Anomalous COVID-19 tests hinder researchers

Lindsey R. Robinson-McCarthy; 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; Peng Yin; James J. Collins; Donald E. Ingber; George M. Church; Jenny M. Tam

doi:10.1126/science.abf8873

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Anomalous COVID-19 tests hinder researchers

Lindsey R. Robinson-McCarthy1,
Alexander J. Mijalis1,
Gabriel T. Filsinger3,
Helena de Puig2,4,
Nina M. Donghia2,
Thomas E. Schaus2,
Robert A. Rasmussen2,
Raphael Ferreira1,2,
Jeantine E. Lunshof2,5,6,
George Chao1,
Dmitry Ter-Ovanesyan2,
Oliver Dodd1,2,
Erkin Kuru1,2,
Adama M. Sesay2,
Joshua Rainbow2,7,
Andrew C. Pawlowski1,2,
Timothy M. Wannier1,
Peng Yin2,3,
James J. Collins2,4,8,9,10,11,
Donald E. Ingber2,12,13,14,
George M. Church1,2,11,
Jenny M. Tam1,2,*

¹Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.
²Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.
³Department of Systems Biology, Harvard Medical School, Boston, MA 02115, USA.
⁴Institute for Medical Engineering and Science, Massachusetts Institute of Technology (MIT), Cambridge, MA 02139, USA.
⁵Department of Global Health and Social Medicine, Harvard Center for Bioethics, Harvard Medical School, Boston, MA 02115, USA.
⁶Department of Genetics, University Medical Center Groningen, University of Groningen, Netherlands.
⁷Department of Electrical and Electronic Engineering, University of Bath, Bath, BA2 7AY, UK.
⁸Department of Biological Engineering, MIT, Cambridge, MA 02139, USA.
⁹Synthetic Biology Center, MIT, Cambridge, MA 02139, USA.
¹⁰Infectious Disease and Microbiome Program, Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA.
¹¹Harvard–Massachusetts Institute of Technology Program in Health Sciences and Technology, Cambridge, MA 02139, USA.
¹²Vascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, MA 02115, USA.
¹³Harvard Medical School, Boston, MA 02115, USA.
¹⁴Harvard John A. Paulson School of Engineering and Applied Sciences, Cambridge, MA 02138, USA.

↵* Corresponding author. Email: jenny.tam{at}wyss.harvard.edu

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Science 15 Jan 2021:
Vol. 371, Issue 6526, pp. 244-245
DOI: 10.1126/science.abf8873

Jennifer Sills

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

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Lindsey R. Robinson-McCarthy

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

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Alexander J. Mijalis

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

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Gabriel T. Filsinger

3Department of Systems Biology, Harvard Medical School, Boston, MA 02115, USA.

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Helena de Puig

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

4Institute for Medical Engineering and Science, Massachusetts Institute of Technology (MIT), Cambridge, MA 02139, USA.

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Nina M. Donghia

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Thomas E. Schaus

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Robert A. Rasmussen

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Raphael Ferreira

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Jeantine E. Lunshof

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

5Department of Global Health and Social Medicine, Harvard Center for Bioethics, Harvard Medical School, Boston, MA 02115, USA.

6Department of Genetics, University Medical Center Groningen, University of Groningen, Netherlands.

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George Chao

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

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Dmitry Ter-Ovanesyan

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Oliver Dodd

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Erkin Kuru

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Adama M. Sesay

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Joshua Rainbow

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

7Department of Electrical and Electronic Engineering, University of Bath, Bath, BA2 7AY, UK.

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Andrew C. Pawlowski

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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Timothy M. Wannier

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

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Peng Yin

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

3Department of Systems Biology, Harvard Medical School, Boston, MA 02115, USA.

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James J. Collins

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

4Institute for Medical Engineering and Science, Massachusetts Institute of Technology (MIT), Cambridge, MA 02139, USA.

8Department of Biological Engineering, MIT, Cambridge, MA 02139, USA.

9Synthetic Biology Center, MIT, Cambridge, MA 02139, USA.

10Infectious Disease and Microbiome Program, Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA.

11Harvard–Massachusetts Institute of Technology Program in Health Sciences and Technology, Cambridge, MA 02139, USA.

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Donald E. Ingber

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

12Vascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, MA 02115, USA.

13Harvard Medical School, Boston, MA 02115, USA.

14Harvard John A. Paulson School of Engineering and Applied Sciences, Cambridge, MA 02138, USA.

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George M. Church

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

11Harvard–Massachusetts Institute of Technology Program in Health Sciences and Technology, Cambridge, MA 02139, USA.

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Jenny M. Tam

1Department of Genetics, Blavatnik Institute, Harvard Medical School, Boston, MA 02115, USA.

2Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA 02115, USA.

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For correspondence: jenny.tam@wyss.harvard.edu

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RE: Interpreting the Outcomes of COVID-19 Tests
- Michael John McAleer, University Research Chair Professor, Asia University, Taiwan
(3 February 2021)

The expert team of researchers examine the anomalous outcomes of COVID-19 tests.

Correct outcomes can only be determined from clinical trials where volunteers are monitored against confirmed infections and placebos.

In the real world, there can be false positives and false negatives, each with associated social consequences, especially arising from nasal swabs as compared with saliva samples, which can lead to mixed results.

Asymptomatic medical researchers working with non-infectious SARS-CoV-2 nucleic acids can be detected with anomalous surveillance test results, so that further testing is required to determine if there is a true active infection.

Waste water checks frequently lead to false positive outcomes, even without an outbreak of infections in the locality.

These mixed results suggest that caution should be exercised before determining the outcome of tests for the presence of COVID-19.

Competing Interests: None declared.

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Anomalous COVID-19 tests hinder researchers

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