Performance of Repeat BinaxNOW Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Testing in a Community Setting, Wisconsin, November 2020–December 2020

Shah, Melisa M; Salvatore, Phillip P.; Ford, Laura; Kamitani, Emiko; Whaley, Melissa; Mitchell, Kaitlin; Currie, Dustin W.; Morgan, Clint N.; Segaloff, Hannah E; Lecher, Shirley Lee; Somers, Tarah; Dyke, Miriam E. Van; Bigouette, John Paul; Delaney, Augustina; DaSilva, Juliana; O’Hegarty, Michelle; Boyle-Estheimer, Lauren; Abdirizak, Fatima; Karpathy, Sandor E.; Ivanic, Lynn; Goffard, Kimberly; Gieryn, Doug; Sterkel, Alana; Bateman, Allen C.; Kahrs, Juliana; Langolf, Kimberly; Zochert, Tara; Knight, Nancy; Hsu, Christopher H.; Kirking, Hannah L.; Tate, Jacqueline E.

doi:10.1093/cid/ciab309

Cited by 37 publications

(56 citation statements)

References 6 publications

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“…Eighteen studies with 34,865 participants were retrieved [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Figure 1 depicts the process of the literature search, and Table 1 presents detailed characteristics of the studies.…”

Section: Resultsmentioning

confidence: 99%

“…All studies in the meta-analysis used a prospective study design, and five studies enrolled participants in the drive-through testing sites [16,19,26,28,31]. Eight studies evaluated the diagnostic performance of antigen tests with nasal swab specimens [16,18,22,23,[28][29][30]33], six assessed the accuracy of antigen tests with nasopharyngeal swab specimens [21,[24][25][26][27]31], seven provided cycle threshold (Ct) values of positive RT-PCR tests [24,25,[28][29][30][31][32], and eight reported cutoff values of Ct [16,[21][22][23]25,27,28,33]. Table 2 lists the statistical data.…”

Section: Resultsmentioning

confidence: 99%

“…The meta-analysis for antigen tests generated a pooled sensitivity of 0.82 (95% CI: 0.71-0.89) and a pooled specificity of 1.00 (95% CI: 0.99-1.00) (Figure 2). Eight studies with 16,470 patients discussed the accuracy of antigen tests using nasal swab specimens [16,18,22,23,[28][29][30]33]. The meta-analysis produced a pooled sensitivity of 0.76 (95% CI: 0.58-0.88) and a pooled specificity of 1.00 (95% CI: 0.99-1.00).…”

Section: Resultsmentioning

confidence: 99%

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Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Chen

Bai

et al. 2021

IJERPH

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Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) caused the global pandemic of coronavirus disease 2019 (COVID-19). Rapid identification and isolation of infectious patients are critical methods to block COVID-19 transmission. Antigen tests can contribute to prompt identification of infectious individuals. This meta-analysis aims to evaluate the diagnostic accuracy of antigen tests for SARS-CoV-2. We conducted a literature search in PubMed, Embase, the Cochrane Library, and Biomed Central databases. Studies evaluating the diagnostic accuracy of antigen tests for SARS-CoV-2 in community participants were included. Only English-language articles were reviewed. We included eligible studies that provided available data to construct a 2 × 2 table on a per-patient basis. Overall sensitivity and specificity for antigen tests were generated using a bivariate random-effects model. Eighteen studies with 34,865 participants were retrieved. The meta-analysis for SARS-CoV-2 antigen tests generated a pooled sensitivity of 0.82 and a pooled specificity of 1.00. A subgroup analysis of ten studies that reported outcomes for 5629 symptomatic participants generated a pooled sensitivity of 0.87 and a pooled specificity of 1.00. Antigen tests might have higher sensitivity in detecting SARS-CoV-2 in symptomatic patients in the community and may be an effective tool to identify patients to be quarantined to prevent further SARS-CoV-2 transmission.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Chen

Bai

et al. 2021

IJERPH

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“…Due to insufficient data, we did not perform subgroup analysis with respect to test type (antigen vs. molecular) and end-user (layperson (self-testing) vs. trained staff/health care worker). Except for 1 study [61,74] where the testing procedure involved (supervised) self-collection of samples by study participants, in all other studies, testing was conducted with trained staff and/or health care workers (if reported). Univariate metaanalysis with random effects for sensitivity and specificity in cases where only a few studies were included (mixed population of symptomatic and asymptomatic children) did not show remarkable differences to the bivariate analysis.…”

Section: Synthesis Of Resultsmentioning

confidence: 99%

“…CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) 1 1 queries led to the inclusion of 8 further studies [48,50,51,54,61,63,64,67] resulting in a total of 17 relevant studies for this review (12 peer-reviewed journal articles and 5 preprints). The full list of included studies is reported in Table 3.…”

Section: Diagnostic Accuracy Measures and Data Synthesismentioning

confidence: 99%

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Fujita-Rohwerder

Beckmann

Zens

et al. 2021

Preprint

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Objective: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions. Study design: Multiple bibliographic databases including MEDLINE and Embase, clinical trial registries and further information sources were systematically searched for literature (last bibliographic search: May 7, 2021). Diagnostic cross-sectional or cohort studies that included paediatric study participants and evaluated rapid point-of care tests for diagnosing current SARS-CoV-2 infections against RT-PCR as the reference standard were eligible for inclusion. QUADAS-2 was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses. Results: We included 17 studies with a total of 6355 paediatric study participants. All included studies compared antigen tests against RT-PCR. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI: 57.4%-70.5%) and 99.1% (95% CI: 98.2%-99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI: 63.6%-78.8%) and the pooled diagnostic specificity was 98.7% (95% CI: 96.6%-99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI: 47.6%-64.4%) and the pooled diagnostic specificity was 98.6% (95% CI: 97.3%-99.3%). Conclusions: Performance of current antigen tests under real-life conditions varies broadly. Policymakers should especially be aware of the low diagnostic sensitivity of current antigen tests. Results should be interpreted with caution since risk of bias was predominantly judged as unclear due to poor reporting. Study Registration: CRD42021236313 (PROSPERO).

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Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection

et al. 2022

Self Cite

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IMPORTANCEAs self-collected home antigen tests become widely available, a better understanding of their performance during the course of SARS-CoV-2 infection is needed. OBJECTIVE To evaluate the diagnostic performance of home antigen tests compared with reverse transcription-polymerase chain reaction (RT-PCR) and viral culture by days from illness onset, as well as user acceptability. DESIGN, SETTING, AND PARTICIPANTS This prospective cohort study was conducted from January to May 2021 in San Diego County, California, and metropolitan Denver, Colorado. The convenience sample included adults and children with RT-PCR-confirmed infection who used self-collected home antigen tests for 15 days and underwent at least 1 nasopharyngeal swab for RT-PCR, viral culture, and sequencing. EXPOSURES SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES The primary outcome was the daily sensitivity of home antigen tests to detect RT-PCR-confirmed cases. Secondary outcomes included the daily percentage of antigen test, RT-PCR, and viral culture results that were positive, and antigen test sensitivity compared with same-day RT-PCR and cultures. Antigen test use errors and acceptability were assessed for a subset of participants. RESULTS This study enrolled 225 persons with RT-PCR-confirmed infection (median [range] age, 29 [1-83] years; 117 female participants [52%]; 10 [4%] Asian, 6 [3%] Black or African American, 50 [22%] Hispanic or Latino, 3 [1%] Native Hawaiian or Other Pacific Islander, 145[64%] White, and 11 [5%] multiracial individuals) who completed 3044 antigen tests and 642 nasopharyngeal swabs. Antigen test sensitivity was 50% (95% CI, 45%-55%) during the infectious period, 64% (95% CI, 56%-70%) compared with same-day RT-PCR, and 84% (95% CI, 75%-90%) compared with same-day cultures. Antigen test sensitivity peaked 4 days after illness onset at 77% (95% CI, 69%-83%). Antigen test sensitivity improved with a second antigen test 1 to 2 days later, particularly early in the infection. Six days after illness onset, antigen test result positivity was 61% (95% CI, 53%-68%). Almost all (216 [96%]) surveyed individuals reported that they would be more likely to get tested for SARS-CoV-2 infection if home antigen tests were available over the counter. CONCLUSIONS AND RELEVANCEThe results of this cohort study of home antigen tests suggest that sensitivity for SARS-CoV-2 was moderate compared with RT-PCR and high compared with viral culture. The results also suggest that symptomatic individuals with an initial negative home antigen test result for SARS-CoV-2 infection should test again 1 to 2 days later because test sensitivity peaked several days after illness onset and improved with repeated testing.

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Performance of Repeat BinaxNOW Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Testing in a Community Setting, Wisconsin, November 2020–December 2020

Cited by 37 publications

References 6 publications

Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection

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