Impaired performance of SARS-CoV-2 antigen-detecting rapid tests at elevated and low temperatures
| Autor: | Christian Drosten, Edmilson Ferreira de Oliveira-Filho, Jan Felix Drexler, Verena Haage, Marcel A. Müller, Carlo Fischer, Arne Kühne, Victor M. Corman, Jilian A. Sacks, Andres Moreira-Soto |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Veterinary medicine Hot Temperature Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030106 microbiology Global South specificity Sensitivity and Specificity World health Article COVID-19 Serological Testing tropics 03 medical and health sciences 0302 clinical medicine Antigen Virology parasitic diseases Humans False Positive Reactions 030212 general & internal medicine rapid antigen test False Negative Reactions Chemistry Diagnostic Tests Routine SARS-CoV-2 Diagnostic test COVID-19 equipment and supplies sensitivity winter Cold Temperature Infectious Diseases temperature stability Rapid antigen test Cell culture supernatant Reagent Kits Diagnostic |
| Zdroj: | Journal of Clinical Virology |
| ISSN: | 1873-5967 1386-6532 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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