Objective:

To evaluate the performance of the Mpox SHINE assay for diagnosing Mpox in decentralized settings during the 2025 outbreak in Sierra Leone.

Approach:

Key Findings:

• Mpox SHINE achieved 100% sensitivity and specificity compared to qPCR for both extracted and unextracted samples.
• Positive specimens were detected in an average of 11.4 minutes for extracted samples and 27.9 minutes for unextracted samples.
• The assay maintained accuracy across clinical samples with qPCR cycle threshold values ranging from 15 to 36.

Interpretation:

The study demonstrates the potential of CRISPR-based diagnostics to provide rapid and accurate molecular testing in lower-resource settings.

Limitations:

• The evaluation of unextracted samples included only 16 specimens, leading to wide confidence intervals.
• The current system is not a fully automated sample-to-answer platform.
• Further studies are needed to assess performance in larger cohorts and long-term reagent stability.

Conclusion:

The study shows the feasibility of deploying a CRISPR-based molecular assay during an outbreak, providing results in less than 30 minutes from minimally processed samples.

Sources:

• Nature Communications
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