UMMS Affiliation

Division of Infectious Disease and Immunology, Department of Medicine

Publication Date

2021-02-23

Document Type

Article Postprint

Disciplines

Analytical, Diagnostic and Therapeutic Techniques and Equipment | Health Services Administration | Health Services Research | Immunoprophylaxis and Therapy | Infectious Disease | Medical Microbiology | Microbiology | Virus Diseases

Abstract

Background: Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point-of-care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations. We evaluated the Abbott BinaxNOW COVID-19 Ag Card in a high-throughput, drive-through, free community testing site in Massachusetts (MA) using anterior nasal (AN) swab RT-PCR for clinical testing.

Methods: Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. Dual AN swabs were collected from symptomatic and asymptomatic children ( < /= 18 years) and adults. BinaxNOW testing was performed in a testing pod with temperature/humidity monitoring. One individual performed testing and official result reporting for each test, but most tests had a second independent reading to assess inter-operator agreement. Positive BinaxNOW results were scored as faint, medium, or strong. Positive BinaxNOW results were reported to patients by phone and they were instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations.

Results: Of 2482 participants, 1380 adults and 928 children had paired RT-PCR/BinaxNOW results and complete symptom data. 974/1380 (71%) adults and 829/928 (89%) children were asymptomatic. BinaxNOW had 96.5% (95% confidence interval [CI] 90.0- 99.3) sensitivity and 100% (98.6-100.0) specificity in adults within 7 days of symptoms, and 84.6% (65.1-95.6) sensitivity and 100% (94.5-100.0) specificity in children within 7 days of symptoms. Sensitivity and specificity in asymptomatic adults were 70.2% (56.6-81.6) and 99.6% (98.9-99.9), respectively, and in asymptomatic children were 65.4% (55.6-74.4) and 99.0% (98.0-99.6), respectively. By cycle threshold (Ct) value cutoff, sensitivity in all subgroups combined (n=292 RT-PCR-positive individuals) was 99.3% with Ct < /=25, 95.8% with < /=30, and 81.2% with < /=35. Twelve false positive BinaxNOW results (out of 2308 tests) were observed; in all twelve, the test bands were faint but otherwise normal, and were noted by both readers. One invalid BinaxNOW result was identified. Inter-operator agreement (positive versus negative BinaxNOW result) was 100% (n = 2230/2230 double reads). Each operator was able to process 20 RDTs per hour. In a separate set of 30 specimens (from individuals with symptoms < /=7 days) run at temperatures below the manufacturer's recommended range (46-58.5 degrees F), sensitivity was 66.7% and specificity 95.2%.

Conclusions: BinaxNOW had very high specificity in both adults and children and very high sensitivity in newly symptomatic adults. Overall, 95.8% sensitivity was observed with Ct < /= 30. These data support public health recommendations for use of the BinaxNOW test in adults with symptoms for < /=7 days without RT-PCR confirmation. Excellent inter-operator agreement indicates that an individual can perform and read the BinaxNOW test alone. A skilled laboratorian can perform and read 20 tests per hour. Careful attention to temperature is critical.

Keywords

COVID-19, SARS-CoV-2, diagnostic, antigen, point-of-care

Rights and Permissions

Copyright © 2021, American Society for Microbiology. Accepted manuscript posted with 6 month embargo as allowed by the publisher's author rights policy at https://journals.asm.org/content/statement-author-rights.

DOI of Published Version

10.1128/JCM.00083-21

Source

Pollock NR, Jacobs JR, Tran K, Cranston AE, Smith S, O'Kane CY, Roady TJ, Moran A, Scarry A, Carroll M, Volinsky L, Perez G, Patel P, Gabriel S, Lennon NJ, Madoff LC, Brown C, Smole SC. Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-throughput Drive-through Community Testing Site in Massachusetts. J Clin Microbiol. 2021 Feb 23:JCM.00083-21. doi: 10.1128/JCM.00083-21. Epub ahead of print. PMID: 33622768. Link to article on publisher's site

Journal/Book/Conference Title

Journal of clinical microbiology

Comments

This article is based on a previously available preprint on medRxiv that is also available in eScholarship@UMMS.

Full author list omitted for brevity. For the full list of authors, see article.

Related Resources

Link to Article in PubMed

PubMed ID

33622768

Available for download on Monday, August 23, 2021

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