Determining the reliability of rapid SARS-CoV-2 antigen detection in fully vaccinated individuals

Poopalasingam, Nareshkumar; Korenkov, Michael; Ashurov, Artem; Strobel, J.; Fish, Irina; Hellmich, Martin; Gruell, Henning; Lehmann, Clara; Heger, Eva; Klein, Florian

doi:10.1016/j.jcv.2022.105119

Cited by 13 publications

(16 citation statements)

References 29 publications

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“…All studies avoided case-control design; however, there were insufficient descriptions about the inappropriate exclusion of patients and non-random sampling of patients. The two studies [ 19 , 28 ] utilizing prospectively collected or routine samples were classified as having a low risk of bias. Regarding applicability, low risks were determined for the included studies because the study population of all studies could be the predefined population of the review question.…”

Section: Resultsmentioning

confidence: 99%

“…A study evaluating RATs for the Delta or Omicron variants in fully vaccinated participants showed the lowest sensitivity (57.3%) [ 28 ]. When the data in this study were excluded, the estimated sensitivity (71.7%) marginally increased without a statistical difference.…”

Section: Resultsmentioning

confidence: 99%

“…In this study based on a living systematic review and meta-analysis, the evidence of the diagnostic utility of RATs without instruments for SARS-CoV-2 variants of concern were combined and compared according to the presence of symptoms. The pooled sensitivity and specificity of RATs for variants from 6904 participants in six studies [ 19 , 20 , 28 , 29 , 30 , 31 ] were 69.7% and 100.0%, respectively. The reported sensitivities of symptomatic patients were higher than those of asymptomatic individuals.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Kim

Sung

Lee

et al. 2022

Viruses

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Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Kim

Sung

Lee

et al. 2022

Viruses

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“…During the delta wave, a total of 692 samples from vaccinated individuals were tested for COVID‐19 nucleic acid and antigen, among which 76 samples (11.0%) tested positive for SARS‐CoV‐2 by RT–qPCR and 45 samples (6.5%) tested positive by Standard Q COVID‐19 AGT. 39 Stratified by C t values, the sensitivity of the SARS‐COV‐2 antigen assay was 100.0%, 94.4% and 81.1% for C t ≤ 20 ( n = 18), C t ≤ 25 ( n = 36) and C t ≤ 30 ( n = 53), respectively. Samples with C t values ≥ 30 ( n = 23) could not be detected.…”

Section: Introductionmentioning

confidence: 97%

“…Samples with C t values ≥ 30 ( n = 23) could not be detected. 39 The overall specificity of the COVID‐19 antigen reagent was 99.7%. 39 The sensitivity of the Panbio™ COVID‐19 assay is even worse for the diagnosis of COVID‐19 due to vaccination breakthrough Omicron infection compared with Delta (the sensitivity is 36.1% vs. 67.7%).…”

Section: Introductionmentioning

confidence: 97%

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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Diagnostic approaches for monkeypox virus

Fan,

Kuang,

Zhang

et al. 2024

iLABMED

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Mpox (formerly Monkeypox) is a zoonotic infection caused by Monkeypox virus (MPXV). Since 2022, Mpox epidemics have occurred in many non‐endemic countries and regions, leading the World Health Organization to declare a public health emergency of international concern. With the persistent transmission and evolution of MPXV, symptoms of Mpox have become milder, with some infections being asymptomatic. In addition, MPXV has become more contagious. Therefore, rapid and accurate diagnosis and screening of MPXV is vital to prevent and control MPXV epidemics. Here, we review and summarize the technical details, application scenarios, and the advantages and disadvantages of MPXV‐specific diagnostic methods.

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Determining the reliability of rapid SARS-CoV-2 antigen detection in fully vaccinated individuals

Cited by 13 publications

References 29 publications

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

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

Diagnostic approaches for monkeypox virus

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