Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant

Michelena, Paula de; Torres, Ignacio; Ramos-García, Ángela; Gozalbes, Victoria; Ruiz, Nidia; Sanmartín, Ana; Botija, Pilar; Poujois, Sandrine; Huntley, Dixie; Albert, Eliseo

doi:10.1016/j.jinf.2022.02.022

Cited by 32 publications

(37 citation statements)

References 8 publications

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“…Recent studies from the USA and Italy that evaluated Ag-RDTs when Omicron was dominant, found comparable sensitivities of 74% (128/173 RT-PCR positives) and 82% (126/154 RT-PCR positives), but sampling was performed by professionals and sample sizes were smaller. 11,12…”

Section: Discussionmentioning

confidence: 99%

“…Initial studies comparing Omicron and Delta variants found similar sensitivities for molecular tests 8 , mixed analytical performance of lateral flow devices 9,10 , and similar real-world sensitivities for Ag-RDTs with sampling and testing by trained professionals. 11,12 Additionally, anecdotal concerns were raised about the performance of Ag-RDTs when applying nasal self-sampling only since Omicron variant’s viral particles seem more prevalent in the throat than nose. One study indeed showed improved Ag-RDT sensitivity with combined throat and nasal sampling by trained professionals.…”

Section: Introductionmentioning

confidence: 99%

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Accuracy of COVID-19 self-tests with unsupervised nasal or nasal plus oropharyngeal self-sampling in symptomatic individuals in the Omicron period

Schuit

Venekamp

Hooft

et al. 2022

Preprint

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Background Performances of rapid antigen diagnostic tests (Ag-RDTs) with nasal self-sampling, and oropharyngeal plus nasal (OP-N) self-sampling, in the Omicron period are unknown. Methods Prospective diagnostic accuracy study among 6,497 symptomatic individuals aged ≥16 years presenting for SARS-CoV-2 testing at three test-sites. Participants were sampled for RT-PCR (reference test) and received one Ag-RDT to perform unsupervised with either nasal self-sampling (during the emergence of Omicron, and after Omicron share was >90%, phase-1) or with OP-N self-sampling (in a subsequent phase-2; Omicron share >99%). The evaluated tests were Acon Flowflex (Flowflex; phase-1 only), MP Biomedicals (MPBio), and Siemens-Healthineers Clinitest (Clinitest). Findings During phase-1, 45% of Flowflex, 29% of MPBio, and 35% of Clinitest participants were confirmatory testers (previously tested positive by a self-test at own initiative). Overall sensitivities with nasal self-sampling were 79.0% (95% CI: 74.7-82.8%) for Flowflex, 69.9% (65.1-74.4%) for MPBio, and 70.2% (65.6-74.5%) for Clinitest. Sensitivities were substantially higher in confirmatory testers (93.6%, 83.6%, and 85.7%, respectively) than in those who tested for other reasons (52.4%, 51.5%, and 49.5%, respectively). Sensitivities decreased by 6.1 (p=0.16 by Chi-square test), 7.0 (p=0.60), and 12.8 (p=0.025) percentage points, respectively, when transitioning from 29% to >95% Omicron. During phase-2, 53% of MPBio, and 44% of Clinitest participants were confirmatory testers. Overall sensitivities with OP-N self-sampling were 83.0% (78.8%-86.7%) for MPBio and 77.3% (72.9%-81.2%) for Clinitest. Comparing OP-N to nasal sampling, sensitivities were slightly higher in confirmatory testers (87.4% and 86.1%, respectively), and substantially higher in those testing for other reasons (69.3% and 59.9%, respectively). Interpretation Sensitivities of three Ag-RDTs with nasal self-sampling decreased during Omicron emergence but was only statistically significant for Clinitest. Sensitivities were substantially influenced by the proportion of confirmatory testers. Addition of oropharyngeal to nasal self-sampling improved sensitivities of MPBio and Clinitest. Funding Dutch Ministry of Health, Welfare, and Sport.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Accuracy of COVID-19 self-tests with unsupervised nasal or nasal plus oropharyngeal self-sampling in symptomatic individuals in the Omicron period

Schuit

Venekamp

Hooft

et al. 2022

Preprint

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“…A study by Michelena et al, using nasopharyngeal samples (confirmed as Omicron variants by sequencing), showed that the Panbio™ COVID-I9 Ag Rapid Test Device had high sensitivity: 95.6% (Ct ≤20), 92.6% (Ct ≤25), 87.2% (Ct ≤30) and 81.8% (Ct ≤35) compared with nasopharyngeal RT-PCR, with a specificity of 100% [27]. In another study, Deerain et al evaluated the analytical sensitivity of lateral flow devices against the SARS-CoV-2 Omicron variant using isolates cultured from clinical samples, and demonstrated that the Panbio TM COVID-I9 Ag Rapid Test Device consistently detected a sample (4/4 replicates or 100%) at a concentration of 6.39 log 10 copies/mL, corresponding to a Ct value of 25.8, underlining the high sensitivity of the test device [28].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Panbio™ COVID-19 Antigen Rapid Diagnostic Test in subjects infected with Omicron using different specimens

Galiez

Bomfim

Mariani

et al. 2022

Preprint

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Community testing is a crucial tool for the early identification of SARS-CoV-2 infection and transmission control. The emergence of the highly mutated Omicron variant (B.1.1.259) raised concerns about its primary site of replication, impacting sample collection, and its detectability by rapid antigens tests. We tested the Antigen Rapid Diagnostic Test (Ag-RDT) performance using nasal, oral, and saliva specimens for COVID-19 diagnosis in 192 symptomatic individuals, using RT-qPCR from nasopharyngeal samples as control. Variant of Concern (VOC) investigation was determined by the 4Plex SARS-CoV-2 screening kit. SARS-CoV-2 positivity rate was 66.2%, with 99% of the positive samples showing an amplification profile consistent with that of the Omicron variant. Nasal Ag-RDT showed higher sensitivity (89%) than oral (12.6%) and saliva (22.1%) Ag-RDTs. Our data showed the good performance of the Ag-RDT in a pandemic scenario dominated by the Omicron VOC. Furthermore, our data also demonstrated that nasal specimens perform better than oral and saliva ones for Omicron Ag-RDT detection.

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“…The sensitivity of the samples collected 0–1 days after symptom onset increased from 79.6% to 86.4% when the samples collected 4–5 days after symptom onset were grouped. 30 In another study, symptom onset within 3 days and between 4 and 7 days showed a sensitivity above 80%, while the onset of symptoms between 8 and 14 days was associated with a far lower sensitivity. 32 From the above results, it appears to be acceptable to screen patients with SARS‐CoV‐2 at the early stage of symptoms and high viral load.…”

Section: Introductionmentioning

confidence: 90%

“… 34 Some clinical studies think that antigen reagents are less sensitive to detect Omicron. 30 , 34 , 35 None of the kits consistently detected either Delta or Omicron at the lowest dilutions (5.23 log10 copies/ml, with a C t of 28.8 [Delta]; 5.33 log10 copies/ml, with a C t of 28.8 [Omicron]). 36 , 37 It compromises the diagnosis of SARS‐CoV‐2 (K417N/T, E484K, and N501Y) associated with the beta or gamma SARS‐CoV‐2 variants.…”

Section: Introductionmentioning

confidence: 99%

Performance and application evaluation of SARS‐CoV‐2 antigen assay

Shao

Meng

2022

Journal of Medical Virology

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Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleic acid detection is the gold standard for the laboratory diagnosis of coronavirus disease 2019 (COVID‐19). However, this method has high requirements for practitioners' skills and testing sites, so it is not easy to popularize and promote the application in places other than large hospitals. In addition, the detection flux of SARS‐CoV‐2 nucleic acid is small, and the whole detection process takes much time, which cannot meet the actual needs of rapid screening in large quantities. The WHO conditionally approved a batch of SARS‐CoV‐2 antigen reagents for clinical application to alleviate this contradiction. SARS‐CoV‐2 antigen detection offers a trade‐off among clinical performance, speed and accessibility. With the gradual increase in clinical application, the accumulated clinical data show that the sensitivity and specificity of the SARS‐CoV‐2 antigen assay are over 80% and 97%, respectively, which can basically meet the requirements of the WHO. However, the sensitivity of the SARS‐CoV‐2 Antigen Assay among asymptomatic people in low prevalence areas of COVID‐19 cannot meet the standard, leading to a large number of missed diagnoses. In addition, the detection ability of SARS‐CoV‐2 antigen reagent for different SARS‐CoV‐2 mutant strains differs greatly, especially for those escaping the COVID‐19 vaccines. In terms of results interpretation, it is highly reliable to exclude SARS‐CoV‐2 infection based on the high negative predictive value of the SARS‐CoV‐2 antigen assay. However, in the low prevalence environment, the probability of false positives of the SARS‐CoV‐2 antigen assay is high, so the positive results need to be confirmed by the SARS‐CoV‐2 nucleic acid reagent. The SARS‐CoV‐2 antigen assay is only a supplement to SARS‐CoV‐2 nucleic acid detection and can never completely replace it. To date, SARS‐CoV‐2 nucleic acid detection continues to be the standard laboratory method for COVID‐19 diagnosis.

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Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant

Cited by 32 publications

References 8 publications

Accuracy of COVID-19 self-tests with unsupervised nasal or nasal plus oropharyngeal self-sampling in symptomatic individuals in the Omicron period

Accuracy of COVID-19 self-tests with unsupervised nasal or nasal plus oropharyngeal self-sampling in symptomatic individuals in the Omicron period

Evaluation of the Panbio™ COVID-19 Antigen Rapid Diagnostic Test in subjects infected with Omicron using different specimens

Performance and application evaluation of SARS‐CoV‐2 antigen assay

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