins for their input and thoughtful discussion. This work was funded through internal royalty funds to G.M.C.
PY - 2021/10/31
Y1 - 2021/10/31
N2 - 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 the same time, many laboratories have shifted focus to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) research and diagnostic development, leading to large-scale production of SARS-CoV-2 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 to SARS-CoV-2 testing samples can result in anomalous test results. The impact of these incidents stretches into the public sphere, placing additional burdens on public health resources, placing affected researchers and their contacts in isolation and quarantine, removing them from the testing pool for 3 months, 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 the use and development of diagnostics.
AB - 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 the same time, many laboratories have shifted focus to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) research and diagnostic development, leading to large-scale production of SARS-CoV-2 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 to SARS-CoV-2 testing samples can result in anomalous test results. The impact of these incidents stretches into the public sphere, placing additional burdens on public health resources, placing affected researchers and their contacts in isolation and quarantine, removing them from the testing pool for 3 months, 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 the use and development of diagnostics.
KW - COVID-19
KW - Diagnostics
KW - Nucleic acids
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85119186821&partnerID=8YFLogxK
U2 - 10.1128/Spectrum.00313-21
DO - 10.1128/Spectrum.00313-21
M3 - Article
C2 - 34523989
AN - SCOPUS:85119186821
VL - 9
JO - Microbiology Spectrum
JF - Microbiology Spectrum
SN - 2165-0497
IS - 2
M1 - e00313-21
ER -