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Diagnostic performance of CerTest and Panbio antigen rapid diagnostic tests to diagnose SARS-CoV-2 infection.
Pérez-García, Felipe; Romanyk, Juan; Gómez-Herruz, Peña; Arroyo, Teresa; Pérez-Tanoira, Ramón; Linares, Manuel; Pérez Ranz, Inés; Labrador Ballestero, Andrea; Moya Gutiérrez, Helena; Ruiz-Álvarez, Mª Jesús; Cuadros-González, Juan.
  • Pérez-García F; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain. Electronic address: felipe.perez.garcia.87@gmail.com.
  • Romanyk J; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain; Departamento de Biomedicina y Biotecnología, Facultad de Medicina, Universidad de Alcalá de Henares, Spain.
  • Gómez-Herruz P; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Arroyo T; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Pérez-Tanoira R; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain; Departamento de Biomedicina y Biotecnología, Facultad de Medicina, Universidad de Alcalá de Henares, Spain.
  • Linares M; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Pérez Ranz I; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Labrador Ballestero A; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Moya Gutiérrez H; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Ruiz-Álvarez MJ; Servicio de Análisis Clínicos, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
  • Cuadros-González J; Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain; Departamento de Biomedicina y Biotecnología, Facultad de Medicina, Universidad de Alcalá de Henares, Spain.
J Clin Virol ; 137: 104781, 2021 04.
Article in English | MEDLINE | ID: covidwho-1091783
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<25) for CerTest (98.0 %, k = 0.954) and Panbio (98.8 %, k = 0.973).

CONCLUSIONS:

CerTest SARS-CoV-2 and Panbio COVID-19 Ag showed excellent performance and agreement results for samples with high viral loads (Ct ≤ 25) or samples taken within the first 5 days after the onset of symptoms.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article