Evidence map›Paper›PMID 41403283›Full record

ArticleAnnals of laboratory medicine2026

Accuracy of an Optical Waveguide-Based Biosensor Antigen-Detection Test for Severe Acute Respiratory Syndrome Coronavirus-2 and Seasonal Influenza Viruses During the Co-circulating Season.

Hideaki Kato, Nobuko Yoshinaga, Naoko Ando, Shundai Ko, Akifumi Tokita, Toshifumi Kawashima, Akira Shoji, Yuzo Suzuki, Makoto Kudo

Abstract read
In one paragraph

Article in Annals of laboratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Hideaki KatoInfection Prevention and Control Department, Yokohama City University Hospital, Yokohama, Japan.ORCID https://orcid.org/0000-0002-7853-5721
Nobuko YoshinagaYumegaoka General Hospital, Yokohama, Japan.ORCID https://orcid.org/0009-0005-3957-0283
Naoko AndoYumegaoka General Hospital, Yokohama, Japan.ORCID https://orcid.org/0009-0002-7553-3875
Shundai KoCenter Hospital of the National Center for Global Health and Medicine, Japan Institute for Health Security, Tokyo, Japan.ORCID https://orcid.org/0009-0008-2914-9913
Akifumi TokitaClinic Bambini, Tokyo, Japan.ORCID https://orcid.org/0009-0000-7023-4425
Toshifumi KawashimaKawashima Clinic, Ootawara, Japan.ORCID https://orcid.org/0009-0000-9183-3953
Akira ShojiShoji Clinic, Yokohama, Japan.ORCID https://orcid.org/0009-0006-4499-4520
Yuzo SuzukiClover Hospital, Fujisawa, Japan.ORCID https://orcid.org/0009-0000-3549-3499
Makoto KudoRespiratory Disease Center, Yokohama City University Medical Center, Yokohama, Japan.ORCID https://orcid.org/0000-0002-1837-0267

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Antigens, ViralBiosensing TechniquesCOVID-19Influenza, HumanOrthomyxoviridaeSARS-CoV-2AdultAgedFemaleHumansMaleMiddle AgedNasopharynxPoint-of-Care TestingRapid Diagnostic TestsSeasonsAntigens, ViralCoronavirus disease 2019Optical waveguide-based biosensorPoint-of-care testingRapid antigen testRapiimSeasonal influenzaSevere acute respiratory syndrome coronavirus-2

Identifiers

PMID41403283
PMCPMC13662484

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.