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. 2021 Mar;82(3):391-398.
doi: 10.1016/j.jinf.2021.02.014. Epub 2021 Feb 13.

Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care

Oana Bulilete  1 , Patricia Lorente  2 , Alfonso Leiva  3 , Eugenia Carandell  4 , Antonio Oliver  5 , Estrella Rojo  6 , Pau Pericas  7 , Joan Llobera  8 ; COVID-19 Primary Care Research Group
Affiliations

Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care

Oana Bulilete et al. J Infect. 2021 Mar.

Abstract

Objectives: We aimed to evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.

Methods: The study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.

Findings: A total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.

Interpretation: Ag-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our data do not support the sole use of Panbio™ Ag-RDT in asymptomatic individuals.

Funding: None.

Keywords: COVID-19; Primary care; Rapid antigen test; Sar-CoV-2.

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Conflict of interest statement

Declaration of Competing Interest The authors declared no conflict of interest.

Figures

Fig 1:
Fig. 1
Enrollment and clinical characteristics of patients who received the RT-PCR test and the Panbio™ test.
Fig 2:
Fig. 2
Sensitivity of the Panbio™ test in patients with different clinical status and N gene viral load.
See this image and copyright information in PMC

Comment in

  • Rapid antigen test for SARS-CoV-2 and primary health care.
    Fernández-Villa T, Vazquez-Casares A, Rivero-Rodriguez A, Carvajal-Ureña A, Martín V. Fernández-Villa T, et al. J Infect. 2021 Aug;83(2):237-279. doi: 10.1016/j.jinf.2021.05.001. Epub 2021 May 8. J Infect. 2021. PMID: 33971208 Free PMC article. No abstract available.

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