Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests

Scheiblauer, Heinrich; Filomena, Angela; Nitsche, Andreas; Puyskens, Andreas; Corman, Victor M.; Drosten, Christian; Zwirglmaier, Katrin; Lange, Constanze; Emmerich, Petra; Mueller, Christoph; Knauer, Olivia; Nuebling, Micha

doi:10.1101/2021.05.11.21257016

Cited by 24 publications

(17 citation statements)

References 8 publications

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“…In a comparison of commercially available antigen POC tests, Scheiblauer et al [8] reported a sensitivity of 83.3% at Ct-values 25 or less for the antigen test used in this trial. We used this value as the presumed sensitivity for unvaccinated patients.…”

Section: Methodsmentioning

confidence: 70%

Sensitivity of severe acute respiratory syndrome coronavirus type 2 rapid antigen point-of-care tests in vaccinated patients

Bollinger

Saile

Shapeton

et al. 2022

European Journal of Emergency Medicine

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Background and importance Rapid antigen point-of-care tests (antigen POC tests) are frequently used to detect COVID-19 infections. Based on clinical impressions, we suspected that the sensitivity of antigen POC tests might be lower in vaccinated patients. Objective To evaluate the sensitivity of antigen POC tests in vaccinated patients. Design, setting and participants We retrospectively evaluated all patients over 18 years of age that tested positive for severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in November 2021 at our institution, whose antigen POC test result had been recorded. We considered patients who were either fully vaccinated or unvaccinated, as well as whether they were symptomatic. Outcome measure and analysis We calculated the sensitivity of antigen POC tests in vaccinated and unvaccinated as well as in symptomatic and asymptomatic patients and compared the results. Results A total of 4080 reverse transcription PCR tests were performed in our institution in November 2021, of which 360 patients tested positive for SARS-CoV-2. Of those, 234 patients met inclusion criteria and were further evaluated. The sensitivity of the antigen POC test was only 39.4% [95% confidence interval (CI), 31.3–48.1%] in vaccinated patients and differed significantly from the sensitivity of 53.3% (95% CI, 43.9–62.4%) in unvaccinated patients (difference of sensitivities, 13.9%; 95% CI, 1.1–26.1%). In symptomatic patients, the sensitivity increased by only 11.8% from 45.7% in all patients (95% CI, 39.5–52.1%) to 57.5% in symptomatic patients (95% CI, 49.9–64.7%). In asymptomatic patients, the antigen POC test was only able to detect SARS-CoV-2 positive patients in 16.4% of the cases (95% CI, 9.4–27.1%). Conclusion Point-of-care antigen tests are likely not useful for ruling out SARS-CoV-2 infection, especially in vaccinated and asymptomatic patients, potentially due to lower viral load. Moreover, the use of these tests might lead to a false sense of security, especially when used by the public as part of a public health testing strategy.

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Section: Methodsmentioning

confidence: 70%

Sensitivity of severe acute respiratory syndrome coronavirus type 2 rapid antigen point-of-care tests in vaccinated patients

Bollinger

Saile

Shapeton

et al. 2022

European Journal of Emergency Medicine

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“…The timely initiation of antiviral therapy for SARS-CoV-2 will require the widespread availability of simple, affordable, and self-administered tests for the early diagnosis of SARS-CoV-2 infection. Current antigen tests fit well this demand with enough good sensitivity and specificity [47][48][49][50] . For the subset of persons at high risk for developing severe COVID-19 infection, short courses of antivirals as post-exposure prophylaxis might be considered.…”

Section: Prophylaxismentioning

confidence: 99%

Oral antivirals for the prevention and treatment of SARS-CoV-2 infection

Soriano¹,

de-Mendoza²,

Edagwa³

et al. 2022

AIDSRev

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Vaccines and antivirals are the classical weapons deployed to contain, prevent, and treat life-threatening viral illnesses. Specifically, for SARS-CoV-2 infection, vaccines protect against severe COVID-19 disease manifestations and complications. However, waning immunity and emergence of vaccine escape mutants remains a growing threat. This is highlighted by the current surge of the omicron COVID-19 variant. Thus, there is a race to find treatment alternatives. We contend that oral small molecule antivirals that halt SARS-CoV-2 infection are essential. Compared to currently available monoclonal antibodies and remdesivir, where parenteral administration is required, oral antivirals offer treatments in an outpatient setting with dissemination available on a larger scale. In response to this need at 2021's end, regulatory agencies provided emergency use authorization for both molnupiravir and nirmatrelvir. These medicines act on the viral polymerase and protease, respectively. Each is given for 5 days and can reduce disease progression by 30% and 89%, respectively. The advent of additional oral antivirals, the assessment of combination therapies, the formulation of extended-release medications, and their benefit for both early treatment and prophylaxis will likely transform the landscape of the COVID-19 pandemic.

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“…In Europe, 950 CE-marked antigen tests (560 rapid) are currently on the market [12] . With continual increases in available tests, the number of validation studies has also increased but there are still only a small number of independent extensive comparative evaluations [13] , [14] , [15] . Also, data from external quality assessment (EQA) studies to evaluate the test performance amongst different users are required.…”

Section: Introductionmentioning

confidence: 99%

Importance of external quality assessment for SARS-CoV-2 antigen detection during the COVID-19 pandemic

Mantke¹,

Corman

Taddei

et al. 2022

Journal of Clinical Virology

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Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests

Cited by 24 publications

References 8 publications

Sensitivity of severe acute respiratory syndrome coronavirus type 2 rapid antigen point-of-care tests in vaccinated patients

Sensitivity of severe acute respiratory syndrome coronavirus type 2 rapid antigen point-of-care tests in vaccinated patients

Oral antivirals for the prevention and treatment of SARS-CoV-2 infection

Importance of external quality assessment for SARS-CoV-2 antigen detection during the COVID-19 pandemic

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