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10.1016/j.jcv.2021.104796

http://scihub22266oqcxt.onion/10.1016/j.jcv.2021.104796
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suck abstract from ncbi


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pmid33773413      J+Clin+Virol 2021 ; 138 (ä): 104796
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  • Impaired performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests at elevated and low temperatures #MMPMID33773413
  • Haage V; Ferreira de Oliveira-Filho E; Moreira-Soto A; Kuhne A; Fischer C; Sacks JA; Corman VM; Muller MA; Drosten C; Drexler JF
  • J Clin Virol 2021[May]; 138 (ä): 104796 PMID33773413show ga
  • 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 degrees C. In the global South, mean temperatures can exceed 30 degrees 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 degrees C or at 37 degrees C. The limits of detection of SARS-CoV-2 Ag-RDTs under recommended conditions ranged from 1.0x10(6)- 5.5x10(7) 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 degrees 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 degrees 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 degrees C, whereas false-positive results occurred at outside temperatures of 2-4 degrees 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.
  • |*COVID-19 Serological Testing[MESH]
  • |*Diagnostic Tests, Routine[MESH]
  • |*Reagent Kits, Diagnostic[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Cold Temperature/adverse effects[MESH]
  • |False Negative Reactions[MESH]
  • |False Positive Reactions[MESH]
  • |Hot Temperature/adverse effects[MESH]
  • |Humans[MESH]


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