Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting

Article Article scientifique Article Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting eng 2021 author L'Huillier Arnaud author Lacour Matthieu Christian 858293 author Sadiku Debora 840703 author Gadiri Mehdi Ali 906803 author De Siebenthal Loraine Jeanne 850580 Loraine De Siebenthal author Schibler Manuel 96444 author Eckerle Isabella Anne 894639 author Pinoesch Selina 87677 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) Selina Helen Pinoesch author Kaiser Laurent 28229 author Gervaix Alain 31715 author Glangetas Alban 779424 author Galetto-Lacour Annik 32921 Structure enseignement (ENSI) Annick Galetto-Lacour author Lacroix Laurence Elisabeth 84201 e0099121 10.1128/JCM.00991-21 34190574 0095-1137 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373030/ 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. Adolescent Antigens Viral COVID-19 COVID-19 Serological Testing Child Child Preschool Humans Infant Infant Newborn SARS-CoV-2 Sensitivity and Specificity Dewey 616 Dewey 618 56 Département de médecine 221 58 Département de pédiatrie, gynécologie et obstétrique 223 false 1255 Virus émergents 993 149 Etiologie des pneumonies et marqueurs inflammatoires chez l'enfant fébrile 183 400 Virologie clinique 668 Journal of Clinical Microbiology 59 9 9b4eb1b1-2468-43ed-964a-feaec8d6ae9a Article (Published version) Restricted ALHuillier_Diagnostic_accuracy_SARS-CoV-2_rapid_antigen_detection_testing_in_symptomatic_and_asymptomatic_children_in_clinical_setting.pdf 535788 application/pdf restrictedAccess Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

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Sadiku, Debora