Performance Data
This review framework separates a catalog value from evidence that can be reproduced in a specific laboratory workflow.
Structured evidence
Values are example protocol targets from project requirements, not declared specifications for every Agilent model.
| Metric | Example requirement | Test condition | Evidence to retain | Decision limitation |
|---|---|---|---|---|
| Analyzer throughput | 600–2,000 tests/hour | Defined assay mix, STAT rate, reruns, calibration, and staffing | Timed run log and exception count | Headline maximum may omit interruptions |
| Precision | Site-defined CV threshold | At least two concentration levels across repeated runs | Raw results, mean, SD, CV, operator, lot, and date | One matrix or level does not establish full-range precision |
| Detection capability | Method-specific LOD/LOQ | Blank and low-level replicates with declared calculation | Protocol, raw signals, exclusions, model, and calculation | LOD does not equal clinical decision performance |
| Method comparison | Predefined bias limits | Samples spanning the reportable range | Deming regression, Bland–Altman plot, residual review | Correlation alone can hide systematic bias |
| LIS interface | 100% pass for approved cases | Normal, amended, rerun, rejected, and outage scenarios | Message capture, expected result, actual result, approval | Lab test success does not cover every production exception |
Reproducibility checklist
A higher-throughput platform can improve batching efficiency but may increase dependency on automation, reagent logistics, and centralized downtime planning. A smaller distributed platform may improve local turnaround yet require more instruments, competency records, QC events, and interface endpoints. Compare both paths against the same volume and failure scenarios.