Define the test
Name the target, sample type, collection or preparation requirements, users and setting. Identify the reader, reagent and software combinations covered. Describe research-use or clinical-use status and the declared market accurately.
Separate analytical and clinical evidence
Organise reports by the questions they answer. Explain the reference method, sample selection, relevant population, performance measures and limitations. Clinical claims need evidence addressing those claims; analytical findings alone do not establish every clinical interpretation.
Explain the workflow and its limits
Provide current instructions, result interpretation, invalid-result handling, relevant interferences and restrictions. Tie reports to the entered version and remove identifiable patient data. Online demonstrations explain the workflow without replacing the evidence required for a performance claim.
Evidence checklist
| Area | Required material | Check before submitting |
|---|---|---|
| Identity | Target, sample, users, setting, components and version | The assessed scope is explicit. |
| Analytical performance | Protocols, references, conditions, results and uncertainty | Relevant properties, interferences and limits are addressed. |
| Clinical performance | Population, sample selection, reference approach and analysis | Findings apply to the intended clinical setting. |
| Interpretation | Instructions, warnings and invalid or indeterminate results | Users can understand the result's scope. |
| Quality and supply | Relevant market records, batches, versions and concerns | Reports and supply claims concern the entered product. |
Explaining applicability
Evidence for one sample type and setting does not automatically cover another. Identify exclusions and uncertainty and explain how indeterminate results were handled. Research-use material must not be presented as clinical authorisation. Use summaries or de-identified evidence, rather than personal patient records, for review.
Map claims to sources
For each principal claim, record its exact wording, report or study, file and page, assessed version, method or population, finding and limitation. Identify the author and relevant relationship with the applicant. Explain how evidence about a different formulation, component or version applies to your product.
Prepare readable files
Supply readable reports, with the original and relevant English passages where needed. Keep private reports separate from proposed public information. Remove personal information not needed for review.
The entry permits up to 20 attachments and 250 MB in total: 25 MB per PDF and 10 MB per image. Video is supplied by link. Contact the awards team if an essential report exceeds these limits.
Return to the category · Use the evidence worksheet · Read the rubric