Evaluation of the Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection in children: Implications for screening in a school setting

Sood, Neeraj; Shetgiri, Rashmi; Rodriguez, Anna; Jiménez, D. L. C. B.; Treminino, Sonia; Daflos, Amanda; Simon, Paul

doi:10.1371/journal.pone.0249710

Cited by 47 publications

(64 citation statements)

References 10 publications

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“…This finding is in agreement with other published studies 14,15,[32][33][34] . Sood et al recently described that the positive concordance of RADT was higher among symptomatic children (64.4%) compared to asymptomatic children (51.1%) presenting at a walk-in testing site in Los Angeles County 33 . Similarly, L'Huillier et al described a sensitivity of 73.0% in symptomatic vs. 43.3% in asymptomatic children 34 .…”

Section: (Which Was Not Certified By Peer Review)supporting

confidence: 94%

Evaluation of real-life use of Point-Of-Care Rapid Antigen TEsting for SARS-CoV-2 in schools (EPOCRATES)

Blanchard

Desforges

Labbé

et al. 2021

Preprint

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We evaluated the use of rapid antigen detection tests (RADT) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in school settings to determine RADT performance characteristics compared to PCR. Methods: We did a real-world, prospective observational cohort study where recruited high-school students and staff from two high-schools in Montreal (Canada) were followed from January 25th to June 10th, 2021. Twenty-five percent of asymptomatic participants were tested weekly by RADT (nasal) and PCR (gargle). Class contacts of a case were tested. Symptomatic participants were tested by RADT (nasal) and PCR (nasal and gargle). The number of cases/outbreak and number of outbreaks were compared to other high schools in the same area. Results: Overall, 2,099 students and 286 school staff members consented to participate. The overall RADT specificity varied from 99.8 to 100%, with a lower sensitivity, varying from 28.6% in asymptomatic to 83.3% in symptomatic participants. The number of outbreaks was not different in the 2 participating schools compared to other high schools in the same area, but included a greater proportion of asymptomatic cases. Returning students to school after a 7-day quarantine, with a negative PCR on D6-7 after exposure, did not lead to subsequent outbreaks, as shown by serial testing. Of cases for whom the source was known, 37 of 57 (72.5%) were secondary to household transmission, 13 (25%) to intra-school transmission and one to community contacts between students in the same school. Conclusion: RADT did not perform well as a screening tool in asymptomatic individuals. Reinforcing policies for symptom screening when entering schools and testing symptomatic individuals with RADT on the spot may avoid subsequent significant exposures in class.

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Section: (Which Was Not Certified By Peer Review)supporting

confidence: 94%

Evaluation of real-life use of Point-Of-Care Rapid Antigen TEsting for SARS-CoV-2 in schools (EPOCRATES)

Blanchard

Desforges

Labbé

et al. 2021

Preprint

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“…Across other studies, BinaxNOW sensitivity varied between 64.4% to 96.5% among symptomatic persons [6,8,[10][11][12][13] and between 20.0% to 70.2% among asymptomatic participants ( [9,14]). Several factors may contribute to variability in test performance including differences in population characteristics, the timing during disease course, test operator training [7] and methodological differences such as the comparator rRT-PCR assay, specimen type and collection method.…”

Section: Discussionmentioning

confidence: 89%

“…Prior studies [6][7][8][9][10][11][12][13][14] have examined BinaxNOW antigen test performance; however, detailed data on the association of antigen test performance compared to rRT-PCR and viral culture by key epidemiologic characteristics such as symptom and known exposure status, timing during infection, and demographic variables are limited. An earlier brief report [15] analyzing these data showed high specificity for BinaxNOW, but low sensitivity in specimens from either symptomatic (64.2%) or asymptomatic persons (35.8%) and showed improved sensitivity compared to rRT-PCR when limiting the analysis to culture positive specimens.…”

Section: Introductionmentioning

confidence: 99%

Performance Characteristics of the Abbott BinaxNOW SARS-CoV-2 Antigen Test in Comparison to Real-Time Reverse Transcriptase PCR and Viral Culture in Community Testing Sites during November 2020

et al. 2022

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Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse-transcriptase PCR (rRT-PCR). Data on the performance of the BinaxNOW antigen test compared to rRT-PCR and viral culture by symptom and known exposure status, timing during disease or exposure period and demographic variables are limited. During November 3 rd -17 th , 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW (BinaxNOW) antigen test at two community testing sites in Pima County, Arizona. We administered a questionnaire to capture symptoms, known exposure status and previous SARS-CoV-2 test results. Specimens positive by either test were analyzed by viral culture. Previously we showed overall BinaxNOW sensitivity was 52.5%. Here we showed BinaxNOW sensitivity increased to 65.7% among currently symptomatic individuals reporting a known exposure. BinaxNOW sensitivity was lower among participants with a known exposure and previously symptomatic (32.4%) or never symptomatic (47.1%) within 14 days of testing. Sensitivity was 71.1% in participants within a week of symptom onset. In participants with a known exposure, sensitivity was highest 8-10 days post-exposure (75%). The positive predictive value for recovery of virus in cell culture was 56.7% for BinaxNOW-positive and 35.4% for rRT-PCR-positive specimens. Result reporting time was 2.5 hours for BinaxNOW and 26 hours for rRT-PCR. Point-of-care antigen tests have a shorter turn-around time compared to laboratory-based nucleic acid amplification tests, which allows for more rapid identification of infected individuals. Antigen test sensitivity limitations are important to consider when developing a testing program.

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“…Searches of PubMed, Google Scholar, medRxiv, and bio-Rxiv yielded 15 unique studies after de-duplication. [36][37][38][39][40][41][42][43][44][45][46][47][48][49][50] Studies identified can be found in Appendix 2. Fourteen of the studies examined the BinaxNOW platform, and 1 examined the Cue COVID-19 Test.…”

Section: Resultsmentioning

confidence: 99%

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

Kepczynski¹,

Genigeski²,

Koski³

et al. 2021

Journal of the American Pharmacists Association

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Objectives Home-based rapid diagnostic testing can play an integral role in controlling the spread of COVID-19. This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUA) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. Methods Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as well as linked resources from the FDA’s webpages. Homepages of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed literature searches were performed, most recently in May 2021, to locate literature about the identified home tests, as were searches of Google Scholar, medRxiv, and bioRxiv. Literature Selection Studies were included if they were performed at home or were self-collected (or collected by a parent or guardian for patients under 18 years of age), and evaluated the positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of SARS-CoV-2 virus. Results Limited data has been published for these home tests given that they are available through EUAs that do not require clinical trials. Fifteen studies were located from searching the literature, but only 2 met the inclusion criteria. Review of the home-tests' websites yielded a single study for each test with the 3 BinaxNow platforms using the same study for their EUAs. The 9 COVID-19 home tests with EUAs as of May 7, 2021 include 3 molecular tests and 6 antigen tests. These tests had similar performance based on positive percent agreement ranging from 83.5% to 97.4% and negative percent agreement ranging from 97% to 100%. Conclusions The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison to laboratory real time reverse-transcription polymerase chain reaction (RT-PCR) tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.

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Evaluation of the Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection in children: Implications for screening in a school setting

Cited by 47 publications

References 10 publications

Evaluation of real-life use of Point-Of-Care Rapid Antigen TEsting for SARS-CoV-2 in schools (EPOCRATES)

Evaluation of real-life use of Point-Of-Care Rapid Antigen TEsting for SARS-CoV-2 in schools (EPOCRATES)

Performance Characteristics of the Abbott BinaxNOW SARS-CoV-2 Antigen Test in Comparison to Real-Time Reverse Transcriptase PCR and Viral Culture in Community Testing Sites during November 2020

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

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