1. Diagnostic performance of CerTest and Panbio antigen rapid diagnostic tests to diagnose SARS-CoV-2 infection
- Author
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Manuel Linares, Mª Jesús Ruiz-Álvarez, Juan Cuadros-González, Andrea Labrador Ballestero, Peña Gómez-Herruz, Ramón Pérez-Tanoira, Felipe Pérez-García, Inés Pérez Ranz, Teresa Arroyo, Helena Moya Gutiérrez, and Juan Romanyk
- Subjects
Adult ,Male ,0301 basic medicine ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,Panbio COVID-19 Ag ,Antibodies, Viral ,Sensitivity and Specificity ,Article ,Antigen rapid diagnostic test ,03 medical and health sciences ,COVID-19 Testing ,0302 clinical medicine ,McNemar's test ,Antigen ,Lateral flow immunoassay ,Nasopharynx ,Virology ,CerTest SARS-CoV-2 Ag ,Humans ,Medicine ,Serologic Tests ,030212 general & internal medicine ,Antigens, Viral ,Aged ,Cycle threshold ,Diagnostic Tests, Routine ,SARS-CoV-2 ,business.industry ,COVID-19 ,Diagnostic test ,Kappa score ,Middle Aged ,Viral Load ,Infectious Diseases ,COVID-19 Nucleic Acid Testing ,Female ,Nuclear medicine ,business ,Viral load - Abstract
Objectives Antigen rapid diagnostic tests (Ag-RDT) have been developed as reliable tools to control the SARS-CoV-2 pandemic. The objective of our study was to evaluate the diagnostic performance of two Ag-RDTs. Methods We evaluated CerTest SARS-CoV-2 Ag One Step Card Test and Panbio COVID-19 Ag Rapid Test Device Ag-RDTs. We included 320 nasopharyngeal samples: 150 PCR negative samples to assess the specificity and 170 PCR positive samples to evaluate the sensitivity. We also evaluated their sensitivity according to cycle threshold (Ct) values and the time from the onset of symptoms. Tests were compared using the McNemar’s test and agreement was evaluated using the kappa score (k). Results Both Ag-RDTs showed a specificity of 100 %. Overall sensitivity was 53.5 % for CerTest and 60.0 % for Panbio. For samples with Ct≤ 25, sensitivity was 94.0 % for CerTest and 96.4 % for Panbio (p = 0.500). Regarding samples with Ct>25, sensitivity was 14.0 % for CerTest and 24.4 % for Panbio (p = 0.004). Sensitivity for samples within the first 5 days after the onset of symptoms were 84.8 % for CerTest and 91.3 % for Panbio (p = 0.250) and notably decreased for samples taken after the fifth day. Both Ag-RDTs showed an excellent agreement between them (agreement = 96.7 %, k = 0.920). Agreement with PCR was also excellent for high viral load samples (Ct
- Published
- 2021
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