ArticleHeliyon2025
Evaluation of a PCR-based lateral flow device for detecting
Article in Heliyon, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Nucleic Acid Amplification Tests forPathogens (Basel, Switzerland) · 2026Pooled it
- The future of fungal diagnostics: What's next in laboratory testing for invasive fungal infection?Medical mycology · 2026Review
- The evolution of next-generation lateral flow assays for bacterial and fungal diagnostics.Mikrochimica acta · 2026Review
- Oligonucleotide-Driven Nanoparticle Biosensor forACS omega · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: The diagnosis of invasive fungal diseases (IFDs) is time consuming and lacks sensitivity. In this research a rapid and easy to use immunochromatography-based DNA biosensor system was developed to detect Methods: Three separate multiplexed PCR reactions were designed together with a testing algorithm, using biotin, digoxigenin and Tamra fluorophore-labelled fungal internal transcribed spacer universal fungal primers, fungal genera-specific primers, and species-specific primers to produce labelled PCR products that were detected on the LFA dipstick. The LFA dipstick, in a modified sandwich format, utilises immobilised antibodies complementary to the fluorophore labels on the PCR products, and gold nanoparticles to form a visible red line that indicates the presence of the targeted fungus. To validate the developed system, 203 clinical samples suspected of fungal infection were collected from two hospitals in Kuala Lumpur and tested. Results: The limits of detection of the multiplexed PCR were in the range of 5-100 CFU/mL for fungal spiked human blood samples. Against the clinical diagnosis of proven or probable IFDs, the findings show that the LFA system produced a high specificity of 99.4 % while the sensitivity was only moderate at 47.8 % due to the difficulty of extracting fungal DNA from blood samples. The positive and negative predictive values however were promising at 91.7 % and 93.7 %, respectively. Conclusion: The developed LFA system has great potential for further refinement to be used as a new tool in the detection of IFDs.
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Registered trials
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.