tetano
Editor, Senior Moderator
Ann Lab Med
. 2025 Dec 17.
doi: 10.3343/alm.2025.0516. Online ahead of print. Accuracy of an Optical Waveguide-Based Biosensor Antigen-Detection Test for Severe Acute Respiratory Syndrome Coronavirus-2 and Seasonal Influenza Viruses During the Cocirculating Season
Hideaki Kato[SUP] 1 [/SUP], Nobuko Yoshinaga[SUP] 2 [/SUP], Naoko Ando[SUP] 2 [/SUP], Shundai Ko[SUP] 3 [/SUP], Akifumi Tokita[SUP] 4 [/SUP], Toshifumi Kawashima[SUP] 5 [/SUP], Akira Shoji[SUP] 6 [/SUP], Yuzo Suzuki[SUP] 7 [/SUP], Makoto Kudo[SUP] 8 [/SUP]
Affiliations
Background: Coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and seasonal influenza are responsible for recurring seasonal epidemics. We tested the accuracy of an optical waveguide-based biosensor for detecting SARS-CoV-2 and seasonal influenza viruses in nasal and nasopharyngeal specimens.
Methods: We consecutively collected 252 nasopharyngeal swabs (NPSs) and 107 nasal specimens from febrile patients with respiratory symptoms who visited two university hospitals and six clinics between January and March 2025. Point-of-care testing data from an optical waveguide-based biosensor test (Rapiim SARS-CoV-2-N/Flu) and a lateral flow test were compared with those obtained using conventional quantitative real-time reverse transcription PCR.
Results: With NPS specimens, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 95.2% and 100%, respectively, for SARS-CoV-2 (98.8% concordance) and 92.3% and 92.2%, respectively, for seasonal influenza viruses (95.2% concordance). When nasal specimens were used, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 93.1% and 98.0%, respectively, for detecting SARS-CoV-2. The sensitivities for detecting SARS-CoV-2 and seasonal influenza were higher than a lateral flow test. The Rapiim SARS-CoV-2-N/Flu test detected SARS-CoV-2 and seasonal influenza viruses at 10 and 6 days after symptom onset, respectively.
Conclusions: Rapid test with greater accuracy than lateral flow tests that can differentiate between SARS-CoV-2 and influenza were needed. Point of care antigen testing using the optical waveguide-based biosensor yielded higher sensitivity and specificity for detecting SARS-CoV-2 and seasonal influenza viruses in NPS and nasal specimens than conventional tests, enabling differentiation between both types of acute respiratory infections.
Keywords: Coronavirus disease 2019; Optical waveguide-based biosensor; Point-of-care testing; Rapid antigen test; Rapiim; Seasonal influenza; Severe acute respiratory syndrome coronavirus-2.
. 2025 Dec 17.
doi: 10.3343/alm.2025.0516. Online ahead of print. Accuracy of an Optical Waveguide-Based Biosensor Antigen-Detection Test for Severe Acute Respiratory Syndrome Coronavirus-2 and Seasonal Influenza Viruses During the Cocirculating Season
Hideaki Kato[SUP] 1 [/SUP], Nobuko Yoshinaga[SUP] 2 [/SUP], Naoko Ando[SUP] 2 [/SUP], Shundai Ko[SUP] 3 [/SUP], Akifumi Tokita[SUP] 4 [/SUP], Toshifumi Kawashima[SUP] 5 [/SUP], Akira Shoji[SUP] 6 [/SUP], Yuzo Suzuki[SUP] 7 [/SUP], Makoto Kudo[SUP] 8 [/SUP]
Affiliations
- PMID: 41403283
- DOI: 10.3343/alm.2025.0516
Background: Coronavirus disease 2019, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and seasonal influenza are responsible for recurring seasonal epidemics. We tested the accuracy of an optical waveguide-based biosensor for detecting SARS-CoV-2 and seasonal influenza viruses in nasal and nasopharyngeal specimens.
Methods: We consecutively collected 252 nasopharyngeal swabs (NPSs) and 107 nasal specimens from febrile patients with respiratory symptoms who visited two university hospitals and six clinics between January and March 2025. Point-of-care testing data from an optical waveguide-based biosensor test (Rapiim SARS-CoV-2-N/Flu) and a lateral flow test were compared with those obtained using conventional quantitative real-time reverse transcription PCR.
Results: With NPS specimens, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 95.2% and 100%, respectively, for SARS-CoV-2 (98.8% concordance) and 92.3% and 92.2%, respectively, for seasonal influenza viruses (95.2% concordance). When nasal specimens were used, the sensitivity and specificity of the Rapiim SARS-CoV-2-N/Flu test were 93.1% and 98.0%, respectively, for detecting SARS-CoV-2. The sensitivities for detecting SARS-CoV-2 and seasonal influenza were higher than a lateral flow test. The Rapiim SARS-CoV-2-N/Flu test detected SARS-CoV-2 and seasonal influenza viruses at 10 and 6 days after symptom onset, respectively.
Conclusions: Rapid test with greater accuracy than lateral flow tests that can differentiate between SARS-CoV-2 and influenza were needed. Point of care antigen testing using the optical waveguide-based biosensor yielded higher sensitivity and specificity for detecting SARS-CoV-2 and seasonal influenza viruses in NPS and nasal specimens than conventional tests, enabling differentiation between both types of acute respiratory infections.
Keywords: Coronavirus disease 2019; Optical waveguide-based biosensor; Point-of-care testing; Rapid antigen test; Rapiim; Seasonal influenza; Severe acute respiratory syndrome coronavirus-2.