Diagnostic Accuracy of the Panbio Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Rapid Test Compared with Reverse-Transcriptase Polymerase Chain Reaction Testing of Nasopharyngeal Samples in the Pediatric Population

Villaverde, Serena; Domínguez‐Rodríguez, Sara; Sabrido, Gema; Pérez‐Jorge, Concepción; Plata, M. Gutiérrez; Romero, María Pilar; Grasa, Carlos; Jiménez, Ana Belén; Heras, Elena de las; Broncano, Antonio; Núñez, María del Mar; Illán, Marta; Merino, Paloma; Soto, Beatriz; Arana, David M.; Bermejo, Amanda; Mendoza, Pablo; Gijón, Manuel; Pérez-Moneo, Begoña; Moraleda, Cinta; Tagarro, Alfredo

doi:10.1016/j.jpeds.2021.01.027

Cited by 62 publications

(64 citation statements)

References 12 publications

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“…Specificity for all used RDT was above 99·6%, which is comparable to manufacturers’ data (99·4% (Panbio™), 99·8% (MEDsan®), or >99·9% (NADAL®)). Sensitivity and specificity data is comparable with performance data from other studies: The Panbio™ RDT has been evaluated in several studies, [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] and reported sensitivity values range from 44·6% [12] to 91·7% [13] . The specificity was continuously in the range of 98·9% [13] to 100%.…”

Section: Discussionsupporting

confidence: 80%

“…The SARS-CoV-2 prevalence in the study population of 2 % was higher compared to the general population but lower compared to studies mainly conducted in symptomatic patients [ [14] , [15] , [16] , [17] , 21 ]. PPV was significantly higher in symptomatic persons compared to asymptomatic which reflects mainly a presumably higher prevalence but also a higher sensitivity of the tests due to higher viral loads.…”

Section: Discussioncontrasting

confidence: 59%

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Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

et al. 2021

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Background: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse. Methods: In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C t ) values. The data collection period ranged from November 12, 2020 to February 28, 2021. Findings: The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%–52·31%). The specificity was 99·68% (95% CI 99·48%–99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥10 8 SARS-CoV-2 RNA copies per ml to 8·82% in samples with a viral load lower than 10 4 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98·84%; the PPV in persons with typical COVID-19 symptoms was 97·37%, and 28·57% in persons without or with atypical symptoms. Interpretation: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available.

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Section: Discussionsupporting

confidence: 80%

Section: Discussioncontrasting

confidence: 59%

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

et al. 2021

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“…Our results showed an accurate performance of Ag-RDTs in the age-group 5–14, unlike other studies [ 19 , 20 ]. The differences between age-groups could be related to differences in SARS-CoV-2 viral load [ 20 , 21 ]. However, age-related differences in the performance of Ag-RDT remain unknown.…”

Section: Discussioncontrasting

confidence: 90%

Diagnostic Performance of Ag-RDTs and NAAT for SARS-CoV2 Identification in Symptomatic Patients in Catalonia

Basile

Guadalupe-Fernández

Guijarro

et al. 2021

Viruses

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The use of rapid antigenic tests (Ag-RDTs) to diagnose a SARS-CoV-2 infection has become a common practice recently. This study aimed to evaluate performance of Abbott PanbioTM Ag-RDTs with regard to nucleic acid amplification testing (NAAT) in the early stages of the disease. A cohort of 149,026 infected symptomatic patients, reported in Catalonia from November 2020 to January 2021, was selected. The positivity rates of the two tests were compared with respect to the dates of symptom onset. Ag-RDTs presented positivity rates of 84% in the transmission phases of the disease and 31% in the pre-symptomatic period, compared to 93% and 91%, respectively, for NAAT. The detection of many false negatives with Ag-RDTs during the pre-symptomatic period demonstrates the risk of virus dissemination with this diagnostic technique if used outside the symptomatic period.

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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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Diagnostic Accuracy of the Panbio Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Rapid Test Compared with Reverse-Transcriptase Polymerase Chain Reaction Testing of Nasopharyngeal Samples in the Pediatric Population

Cited by 62 publications

References 12 publications

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

Diagnostic Performance of Ag-RDTs and NAAT for SARS-CoV2 Identification in Symptomatic Patients in Catalonia

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

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