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Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection.
Gremmels, Hendrik; Winkel, Beatrice M F; Schuurman, Rob; Rosingh, Andert; Rigter, Nicolette A M; Rodriguez, Olga; Ubijaan, Johan; Wensing, Annemarie M J; Bonten, Marc J M; Hofstra, L Marije.
  • Gremmels H; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
  • Winkel BMF; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
  • Schuurman R; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
  • Rosingh A; LABHOH, Fundacion Servicio Medico Laboratorio Aruba, Dr. Horacio E. Oduber Hospital, Boulevard 1, Oranjestad, Aruba.
  • Rigter NAM; GGD regio Utrecht, De Dreef 5, 3706 BR Zeist, the Netherlands.
  • Rodriguez O; Dr. Horacio E. Oduber Hospital, Boulevard 1, Oranjestad, Aruba.
  • Ubijaan J; LABHOH, Fundacion Servicio Medico Laboratorio Aruba, Dr. Horacio E. Oduber Hospital, Boulevard 1, Oranjestad, Aruba.
  • Wensing AMJ; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
  • Bonten MJM; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
  • Hofstra LM; Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
EClinicalMedicine ; 31: 100677, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-957035
Preprint
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ABSTRACT

BACKGROUND:

RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined.

METHODS:

The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in  comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs.

Findings:

1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI 99.7-100%) in both settings. Test sensitivity was 72.6% (95%CI 64.5-79.9%) in the Netherlands and 81.0% (95% CI 69.0-89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI 89.3-98.5%) in Utrecht and 98.0% (95%CI 89.2-99.95%) in Aruba.

INTERPRETATION:

In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study / Prognostic study Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2020.100677

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study / Prognostic study Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2020.100677