Calibration Verification & Instrument Validation¶
Calibration verification confirms that the analyzer — and its loaded standard curve — produces correct results. This page covers what to verify, how often, and why.
Calibration vs Verification¶
| Term | Meaning |
|---|---|
| Calibration | Establishing the curve (done at manufacturing; loaded via QR/cloud) |
| Verification | Confirming the loaded curve reads correctly on your instrument |
The operator does not calibrate — they verify that the pre-loaded curve is reading correctly.
Verification Methods¶
| Method | What it confirms |
|---|---|
| QC cartridge (known value) | Analyzer reads the expected control concentration |
| Control material | Curve accuracy at a defined concentration |
| Proficiency sample | Agreement with external reference |
Verification Frequency¶
| Trigger | Action |
|---|---|
| Daily | QC cartridge verification |
| New assay lot | Verify the new lot's curve |
| Instrument service/repair | Full verification |
| Suspicion of drift | Immediate verification |
Acceptance Criteria¶
| Parameter | Acceptance |
|---|---|
| QC result | Within the control's stated range |
| Curve integrity | No error on load |
| Inter-operator agreement | Consistent results across operators |
FAQ¶
Do I ever build a standard curve myself? No — curves are pre-loaded (QR code or cloud). Your role is verification, not construction.
What if my QC value drifts within range? Monitor the trend; consistent drift toward the limit warrants proactive service.
For the QC program, see Internal QC Program.
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.