Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting

Okoye, Nkemakonam C; Barker, Adam P.; Curtis, Kenneth; Orlandi, Richard R.; Snavely, Emily; Wright, Cameron; Hanson, Kimberly E.; Pearson, Linda

doi:10.1128/jcm.03282-20

Cited by 75 publications

(71 citation statements)

References 13 publications

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“…The specificity of both tests was comparable at nearly > 99 %. Consistent with several studies, the sensitivity of antigen detecting RDTs was modest in individuals with no or mild symptoms (8,(14)(15)(16)20). Although viral loads (30) and recovery of viable virus (31) peak in the early days following symptom onset, transmission by asymptomatic individuals remains a main driver of the pandemic (6), especially since absence of symptoms removes the prompt to quarantine.…”

Section: Discussionsupporting

confidence: 63%

Evaluation of the Access Bio CareStart™ rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts

Suliman

Matias

Fulcher

et al. 2021

Preprint

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Background: Point-of-care antigen-detecting rapid diagnostic tests (RDTs) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) represent a scalable tool for SARS-CoV-2 infections surveillance. Data on their performance in real-world community settings is paramount for their implementation. Method: We evaluated the accuracy of CareStartTM COVID-19 Antigen test (CareStart) in a testing site in Holyoke, Massachusetts. We compared CareStart to a SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) reference, using anterior nasal swab samples. We calculated the sensitivity, specificity, and expected positive and negative predictive values at different SARS-CoV-2 prevalence estimates. Results: We performed 666 tests on 591 unique individuals. 573 (86%) were asymptomatic. There were 52 positive tests by RT-qPCR. The sensitivity of CareStart was 49.0% (95% Confidence Interval (CI): 34.8 - 63.4) and specificity was 99.5% (95% CI: 98.5 - 99.9). Among positive RT-qPCR tests, the median cycle threshold (Ct) was significantly lower in samples that tested positive on CareStart. Using a Ct ≤ 30 as a benchmark for positivity increased the sensitivity to 64.9% (95% CI: 47.5 - 79.8). Conclusions: CareStart has a high specificity and moderate sensitivity. The utility of RDTs, such as CareStart, in mass implementation should prioritize use cases in which a higher specificity is more important.

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Section: Discussionsupporting

confidence: 63%

Evaluation of the Access Bio CareStart™ rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts

Suliman

Matias

Fulcher

et al. 2021

Preprint

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“…This study expands the external evaluation of BinaxNOW sensitivity beyond what has been previously reported. While several prior studies define test sensitivity in various real-world populations, these have omitted a usability assessment for self/caregiver collection, as well as evaluation of patients < 10 years old 10,11,17 . Pilarowski et al utilized a community-based testing platform in San Francisco, CA, to report a test sensitivity of 95.4% (95% CI 90.2-98.3) among patients meeting current criteria for use of BinaxNOW (onset of symptoms associated with COVID-19 ≤ 7 days) 10 .…”

Section: Discussionmentioning

confidence: 99%

Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration

Frediani

Levy

Rao

et al. 2021

Sci Rep

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While there has been significant progress in the development of rapid COVID-19 diagnostics, as the pandemic unfolds, new challenges have emerged, including whether these technologies can reliably detect the more infectious variants of concern and be viably deployed in non-clinical settings as “self-tests”. Multidisciplinary evaluation of the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW, a widely used rapid antigen test, included limit of detection, variant detection, test performance across different age-groups, and usability with self/caregiver-administration. While BinaxNOW detected the highly infectious variants, B.1.1.7 (Alpha) first identified in the UK, B.1.351 (Beta) first identified in South Africa, P.1 (Gamma) first identified in Brazil, B.1.617.2 (Delta) first identified in India and B.1.2, a non-VOC, test sensitivity decreased with decreasing viral loads. Moreover, BinaxNOW sensitivity trended lower when devices were performed by patients/caregivers themselves compared to trained clinical staff, despite universally high usability assessments following self/caregiver-administration among different age groups. Overall, these data indicate that while BinaxNOW accurately detects the new viral variants, as rapid COVID-19 tests enter the home, their already lower sensitivities compared to RT-PCR may decrease even more due to user error.

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“…1), which could explain this finding [14]. A few studies have observed a similar trend of lower antigen test sensitivity in asymptomatic individuals (45.4% vs. 79.1% [15], 53.3% vs. 84.6% [14]). Nevertheless, the lower sensitivity of COVID-19 antigen tests for asymptomatic individuals does not necessarily negate the utility of these assays for screening purposes.…”

Section: 3%mentioning

confidence: 72%

Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

Kiyasu

Takeuchi

Akashi

et al. 2021

Preprint

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Introduction Antigen testing may help screen for and detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in asymptomatic individuals. However, limited data regarding the diagnostic performance of antigen tests for this group are available. Methods We used clinical samples to prospectively evaluate the analytical and clinical performance of the antigen test QuickNavi™-COVID19 Ag. This study was conducted at a PCR center between October 7, 2020 and January 9, 2021. Two nasopharyngeal samples per patient were obtained with flocked swabs; one was used for the antigen test, and the other for real-time reverse transcription PCR (RT-PCR). The diagnostic performance of the antigen test was compared between asymptomatic and symptomatic patients, and the RT-PCR results were used as a reference. Results Among the 1,934 collected samples, SARS-CoV-2 was detected by real-time RT-PCR in 188 (9.7%); 76 (40.4%) of these samples were from asymptomatic individuals. Over half of the total samples (1,073; 55.5%) were obtained from asymptomatic volunteers. The sensitivity of the antigen test was significantly lower for asymptomatic group than for symptomatic patients (67.1% vs 89.3%, p < 0.001). The specificity was 100% for both groups, and no false positives were observed among all 1,934 samples. The median Ct value for the asymptomatic group was significantly higher than that of the symptomatic group (24 vs 20, p < 0.001). Conclusions The QuickNavi™-COVID19 Ag showed a lower sensitivity for asymptomatic group than for symptomatic patients. However, its specificity was consistently high, and no false positives were found in this study.

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Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting

Cited by 75 publications

References 13 publications

Evaluation of the Access Bio CareStart™ rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts

Evaluation of the Access Bio CareStart™ rapid SARS-CoV-2 antigen test in asymptomatic individuals tested at a community mass-testing program in Western Massachusetts

Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration

Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

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