Clinical Report: Portable CRISPR Takes on Mpox
Overview
A portable CRISPR-based assay, Mpox SHINE, demonstrated complete concordance with qPCR in detecting Mpox during the 2025 outbreak in Sierra Leone. The assay achieved 100% sensitivity and specificity, providing rapid results from minimally processed samples.
Background
The Mpox outbreak in Sierra Leone highlighted the need for accessible diagnostic tools in decentralized settings. Traditional molecular testing methods, such as qPCR, often require centralized laboratory infrastructure, which may not be available in outbreak scenarios. The development of portable diagnostic solutions like Mpox SHINE could enhance outbreak response.
Data Highlights
| Parameter | Value |
|---|---|
| Limit of Detection | 1-10 viral copies/µL |
| Time to Detection (extracted DNA) | 11.4 minutes |
| Time to Detection (unextracted swabs) | 27.9 minutes |
| Sensitivity | 100% |
| Specificity | 100% |
Key Findings
- The Mpox SHINE assay achieved 100% sensitivity and specificity compared to qPCR.
- Positive specimens were detected in an average of 11.4 minutes using extracted DNA.
- For unextracted lesion swabs, the assay maintained 100% sensitivity and specificity with a mean detection time of 27.9 minutes.
- The assay is designed for use in lower-resource settings, utilizing minimally processed samples.
- Analytical testing showed consistent detection at 10 copies/µL.
Clinical Implications
The Mpox SHINE assay provides a rapid and accurate diagnostic option for Mpox in decentralized settings.
Conclusion
The study demonstrates the feasibility of deploying a CRISPR-based molecular assay during an active outbreak, with results available in less than 30 minutes from minimally processed samples.
Related Resources & Content
- WHO, Diagnostic testing and testing strategies for mpox: interim guidance, 2024 -- https://www.who.int/publications/i/item/B09166
- WHO, Multi-country outbreak of mpox, External situation report #56 - 31 July 2025 -- https://www.who.int/publications/m/item/multi-country-outbreak-of-mpox--external-situation-report--56---31-july-2025?utm_source=openai
- PMC, Diagnostic accuracy of polymerase chain reaction for detection of mpox in humans -- https://pmc.ncbi.nlm.nih.gov/articles/PMC11616455/?utm_source=openai
- conexiant — Conjugative CRISPR System Cuts Resistance
- Basic Research in Cardiology — Position Statement from DGK and DZHK on Genome Editing: Applications in Basic Science and Future Outlook
- Archives of Toxicology — Endogenous Heme Oxygenase-1 Fluorescent Labeling in Human Induced Pluripotent Stem Cells for Advanced Imaging of Oxidative Stress Across Differentiated Cell Types
- Journal of Medical Internet Research (JMIR) — CRISPR Diagnostics, in Your Pocket
- CRISPR Diagnostics, in Your Pocket
- Diagnostic testing and testing strategies for mpox: interim guidance, 12 November 2024
- Multi-country outbreak of mpox, External situation report #56 - 31 July 2025
- Diagnostic accuracy of polymerase chain reaction for detection of mpox in humans - PMC
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