Research & Analytical Performance
This page summarizes the analytical performance of Migibio’s fluorescence immunochromatographic (FICT) platform. It separates manufacturer-reported analytical specifications — the instrument and platform characteristics published in the FIA680 and FIA880 product attributes — from clinical validation status, which is assay-specific and documented in each reagent’s Instructions for Use (IFU).
What This Page Covers
- Analytical platform specifications — precision, sensitivity, result time, throughput, and detection method reported by the manufacturer.
- Clinical performance — how to find assay-level sensitivity, specificity, and interpretation guidance.
- Method comparison — how FICT compares with LFIA, ELISA, and PCR for veterinary testing workflows.
- Third-party evidence status — a clear statement on what has and has not been independently published.
- Quality and manufacturing — archived company credentials relevant to production quality.
Analytical Platform Specifications
The following values are manufacturer-reported from the Migibio FIA680 and FIA880 analyzer product attributes.
| Metric | FIA680 | FIA880 | Source |
|---|---|---|---|
| Detection method | Fluorescence immunoassay (FICT) | Fluorescence immunoassay (FICT) | Manufacturer-reported |
| Precision | CV% < 10% | CV% < 10% | Manufacturer-reported |
| Sensitivity (LoD) | pg/ml (LOD) | pg/ml (LOD) | Manufacturer-reported |
| Result time | 3–11 minutes | 3–15 minutes | Manufacturer-reported |
| Throughput | Up to 200 tests/hour | Up to 300 tests/hour | Manufacturer-reported |
| Channels | Single-channel | Six independent channels | Manufacturer-reported |
Result time and assay-specific performance can vary by test item. Follow the current analyzer manual and the individual reagent IFU for the specific assay being run.
Clinical Performance
Clinical sensitivity and specificity are assay-specific and documented in each reagent’s Instructions for Use (IFU). This page summarizes the analytical platform level; assay-level performance is published per kit.
For interpretation, always combine the quantitative result with the patient’s signalment, history, clinical signs, vaccination or treatment history where relevant, and any other laboratory findings.
Method Comparison
FICT retains lateral-flow simplicity while adding instrument-read quantification. A broader method comparison is available in FICT vs LFIA vs ELISA vs PCR.
| Method | Typical result | Typical time to result | Typical veterinary role |
|---|---|---|---|
| LFIA (colloidal gold) | Qualitative or semi-quantitative | Minutes, visual | Rapid yes/no screening |
| FICT | Quantitative | 3–11 minutes on FIA680; 3–15 minutes on FIA880 (manufacturer-reported) | Point-of-care quantitative testing and trend monitoring |
| ELISA | Quantitative with a standard curve | Hours, laboratory | Batch laboratory testing |
| PCR | Qualitative or quantitative depending on assay design | Hours, laboratory | Molecular confirmation or direct nucleic-acid detection |
For technical background, see Core Technology.
Third-Party Evidence Status
Independent third-party validation studies are not yet published. The specifications above are manufacturer-reported internal validation data. Prospective users should request the full validation report from Migibio.
Quality & Manufacturing
The archived company pages confirm the following credentials and facility information:
- ISO 13485 and ISO 9001-certified quality management, and GMP-certified processes
- 30 core patents
- Standardized 2,000 m² R&D and production workshop
- Products sold in 30+ countries and regions
See About Migibio and Corporate Identity for the source pages.
Related Resources
Frequently asked questions
- What does this Research Center page cover?
- It summarizes the manufacturer-reported analytical platform specifications for the Migibio FIA680 and FIA880 systems and separates those platform-level figures from assay-specific clinical performance published in each reagent's Instructions for Use (IFU).
- Are the analytical specifications independently validated?
- Independent third-party validation studies are not yet published. The specifications shown are manufacturer-reported internal validation data, and prospective users should request the full validation report from Migibio.
- Where are clinical sensitivity and specificity documented?
- Clinical sensitivity and specificity are assay-specific and documented in each reagent's Instructions for Use (IFU). This page does not publish aggregate sensitivity or specificity numbers at the platform level.