Evaluation of a rapid antigen test (Panbio™ COVID-19 Ag rapid test device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients

Torres, Ignacio; Poujois, Sandrine; Albert, Eliseo; Colomina, Javier; Navarro, David

doi:10.1016/j.cmi.2020.12.022

Cited by 132 publications

(113 citation statements)

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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: 60%

“…The specificity was continuously in the range of 98·9% [13] to 100%. [14] , [15] , [16] , [17] Three small laboratory or cohort studies are published on NADAL®. [18] , [19] , [20] Overall sensitivity ranged between 24·3% [19] and 73·1% [20] , and test specificity estimated at more than 99% [18] , [19] , [20] .…”

Section: Discussionmentioning

confidence: 99%

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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: 60%

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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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“…Studies have noted lower sensitivity in asymptomatic (48.1%-56.5%) individuals compared to symptomatic ones (71.4%-80.4%) [39][40][41][42] . Since Ag-RDT sensitivity is largely related to viral load, these differences might reflect dissimilarities in the kinetics of SARS-CoV-2 viral load in the upper respiratory tract.…”

Section: Discussionmentioning

confidence: 97%

“…Since Ag-RDT sensitivity is largely related to viral load, these differences might reflect dissimilarities in the kinetics of SARS-CoV-2 viral load in the upper respiratory tract. While it is well known that SARS-CoV-2 load peaks around the time of symptoms onset 42,43 , the timing is uncertain in asymptomatic cases.…”

Section: Discussionmentioning

confidence: 99%

Accuracy of the Mologic COVID-19 rapid antigen test: a prospective multi-centre analytical and clinical evaluation

Atienzar¹,

Bell²,

Byrne³

et al. 2021

Wellcome Open Res

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Background: The coronavirus disease 2019 (COVID-19) pandemic has highlighted the reliance on antigen detection rapid diagnostic tests (Ag-RDTs). Their evaluation at point of use is a priority. Methods: Here, we report a multi-centre evaluation of the analytical sensitivity, specificity, and clinical accuracy of the Mologic COVID-19 Ag-RDT by comparing to reverse transcriptase polymerase chain reaction (RT-qPCR) results from individuals with and without COVID-19 symptoms. Participants had attended hospitals in Merseyside, hospital and ambulance services in Yorkshire, and drive-through testing facilities in Northumberland, UK. Results: The limit of detection of the Mologic COVID-19 Ag-RDT was 5.0 x 102 pfu/ml in swab matrix with no cross-reactivity and interference for any other pathogens tested. A total of 347 participants were enrolled from 26th of November 2020 to 15th of February 2021 with 39.2% (CI 34.0-44.6) testing RT-qPCR positive for SARS-CoV-2. The overall sensitivity and specificity of the Mologic Ag-RDT compared to the reference SARS-CoV-2 RT-qPCR were 85.0% (95% CI 78.3-90.2) and 97.8% (95.0-99.3), respectively. Sensitivity was stratified by RT-qPCR cycle threshold (Ct) and 98.4% (91.3-100) of samples with a Ct less than 20 and 93.2% (86.5-97.2) of samples with a Ct less than 25 were detected using the Ag-RDT. Clinical accuracy was stratified by sampling strategy, swab type and clinical presentation. Mologic COVID-19 Ag-RDT demonstrated highest sensitivity with nose/throat swabs compared with throat or nose swabs alone; however, the differences were not statistically significant. Conclusions: Overall, the Mologic test had high diagnostic accuracy across multiple different settings, different demographics, and on self-collected swab specimens. These findings suggest the Mologic rapid antigen test may be deployed effectively across a range of use settings.

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Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Dinnes

Sharma

Berhane

et al. 2022

Cochrane Database of Systematic Reviews

151

133

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Evaluation of a rapid antigen test (Panbio™ COVID-19 Ag rapid test device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients

Cited by 132 publications

References 10 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

Accuracy of the Mologic COVID-19 rapid antigen test: a prospective multi-centre analytical and clinical evaluation

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

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