Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres

Albert, Eliseo; Torres, Ignacio; Bueno, Felipe; Huntley, Dixie; Molla, Estefanía; Fernández-Fuentes, Miguel Ángel; Martínez, Mireia; Poujois, Sandrine; Forqué, Lorena; Valdivia, Arantxa; Asunción, Carlos Solano de la; Ferrer, Jaime; Colomina, Javier; Navarro, David

doi:10.1016/j.cmi.2020.11.004

Cited by 288 publications

(375 citation statements)

References 9 publications

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“…Various other reports regarding the performance of the commercially available rapid antigen tests have been published from Germany [39], India [40], Italy [41], Spain [42,43], Thailand [44], and USA [45]. All these results indicated that the sensitivity was decent (70.6%-100%) and the specificity was high (96%-100%).…”

Section: Antigen Tests For Covid-19mentioning

confidence: 92%

Antigen tests for COVID-19

et al. 2021

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PCR diagnosis has been considered as the gold standard for coronavirus disease 2019 (COVID-19) and other many diseases. However, there are many problems in using PCR, such as non-specific (i.e., false-positive) and false-negative amplifications, the limits of a target sample volume, deactivation of the enzymes used, complicated techniques, difficulty in designing probe sequences, and the expense. We, thus, need an alternative to PCR, for example an ultrasensitive antigen test. In the present review, we summarize the following three topics. (1) The problems of PCR are outlined. (2) The antigen tests are surveyed in the literature that was published in 2020, and their pros and cons are discussed for commercially available antigen tests. (3) Our own antigen test on the basis of an ultrasensitive enzyme-linked immunosorbent assay (ELISA) is introduced. Finally, we discuss the possibility that our antigen test by an ultrasensitive ELISA technique will become the gold standard for diagnosis of COVID-19 and other diseases.

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Section: Antigen Tests For Covid-19mentioning

confidence: 92%

Antigen tests for COVID-19

et al. 2021

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“…Subgenomic, but not total RNA detection in clinical samples, has demonstrated a better correlation with cell culture testing. Monitoring SARS-CoV-2 infectivity in cell culture may therefore be more informative to determine the infectiousness of a patient and potential transmission than standard rRT-PCR, which can reflect the persistence of non-replicating viral RNA [ 16 , 17 ]. Cell culture testing, however, is laborious and can only be performed in a BSL-3 laboratory by experienced personnel.…”

Section: Introductionmentioning

confidence: 99%

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Kohmer

Toptan

Pallas

et al. 2021

JCM

143

137

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Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread.

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“…The copyright holder for this preprint this version posted December 8, 2020. ; https://doi.org/10.1101/2020.12.07.20239558 doi: medRxiv preprint RT-LAMP vs. RT-PCR -Manuscript 10 jurisdictions are exploring use of PanBio Ag Rapid Test Device to identify positives early, assuming that negative results will need additional testing in order to be confirmed [26][27][28] .…”

Section: Discussionmentioning

confidence: 99%

Is the glass half full? Extraction-free RT-LAMP to detect SARS-CoV-2 is less sensitive but highly specific compared to standard RT-PCR in 101 samples

Schellenberg

Ormond²,

Keynan

2020

Preprint

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The current scale of public and private testing cannot be expected to meet the emerging need for higher levels of community-level and repeated screening of asymptomatic Canadians for SARS-CoV-2. Rapid point-of-care techniques are increasingly being deployed to fill the gap in screening levels required to identify undiagnosed individuals with high viral loads. However, rapid, point-of-care tests often have lower sensitivity in practice. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) for SARS-CoV-2 has proven sensitive and specific and provides visual results in minutes. Using a commercially available kit for RT-LAMP and primer set targetting nucleocapsid (N) gene, we tested a blinded set of 101 archived nasopharyngeal (NP) swab samples with known RT-PCR results. RT-LAMP reactions were incubated at 65°C for 30 minutes, using heat-inactivated nasopharyngeal swab sample in viral transport medium, diluted tenfold in water, as input. RT-LAMP agreed with all RT-PCR defined negatives (N=51), and all positives with Ct less than 20 (N=24), 65% of positives with Ct between 20-30 (N=17), and no positives with Ct greater than 30 (N=9). RT-LAMP requires fewer and different core components, so may not compete directly with the mainline testing workflow, preserving precious central laboratory resources and gold standard tests for those with the greatest need. Careful messaging must be provided when using less-sensitive tests, so that people are not falsely reassured by negative results – “glass half empty” – in exchange for reliable detection of those with high levels of virus within an hour, using <$10 worth of chemicals – “glass half full”.

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Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres

Cited by 288 publications

References 9 publications

Antigen tests for COVID-19

Antigen tests for COVID-19

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Is the glass half full? Extraction-free RT-LAMP to detect SARS-CoV-2 is less sensitive but highly specific compared to standard RT-PCR in 101 samples

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