Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection

Gremmels, Hendrik; Winkel, B.; Schuurman, Rob; Rosingh, Andert; Rigter, Nicolette A.M.; Rodríguez, Olga Fernández; Ubijaan, Johan; Wensing, Annemarie M. J.; Bonten, Marc J. M.; Hofstra, L. Marije

doi:10.1016/j.eclinm.2020.100677

Cited by 152 publications

(119 citation statements)

References 20 publications

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“…First, all LFAs were performed on VTM and not on the originally collected throat nasopharyngeal swabs in order not to affect the routine COVID-19 diagnostics by RT-qPCR and to be able to compare 5 different LFAs head-to-head. This could theoretically have influenced test characteristics; however, the results of our study are in line with the results of other studies published [ 12 – 14 ]. Second, due to the late availability of two of the five LFAs tested, positive samples were frozen and used after thawing which also is not according to the manufacturers’ instructions.…”

Section: Discussionsupporting

confidence: 92%

“…This is in accordance with the higher sensitivity found in samples with a low C T value corresponding to infected patients with a high viral load. Recently, two other reports have evaluated the performance of a rapid antigen test for COVID-19 community screening in individuals with COVID-19-like symptoms [ 12 , 13 ]. In these studies, specificities of 100% were found whereas sensitivities of two studies with the Panbio™ test were 72.6% and 81.0%, and of the one with the BD Veritor 80.7%.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Koeleman

Brand

Man

et al. 2021

Eur J Clin Microbiol Infect Dis

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The RT-qPCR in respiratory specimens is the gold standard for diagnosing acute COVID-19 infections. However, this test takes considerable time before test results become available, thereby delaying patients from being diagnosed, treated, and isolated immediately. Rapid antigen tests could overcome this problem. In the first study, clinical performances of five rapid antigen tests were compared to RT-qPCR in upper respiratory specimens from 40 patients with positive and 40 with negative RTq-PCR results. In the second study, the rapid antigen test with one of the best test characteristics (Romed) was evaluated in a large prospective collection of upper respiratory specimens from 900 different COVID-19-suspected patients (300 emergency room patients, 300 nursing home patients, and 300 health care workers). Test specificities ranged from 87.5 to 100.0%, and test sensitivities from 55.0 to 80.0%. The clinical specificity of the Romed test was 99.8% (95% CI 98.9–100). Overall clinical sensitivity in the study population was 73.3% (95% CI 67.9–78.2), whereas sensitivity in the different patient groups varied from 65.3 to 86.7%. Sensitivity was 83.0 to 86.7% in patients with short duration of symptoms. In a population with a COVID-19 prevalence of 1%, the negative predictive value in all patients was 99.7%. There is a large variability in diagnostic performance between rapid antigen tests. The Romed rapid antigen test showed a good clinical performance in patients with high viral loads (RT-qPCR cycle threshold ≤30), which makes this antigen test suitable for rapid identification of COVID-19-infected health care workers and patients.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Koeleman

Brand

Man

et al. 2021

Eur J Clin Microbiol Infect Dis

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“…Although more evidence is needed, data suggest Ag-RDTs are likely to perform well (91-100% sensitivity) in patients with high viral loads (Ct values ≤25 or >10 6 genomic virus copies/mL) (302), which usually appear in the pre-symptomatic (1-3 days before symptom onset) and early symptomatic phases of the illness (within the first 5-7 days of illness) (303)(304)(305). A recent study on community-dwelling subjects with mild respiratory symptoms showed the Ag Rapid Test had 100% specificity and sensitivity above 95% for nasopharyngeal samples when using Ct-values < 32 cycles as the cut-off for RT-qPCR test positivity (306). In its September 11th, 2020, interim guidance, WHO recommends use of SARS-CoV-2 Ag-RDTs that meet the minimum performance requirements of ≥80% sensitivity and ≥97% specificity compared to a NAAT reference assay.…”

Section: In-vitro Diagnostics: Antigen Testingmentioning

confidence: 99%

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Mardian¹,

Kosasih²,

et al. 2021

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Diagnostic testing plays a critical role in addressing the coronavirus disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Rapid and accurate diagnostic tests are imperative for identifying and managing infected individuals, contact tracing, epidemiologic characterization, and public health decision making. Laboratory testing may be performed based on symptomatic presentation or for screening of asymptomatic people. Confirmation of SARS-CoV-2 infection is typically by nucleic acid amplification tests (NAAT), which requires specialized equipment and training and may be particularly challenging in resource-limited settings. NAAT may give false-negative results due to timing of sample collection relative to infection, improper sampling of respiratory specimens, inadequate preservation of samples, and technical limitations; false-positives may occur due to technical errors, particularly contamination during the manual real-time polymerase chain reaction (RT-PCR) process. Thus, clinical presentation, contact history and contemporary phyloepidemiology must be considered when interpreting results. Several sample-to-answer platforms, including high-throughput systems and Point of Care (PoC) assays, have been developed to increase testing capacity and decrease technical errors. Alternatives to RT-PCR assay, such as other RNA detection methods and antigen tests may be appropriate for certain situations, such as resource-limited settings. While sequencing is important to monitor on-going evolution of the SARS-CoV-2 genome, antibody assays are useful for epidemiologic purposes. The ever-expanding assortment of tests, with varying clinical utility, performance requirements, and limitations, merits comparative evaluation. We herein provide a comprehensive review of currently available COVID-19 diagnostics, exploring their pros and cons as well as appropriate indications. Strategies to further optimize safety, speed, and ease of SARS-CoV-2 testing without compromising accuracy are suggested. Access to scalable diagnostic tools and continued technologic advances, including machine learning and smartphone integration, will facilitate control of the current pandemic as well as preparedness for the next one.

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“…Given that we assumed that positive antigen tests are in general confirmed by molecular ones, false positives do not pose a significant problem for the model. Although, the false negatives percentages reported in the literature for novel antigen tests are not high [3,4,5], some scientists still doubt about their sensitivity in specific situations, for example with asymptomatic individuals [7], albeit the presented results are about salivary tests [6] not NS. However, the results of these studies strongly depend on the tests used, and actually there are many different tests around, see for example [2,26].…”

Section: The Impact Of Antigen Tests On the Tpr Indexmentioning

confidence: 89%

COVID-19 Test Positivity Rate as a marker for hospital overload

Gáspari

2021

Preprint

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The use of antigen tests for the diagnosis of COVID-19 in Italy has risen sharply in autumn 2020. Although, Italian regions like Alto Adige, Veneto, Toscana, Lazio, Piemonte and Marche did a large use of these tests for screening and surveillance purposes or for implementing diagnosis protocols, in addition to molecular tests, they were not reported in the statistics in the last months of 2020. As a consequence of this situation the test positivity rate (TPR) index, defined as the number of new positive cases divided by the number of tests, has lost in accuracy. Only in the recent days, starting from the 15th of January 2021, antigen tests have become part of the statistics for all the Italian regions. Despite the lack of data, we have noticed that TPR has a strong correlation with the number of patients admitted in hospitals, and that TPR peaks in general precede the peaks of hospitalized people which occur on average about 15 days later.In this paper, we have deepened this intuition, analysing the TPR course and its relationship with the number of hospitalized people. To conduct the study we have defined a novel version of the TPR index which takes into account the number of tests done with respect to the population (considering both molecular and antigen tests), the number of infected individuals, and the number of patients healed. Successively, starting from a limited set of data which were made available in November 2020, we have reconstructed the antigen tests time series of four Italian regions, and we computed the TPR index for them.The results show that TPR peaks precede peaks of hospitalized people in both the first and the second phases of the pandemic in Italy, provided that antigen tests are considered. Moreover, the TPR index trend, can be used to deduct important information on the course of the epidemic, and on the impact of COVID-19 in the health care system, which can be monitored in advance.

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Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection

Cited by 152 publications

References 20 publications

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

COVID-19 Test Positivity Rate as a marker for hospital overload

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