Abstract
The reverse transcriptase polymerase chain reaction (RT-PCR) continues to be the reference diagnostic method for the confirmation of COVID-19 cases; however, rapid antigen detection tests (RADT) have recently been developed. The purpose of the study is to assess the performance of rapid antigen-based COVID-19 testing in the context of hospital outbreaks. This was an observational, cross-sectional study. The study period was from October 2020 to January 2021. The “Panbio COVID-19 AG” RADT (Abbott) was performed and TaqPath COVID-19 test RT-PCR. The samples were obtained from hospitalised patients in suspected outbreak situations at the Ramón y Cajal Hospital. A hospital outbreak was defined as the presence of 3 or more epidemiologically linked cases. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the RADT were calculated using RT-PCR as a reference. A total of 17 hospital outbreaks were detected in 11 hospital units during the study period, in which 34 RT-PCR and RADT screenings were performed. We obtained 541 samples, which were analysed with RT-PCR and a further 541 analysed with RADT. Six RADT tests gave conflicting results with the RT-PCR, 5 of them with a negative RADT and positive RT-PCR and one with positive RADT and a negative RT-PCR. The sensitivity of the RADT was 83.3% (65.3–94.4%) and the specificity was 99.8% (98.9–100%). The PPV was 96.2% (80.4–99.9%) and the NPV was 99% (97.7–99.7%). The RADT shows good diagnostic performance in patients on non-COVID-19 hospital wards, in the context of an outbreak.
Highlights
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the rapid antigen detection tests (RADT) were calculated using reverse transcriptase polymerase chain reaction (RT-PCR) as a reference
We obtained 541 samples, which were analysed with RT-PCR and a further 541 analysed with RADT
We obtained 541 samples, which were analysed with RT-PCR and a further analysed with RADT
Summary
In the current COVID-19 pandemic period, outbreaks have occurred at both community and hospital levels [1].Preventive Medicine and Public Health, HospitalUniversitario Ramón Y Cajal and Instituto Ramón Y Cajal de Investigación Sanitaria (IRYCIS), Madrid, SpainCIBER Epidemiología Y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, SpainUniversidad Internacional de La Rioja (UNIR), Logroño, SpainServicio de Microbiología, Hospital Universitario Ramón YCajal and Instituto Ramón Y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, SpainRed Española de Investigación en Patología Infecciosa (REIPI), Instituto de Salud Carlos III, Madrid, SpainThe presence of three or more epidemiologically linked cases is defined as a hospital outbreak of SARS-CoV-2 and an outbreak is considered over when there are no more epidemiologically linked cases [2]. Universitario Ramón Y Cajal and Instituto Ramón Y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain. Cajal and Instituto Ramón Y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, Spain. Red Española de Investigación en Patología Infecciosa (REIPI), Instituto de Salud Carlos III, Madrid, Spain. The presence of three or more epidemiologically linked cases is defined as a hospital outbreak of SARS-CoV-2 and an outbreak is considered over when there are no more epidemiologically linked cases [2]. Selective screening without an outbreak is defined as testing performed on hospital wards with an apparently higher risk of viral transmission or where clusters of cases have appeared. The basic strategy for breaking the transmission chains of SARS-CoV-2 in the above contexts is the follow-up and diagnosis of the patients involved. Somewhat less sensitive and specific than RT-PCR, these tests are faster
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