Laboratory-Generated DNA Can Cause Anomalous Pathogen Diagnostic Test Results.

Area of Science:

• Molecular diagnostics
• Infectious disease research
• Laboratory safety

Background:

• The COVID-19 pandemic spurred rapid development and use of molecular diagnostics for SARS-CoV-2.
• Laboratories shifted focus to SARS-CoV-2 research, increasing production of viral nucleic acids.
• Contamination from research-generated nucleic acids can lead to inaccurate diagnostic results.

Purpose of the Study:

• To report instances of researchers testing positive for SARS-CoV-2 due to laboratory contamination.
• To emphasize the importance of stewardship over nucleic acids in diagnostic settings.
• To caution against potential impacts on public health resources and workplace safety.

Main Methods:

• Observation of false positive SARS-CoV-2 test results in researchers at two institutes.
• Identification of contamination by research-generated SARS-CoV-2 nucleic acids.
• Analysis of exposure routes, including contaminated surfaces.

Main Results:

• Fifteen researchers tested positive for SARS-CoV-2 on routine surveillance tests without symptoms or transmission.
• Contamination was linked to nonhazardous nucleic acids from diagnostic development.
• Contaminating nucleic acids were persistent and widespread within the laboratory environment.

Conclusions:

• Laboratory-generated nucleic acids can cause false positive diagnostic results, impacting surveillance and research.
• Increased vigilance and stewardship are crucial for managing nucleic acid contaminants in research and diagnostic settings.
• These findings are particularly relevant with the rise of at-home testing and potential public impact.