Release Specifications¶
Every Migibio production lot must pass a release specification before its Certificate of Analysis (COA) is issued and the lot ships. This page documents the release criteria. Values are Migibio release specifications; specific per-assay numbers are stated in each product's COA.
1. Analytical Release Criteria¶
| Parameter | Release requirement |
|---|---|
| Limit of detection (LOD) | Meets the assay's stated LOD |
| Precision (intra-assay CV%) | Within the assay's stated range (typically < 10%) |
| Linearity | Within stated range across the measuring interval |
| Accuracy / recovery | Within stated acceptance range |
2. Physical & Packaging Release Criteria¶
| Parameter | Release requirement |
|---|---|
| Appearance | No visible defects; strips intact |
| Pouch seal | Hermetic; desiccant present |
| Labeling | Correct lot number and expiry date |
| Documentation | IFU insert present; COA generated |
3. The Release Flow¶
| Step | Gate |
|---|---|
| FQC testing | Finished lot tested against release criteria |
| Spec comparison | All criteria must pass — no exceptions |
| COA issuance | Lot-specific performance data documented |
| Batch release | Lot approved for shipment |
| OQC | Final packaging & documentation check |
4. Data Provenance¶
- LOD / CV% / linearity are measured on reference material during FQC.
- Each value is lot-specific — the COA for your lot lists the actual numbers for that lot.
- Release values are traceable to the assay's analytical validation (see Validation Methodology).
5. Key Takeaway¶
The COA is not generic marketing — it certifies that your specific lot met every release criterion listed above.
For the release process narrative, see the Knowledge Base.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-14
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.