ArticleAnnals of laboratory medicine2025
Sensitivity and Specificity of an All-in-one Cartridge-based Dengue Real-time Reverse Transcription-PCR for Point-of-care Detection and Serotyping of Dengue Virus in Samples from Indonesian Patients.
Article in Annals of laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed.
- Evaluation of a Fully Automated Assay for Detection of Antidengue IgM Antibodies in a Nonendemic Area.Journal of tropical medicine · 2025Article
- Early diagnostic value of dengue virus NS1 antigen and nucleic acid testing.American journal of translational research · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: : Dengue is a systemic, viral, mosquito-borne infection that continues to be a major public health issue in endemic regions in tropical and subtropical climates. Accurate tests for rapid diagnosis in point-of-care settings are important to reduce the fatality rates of severe dengue. We evaluated the diagnostic accuracy of the Standard M10 DENV 1-4 system (SD Biosensor, Gyeonggi, Korea), which is a cartridge-based, automated system that integrates nucleic acid extraction, reverse transcription-PCR (RT-PCR) amplification, and detection of dengue virus (DENV) serotypes. Methods: : This was a retrospective diagnostic evaluation study. The index test, Standard M10 DENV 1-4, was evaluated using 320 dengue-positive and 279 dengue-negative archived samples. The reference tests were a combination of Centers for Disease Control and Prevention (CDC) DENV 1-4 real-time RT-PCR, dengue NS1 antigen and IgM antibody detection, and DENV whole-genome sequencing. Results: : The overall sensitivity and specificity of Standard M10 DENV 1-4 were 94% and 100%, respectively. By serotype, the highest sensitivity was 100% for DENV-1, and the lowest was 82% for DENV-4. The overall between the CDC RT-PCR dengue serotyping method and the Standard M10 DENV 1-4 was 95%. Standard M10 DENV 1-4 RT-PCR had comparable sensitivity and specificity to CDC DENV RT-PCR. Conclusions: : Based on its commensurate performance to an established RT-PCR method combined with additional benefits of convenient storage and transport, easy use, and rapid processing, the Standard M10 DENV 1-4 system has potential for DENV detection and serotyping in point-of-care settings.
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