Decreased Sensitivity of Rapid Antigen Test Is Associated with a Lower Viral Load of Omicron than Delta SARS-CoV-2 Variant

Cocherie, Théophile; Bastide, Mathilda; Sakhi, Soraya; Zafilaza, Karen; Flandre, Philippe; Leducq, Valentin; Jary, Aude; Burrel, Sonia; Louet, Martine; Cálvez, Vincent; Marcelin, Anne‐Geneviève; Marot, Stéphane

doi:10.1128/spectrum.01922-22

Cited by 24 publications

(26 citation statements)

References 13 publications

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“…It was an effective approach during the COVID-19 pandemic as it reduced the community transmission of SARS-CoV-2 [ 9 ]. Despite these advantages, numerous studies have reported a lower analytical sensitivity of RAT kits than that of rRT-PCR methods and analyzed a wide range of Ct values in the optimal cut-off score [ 31 , 32 , 33 ]. Thus, in this study, the cut-off values from Ct values between 20 and 30 were estimated using a similar number of samples.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Lim

Park²,

Baek³

et al. 2023

Biomedicines

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Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription–polymerase chain reaction (rRT-PCR) is limited. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required. Here, using 1503 nasopharyngeal swabs, we compared the diagnostic performance of four RAT kits (Abbott Panbio™ COVID-19 Ag Rapid Test, SD Biosensor Standard™ Q COVID-19 Ag Test, Humasis COVID-19 Ag Test, and SG Medical Acrosis COVID-19 Ag Test) to the cycle threshold (Ct) values obtained from rRT-PCR. The precision values, area under the curve values, SARS-CoV-2 variant detection ability, and non-SARS-CoV-2 specificity of all four kits were similar. An assay using the Acrosis kit had a significantly better positive detection rate with a higher recall value and cut-off value than that using the other three RAT kits. During the current COVID-19 pandemic, the Acrosis kit is an effective tool to prevent the spread of SARS-CoV-2 in communities.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Lim

Park²,

Baek³

et al. 2023

Biomedicines

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“…The lower sensitivity of antigen tests for detection of the Omicron variant could be justified by considering the clinical and virological aspects. As Cocherie et al reported, lower viral load is observed in Omicron‐infected patients compared with Delta‐infected patients even at the same stage of disease 69 . However, there is still noticeable difference in the sensitivity of various antigen diagnostics between Omicron and Delta variants even at similar Ct values which could probably be associated with different factors such as genetic variations of N protein and assay design.…”

Section: Mutations In N Protein Of Sars‐cov‐2 Variantsmentioning

confidence: 96%

“…The Omicron variant is the latest strain with high transmissibility potential harbouring P13L, R203K, G204R substitutions, and amino acid deletions at positions 31–33 of N protein 67 . Due to these genetic variations, several reports suggested lower sensitivity of diagnostics targeting N protein especially for samples with Ct values >25 (lower viral load) (Table 2), 57,68–70 while some other studies reported similar sensitivities 71–73 . The lower sensitivity of antigen tests for detection of the Omicron variant could be justified by considering the clinical and virological aspects.…”

Section: Mutations In N Protein Of Sars‐cov‐2 Variantsmentioning

confidence: 99%

“…As Cocherie et al reported, lower viral load is observed in Omicron-infected patients compared with Delta-infected patients even at the same stage of disease. 69 However, there is still noticeable difference in the sensitivity of various antigen diagnostics between Omicron and Delta variants even at similar Ct values which could probably be associated with different factors such as genetic variations of N protein and assay design. Oulas et al suggested that P13L is correlated with decreased death rates.…”

Section: Mutations In N Protein Of Sars-cov-2 Variantsmentioning

confidence: 99%

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SARS‐CoV‐2 nucleocapsid: Biological functions and implication for disease diagnosis and vaccine design

Maghsood

Ghorbani

Yadegari

et al. 2023

Reviews in Medical Virology

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The coronavirus disease 2019 (COVID‐19) pandemic is transmitted by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and has affected millions of people all around the world, leading to more than 6.5 million deaths. The nucleocapsid (N) phosphoprotein plays important roles in modulating viral replication and transcription, virus‐infected cell cycle progression, apoptosis, and regulation of host innate immunity. As an immunodominant protein, N protein induces strong humoral and cellular immune responses in COVID‐19 patients, making it a key marker for studying N‐specific B cell and T cell responses and the development of diagnostic serological assays and efficient vaccines. In this review, we focus on the structural and functional features and the kinetic and epitope mapping of B cell and T cell responses against SARS‐CoV‐2 N protein to extend our understanding on the development of sensitive and specific diagnostic immunological tests and effective vaccines.

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“…Several groups found that RATs maintained sensitivity to omicron variants, 18,21 but others reported that RATs performed poorly with these variants 16,20,23 . The decreased sensitivity could be associated with a lower viral load of Omicron than delta 24 . Therefore, sensitivity comparisons of RATs using clinical specimens may be affected by changes in viral properties.…”

Section: Introductionmentioning

confidence: 99%

Sensitivity of rapid antigen tests for Omicron subvariants of SARS‐CoV‐2

Sakai‐Tagawa

Yamayoshi

Halfmann

et al. 2023

Journal of Medical Virology

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Diagnosis by rapid antigen tests (RATs) is useful for early initiation of antiviral treatment.Because RATs are easy to use, they can be adapted for self-testing. Several kinds of RATs approved for such use by the Japanese regulatory authority are available from drug stores and websites. Most RATs for COVID-19 are based on antibody detection of the SARS-CoV-2 N protein. Since Omicron and its subvariants have accumulated several amino acid substitutions in the N protein, such amino acid changes might affect the sensitivity of RATs. Here, we investigated the sensitivity of seven RATs available in Japan, six of which are approved for public use and one of which is approved for clinical use, for the detection of BA.5, BA.2.75, BF.7, XBB.1, and BQ.1.1, as well as the delta variant (B.1.627.2). All tested RATs detected the delta variant with a detection level between 7500 and 75 000 pfu per test, and all tested RATs showed similar sensitivity to

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Decreased Sensitivity of Rapid Antigen Test Is Associated with a Lower Viral Load of Omicron than Delta SARS-CoV-2 Variant

Abstract: Previous reports have shown a variability in the diagnostic performance of RDTs. In the era of SARS-CoV-2 variants and the use of RDT, mutation associated with these variants could affect the test performance.

Cited by 24 publications

References 13 publications

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

SARS‐CoV‐2 nucleocapsid: Biological functions and implication for disease diagnosis and vaccine design

Sensitivity of rapid antigen tests for Omicron subvariants of SARS‐CoV‐2

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