Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site

Siddiqui, Zishan K.; Chaudhary, Mihir; Robinson, Matthew L.; McCall, Anna B; Peralta, Ria; Esteve, Rogette; Callahan, Charles W.; Manabe, Yukari C.; Campbell, James D.; Johnson, J. Kristie; Elhabashy, Maryam; Kantsiper, Melinda E.; Ficke, James R.

doi:10.1128/spectrum.01008-21

Cited by 27 publications

(30 citation statements)

References 11 publications

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“…One such assay, the Abbott BinaxNow, has been recommended for in-home testing and implemented in public health screening campaigns (2)(3)(4)(5)(6). The diagnostic validity of the assay has been demonstrated in laboratory-based and clinical settings, with a sensitivity ranging from approximately 50-90%, depending on disease stage and degree of symptom, and a specificity >99%, compared to laboratory-based PCR assays (3,4,7,8).…”

Section: Introductionmentioning

confidence: 99%

Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

Regan

Flynn

Choudhary

et al. 2021

Preprint

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The US Centers for Disease Control and Prevention recommends rapid testing for SARS-CoV-2 infection as a key element of epidemic control. The Abbott BinaxNow is in widespread use in the United States for self-testing and as part of public health screening campaigns, but has not been evaluated for use with the omicron variant of SARS-CoV-2. We recruited individuals testing positive for COVID-19 PCR at an academic medical center. Anterior nasal swabs were stored in viral transport media and evaluated by viral load quantification and whole genome sequencing. We created serial dilutions from 2.5x103- 2.5x105 viral copies/specimen for two delta and omicron specimens, respectively, and tested each with the BinaxNow assay per manufacturer instructions. Results were interpreted by three readers, blinded to the specimen variant and concentration. All omicron and delta specimens with concentrations of 100,000 copies/swab or greater were positive by the BinaxNow Assay, a concentration similar to previously reported limits of detection for this assay. Assay sensitivity diminished below that. This study demonstrates that Omicron variant SARS-CoV-2 infections are detected by the BinaxNow rapid antigen assay. Additional laboratory and clinical validation assessments are needed to better determine their limits of detection and performance in real-world settings.

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Section: Introductionmentioning

confidence: 99%

Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

Regan

Flynn

Choudhary

et al. 2021

Preprint

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“…However, with implementation of best practices, similar accuracy would be expected. 12 Our study enrolled only a small number of children with high-risk exposure and the estimates of accuracy had broad confidence interval.…”

Section: Discussionmentioning

confidence: 94%

“…Test implementation, education, and training processes have been previously described. 12 Sample collection. The rapid antigen and RT-PCR samples were collected sequentially for each participant in the study by medical staff who were trained to perform rapid antigen tests.…”

Section: Introductionmentioning

confidence: 99%

High Sensitivity and NPV for BinaxNOW Rapid Antigen Test in Children at a Mass Testing Site During Prevalent Delta Variant Period

Sun

Vaeth²,

Robinson

et al. 2022

Preprint

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SARS-CoV-2 continues to develop new, increasingly infectious variants, such as delta and omicron. Here, we evaluate the efficacy of the Abbott BinaxNOW Rapid Antigen Test against the gold standard of Reverse Transcription Polymerase Chain Reaction (RT-PCR) in 1054 pediatric participants presenting to a state-owned high-volume Coronavirus Disease 2019 (COVID-19) testing site. During the testing period, the delta variant was predominant. Prior to sample collection, symptomatic and exposure status was collected for all participants based on Centers for Disease Control (CDC) criteria. RT-PCR results demonstrated an overall prevalence rate of 5.2%. For all participants, the sensitivity of the rapid antigen tests was 92.7% (95% CI 82.4% - 98.0%) and specificity was 98.0% (95% CI 97.0%-98.8%). For symptomatic participants, the sensitivity was 92.3% (95% CI 74.9% - 99.1%), specificity was 96.6% (95% CI 93.6%- 98.4%), positive predictive value (PPV) was 72.7% (95% CI 54.5% - 86.7%) and negative predictive value (NPV) was 99.2% (95% CI 98.2% - 100%). Among asymptomatic participants, the sensitivity was 92.6% (95% CI 75.7% - 99.1%), specificity was 98.6% (95% CI 97.5% - 99.3%) the PPV was 71.4% (95% CI 53.7% - 85.4%) and the NPV was 99.7% (95% CI 99.0% - 100%). Our reported sensitivity and NPV are higher than other pediatric studies, but specificity and PPV are lower. Importance Children are especially impacted by the disease and its ability to disrupt educational opportunities. Although vaccinations have been approved for children 5 years and older, many children remain unvaccinated. Widespread testing may improve the ability for children to remain in in-person activities, minimizing absences from school and extracurriculars. Highly accurate rapid antigen tests may be vital to containing future COVID-19 waves while mitigating detrimental effects.

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“…It is expected that antigen testing will miss a proportion of SARS-CoV-2 cases, particularly those with lower viral burden (identified by higher Ct values) particularly among asymptomatic individuals; a recent meta-analysis reported a sensitivity of 58.1% (95% CI 40.2% to 74.1%),(24) and more focused studies including asymptomatic close contacts reported a sensitivity of 59-82% compared to NAT. (25, 26) However, the hope has been that persons with potential to transmit SARS-CoV-2 may be excluded, at least in the moment, by a negative antigen test. (27-29) Used as intended, in the first 5 days of symptom onset, only one patient with culture-positive SARS-CoV-2 tested negative by antigen testing, but two asymptomatic patients who tested negative by antigen tests had positive cultures.…”

Section: Discussionmentioning

confidence: 99%

Limitations of molecular and antigen test performance for SARS-CoV-2 in symptomatic and asymptomatic COVID-19 contacts

Robinson¹,

Mirza

Gallagher

et al. 2022

Preprint

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Objectives: COVID-19 has brought unprecedented attention to the crucial role of diagnostics in pandemic control. We compared SARS-CoV-2 test performance by sample type and modality in close contacts of SARS-CoV-2 cases. Methods: Close contacts of SARS-CoV-2 positive individuals were enrolled after informed consent. Clinician-collected nasopharyngeal (NP) swabs in viral transport media (VTM) were tested with a nucleic acid test (NAT). NP VTM and self-collected passive drool were tested using the PerkinElmer real-time reverse transcription PCR (RT-PCR) assay. For the first 4 months of study, mid-turbinate swabs were tested using the BD Veritor rapid antigen test. NAT positive NP samples were tested for infectivity using a VeroE6TMPRSS2 cell culture model. Results: Between November 17, 2020, and October 1, 2021, 235 close contacts of SARS-CoV-2 cases were recruited, including 95 with symptoms (82% symptomatic for <5 days) and 140 asymptomatic individuals. NP swab reference tests were positive for 53 (22.6%) participants; 24/50 (48%) were culture positive. PerkinElmer testing of NP and saliva samples identified an additional 28 (11.9%) SARS-CoV-2 cases who tested negative by clinical NAT. Antigen tests performed for 99 close contacts showed 83% positive percent agreement (PPA) with reference NAT among early symptomatic persons, but 18% PPA in others; antigen tests in 8 of 11 (72.7%) culture-positive participants were positive. Conclusions: Contacts of SARS-CoV-2 cases may be falsely negative early after contact, which more sensitive platforms may identify. Repeat or serial SARS-CoV-2 testing with both antigen and molecular assays may be warranted for individuals with high pretest probability for infection.

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Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site

Cited by 27 publications

References 11 publications

Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

Detection of the omicron variant virus with the Abbott BinaxNow SARS-CoV-2 Rapid Antigen Assay

High Sensitivity and NPV for BinaxNOW Rapid Antigen Test in Children at a Mass Testing Site During Prevalent Delta Variant Period

Limitations of molecular and antigen test performance for SARS-CoV-2 in symptomatic and asymptomatic COVID-19 contacts

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