Think of the Children

González-Donapetry, Patricia; García-Clemente, Paloma; Bloise, Iván; García-Sánchez, Consuelo; Castellano, Miguel A.; Romero, María Pilar; Arroyo, Almudena Gutiérrez; Mingorance, Jesús; Calle, María de Ceano-Vivas La; García-Rodríguez, Julio

doi:10.1097/inf.0000000000003101

Cited by 43 publications

(27 citation statements)

References 25 publications

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“… 6 However, previously conducted studies in children have demonstrated lower performance of antigen tests. 7 In a primary care setting, the PANBIO RAD test had a significantly higher sensitivity in adults (82.6%) compared to pediatric patients (62.5%). 8 Masiá et al 9 found that younger age was independently associated with the poorest performance.…”

Section: Discussionmentioning

confidence: 91%

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

Eleftheriou

Dasoula

Dimopoulou

et al. 2021

Journal of Medical Virology

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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.

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Section: Discussionmentioning

confidence: 91%

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

Eleftheriou

Dasoula

Dimopoulou

et al. 2021

Journal of Medical Virology

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“…Of the 13 TGA approved antigen tests, the Panbio COVID-19 Ag rapid test (Abbott) currently has the most peer-reviewed literature, including for children. 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 Two early studies of the Panbio COVID-19 Ag rapid test found sensitivity between 73–81% and 100% specificity. 61 , 62 In addition, FINDdx independent evaluations found Panbio sensitivity for NPS in symptomatic persons to be 85.5% (95%CI 78.2–90.6%) with clinical specificity of 100% (95%CI 99.1–100%).…”

Section: Antigen Testsmentioning

confidence: 99%

Use of emerging testing technologies and approaches for SARS-CoV-2: review of literature and global experience in an Australian context

et al. 2021

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Emerging testing technologies for detection of SARS-CoV-2 include those that are rapid and can be used at point-of-care (POC), and those facilitating high throughput laboratory-based testing. Tests designed to be performed at POC (such as antigen tests and molecular assays) have the potential to expedite isolation of infectious patients and their contacts, but most are less sensitive than standard-of-care reverse transcription polymerase chain reaction (RT-PCR). Data on clinical performance of the majority of emerging assays is limited with most evaluations performed on contrived or stored laboratory samples. Further evaluations of these assays are required, particularly when performed at POC on symptomatic and asymptomatic patients and at various time-points after symptom onset. A few studies have so far shown several of these assays have high specificity. However, large prospective evaluations are needed to confirm specificity, particularly before the assays are implemented in low prevalence settings or asymptomatic populations. High throughput laboratory-based testing includes the use of new sample types (e.g., saliva to increase acceptability) or innovative uses of existing technology (e.g., sample pooling). Information detailing population-wide testing strategies for SARS-COV-2 is largely missing from peer-reviewed literature. Logistics and supply chains are key considerations in any plan to ‘scale up’ testing in the Australian context. The strategic use of novel assays will help strike the balance between achieving adequate test numbers without overwhelming laboratory capacity. To protect testing of high-risk populations, the aims of testing with respect to the phase of the pandemic must be considered.

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“…In symptomatic children, the overall sensitivity of the P-RDT was 45-78% 5,8,9 but published data do not take into account the effect of VL nor the duration of symptoms. Moreover, to our knowledge no study has evaluated this assay in asymptomatic children at time of sampling.…”

Section: Introductionmentioning

confidence: 99%

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

L’Huillier

Lacour²,

Sadiku³

et al. 2021

Preprint

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Importance. Antigen-based rapid diagnostic tests (RDTs) have shown good sensitivity for SARS-CoV-2 detection in adults and are used in children despite the lack data from children. Objective. We evaluated the diagnostic performance of the PanbioTM-COVID-19 Ag Rapid Test Device (P-RDT) in symptomatic and asymptomatic children against reverse-transcription polymerase chain reaction (RT-PCR) on nasopharyngeal swabs (NPS). Design. Prospective diagnostic study from 11.2020 to 03.2021 Setting. Single-center Participants. Consecutive symptomatic and asymptomatic participants 0-16yo Intervention. Two NPS for both RT-PCR and P-RDT Main outcome. P-RDT sensitivity and specificity Results. Eight-hundred and twenty-two participants completed the study, of which 533 (64.9%) were symptomatic. Among the 119 (14.5%) RT-PCR positive patients, the overall P-RDT sensitivity was 0.66 (95%CI 0.57-0.74). Mean viral load (VL) was higher among P-RDT positive than negative ones (p<0.001). Sensitivity was 0.87 in specimens with VL>1.0E6 copies/mL (95%CI 0.87-1.00), which is the accepted cut-off for the presence of infectious virus, and decreased to 0.67 (95%CI 0.59-0.76) for specimens >1.0E3 copies/mL. Among symptomatic participants, the P-RDT displayed a sensitivity of 0.73 (95%CI 0.64-0.82), which peaked at 1.00 at 2 days post onset of symptoms (DPOS; 95%CI 1.00-1.00), then decreased to 0.56 (95%CI 0.23-0.88) at 5 DPOS. There was a trend towards lower P-RDT sensitivity in symptomatic children <12 years (0.62 [95%CI 0.45-0.78]) versus > 12 years (0.80 [95%CI 0.69-0.91]; p=0.09). VL which was significantly lower in asymptomatic participants than in symptomatic ones (p<0.001). The P-RDT displayed a sensitivity of 0.43 (95%CI 0.26-0.61). Specificity was 1.00 in symptomatic and asymptomatic children (95%CI 0.99-1.00). Conclusion and relevance. The overall respective 73% and 43% sensitivities of P-RDT in symptomatic and asymptomatic children was below the 80% cut-off recommended by the World Health Organization. These findings are likely explained by lower VLs in children at the time of diagnosis. As expected, we observed a direct 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 both in symptomatic and asymptomatic children, with the potential exception in early symptomatic children >12yrs where sensitivity reached 80%.

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Think of the Children

Cited by 43 publications

References 25 publications

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

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

Use of emerging testing technologies and approaches for SARS-CoV-2: review of literature and global experience in an Australian context

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

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