What is “Data Analysis”?
In the RARE system, Data Analysis refers to the suite of tools used to manage, re-process, and evaluate the performance of your lateral flow (LF) assay data.
While the mobile app and portal capture and store individual scan results, the Data Analysis module allows you to look at that data collectively. It provides the environment where you can:
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Organize results into curated sets for specific studies or QC checks.
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Re-evaluate existing data using new reader settings or interpretation logic without needing to recollect samples.
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Quantify how well your assay is performing by comparing results against a known reference (Ground Truth).
At a high level, Data Analysis bridges the gap between raw measurement data and the statistical evidence required for clinical validation and ongoing manufacturing control.
Why Data Analysis matters to you
Using the Data Analysis features allows you to:
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Accelerate Validation and Optimization
Test the impact of new thresholds, calibration curves, or reader settings on historical data. This "what-if" capability lets you optimize your assay's performance before committing to a final configuration. -
Maintain Uncompromising Traceability
Every analysis run and performance report is versioned and linked back to the original raw data. This ensures a clear, auditable lineage that supports regulatory submissions and internal quality audits. -
Enhance Data Integrity
RARE preserves your original results. Reprocessing and analysis create new, linked records, ensuring that your primary data remains an unalterable "source of truth" while still allowing for retrospective investigation. -
Generate Regulatory-Ready Insights
Automatically calculate key diagnostic metrics—such as Sensitivity, Specificity, and ROC curves—formatted for inclusion in technical files and performance evaluations.
What’s included in Data Analysis?
To help you manage your workflow effectively, Data Analysis is organized into four key areas. Each has its own detailed guide:
How this relates to your product
For every IVD system you develop and maintain with RARE:
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Data Analysis is the engine for continuous improvement. It allows you to refine your product's performance based on real-world data.
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Traceability is built-in. Whether you are troubleshooting a QC outlier or preparing a 510(k) submission, the lineage from raw image to final performance claim is preserved.
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Efficiency is maximized. By reusing datasets for multiple "what-if" scenarios, you reduce the need for expensive and time-consuming sample recollection during the optimization phase.
This structured approach ensures that your assay's performance is not just a static measurement, but a well-documented and optimized outcome of a controlled analytical process.