Name the study question
Write the exact product, specimen or input, configuration, intended users, setting and performance question. A report about one sample type or operating condition may not answer the broader question suggested by a short product description.
Illustrative report extract
A hypothetical report evaluates test system B with reagent lot R3 and software 2.1 using 240 archived specimens. The analysis includes 118 reference-positive and 116 reference-negative specimens; six indeterminate test results are reported separately. Results are compared with method C under the study protocol.
This extract is designed to teach reading. The numbers do not describe a real product and are not acceptance criteria.
Read beyond the headline
Ask whether the denominator includes every tested specimen, how indeterminate and missing results are handled, whether estimates include uncertainty and whether performance varies by specimen type, site, user or other relevant subgroup. Recalculate simple totals where the report permits it.
In the example, 118 + 116 + 6 = 240. A percentage reported only for the 234 determinate results must not be described as if all 240 produced determinate results.
Blank review note
| Item | Review entry |
|---|---|
| Decision the report will inform | |
| Evaluated configuration | |
| Specimen/input and setting | |
| Comparison and study design | |
| Analysis set and exclusions | |
| Principal results and uncertainty | |
| Indeterminate or missing results | |
| Limits on transfer to intended use | |
| Outstanding evidence question |
Connect the result to use
Keep demonstrated technical performance separate from workflow, user behaviour or health outcomes that the study did not assess. If a conclusion extends to a different product configuration or setting, record the additional basis for the extension.
Limits
This resource does not set a clinical decision threshold or determine whether a test is suitable for an individual. Check current official requirements and product-specific evidence for the market and intended use concerned.