Configurations

What is a “Configuration”?

In the RARE system, a Configuration describes how the app and portal are set up to work with a specific lateral flow (LF) test.

Each configuration brings together the information RARE needs so that, when a user scans a test:

• The app recognises the correct test housing

• The right analysis method is applied

• Results are interpreted correctly (quantitative or qualitative)

• Reported outcomes match the intended behaviour of that particular test system

At a high level:

• Housings and Methods tell RARE what this test looks like and how to read it.

• Batches, Classifiers, and Ground Truth define how those readings are turned into meaningful diagnostic outputs (values, categories, and performance claims).

Why configurations matter to you

Using configurations allows us to:

• Tailor RARE to your test system
  Each assay or product line can be configured with its own rules and characteristics, without needing a custom app.

• Maintain consistency and reliability
  Once a configuration is defined and approved, RARE will apply the same rules every time the test is run, supporting consistent performance.

• Support changes and improvements
  If your test design, thresholds, or analysis approach evolve, we can update the configuration while keeping clear control and traceability.

What’s included in configurations?

To keep things clear, we describe configurations across a set of focused topics. Each of these has its own page with more detail.

How this relates to your product

For each IVD system you deploy with RARE:

• One or more Configurations define how that system behaves in the app and portal.

• These configurations are created and maintained under document control, aligned with your product requirements and performance claims.

• Any changes to how a test is read, interpreted, or reported are managed through updates to its configuration, with appropriate review and approval.

This approach allows RARE to support your products in a controlled, configurable, and scalable way, while giving you clarity on how the system is interpreting your tests and generating diagnostic outputs.