1. Easily identifiable as a study of diagnostic accuracy | | | | | | | | | | |
2. State the research questions or study aims | | | | | | | | | | |
3. Describes the study population: the inclusion and exclusion criteria, the setting and the locations where the data were collected | | | | | | | | | | |
4. Describes participant recruitment and sampling (prospective or retrospective study) | | | | | | | | | | |
5. Describes the test under evaluation | | | | | | | | | | |
6. Describes the reference standard and its rationale | | | | | | | | | | |
7. Describes specimen acquisition | | | | | | | | | | |
8. Describes specimen storage | | | | | | | | | | |
9. Describes training in specimen processing | | | | | | | | | | |
10. Describes blinding mechanism between index and reference test results | | | | | | | | | | |
11. Uses appropriate statistical analysis | | | | | | | | | | |
12. Shows cross-tabulation of results of index and reference tests | | | | | | | | | | |
13. Estimates diagnostic accuracy with statistical uncertainty (CIs) | | | | | | | | | | |
14. Shows how indeterminate results are handled | | | | | | | | | | |
15. Describes variability and subgroup analysis | | | | | | | | | | |
16. Discusses clinical applicability of findings | | | | | | | | | | |