Analytical Performance¶
This section documents how Migibio validates the analytical performance of its FICT veterinary assays — and what the resulting figures mean for a veterinarian interpreting a result.
Analytical performance is the foundation of everything else on this site. A reference range is only meaningful if the assay measuring it is precise and accurate. This section explains the metrics, the method, and the representative numbers.
Why Analytical Performance Matters¶
Before an assay can answer a clinical question, it must answer four analytical questions:
| Question | Metric | What it tells you |
|---|---|---|
| Can it detect the analyte at low levels? | LOD (limit of detection) | The lowest concentration reliably distinguished from zero |
| Can it quantify at low levels? | LOQ (limit of quantitation) | The lowest concentration measurable with acceptable precision |
| Is it repeatable? | CV% (coefficient of variation) | Run-to-run and day-to-day consistency |
| Does it read the right value? | Accuracy / correlation | Agreement with a reference method |
The Validation Framework¶
Migibio validates each assay against a defined protocol:
- LOD/LOQ determination — serial dilution of a high-concentration sample to establish the detection floor.
- Linearity — dilution series across the claimed measuring range.
- Precision — intra-assay (within-run) and inter-assay (between-run) CV% using control material.
- Accuracy — method comparison against a reference analyzer/laboratory method, reported as correlation coefficient (r).
- Interference — spiking studies for lipemia, hemolysis, icterus, and common interferents.
The full protocol is documented in Validation Methodology.
Representative Performance (FICT Platform)¶
Typical performance across the Migibio FICT assay portfolio:
| Metric | Typical Value | Notes |
|---|---|---|
| Limit of Detection (LOD) | 0.1–1.0 ng/ml | Assay-dependent |
| Limit of Quantitation (LOQ) | 0.5–5.0 ng/ml | Assay-dependent |
| Linear range | 2–3 orders of magnitude | Wide dynamic range |
| Intra-assay CV% | < 8% | Within-run repeatability |
| Inter-assay CV% | < 10% | Between-run reproducibility |
| Correlation vs reference (r) | > 0.95 | Method comparison |
These are representative platform-level figures. Assay-specific values are published on each biomarker data card in the Data Hub.
Why FICT Achieves This¶
The instrument-read, fluorescence-based signal chain of FICT is the reason these figures are achievable — it removes the visual-judgment variability inherent in colloidal-gold strips. See the FICT technical white paper for the mechanism.
FAQ¶
What is an acceptable CV% for a quantitative POCT assay? For quantitative immunoassays, intra-assay CV% below 10% and inter-assay CV% below 15% are generally considered acceptable; Migibio's platform targets intra-assay < 8% and inter-assay < 10%.
Why does LOD differ between assays? LOD depends on the antibody affinity for the specific analyte and the fluorophore labeling efficiency — both are analyte-specific, so no single LOD applies across the whole portfolio.
How do I find the LOD for a specific assay? See the assay's data card in the Data Hub, or the product's COA (Certificate of Analysis).
For the structured performance data, see the Data Hub assay performance section.
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.