Evidence map›Paper›PMID 34972195›Full record

ArticlePloS one2021

The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol.

Asami Naito, Yoshihiko Kiyasu, Yusaku Akashi, Akio Sugiyama, Masashi Michibuchi, Yuto Takeuchi, Shigeyuki Notake, Koji Nakamura, Hiroichi Ishikawa, Hiromichi Suzuki

Open access · goldAbstract readComparative StudyEvaluation Study
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2023
    Observational
  5. Analytical performance of the rapid qualitative antigen kit for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2023
    Observational
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

10 authors at 5 institutions in 1 country.

Asami NaitoTsukuba i-Laboratory LLP, Tsukuba, Ibaraki, Japan.
Yoshihiko KiyasuDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
Yusaku AkashiDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
Akio SugiyamaDiagnostic System Department, TOYOBO Co., Ltd., Kita-ku, Osaka, Japan.
Masashi MichibuchiDiagnostic System Department, TOYOBO Co., Ltd., Kita-ku, Osaka, Japan.
Yuto TakeuchiDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.ORCID 0000-0002-6643-6208
Shigeyuki NotakeDepartment of Clinical Laboratory, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
Koji NakamuraDepartment of Clinical Laboratory, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
Hiroichi IshikawaDepartment of Respiratory Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
Hiromichi SuzukiDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.ORCID 0000-0003-1434-7104
Tsukuba Medical Center Hospital · JPToyobo (Japan) · JPUniversity of Tsukuba Hospital · JPOsaka Nishi Clinic · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated.

methodsThis prospective comparison between GENECUBE® HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE® HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes.

resultsFor 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations.

conclusionGENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.

Indexed as

PandemicsCOVID-19COVID-19 Nucleic Acid TestingDiagnostic Tests, RoutineHumansNasopharynxProspective StudiesSaliva

Identifiers

PMID34972195
PMCPMC8719657
OpenAlexW4206842066

What OpenQuestion holds

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LicenceCC BY
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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.