Evidence map›Paper›PMID 41559845›Full record

ArticleTropical medicine and health2026

Development of a colorimetric RT-LAMP-based microfluidic device for SARS-CoV-2 detection.

Tatsuya Sakurai, Hiroka Aonuma, Daigo Natsuhara, Tokio Hoshina, Manabu Ote, Erisha Saiki, Takayuki Shibata, Hirotaka Kanuka

Abstract read
In one paragraph

Article in Tropical medicine and health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

8 authors.

Tatsuya Sakurai *Laboratory Animal Facilities, The Jikei University School of Medicine, Tokyo, Japan. tsakurai@jikei.ac.jp.
Hiroka Aonuma *Department of Tropical Medicine, The Jikei University School of Medicine, Tokyo, Japan. aonuma@jikei.ac.jp.
Daigo NatsuharaDepartment of Materials Process Engineering, Nagoya University, Nagoya, Japan.
Tokio HoshinaDepartment of Infectious Diseases and Infection Control, The Jikei University School of Medicine, Tokyo, Japan.
Manabu OteDepartment of Tropical Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Erisha SaikiLaboratory Animal Facilities, The Jikei University School of Medicine, Tokyo, Japan.
Takayuki ShibataDepartment of Mechanical Engineering, Toyohashi University of Technology, Toyohashi, Japan.
Hirotaka KanukaDepartment of Tropical Medicine, The Jikei University School of Medicine, Tokyo, Japan. kanuka@jikei.ac.jp.

Funding

Japan Agency for Medical Research and Development JP20he0622021
6 · The paper itself

Abstract

backgroundDiagnosing COVID-19, caused by the coronavirus SARS-CoV-2, mainly involves detecting specific viral gene sequences. To effectively control highly contagious diseases, such as COVID-19, it is essential to develop quick, accurate, sensitive, and easy-to-use diagnostic methods for medical settings. The current gold standard, reverse transcription-quantitative polymerase chain reaction (RT-qPCR), requires specialized equipment and trained personnel and is typically conducted in dedicated laboratories. Loop-mediated isothermal amplification (LAMP) provides a rapid and simple alternative under isothermal conditions. In this study, we developed a colorimetric reverse transcription-loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2 detection and integrated it into a microfluidic device.

methodsRT-LAMP primers targeting conserved regions of the SARS-CoV-2 envelope (E) and RNA-dependent RNA polymerase (RdRp) genes were designed. Hydroxy naphthol blue (HNB) was used as a color indicator for visual detection. The microfluidic device, fabricated from polydimethylsiloxane (PDMS), contained five reaction chambers. RNA samples extracted from nasopharyngeal swabs of COVID-19 patients were tested using the RT-LAMP microfluidic device. Detection performance of the device was assessed using RT-qPCR as the reference standard.

resultsAmong 86 RNA samples, 66 were RT-qPCR positive and 20 were negative. The RT-LAMP microfluidic device achieved 100% specificity (95% CI 83.2-100%) and an overall sensitivity of 75.8% (95% CI 63.6-85.5%) for samples with Ct ≤ 35. Sensitivity correlated with viral load, showing 100% for samples with Ct ≤ 25, 88.6% for Ct ≤ 30, and 50% for 30 < Ct ≤ 35.

conclusionsThe colorimetric RT-LAMP-based microfluidic device enables simple, rapid, and reliable detection of SARS-CoV-2 RNA with high specificity and sensitivity. The device enables visual detection of results and requires only simple equipment, making it suitable as a practical molecular detection tool for point-of-care and resource-limited settings. In terms of detection performance, our findings, when considered alongside previously published data, indicate that the sensitivity and specificity of the device are comparable to or exceed those of lateral flow tests commonly used for point-of-care COVID-19 diagnostics.

Indexed as

COVID-19Infectious diseaseMicrofluidic deviceMolecular detectionRT-LAMPVirus

Identifiers

PMID41559845
PMCPMC12849338

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.