Multicenter evaluation of molecular point-of-care testing and digital immunoassays for influenza virus A/B and respiratory syncytial virus in patients with influenza-like illness

Kaku, Norihito; Kodama, Hina; Akamatsu, Norihiko; Ota, Kenji; Kosai, Kosuke; Morinaga, Yoshitomo; Narita, Yusuke; Matsumoto, Yasushi; Matsushita, Takayuki; Mizuta, Yohei; Izumikawa, Koichi; Mukae, Hiroshi; Yanagihara, Katsunori

doi:10.1016/j.jiac.2021.01.010

Cited by 5 publications

(8 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…No previous study has compared the DIAs used in this study and molecular POC tests, but a previous study comparing other DIAs and molecular POC tests reported that the positive rate for influenza with molecular POC tests was much higher than that with DIAs. [11–13] A previous meta-analysis revealed that pooled sensitivity of the molecular POC tests was higher than that of DIAs (91.6% versus 80.0%). [14] Therefore, molecular POC tests, including TRC, can contribute to the accurate diagnosis of influenza compared with DIAs.…”

Section: Discussionmentioning

confidence: 99%

Gargle sample is an effective option in a novel fully automated molecular point-of-care test for influenza: a multicenter study

Kaku

Urabe²,

Iida³

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

We conducted a multicenter study to evaluate a novel transcription-reverse transcription concerted reaction (TRC) that can detect influenza A and B within 15 minutes. We evaluated this rapid TRC using nasopharyngeal swab and gargle samples obtained from patients who visited or were hospitalized at eight clinics and hospitals with influenza-like illnesses between December 2019 and March 2020. After obtaining informed consent, we collected nasopharyngeal swabs from all patients using two swabs and gargle samples from patients whom the physician judged fit to perform gargling. We evaluated 133 nasopharyngeal swabs and 213 gargle samples from 244 patients. In nasal swabs, influenza A or B was detected in 96 and 98 patients using reverse transcription-polymerase chain reaction (RT-PCR) and TRC, respectively. Influenza A and B were detected using sequence analysis in four patients with different RT-PCR and TRC results. Based on the combined RT-PCR and sequencing results, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TRC for influenza detection were 0.990, 1.000, 1.000, and 0.993, respectively. In the gargle samples, influenza A was detected in 100 and 99 patients using RT-PCR and TRC, respectively. Influenza A was detected using sequencing in five patients with different RT-PCR and TRC results. The sensitivity, specificity, PPV, and NPV of the TRC for detecting influenza were 0.970, 0.982, 0.980, and 0.974, respectively. The novel rapid TRC was comparable to RT-PCR for the detection of influenza in nasopharyngeal swabs and gargle samples.

show abstract

Section: Discussionmentioning

confidence: 99%

Gargle sample is an effective option in a novel fully automated molecular point-of-care test for influenza: a multicenter study

Kaku

Urabe²,

Iida³

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…In our previous study [ 4 ], we used nasopharyngeal swab samples collected from adult outpatients with one or more symptoms, such as fever (38 °C or an increase of 1 °C from normal body temperature), nasal discharge, nasal congestion, sore throat, cough, headache, chills, fatigue, joint pain, or muscle pain, at Menoto Hospital, Matsumoto Naika, Narita Naika Clinic, and Shinzato Medicare Group Shinzato Clinic between November 2019 and March 2020. Patients were excluded if they were treated with anti-influenza agents within 1 month prior to the outpatient visit.…”

Section: Methodsmentioning

confidence: 99%

“…The detection of influenza viruses was performed in our previous study [ 4 ] and the results were used as reference results. Briefly, samples were assayed using the cobas Influenza A/B & RSV on the cobas Liat system, as well as an automated immunochromatographic antigen test (digital immunoassay, DIA test).…”

Section: Reference Methodsmentioning

confidence: 99%

“…We recently reported the usefulness of a fully automated molecular point-of-care (POC) testing system, the cobas Influenza A/B & RSV on the cobas® Liat system, for influenza A virus detection. The assay is performed on a single sample within a short time (approximately 20 min) [ 4 ]. In contrast, the cobas® 6800 system, a fully automated molecular testing system, provides a batch assay for 96 samples in approximately 3 h. In this study, we evaluated the performance of the cobas 6800 system and cobas SARS-CoV-2 & Influenza A/B, which targeted severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A and B viruses, focusing on the detection of influenza A virus.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Clinical evaluation of a fully automated and high-throughput molecular testing system for detection of influenza virus

Kosai

Kaku

Horie

et al. 2022

Virol J

Self Cite

View full text Add to dashboard Cite

Introduction We investigated the performance of the cobas® 6800 system and cobas SARS-CoV-2 & Influenza A/B, a fully automated molecular testing system for influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This enabled an assay in a batch of 96 samples in approximately 3 h. Methods An assay was performed using the cobas SARS-CoV-2 & Influenza A/B on the cobas 6800 system for samples collected in four facilities between November 2019 and March 2020 in our previous study. The results were compared with those obtained using the reference methods. Results Of the 127 samples analyzed, the cobas SARS-CoV-2 & Influenza A/B detected influenza A virus in 75 samples, of which 73 were positive using the reference methods. No false negative results were observed. The overall positive and negative percent agreement for influenza A virus detection were 100.0% and 96.3%, respectively. There were no positive results for the influenza B virus or SARS-CoV-2. Conclusion The cobas 6800 system and cobas SARS-CoV-2 & Influenza A/B showed high accuracy for influenza A virus detection and can be useful for clinical laboratories, especially those that routinely assay many samples.

show abstract

“…In addition, this system exhibited desirable specificity with a low detection limit of ∼12 IU/mL. Seasonal influenza is a highly infectious and fast-spreading respiratory disease. − Efforts have been made in developing accurate and rapid POC influenza diagnostic tests. − Microchips have attracted tremendous attention because this system enabled the integration of multiple laboratory processes into simple platforms with high reaction efficiency. A polycarbonate (PC)–polydimethylsiloxane (PDMS) hybrid microchip with an epoxy silica sol–gel coating was fabricated to detect influenza virus with europium NPs (EuNPs) .…”

Section: Microscale Systems “See” In Virusesmentioning

confidence: 99%

What the Microscale Systems “See” In Biological Assemblies: Cells and Viruses?

et al. 2021

View full text Add to dashboard Cite

Multicenter evaluation of molecular point-of-care testing and digital immunoassays for influenza virus A/B and respiratory syncytial virus in patients with influenza-like illness

Cited by 5 publications

References 15 publications

Gargle sample is an effective option in a novel fully automated molecular point-of-care test for influenza: a multicenter study

Gargle sample is an effective option in a novel fully automated molecular point-of-care test for influenza: a multicenter study

Clinical evaluation of a fully automated and high-throughput molecular testing system for detection of influenza virus

What the Microscale Systems “See” In Biological Assemblies: Cells and Viruses?

Contact Info

Product

Resources

About