Virus Variant Specific Clinical Performance Assessment of SARS-CoV-2 Rapid Antigen Tests in Point-of-Care Use Including Omicron VOC

Wagenhäuser, Isabell; Knies, Kerstin; Hofmann, Daniela; Rauschenberger, Vera; Eisenmann, Michael; Gabel, Alexander; Flemming, Sven; Andrés, Oliver; Petri, Nils; Topp, Max S.; McDonogh, Miriam; Verma-Führing, Raoul; Scherzad, Agmal; Zeller, Daniel; Böhm, Hartmut; Gesierich, Anja; Seitz, Anna Katharina; Kiderlen, Michael; Gawlik, Micha; Taurines, Regina; Förster, Johannes; Weismann, Dirk; Weißbrich, Benedikt; Dölken, Lars; Liese, Johannes G.; Kurzai, Oliver; Vogel, Ulrich; Krone, Manuel

doi:10.2139/ssrn.4075840

Cited by 5 publications

(12 citation statements)

References 10 publications

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“…In contrast to previous evidence, 18 no significantly reduced viral load was observed in Omicron VOC. This may be explained by the dominating proportion of Omicron VOC in this study.…”

Section: Discussioncontrasting

confidence: 99%

“…4 This study is a following paediatric specific sub-study of two former RDT performance assessments from November 2020 up to February 2021, the first of which included 1,034 RDT on paediatric patients in a total of 5,068 RDT, 20 as wells as its follow-up study up to January 2022 with 35,479 enrolled specimens including 5,623 from children and adolescents. 18…”

Section: Study Settingmentioning

confidence: 99%

“…19,20 Calculation of viral loads starting from cycle threshold (Ct) values based on reference standards as well as molecular VOC determination were defined previously as well. 18,20 Data collection The following age categories were set for an age-stratified analysis of RDT performance, viral load, COVID-19 symptomatology, and days since symptom onset: first year of life, 1 to 5 years, 6 to 11 year and 12 to 17 years.…”

Section: Test Enrolmentmentioning

confidence: 99%

“…A large-scale, real-life analysis of RDT performance among children and adolescents including COVID-19 vaccination status and SARS-CoV-2 VOC is still missing. [8][9][10][11][12][13][14][15][16][17][18] The aim of this prospective performance evaluation study is to evaluate the clinical performance of RDT compared to RT-qPCR as screening test strategy for hospitalised children and adolescents under the age of 18 years. The analysis includes a standardised viral load determination as reference with the focus on SARS-CoV-2 VOC dependence, COVID-19 vaccination status, and specificity in broad screening use.…”

Section: Introductionmentioning

confidence: 99%

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Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents in comparison to RT-qPCR, November 2020 to September 2022

Krone

Wagenhäuser

Knies

et al. 2022

Preprint

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BackgroundRapid antigen detection tests (RDT) are an easily accessible, feasible, inexpensive, and point of care method in SARS-CoV-2 diagnostics - established in adults as well as in children and adolescents. Despite this, large-scale data of clinical performance in the paediatric population especially regarding the influence of SARS-CoV-2 virus variants of concern (VOC) and COVID-19 vaccination on test accuracy is rare.MethodsThis single centre prospective diagnostic study evaluates three RDT (NADAL®, Panbio™, MEDsan®) in comparison to quantitative reverse transcription polymerase chain reaction (RT-qPCR). 9,760 oropharyngeal screening samples regarding SARS-CoV-2 VOC and COVID-19 vaccination in paediatric hospitalised patients aged younger than 18 years were enrolled.FindingsRDT sensitivity was 44·7% (157/351, 95% CI 39·6%-50·0%) compared to the reference standard RT-qPCR, specificity 99·8% (9,392/9,409, 95% CI 99·7%-99·9%). Most SARS-CoV-2 infections considered were caused by Omicron VOC. Diagnostic accuracy of RDT depended on specimen containing viral load with a decreasing RDT sensitivity by descending viral load, corresponding with a significantly impaired sensitivity in asymptomatic children. A sensitivity of 71·0% was obtained for a viral load higher than 106SARS-CoV-2 RNA copies per ml suggested as infectivity threshold. No significant differences in RDT sensitivity could be observed regarding gender, symptoms, COVID-19 vaccination status, and VOC.InterpretationIn a paediatric population, RDT have proven to reliably detect potentially highly infectious patients with a viral load of at least 106SARS-CoV-2 RNA copies per ml. Due to the low sensitivity in asymptomatic individuals, the usefulness of RDT seems limited in large scale SARS-CoV-2 screening programs.FundingFederal Ministry for Education and Science (BMBF), Free State of Bavaria

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“…In contrast to previous evidence, 18 no significantly reduced viral load was observed in Omicron VOC. This may be explained by the dominating proportion of Omicron VOC in this study.…”

Section: Discussioncontrasting

confidence: 99%

Section: Study Settingmentioning

confidence: 99%

Section: Test Enrolmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents in comparison to RT-qPCR, November 2020 to September 2022

Krone

Wagenhäuser

Knies

et al. 2022

Preprint

Self Cite

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“…Similar findings have been observed in the major previous variants and the Omicron variant [ 8 , 9 ]. However, some reports also indicated the reduced clinical sensitivity of antigen tests for diagnosis of infection with the Omicron variant compared with the previous variants or the wild-type [ 10 , 11 ]. Therefore, more sensitive tests can be better for preventing the increase in false negatives.…”

Section: Discussionmentioning

confidence: 99%

Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2

Morinaga¹,

Yamada²,

Yoshida³

et al. 2023

Journal of Infection and Chemotherapy

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Vaccine-hesitant individuals accumulate additional COVID-19 risk due to divergent perception and behaviors related to SARS-CoV-2 testing: a population-based, cross-sectional study

Wratil

Kotter²,

Bischof³

et al. 2022

Infection

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Purpose To investigate the perception of SARS-CoV-2 detection methods, information sources, and opinions on appropriate behavior after receiving negative or positive test results. Methods In a questionnaire-based, cross-sectional study conducted between September 1 and November 17, 2021, epidemiological, behavioral, and COVID-19-related data were acquired from the public in Munich, Germany. Results Most of the 1388 participants obtained information from online media (82.8%) as well as state and federal authorities (80.3%). 93.4% believed in the accuracy of SARS-CoV-2 PCR testing and 41.2% in the accuracy of rapid antigen tests (RATs). However, RATs were preferred for testing (59.1%) over PCR (51.1%). 24.0% of all individuals were willing to ignore hygiene measures and 76.9% were less afraid of SARS-CoV-2 transmission after receiving a negative PCR test (5.9% and 48.8% in case of a negative RAT). 28.8% reported not to self-isolate after receiving a positive RAT. Multivariate analyses revealed that non-vaccinated individuals relied less on information from governmental authorities (p = 0.0004) and more on social media (p = 0.0216), disbelieved in the accuracy of the PCR test (p ≤ 0.0001) while displaying strong preference towards using RATs (p ≤ 0.0001), were more willing to abandon pandemic-related hygiene measures (p ≤ 0.0001), less afraid of transmitting SARS-CoV-2 after a negative RAT (p ≤ 0.0001), and less likely to isolate after a positive RAT (p ≤ 0.0001). Conclusion Insights into preferred information sources as well as perception, preferences, and behavior related to SARS-CoV-2 testing and hygiene measures are key to refining public health information and surveillance campaigns. Non-vaccinated individuals’ divergent believes and behaviors possibly increase their COVID-19 risk.

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Virus Variant Specific Clinical Performance Assessment of SARS-CoV-2 Rapid Antigen Tests in Point-of-Care Use Including Omicron VOC

Cited by 5 publications

References 10 publications

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents in comparison to RT-qPCR, November 2020 to September 2022

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents in comparison to RT-qPCR, November 2020 to September 2022

Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2

Vaccine-hesitant individuals accumulate additional COVID-19 risk due to divergent perception and behaviors related to SARS-CoV-2 testing: a population-based, cross-sectional study

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