Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care

Bulilete, Oana; Lorente, Patricia; Leiva, Alfonso; Carandell, Eugenia; Oliver, Antonio; Rojo, Estrella; Pericas, Pau; Llobera, Joan

doi:10.1016/j.jinf.2021.02.014

Cited by 56 publications

(47 citation statements)

References 14 publications

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“…Sensitivity and specificity of such antigen rapid diagnostic tests strongly depend on their good execution and reading which are harder to achieve at the frontline where the expertise of personnel can vary; especially in this time of pandemic when the turn-over is higher than usual. This was confirmed by other recently published studies targeting the same population, with sensitivity ranging from 70.0 to 80.4% (29)(30)(31).…”

Section: Discussionsupporting

confidence: 88%

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Yin

Debuysschere

Decroly³

et al. 2021

Front. Med.

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Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions.Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients.Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs.Conclusion: Using tests not considered the “gold standard” for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.

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Section: Discussionsupporting

confidence: 88%

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Yin

Debuysschere

Decroly³

et al. 2021

Front. Med.

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“…There are over 10 clinical studies (8 preprints, 2 published) evaluating the performance of the Panbio™ Ag-RDT [3][4][5][6][7][8][9][10][11][12] using only manufacturer recommended NPS. Those studies, with over 6000 subjects, have reported sensitivity and specificity ranges of 71.4%-91.7% and 94.9%-100%, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Those studies, with over 6000 subjects, have reported sensitivity and specificity ranges of 71.4%-91.7% and 94.9%-100%, respectively. Considering only Ct values <30 yielded test sensitivities from 87.7% to 97.8% [ 3 , 6 – 9 ]. Similarly, samples from <5 DPOS yielded a sensitivity between 77.2 and 94.8% [ 3 , 5 , 6 , 8 , 9 ].…”

Section: Discussionmentioning

confidence: 99%

“…The World Health Organization (WHO) considers a sensitivity �80% and a specificity �97% as acceptable performance for SARS-CoV-2 Ag-RDTs [2]. Currently, only validations of Ag-RDTs performed with NPS have shown satisfactory results [3][4][5][6][7][8][9][10][11][12], and no studies have evaluated Ag-RDTs using oropharyngeal swabs (OPS). OPS sampling could be a useful alternative to NPS sampling, as seen with RT-qPCR tests [13,14].…”

Section: Introductionmentioning

confidence: 99%

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Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2

Nsoga

Kronig

Rodríguez³

et al. 2021

PLoS ONE

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Background Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients. Methods We conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland. Results 402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2–86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9–99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7–99.0%) was obtained with the Ag-RDT using OPS. Interpretation Based on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.

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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%

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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Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care

Cited by 56 publications

References 14 publications

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2

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

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