Lot-to-Lot Consistency: How Migibio Ensures Reproducible Reagents¶
When you monitor a patient's CRP over weeks, you may be using reagents from different production lots. If those lots vary, the "trend" you see could be noise. This page explains how Migibio verifies lot-to-lot consistency.
Why Lot Consistency Matters¶
Quantitative monitoring (CRP, progesterone, SDMA) compares values across time — often across lots. A difference between lots is indistinguishable from a change in the patient. Lot consistency is what makes longitudinal monitoring trustworthy.
The Acceptance Criterion¶
| Parameter | Acceptance |
|---|---|
| Lot-to-lot CV% | < 10% |
Each new production lot is tested against a reference lot; the inter-lot coefficient of variation must stay below 10%.
The Verification Process¶
- Reference lot establishes the baseline performance.
- New lot is run against the same control material and samples.
- Inter-lot CV% is calculated.
- Release only if within the < 10% criterion.
The Traceability Chain¶
Each lot's COA (Certificate of Analysis) certifies its consistency against the reference — the chain that makes published summary data trustworthy.
FAQ¶
How is a lot defined? A lot is a single production batch of reagent manufactured under the same conditions and materials.
Can I request a lot's consistency data? Yes — the COA ships with the lot, and distributors/B2B partners can request the full consistency report.
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.