Field Evaluation: Real-World Performance of FICT Assays¶
Analytical validation uses controlled samples. Field evaluation confirms the assay still performs with real patients, real operators, and real sample quality. This page explains the process.
Why Field Evaluation Is Separate¶
| Validation type | Samples | What it proves |
|---|---|---|
| Analytical validation | Spiked/controlled | The assay measures the analyte |
| Field evaluation | Real clinical samples | The assay works in practice |
A perfectly validated assay can still fail in the field — operator variability, sample handling, and time constraints are all real-world factors.
The Field Evaluation Design¶
| Element | Specification |
|---|---|
| Sites | Multiple (removes single-site bias) |
| Samples | Real clinical samples (unselected) |
| Operators | Multiple (assesses inter-operator variability) |
| Reference | Comparison against a reference method |
| Duration | Sufficient to capture sample variability |
What Field Evaluation Measures¶
| Metric | Real-world question |
|---|---|
| Agreement with reference | Does the result match the lab? |
| Operator reproducibility | Do different operators agree? |
| Failure rate | How often does a test fail in practice? |
| Usability | Is the workflow practical under time pressure? |
FAQ¶
Why multiple sites? A single site can mask site-specific issues (training, equipment, sample population). Multi-site evaluation reveals whether performance generalizes.
Does field evaluation replace analytical validation? No — they are complementary. Analytical validation proves the assay measures correctly; field evaluation proves it works in the real world.
For the full report structure, see Technical Reports.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-13
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.