Technical Reports¶
This section documents the technical reports Migibio produces as part of its quality system — method validation, lot-to-lot consistency, and field evaluation data.
These reports are the raw evidence behind the summary figures published on the Data Hub. They exist so that any distributor, OEM partner, or veterinary professional can trace a published number back to its source.
1. Report Types¶
| Report | Content | Frequency | Primary Audience |
|---|---|---|---|
| Method validation | Full analytical validation (LOD/CV%/linearity) | Per assay launch | Regulatory, R&D |
| Lot-to-lot consistency | Inter-lot CV% verification | Per production lot | QC, distributors |
| Field evaluation | Real-world performance, multi-site | Per assay, periodic | Clinicians, partners |
| Stability study | Shelf-life and accelerated stability | Per assay | Regulatory, distributors |
2. Standard Report Structure¶
Each Migibio technical report follows a consistent, auditable structure:
- Purpose — what was tested and why
- Materials & Methods — samples, reagents, protocol, analyzers used
- Results — LOD, LOQ, CV%, linearity, accuracy, with raw data tables
- Discussion — interpretation against acceptance criteria, limitations
- Conclusion — conformity statement
- Sign-off — reviewer and date (part of the R&D Quality Committee process)
3. Acceptance Criteria (Summary)¶
Every report is judged against these acceptance criteria:
| Parameter | Acceptance |
|---|---|
| Intra-assay CV% | < 8% |
| Inter-assay CV% | < 10% |
| Correlation (r) vs reference | > 0.95 |
| Mean bias | < 10% |
| Lot-to-lot CV% | < 10% |
4. Traceability¶
A report is only useful if it can be traced. Migibio's quality system links:
This chain is what allows the Data Hub to publish summary figures with confidence, and what allows a distributor to audit a specific lot.
5. Availability¶
- Summary data — published openly across this research center and the Data Hub.
- Full technical reports — available to distributors and B2B partners on request; an NDA may apply.
FAQ¶
Can I request the validation report for a specific assay? Yes. Distributors and B2B partners can request full reports via martinwang2024@gmail.com. Summary data is published openly.
What is a COA, and how does it relate to these reports? A COA (Certificate of Analysis) is the lot-specific performance summary shipped with each product. Technical reports are the fuller underlying validation documents that the COA summarizes.
Are field evaluations independent? Field evaluations are conducted using real clinical samples across multiple sites, but are organized and reported by Migibio — they are manufacturer-run studies, not independent academic trials.
For the standard validation methodology, see Analytical Performance.
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.