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. 2021 Aug 18;59(9):e0099121.
doi: 10.1128/JCM.00991-21. Epub 2021 Aug 18.

Diagnostic Accuracy of SARS-CoV-2 Rapid Antigen Detection Testing in Symptomatic and Asymptomatic Children in the Clinical Setting

Arnaud G L'Huillier  1   2 , Matthieu Lacour  3 , Debora Sadiku  3 , Mehdi A Gadiri  3 , Loraine De Siebenthal  3 , Manuel Schibler  2   4   5 , Isabella Eckerle  2   4   5 , Selina Pinösch  6 , Laurent Kaiser  2   4   5 , Alain Gervaix  7 , Alban Glangetas  7 , Annick Galetto-Lacour  7 , Laurence Lacroix  7
Affiliations

Diagnostic Accuracy of SARS-CoV-2 Rapid Antigen Detection Testing in Symptomatic and Asymptomatic Children in the Clinical Setting

Arnaud G L'Huillier et al. J Clin Microbiol. .

Abstract

Antigen-based rapid diagnostic tests (RDTs) are used in children despite the lack of data. We evaluated the diagnostic performance of the Panbio-COVID-19 Ag Rapid Test Device (P-RDT) in children. Symptomatic and asymptomatic participants 0 to 16 years old had two nasopharyngeal swabs (NPS) for both reverse transcription-PCR (RT-PCR) and P-RDT. A total of 822 participants completed the study, of which 533 (64.9%) were symptomatic. Among the 119 (14.5%) RT-PCR-positive patients, the P-RDT sensitivity was 0.66 (95% confidence interval [CI] 0.57 to 0.74). Mean viral load (VL) was higher among P-RDT-positive patients than negative ones (P < 0.001). Sensitivity was 0.91 in specimens with VL of >1.0E6 IU/ml (95% CI 0.83 to 0.99) and decreased to 0.75 (95% CI 0.66 to 0.83) for specimens >1.0E3 IU/ml. Among symptomatic participants, the P-RDT displayed a sensitivity of 0.73 (95% CI 0.64 to 0.82), which peaked at 1.00 at 2 days post-onset of symptoms (DPOS) (95% CI 1.00 to 1.00), then decreased to 0.56 (95% CI 0.23 to 0.88) at 5 DPOS. There was a trend toward lower P-RDT sensitivity in symptomatic children <12 years (0.62 [95% CI 0.45 to 0.78]) versus ≥12 years (0.80 [95% CI 0.69 to 0.91]; P = 0.09). In asymptomatic participants, the P-RDT displayed a sensitivity of 0.43 (95% CI 0.26 to 0.61). Specificity was 1.00 in symptomatic and asymptomatic children (95% CI 0.99 to 1.00). The overall 73% and 43% sensitivities of P-RDT in symptomatic and asymptomatic children, respectively, was below the 80% cutoff recommended by the World Health Organization. We observed a correlation between VL and P-RDT sensitivity, as well as variation of sensitivity according to DPOS, a major determinant of VL. These data highlight the limitations of RDTs in children, with the potential exception in early symptomatic children ≥12yrs.

Keywords: COVID-19; SARS-CoV-2; antigen-based rapid diagnostic tests; children; diagnostics; pediatric infectious disease; rapid diagnostic tests.

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Figures

FIG 1
FIG 1
Mean (standard deviation) SARS-CoV-2 viral load expressed in log IU/ml among RT-PCR-positive individuals according to Panbio RDT results. RDT, antigen-based rapid diagnostic test; RT-PCR, reverse transcription-PCR; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
FIG 2
FIG 2
Sensitivity (95% confidence interval) of Panbio RDT according to SARS-CoV-2 viral load expressed in log IU/ml. RDT, antigen-based rapid diagnostic test; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
FIG 3
FIG 3
Sensitivity (95% confidence interval) of Panbio RDT according to days post onset of symptoms (A) and clinical symptoms (B). RDT, antigen-based rapid diagnostic test.
See this image and copyright information in PMC

References

    1. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. 2020. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill 25:2000045. 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed
    1. Masia M, Fernandez-Gonzalez M, Sanchez M, Carvajal M, Garcia JA, Gonzalo-Jimenez N. 2021. Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infect Dis 8:ofab059. 10.1093/ofid/ofab059. - DOI - PMC - PubMed
    1. Drevinek P, Hurych J, Kepka Z, Briksi A, Kulich M, Zajac M. 2020. The sensitivity of SARS-CoV-2 antigen tests in the view of large-scale testing. MedRxiv 10.1101/2020.11.23.20237198. - DOI - PubMed
    1. Linares M, Perez-Tanoira R, Carrero A, Romanyk J, Perez-Garcia F, Gomez-Herruz P, Arroyo T, Cuadros J. 2020. Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms. J Clin Virol 133:104659. 10.1016/j.jcv.2020.104659. - DOI - PMC - PubMed
    1. Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernandez-Fuentes MA, Martinez M, Poujois S, Forque L, Valdivia A, Solano de la Asuncion C, Ferrer J, Colomina J, Navarro D. 2021. Field evaluation of a rapid antigen test (Panbio COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect 27:472. 10.1016/j.cmi.2020.11.004. - DOI - PMC - PubMed

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