ArticleJournal of medical virology2026
Evaluation and Clinical Validation of Pan-Specific and Clade-Specific Diagnostic Real-Time PCR Assays for Monkeypox Virus.
Article in Journal of medical virology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Evaluation and Clinical Validation of Pan-Specific and Clade-Specific Diagnostic Real-Time PCR Assays for Monkeypox Virus.Journal of medical virology · 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
9 authors.
Funding
Abstract
Human mpox, formerly known as monkeypox, has twice been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization, in 2022 and 2024. Despite this, global access to rapid, reliable diagnostics remains limited, hindering outbreak control and equitable clinical response. To address this gap, we developed and validated a rapid direct real-time PCR assay capable of detecting and differentiating Clade I and Clade II monkeypox virus (MPXV) directly from clinical samples. We designed a new pan-specific B15L assay to complement the published F3L assay and introduced the first clade-specific assay targeting the B1R gene of Clade I MPXV. In silico validation showed that both B15L and F3L assays detected all available MPXV genomes with 100% sensitivity, while B1R selectively detected only Clade I genomes with 100% specificity. Cross-reactivity screening against 40 high-priority non-target organisms revealed minimal risk of false positives. We confirmed analytical sensitivity of 2 copies per reaction for all assays in vitro, with clade-specific B1R showing 100% specificity. When adapted into a lyophilized direct PCR format for near-point-of-care use, the assay demonstrated detection down to 1 copy per reaction for pan-specific targets and 2 copies for clade-specific detection in spiked clinical samples. This direct PCR assay delivers accurate results in under 1 h without requiring nucleic acid extraction. Our combined genomic, laboratory, and clinical validations demonstrate exceptional sensitivity and specificity, positioning this assay as a highly promising tool in emergency mpox diagnostics and a potential model for future outbreak-responsive testing platforms.
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Registered trials
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