Real‐life evaluation of a COVID‐19 rapid antigen detection test in hospitalized children

Abstract

Rapid antigen detection (RAD) tests for the detection of SARS‐CoV‐2 are simpler, faster, and less expensive than the reverse‐transcription polymerase chain reaction (RT‐PCR) that is currently considered the gold standard for the diagnosis of coronavirus disease 2019 (COVID‐19). The objective of this study was to determine the performance of the PANBIO COVID‐19 Ag RAD (Abbott) test, a lateral flow immunoassay that detects the nucleocapsid protein, using as a reference RT‐PCR method the Cobas®8800 System (Roche Diagnostics). This prospective study was conducted in a tertiary Children's Hospital and included individuals aged ≤16 years with COVID‐19‐related symptoms or epidemiological criteria for COVID‐19. Two nasopharyngeal samples were collected to perform the PANBIO RAD test and RT‐PCR. Of 744 children included, 51 (6.86%) had a positive RT‐PCR result. The RAD test detected 42 of 51 PCR‐positive children while there were no false‐positive results. The overall sensitivity and specificity were 82.35% (95% CI, 71.9%–92.8%) and 100%, respectively. Sensitivity was >95% in symptomatic children. The assay performed poorly in asymptomatically infected children. In agreement with previous studies in adults, the PANBIO RAD test can be useful in screening for COVID‐19 in children admitted with symptoms suggestive of the disease, especially in the first days of the illness.

Diagnostic accuracy of the Panbio™ COVID-19 Antigen rapid test device for SARS-CoV-2 detection in Kenya, 2021: A field evaluation

“…In our evaluation, sensitivity was higher among symptomatic individuals compared to asymptomatic ones (60.6% vs. 34.7%). Similar findings were observed in other evaluations with higher sensitivity among symptomatic individuals compared to asymptomatic in a study in Mexico (58.1% vs. 26.3%) (22), in Spain (80.4% vs. 56.6%) (10), among Greek children (95.2% vs. 22.2%) (23), and among Swiss children (73% vs. 43%) (24). However, a German study found similar sensitivities between the two groups (86.8% vs. 85.7%) (25).…”

Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort

“…During this pandemic, adults have been the main affected group with higher morbidity and mortality than children [11][12][13]. Furthermore, it appears that children play a minor role in the dynamics of the pandemic and, therefore, fewer data are available on performance of the SARS-CoV-2 antigen rapid test in the pediatric population [13][14][15].…”

Evaluation of the Roche-SD Biosensor rapid antigen test: Antigen is not reliable in detecting SARS-CoV-2 at the early stage of infection with respiratory symptoms

“…L'Huillier et al concluded that the sensitivity of RAT in symptomatic children was 73% and peaked at the day 2 after the onset of symptoms [6] . Eleftheriou and colleagues observed that the overall sensitivity of RAT in children was 82%, and the sensitivity in symptomatic cases was even >95% [7] . In one cohort of symptomatic children, the overall sensitivity of RAT was 88% compared to NAAT [8] .…”

“…The Infectious Diseases Society of America (IDSA) guideline concluded that RATs should be used within seven days after symptom onset [5] . They also concluded that the RATs perform equally in adults and children, but in children the data is still very limited 6 , 7 , 8 . The guidelines also allow the use of RATs in screening of asymptomatic cases in certain conditions like in high prevalence of COVID-19 or in identifying highly infectious cases 3 , 4 , 5 .…”