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Field evaluation of specificity and sensitivity of a standard SARS-CoV-2 antigen rapid diagnostic test: A prospective study at a teaching hospital in Northern Ghana
Alhassan Abdul-Mumin; Abdulai Abubakari; Faith Agbozo; Abass Abdul-Karim; Benjamin Demah Nuertey; Kareem Mumuni; Anna-Katharina Heuschen; Lisa Hennig; Claudia M. Denkinger; Olaf Mueller; Albrecht Jahn.
  • Alhassan Abdul-Mumin; University for Development Studies, School of Medicine, Department of Paediatrics and Child Health, Tamale, Ghana; Tamale Teaching Hospital, Tamale, Ghana
  • Abdulai Abubakari; University for Development Studies, School of Public Health, Department of Global Health, Tamale, Ghana
  • Faith Agbozo; University of Health and Allied Sciences, School of Public Health, Department of Family and Community Health, Hohoe, Ghana
  • Abass Abdul-Karim; Ghana Health Service, Zonal Public Health and Reference Laboratory, Tamale, Ghana
  • Benjamin Demah Nuertey; Tamale Teaching Hospital, Tamale, Ghana
  • Kareem Mumuni; Tamale Teaching Hospital, Tamale, Ghana
  • Anna-Katharina Heuschen; Institute for Global Health, University Hospital Heidelberg, Ruprecht-Karls-University Heidelberg
  • Lisa Hennig; Institute for Global Health, University Hospital Heidelberg, Ruprecht-Karls-University Heidelberg
  • Claudia M. Denkinger; Institute for Global Health, University Hospital Heidelberg, Ruprecht-Karls-University Heidelberg
  • Olaf Mueller; Institute for Global Health, University Hospital Heidelberg, Ruprecht-Karls-University Heidelberg
  • Albrecht Jahn; Institute for Global Health, University Hospital Heidelberg, Ruprecht-Karls-University Heidelberg
Preprint Dans Anglais | medRxiv | ID: ppmedrxiv-21258300
ABSTRACT
BackgroundThe testing capacity for SARS-CoV-2 in Africa is rather limited. Antigen-detection rapid diagnostic tests (Ag-RDTs) are a cheap and rapid alternative to reverse transcriptase-polymerase chain reaction (RT-PCR) tests, but there is little data about their performance under real life conditions in tropical countries. ObjectiveTo evaluate the performance of a standard Ag-RDT in a population of a major hospital in northern Ghana. MethodsProspective, cross-sectional, blinded verification of the performance of the SD Biosensor Standard Q SARS-CoV-2 Ag-RDT under real life conditions in 135 symptomatic patients and 58 contacts of RT-PCR positives at Tamale Teaching Hospital in February 2021. Nasopharyngeal samples were taken under standard conditions and tested against RT-PCR in the hospital laboratory. Results193 participants (median age 35 years, 109 male) were included into the study for which both RT-PCR test and Ag-RDT results were available. A total of 42 (22%) were RT-PCR positive. Of the 42 RT-PCR positives, 27 were Ag-RDT positive, resulting in a sensitivity of 64% (95% CI 49-79). Sensitivity among symptomatic patients was 58% (95% CI 38-78). 123 were identified Ag-RDT negatives of the 151 RT-PCR negatives, resulting in a specificity of 81% (95% CI 75-87). ConclusionsSARS-CoV-2 Ag-RDTs appear to have a rather low sensitivity and particularly a low specificity under real life conditions in Africa. The role of existing Ag-RDTs in countries with high-temperature climates and limited resources still needs more data and discussion.
Texte intégral: Disponible Collection: Preprints Base de données: medRxiv langue: Anglais Année: 2021 Type de document: Preprint
Texte intégral: Disponible Collection: Preprints Base de données: medRxiv langue: Anglais Année: 2021 Type de document: Preprint