Clinical Evaluation of the Accuracy of the Panbio™ COVID-19/Flu A&B Rapid Panel: A Combination Antigen Rapid Diagnostic Test for the Omicron Variant and Influenza A Virus

• Published in: Viral immunology Vol. 37; no. 6; p. 317
• Main Authors: Yamagishi, Hirokazu, Tamura, Daisuke, Yamazaki, Masahiko, Abe, Takashi, Mitamura, Keiko, Tajima, Toshihiro, Osaka, Hitoshi
• Format: Journal Article
• Language: English
• Published: United States 01.08.2024
• Subjects: Adolescent; Adult; Antigens, Viral - immunology; Child; Child, Preschool; COVID-19 - diagnosis; COVID-19 - immunology; COVID-19 - virology; COVID-19 Serological Testing - methods; Female; Humans; Infant; Infant, Newborn; Influenza A virus - immunology; Influenza A virus - isolation & purification; Influenza B virus - immunology; Influenza B virus - isolation & purification; Influenza, Human - diagnosis; Influenza, Human - immunology; Influenza, Human - virology; Male; Middle Aged; Nasopharynx - virology; Rapid Diagnostic Tests - instrumentation; SARS-CoV-2 - genetics; SARS-CoV-2 - immunology; Sensitivity and Specificity; Young Adult; BA.5; omicron variant; simultaneous detection; clinical specimens; influenza A; BA.2
• ISSN: 1557-8976
• DOI: 10.1089/vim.2024.0039

It is difficult to differentiate between coronavirus disease 2019 (COVID-19) and influenza based on the symptoms. In the present study, a newly developed antigen rapid diagnostic test (Ag-RDT) called Panbio™ COVID-19/Flu A&B that can simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B virus was evaluated. Its accuracy was evaluated using 235 pairs of nasopharyngeal samples collected from patients with respiratory symptoms and fever (>37.5°C). Reverse transcription polymerase chain reaction was used as a reference method to evaluate the accuracy of the SARS-CoV-2 detection. We confirmed the accuracy of the developed Ag-RDT against the Omicron variant where the sensitivity and specificity were 94.8% and 100%, respectively. In addition, to identify the influenza A virus, a noninferiority test was conducted using a commercial Ag-RDT, which has a sensitivity and specificity in comparison with viral culture of 94.8% and 98.4%, respectively. The positive and negative predictive values for influenza A virus were 98.5% and 98.1%, respectively, for the Panbio COVID-19/Flu A&B test. The evaluation of this newly developed Ag-RDT using clinical samples suggests that it has a high efficacy in clinical settings.