Evidence map›Paper›PMID 36869389›Full record

ArticleVirology journal2023

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

Norihito Kaku, Tomohito Urabe, Tetsuya Iida, Chyuns Yun, Yoshiyuki Nishida, Yasunori Onitsuka, Kohji Hashiguchi, Kiyoto Hirose, Akimitsu Tomonaga, Koichi Izumikawa and 2 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Virology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
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

12 authors at 5 institutions in 1 country.

Norihito KakuDepartment of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. norihitk@gmail.com.
Tomohito UrabeUrabe Otorhinolaryngology Clinic, Nagasaki City, Nagasaki, Japan.
Tetsuya IidaIida Naika Syounika Clinic, Nagasaki City, Nagasaki, Japan.
Chyuns YunOhisama Pediatric Clinic, Nagayo-cho, Nagasaki, Japan.
Yoshiyuki NishidaNishida Gastrointestinal Internal Medicine Clinic, Nagasaki City, Nagasaki, Japan.
Yasunori OnitsukaOnitsuka Internal Medicine Clinic, Nagasaki City, Nagasaki, Japan.
Kohji HashiguchiDepartment of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki City, Nagasaki, Japan.
Kiyoto HiroseHirose Clinic, Nagasaki City, Nagasaki, Japan.
Akimitsu TomonagaTomonaga Medical Clinic, Omura City, Nagasaki, Japan.
Koichi IzumikawaDepartment of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan.
Hiroshi MukaeDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan.
Katsunori YanagiharaDepartment of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Nagasaki University · JPAsics (Japan) · JPHirose Electric (Japan) · JPJapanese Red Cross Society, Japan · JPNishida Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe 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).

methodsPatients 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.

resultsWe 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.

conclusionsThe TRCsatFLU showed great sensitivity and specificity for the detection of influenza in nasopharyngeal swabs and gargle samples.

trial registrationThis 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.

Indexed as

Influenza, HumanChildFeverHospitalsHumansPoint-of-Care TestingInfluenzaRapid detectionRT-PCRTRC method

Identifiers

PMID36869389
PMCPMC9983540
OpenAlexW4323041735

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.