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An indeterminate or borderline IVD result is a real study finding. Removing such results can make evaluation artificially easier. Explain the definition, retest rule and place in the principal assessment before analysing outcomes.
Define the assessment
Map device result categories to research codes. Indeterminate output, technical invalidity and a missing record are not identical states. Make counts and subsequent processing visible. Additional testing should not rewrite the initial outcome as though it had always been definitive.
Worked example
For example, some specimens initially produce borderline results. After retesting, a laboratory records them as negative and removes the first result. Review restores original records and verifies the retest rule. The team explains which assessments use initial or final workflow outcomes while retaining the size of the indeterminate group.
Practical checks
- Map every result category consistently across the data dictionary and report tables.
- Link retesting or additional assessment to the original indeterminate record.
- Examine distributions by reference information and intended-use group.
Decision and limitations
The report should reveal practical workload and interpretive limits. Do not present performance calculated only among definitive results as the entire testing experience. Keep analytical handling and exclusions explicit, with appropriate qualified review where clinical decisions are involved.
Frequently asked questions
- Is an indeterminate result simply missing data?
- No. It may be an actual device category that definitions and analysis should preserve.
- Can the first result be deleted after retesting?
- No. Retain traceability and explain which assessment uses each result.