Generation of false positive SARS-CoV-2 antigen results with testing conditions outside manufacturer recommendations: A scientific approach to pandemic misinformation

作者：Glenn Patriquin, Ross Davidson, Todd F. Hatchette, Breanne M. Head, Edgard M. Mejia, Michael G. Becker, Adrienne F. A. Meyers, Paul A. Sandstrom, Jacob Hatchette, Ava Block, Nicole Smith, John Jacob Ross, Jason J. LeBlanc · 发表于：medRxiv · 年份：2021 · DOI：10.1101/2021.07.04.21259490 · 被引用次数：3 · 研究领域：SARS-CoV-2 detection and testing、SARS-CoV-2 and COVID-19 Research、Biosensors and Analytical Detection

Abstract Objectives Antigen-based rapid diagnostics tests (Ag-RDTs) are useful tools for SARS-CoV-2 detection. However, misleading demonstrations of the Abbott Panbio COVID-19 Ag-RDT on social media claimed that SARS-CoV-2 antigen could be detected in municipal water and food products. To offer a scientific rebuttal to pandemic misinformation and disinformation, this study explored the impact of using the Panbio SARS-CoV-2 assay with conditions falling outside of manufacturer recommendations. Methods Using Panbio, various water and food products, laboratory buffers, and SARS-CoV-2-negative clinical specimens were tested, with and without manufacturer buffer. Additional experiments were conducted to assess the role of each Panbio buffer component (tricine, NaCl, pH, and tween-20), as well as the impact of temperatures (4°C, 20°C, and 45°C) and humidity (90%) on assay performance. Results Direct sample testing (without the kit buffer), resulted in false positive signals resembling those obtained with SARS-CoV-2-positive controls tested under proper conditions. The likely explanation of these artifacts is non-specific interactions between the SARS-CoV-2-specific conjugated and capture antibodies, as proteinase K treatment abrogated this phenomenon, and thermal shift assays showed pH-induced conformational changes under conditions promoting artifact formation. Omitting, altering, and reverse engineering the kit buffer all supported the importance of maintaining buffering capacity...