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Impaired performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests at elevated and low temperatures

Authors
  • Haage, Verena1
  • Ferreira de Oliveira-Filho, Edmilson1
  • Moreira-Soto, Andres1
  • Kühne, Arne1
  • Fischer, Carlo1
  • Sacks, Jilian A.2
  • Corman, Victor Max1, 3
  • Müller, Marcel A.1, 3
  • Drosten, Christian1, 3
  • Drexler, Jan Felix1, 3
  • 1 Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany
  • 2 Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland
  • 3 German Centre for Infection Research (DZIF), Associated Partner Charité-Universitätsmedizin Berlin, Berlin, Germany
Type
Published Article
Journal
Journal of Clinical Virology
Publisher
Elsevier Science
Publication Date
May 01, 2021
Volume
138
Identifiers
DOI: 10.1016/j.jcv.2021.104796
PMID: 33773413
PMCID: PMC7962993
Source
PubMed Central
Keywords
Disciplines
  • Article
License
Unknown

Abstract

Antigen-detecting rapid diagnostic tests (Ag-RDTs) can complement molecular diagnostics for COVID-19. The recommended temperature for storage of SARS-CoV-2 Ag-RDTs ranges between 2−30 °C. In the global South, mean temperatures can exceed 30 °C. In the global North, Ag-RDTs are often used in external testing facilities at low ambient temperatures. We assessed analytical sensitivity and specificity of eleven commercially-available SARS-CoV-2 Ag-RDTs using different storage and operational temperatures, including short- or long-term storage and operation at recommended temperatures or at either 2−4 °C or at 37 °C. The limits of detection of SARS-CoV-2 Ag-RDTs under recommended conditions ranged from 1.0×106- 5.5×107 genome copies/mL of infectious SARS-CoV-2 cell culture supernatant. Despite long-term storage at recommended conditions, 10 min pre-incubation of Ag-RDTs and testing at 37 °C resulted in about ten-fold reduced sensitivity for five out of 11 SARS-CoV-2 Ag-RDTs, including both Ag-RDTs currently listed for emergency use by the World Health Organization. After 3 weeks of storage at 37 °C, eight of the 11 SARS-CoV-2 Ag-RDTs exhibited about ten-fold reduced sensitivity. Specificity of SARS-CoV-2 Ag-RDTs using cell culture supernatant from common respiratory viruses was not affected by storage and testing at 37 °C, whereas false-positive results occurred at outside temperatures of 2−4 °C for two out of six tested Ag-RDTs, again including an Ag-RDT recommended by the WHO. In summary, elevated temperatures impair sensitivity, whereas low temperatures impair specificity of SARS-CoV-2 Ag-RDTs. Consequences may include false-negative test results at clinically relevant virus concentrations compatible with transmission and false-positive results entailing unwarranted quarantine assignments. Storage and operation of SARS-CoV-2 Ag-RDTs at recommended conditions is essential for successful usage during the pandemic.

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