Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection

Soni, Apurv; Herbert, Carly; Lin, Honghuang; Yi, Yan; Pretz, Caitlin; Stamegna, Pamela; Wang, Biqi; Orwig, Taylor; Wright, Colton; Tarrant, Seanan; Behar, Stephanie; Suvarna, Thejas; Schrader, Summer; Harman, Emma; Nowak, Christopher; Kheterpal, Vik; Rao, Lokinendi V.; Cashman, Lisa; Orvek, Elizabeth; Ayturk, Didem; Gibson, Laura; Zai, Adrian H.; Wong, Steven; Lázár, Péter; Wang, Ziyue; Filippaios, Andreas; Barton, Bruce; Achenbach, Chad J.; Murphy, Robert L.; Robinson, Matthew L.; Manabe, Yukari C.; Pandey, Shishir; Colubri, Andrés; O’Connor, Laurel; Lemon, Stephenie C.; Fahey, Nisha; Luzuriaga, Katherine; Hafer, Nathaniel; Roth, Kristian M.; Lowe, Timothy J.; Stenzel, Timothy T.; Heetderks, William; Broach, John; McManus, David D.

doi:10.7326/m23-0385

Cited by 22 publications

(19 citation statements)

References 14 publications

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“…However, in one study, we found that two rapid antigen tests in symptomatic populations taken 48 hours apart increased sensitivity to 93.4%. In asymptomatic populations, testing twice 48 hours apart increased the sensitivity to 62.7% while testing thrice increased it to 79% [ 85 ]. This is in line with FDA’s guidelines on the usage of serial testing to reduce the risk of false negative tests [ 86 ].…”

Section: Discussionmentioning

confidence: 99%

Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020–2023)

Anand,

Vialard,

Esmail

et al. 2024

PLOS Glob Public Health

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COVID-19 self-testing strategy (COVIDST) can rapidly identify symptomatic and asymptomatic SARS-CoV-2-infected individuals and their contacts, potentially reducing transmission. In this living systematic review, we evaluated the evidence for real-world COVIDST performance. Two independent reviewers searched six databases (PubMed, Embase, Web of Science, World Health Organization database, Cochrane COVID-19 registry, Europe PMC) for the period April 1st, 2020, to January 18th, 2023. Data on studies evaluating COVIDST against laboratory-based conventional testing and reported on diagnostic accuracy, feasibility, acceptability, impact, and qualitative outcomes were abstracted. Bivariate random effects meta-analyses of COVIDST accuracy were performed (n = 14). Subgroup analyses (by sampling site, symptomatic/asymptomatic infection, supervised/unsupervised strategy, with/without digital supports) were conducted. Data from 70 included studies, conducted across 25 countries with a median sample size of 817 (range: 28–784,707) were pooled. Specificity and DOR was high overall, irrespective of subgroups (98.37–99.71%). Highest sensitivities were reported for: a) symptomatic individuals (73.91%, 95%CI: 68.41–78.75%; n = 9), b) mid-turbinate nasal samples (77.79%, 95%CI: 56.03–90.59%; n = 14), c) supervised strategy (86.67%, 95%CI: 59.64–96.62%; n = 13), and d) use of digital interventions (70.15%, 95%CI: 50.18–84.63%; n = 14). Lower sensitivity was attributed to absence of symptoms, errors in test conduct and absence of supervision or a digital support. We found no difference in COVIDST sensitivity between delta and omicron pre-dominant period. Digital supports increased confidence in COVIDST reporting and interpretation (n = 16). Overall acceptability was 91.0–98.7% (n = 2) with lower acceptability reported for daily self-testing (39.5–51.1%). Overall feasibility was 69.0–100.0% (n = 5) with lower feasibility (35.9–64.6%) for serial self-testing. COVIDST decreased closures in school, workplace, and social events (n = 4). COVIDST is an effective rapid screening strategy for home-, workplace- or school-based screening, for symptomatic persons, and for preventing transmission during outbreaks. These data will guide COVIDST policy. Our review demonstrates that COVIDST has paved the way for self-testing in pandemics worldwide.

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Section: Discussionmentioning

confidence: 99%

Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020–2023)

Anand,

Vialard,

Esmail

et al. 2024

PLOS Glob Public Health

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“…This is not surprising at all, as all sequences obtained were omicron BA.1.H sub-variants; which has been associated with very few symptoms worldwide[ 8 , 9 , 32 , 33 ]. However, previous reports highlighted that rapid COVID-19 tests miss 90 % of asymptomatic cases [ [34] , [35] ]. In effect, on the day of infection onset, rapid tests detected almost 60 % of infected participants who had COVID-19 symptoms, but only 10 % of those who didn't; with more than 75 % of diagnosis among asymptomatic participants after repeating the test 3 times at 48 h intervals [ [34] , [35] ].…”

Section: Discussionmentioning

confidence: 99%

“…However, previous reports highlighted that rapid COVID-19 tests miss 90 % of asymptomatic cases [ [34] , [35] ]. In effect, on the day of infection onset, rapid tests detected almost 60 % of infected participants who had COVID-19 symptoms, but only 10 % of those who didn't; with more than 75 % of diagnosis among asymptomatic participants after repeating the test 3 times at 48 h intervals [ [34] , [35] ]. Thus, Ag-RDT are much more reliable at detecting COVID-19 in symptomatic people than their asymptomatic pairs, with serial testing (48 h apart) improving the diagnosis among asymptomatic individuals.…”

Section: Discussionmentioning

confidence: 99%

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Fokam,

Takou,

Semengue

et al. 2024

Heliyon

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“…There are some limitations, as the study population includes only symptomatic individuals and the performance in intended use with asymptomatic individuals was not evaluated herein. It is known that most Ag-RDTs in general have shown reduced sensitivity in asymptomatic populations [ 12 , 16 , 19 , 21 ], but this can be mitigated by serial testing [ 22 ]. Although the laboratory-based findings indicate that InteliSwab ® can detect all different variants, including VOCs, it is important to have detailed clinical studies in real-world settings.…”

Section: Discussionmentioning

confidence: 99%

Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants

Fischl,

Young,

Kardos

et al. 2023

Viruses

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Background and objectives: Timely detection of SARS-CoV-2 infection with subsequent contact tracing and rapid isolation are considered critical to containing the pandemic, which continues with the emergence of new variants. Hence, there is an ongoing need for reliable point-of-care antigen rapid diagnostic tests (Ag-RDT). This report describes the development, evaluation, and analytical sensitivity of the diagnostic performance of the InteliSwab® COVID-19 Rapid Test. Methods: Samples from 165 symptomatic subjects were tested with InteliSwab® and the results were compared to RT-PCR to determine the antigen test performance. The analytical sensitivity of InteliSwab® for the detection of different variants was assessed by limit of detection (LOD) determination using recombinant nucleocapsid proteins (NPs) and testing with virus isolates. Western immunoblot independently confirmed that each monoclonal Ab is capable of binding to all variants tested thus far. Results: The overall positivity rate by RT-PCR was 37% for the 165 symptomatic subjects. Based on RT-PCR results as the reference standard, InteliSwab® showed clinical sensitivity and specificity of 85.2% (95% CI, 74.3–92.0%) and 98.1% (95% CI, 93.3–99.7%), respectively. The overall agreement was 93.3% (Kappa index value 0.85; 95% CI, 0.77–0.74) between RT-PCR and InteliSwab® test results. Furthermore, the evaluation of analytical sensitivity for different SARS-CoV-2 variants by InteliSwab® was comparable in the detection of all the variants tested, including Omicron subvariants, BA.4, BA.5, and BQ.1. Conclusions: Due to the surge of infections caused by different variants from time to time, there is a critical need to evaluate the sensitivity of rapid antigen-detecting tests for new variants. The study findings showed the robust diagnostic performance of InteliSwab® and analytical sensitivity in detecting different SARS-CoV-2 variants, including the Omicron subvariants. With the integrated swab and excellent sensitivity and variant detection, this test has high potential as a point-of-care Ag-RDT in various settings when molecular assays are in limited supply and rapid diagnosis of SARS-CoV-2 is necessary.

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Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection

Cited by 22 publications

References 14 publications

Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020–2023)

Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020–2023)

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants

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