Virus variant-specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on Omicron variants of concern

Bornemann, Linus; Kaup, Olaf; Kleideiter, Johannes; Ruprecht, Bertram; Hoyer, Annika; Panning, Marcus; Bornemann, Reinhard; Wehmeier, Michael

doi:10.1016/j.cmi.2023.05.009

Cited by 8 publications

(8 citation statements)

References 15 publications

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“…We have systematically explored the capacity of a first- and second-generation rapid antigen test for early detection of SARS-CoV-2 among hospital workers. While other studies have demonstrated the ability of different rapid antigen tests to detect infections with newly emerging Omicron sub-lineages ( 14 , 33 , 34 ), this study for the first time reports on how a higher capacity for the detection of viral nucleocapsids from emerging SARS-CoV-2 Omicron VoCs translates into improved detection of infection with these VoCs in a high-risk cohort of healthcare workers.…”

Section: Discussionmentioning

confidence: 85%

Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

Wettengel,

Strehle,

von Lucke

et al. 2023

Microbiol Spectr

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The continuous genetic evolution of SARS-CoV-2 resulting in the immune escape variant of concern (VoC) Omicron poses a challenge to rapid and accurate diagnosis of infection, especially in high-risk groups such as healthcare workers. We performed a clinical study to determine the diagnostic accuracy and robustness of a second-generation rapid antigen test compared to a first-generation rapid antigen test with an RT-qPCR-based assay as gold standard, for early detection of infections with SARS-CoV-2 Omicron VoC. A total of 428 healthcare workers with COVID-19-associated symptoms or during routine testing participated in the study and completed a questionnaire on infection-associated symptoms, previous SARS-CoV-2 infections, and vaccination status. All participants performed a second- and first-generation rapid antigen test on the day of presentation and repeated the test 2 days later, and a diagnostic SARS-CoV-2 RT-qPCR assay was performed. qPCR-confirmed SARS-CoV-2 infections ( n = 104) with Omicron VoC (BA.2, BA.4, BA.5) were detected by the first-generation rapid antigen test with a sensitivity of 83.7% (95% CI 75.12%–90.18%), whereas the second-generation rapid antigen test performed with a sensitivity of 89.4% (95% CI 81.9%–94.6%). Increased sensitivity of the second-generation rapid antigen test led to earlier detection of SARS-CoV-2 infection, while lower test sensitivity of the first-generation rapid antigen test was compensated by repeated testing 2 days later. Moreover, direct in vitro comparison revealed a lower limit of detection for the second-generation rapid antigen test for isolates of currently circulating Omicron sub-lineages BA.5.2, BQ.1, and XBB.1. IMPORTANCE The results from this study demonstrate the usefulness of a second-generation rapid antigen test for early detection of infection with the SARS-CoV-2 Omicron variant of concern (VoC) and reveal a higher sensitivity to detect immune escape Omicron VoCs compared to a first-generation rapid antigen test (89.4% vs 83.7%) in the high-risk group of healthcare workers.

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Section: Discussionmentioning

confidence: 85%

Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

Wettengel,

Strehle,

von Lucke

et al. 2023

Microbiol Spectr

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“…showed a 9% decrease in Ag‐RDT sensitivity for Omicron variants compared to the variants that emerged during late 2020. Still, Alpha, Delta, and Omicron BA.5 variants had no significant changes in sensitivity to the latter 33 . Another study by Bekliz et al.…”

Section: Discussionmentioning

confidence: 86%

“…The five studies obtained better diagnostic accuracy in samples with Ct values < 25 or high viral load >7 log10 SARS‐CoV‐2 RNA copies/ml, and positive patients had an average duration of symptoms around 3–7 days 21–25 . Sensitivity is shown to be positively correlated to viral load despite the different SARS‐CoV‐2 variants that have emerged 33 . A study by Bornemann et al.…”

Section: Discussionmentioning

confidence: 96%

“…[21][22][23][24][25] Sensitivity is shown to be positively correlated to viral load despite the different SARS-CoV-2 variants that have emerged. 33 A study by Bornemann et al showed a 9% decrease in Ag-RDT sensitivity for Omicron variants compared to the variants that emerged during late 2020. Still, Alpha, Delta, and Omicron BA.5 variants had no significant changes in sensitivity to the latter.…”

Section: Discussionmentioning

confidence: 99%

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Comparable performance of antigen‐detecting rapid test by healthcare worker‐collected and self‐collected swabs for SARS‐CoV‐2 diagnostic: A systematic review and meta‐analysis

Kurniawan,

Kaisar,

Kristin

et al. 2023

Reviews in Medical Virology

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Usage of self‐screening tests has become increasingly relevant in public health perspective for early detection of SARS‐CoV‐2 infection in the transitioning era of the COVID‐19 pandemic into an endemic. This study was designed to compare the diagnostic accuracy of self‐conducted and health professional‐conducted SARS‐CoV‐2 rapid antigen tests (Ag‐RDTs) and whether the sample was taken from anterior nasal or nasal mid‐turbinate. Eligible comparative Ag‐RDTs accuracy studies were retrieved from electronic databases systematically, in accordance with PRISMA. Selected studies were assessed for risk of bias using QUADAS‐2 and QUADAS‐C. In total, we selected five out of 1952 studies retrieved using the keywords. The overall sensitivity for the self‐collected nasal swab method and healthcare worker‐collected nasopharyngeal swab method was 79% (95% CI 68–87; I2 = 62%) and 83% (95% CI 75–89; I2 = 32%), respectively, which was not statistically different (p = 0.499). Nasal mid‐turbinate swabs have a significantly higher sensitivity compared to anterior nasal swabs (p < 0.01). Both sampling methods represent high and comparable specificity values of 98% (95% CI 97–99; I2 = 0%) and 99% (95% CI 98–99; I2 = 0%). Positive predictive value (range 90%–99%) and negative predictive value (range 87%–98%) were equivalent for both methods. Our findings indicated the accuracy of self‐collected Ag‐RDT on nasal swabs was comparable to those performed by healthcare worker‐collected on nasopharyngeal swabs. Self‐collected Ag‐RDT could be considered as a transmission prevention method in the transition of COVID‐19 pandemic.

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“…1). Patients were included if a) substantial immunosuppression was present (see definitions) and b) SARS-CoV-2 with a Ct-value of < 30 (reflecting a concentration of around > 30.000 copies/ml in our setting) was detected in a respiratory sample > 14 days after the first positive test for SARS-CoV-2 [ 14 – 16 ].…”

Section: Methodsmentioning

confidence: 99%

Clinical phenotype and outcome of persistent SARS-CoV-2 replication in immunocompromised hosts: a retrospective observational study in the Omicron era

Götz,

Mathé,

Agarwal

et al. 2023

Infection

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Purpose This study aims to describe clinical, virological and radiological characteristics as well as treatment strategies and outcomes of immunocompromised patients with persistent SARS-CoV-2 replication. Methods We performed a retrospective cohort study of immunocompromised patients at the University Medical Center Freiburg between 01/2022 and 05/2023. Patients with substantial immunosuppression and persistent SARS-CoV-2 detection (Ct-value < 30 after 14 days) were included. Results 36 patients in our cohort reported mainly fever, dyspnoea or continuous cough. Viral load was significantly higher in concurrent samples taken from the lower respiratory tract (Ct-value = 26) than from the upper respiratory tract (Ct-value = 34). Time of detectable viral RNA after start of antiviral treatment was shorter in patients receiving two antivirals (median 15 days vs. 31 days with one antiviral agent). Short-course antiviral therapy (≤ 5 days) was less efficient in reduction of symptoms and viral load than prolonged therapy > 10 days. In 30% (8/27) of patients with repeated CT scans, we found the emergence of chronic pulmonary changes, which were more frequently in patients with B cell depletion (37%, 7/19) compared to patients with organ transplantation (12%, 2/17). Conclusion Ongoing SARS-CoV-2 replication in the lower respiratory tract is a relevant differential diagnosis in patients with severe immunosuppression and continuous cough, fever or dyspnoea even if nasopharyngeal swabs test negative for SARS-CoV-2. Especially in B cell-depleted patients, this may lead to inflammatory or fibrotic-like pulmonary changes, which are partially reversible after inhibition of viral replication. Antiviral therapy seems to be most effective in combination and over a prolonged period of time of > 10 days. Trial registration number DRKS 00027299.

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Virus variant-specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on Omicron variants of concern

Cited by 8 publications

References 15 publications

Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

Improved detection of infection with SARS-CoV-2 Omicron variants of concern in healthcare workers by a second-generation rapid antigen test

Comparable performance of antigen‐detecting rapid test by healthcare worker‐collected and self‐collected swabs for SARS‐CoV‐2 diagnostic: A systematic review and meta‐analysis

Clinical phenotype and outcome of persistent SARS-CoV-2 replication in immunocompromised hosts: a retrospective observational study in the Omicron era

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