Diagnostic Accuracy of the Abbott BinaxNOW COVID‐19 Antigen Card Test, Puerto Rico

• Published in: Influenza and other respiratory viruses Vol. 18; no. 7; pp. e13305 - n/a
• Main Authors: Madewell, Zachary J., Major, Chelsea G., Graff, Nathan, Adams, Cameron, Rodriguez, Dania M., Morales, Tatiana, Medina Lopes, Nicole A., Tosado, Rafael, Sánchez‐González, Liliana, Perez‐Padilla, Janice, Volkman, Hannah R., Bertrán‐Pasarell, Jorge, Sainz de la Peña, Diego, Munoz‐Jordan, Jorge, Santiago, Gilberto A., Lorenzi, Olga, Rivera‐Amill, Vanessa, Rolfes, Melissa A., Paz‐Bailey, Gabriela, Adams, Laura E., Wong, Joshua M.
• Format: Journal Article
• Language: English
• Published: England John Wiley & Sons, Inc 01-07-2024; John Wiley and Sons Inc
• Subjects: Adolescent; Adult; Aged; Antigens; Antigens, Viral - analysis; Asymptomatic; COVID-19; COVID-19 - diagnosis; COVID-19 Serological Testing - methods; COVID-19 Testing - methods; COVID-19 vaccines; Data collection; Decision making; diagnostic accuracy; Disease prevention; Disease transmission; Drug dosages; Emergency medical care; Epidemiology; Female; Fever; Health surveillance; Humans; Illnesses; Immunization; Infections; Influenza; Male; Medical diagnosis; Medical laboratories; Middle Aged; Nucleic acids; Omicron; Original; Pandemics; Performance assessment; Performance evaluation; Polymerase chain reaction; Puerto Rico; Puerto Rico - epidemiology; rapid antigen test; SARS-CoV-2 - genetics; SARS-CoV-2 - immunology; SARS-CoV-2 - isolation & purification; SARS‐CoV‐2; sensitivity; Sensitivity analysis; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; Vaccination; Viral diseases; Young Adult; Puerto Rico; United States > US; rapid antigen test; Puerto Rico; diagnostic accuracy; Omicron; sensitivity; SARS‐CoV‐2
• ISSN: 1750-2640; 1750-2659; 1750-2659
• DOI: 10.1111/irv.13305

ABSTRACT
Background
The COVID‐19 pandemic underscored the need for rapid and accurate diagnostic tools. In August 2020, the Abbott BinaxNOW COVID‐19 Antigen Card test became available as a timely and affordable alternative for SARS‐CoV‐2 molecular testing, but its performance may vary due to factors including timing and symptomatology. This study evaluates BinaxNOW diagnostic performance in diverse epidemiological contexts.
Methods
Using RT‐PCR as reference, we assessed performance of the BinaxNOW COVID‐19 test for SARS‐CoV‐2 detection in anterior nasal swabs from participants of two studies in Puerto Rico from December 2020 to May 2023. Test performance was assessed by days post symptom onset, collection strategy, vaccination status, symptomatology, repeated testing, and RT‐PCR cycle threshold (Ct) values.
Results
BinaxNOW demonstrated an overall sensitivity of 84.1% and specificity of 98.8%. Sensitivity peaked within 1–6 days after symptom onset (93.2%) and was higher for symptomatic (86.3%) than asymptomatic (67.3%) participants. Sensitivity declined over the course of infection, dropping from 96.3% in the initial test to 48.4% in testing performed 7–14 days later. BinaxNOW showed 99.5% sensitivity in participants with low Ct values (≤ 25) but lower sensitivity (18.2%) for participants with higher Cts (36–40).
Conclusions
BinaxNOW demonstrated high sensitivity and specificity, particularly in early‐stage infections and symptomatic participants. In situations where test sensitivity is crucial for clinical decision‐making, nucleic acid amplification tests are preferred. These findings highlight the importance of considering clinical and epidemiological context when interpreting test results and emphasize the need for ongoing research to adapt testing strategies to emerging SARS‐CoV‐2 variants.