Background We conducted a multicenter study to evaluate the performance of a novel fully automated molecular point-of-care test using transcription-reverse transcription concerted reaction that can detect influenza A and B within 15 min in nasopharyngeal swabs and gargle samples (TRCsatFLU). Methods Patients who visited or were hospitalized at eight clinics and hospitals with influenza-like illnesses between December 2019 and March 2020 participated in this study. We collected nasopharyngeal swabs from all patients and gargle samples from patients whom the physician judged fit to perform gargling. The result of TRCsatFLU was compared to a conventional reverse transcription-polymerase chain reaction (RT-PCR). If the results of TRCsatFLU and conventional RT-PCR were different, the samples were analyzed by sequencing. Results We evaluated 233 nasopharyngeal swabs and 213 gargle samples from 244 patients. The average age of the patients was 39.3 ± 21.2. Of the patients, 68.9% visited a hospital within 24 h of symptom onset. The most common symptoms were fever (93.0%), fatigue (79.5%), and nasal discharge (64.8%). All patients in whom the gargle sample was not collected were children. Influenza A or B was detected in 98 and 99 patients in nasopharyngeal swabs and gargle samples using TRCsatFLU, respectively. Four and five patients in nasopharyngeal swabs and gargle samples, respectively, with different TRCsatFLU and conventional RT-PCR results. Influenza A or B was detected using sequencing in all samples with different results. Based on the combined conventional RT-PCR and sequencing results, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TRCsatFLU for influenza detection in nasopharyngeal swabs were 0.990, 1.000, 1.000, and 0.993, respectively. In the gargle samples, the sensitivity, specificity, PPV, and NPV of the TRCsatFLU for detecting influenza were 0.971, 1.000, 1.000, and 0.974, respectively. Conclusions The TRCsatFLU showed great sensitivity and specificity for the detection of influenza in nasopharyngeal swabs and gargle samples. Trial registration: This study was registered in the UMIN Clinical Trials Registry (reference number: UMIN000038276) on October 11, 2019. Before sample collection, written informed consent for the participation and publication of this study was obtained from all participants.
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.
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