Raw Material Specifications¶
Structured specifications for the critical raw materials used in Migibio FICT test-strip production. Values are Migibio incoming-inspection (IQC) specifications unless marked industry reference.
1. Antibodies¶
| Attribute | Specification |
|---|---|
| Purity | ≥ 95% (SDS-PAGE) |
| Specificity | No significant cross-reactivity with screened interferents |
| Affinity | Assay-validated (Kd per analyte) |
| Lot-to-lot consistency | Passes functional reference-lot comparison before release to production |
| Storage | −20 °C (long-term), 2–8 °C (working) |
2. Fluorescent Labels¶
| Attribute | Specification |
|---|---|
| Type | Fluorescent microspheres / organic fluorophores (assay-dependent) |
| Size uniformity | Low CV of particle diameter (microspheres) |
| Quantum yield | High, photostable |
| Conjugation efficiency | ≥ defined threshold (free-label assay) |
| Aggregation | No significant aggregation post-conjugation |
3. Nitrocellulose Membrane¶
| Attribute | Specification |
|---|---|
| Capillary speed | Assay-specific (s/4 cm) industry reference |
| Pore size | Assay-specific (µm) industry reference |
| Background fluorescence | Low (quantitative-readout requirement) |
| Roll consistency | Uniform across roll; verified per incoming lot |
4. Conjugate & Sample Pads¶
| Attribute | Specification |
|---|---|
| Conjugate pad | Glass fiber; validated wicking rate & release efficiency |
| Sample pad | Cellulose; validated absorption capacity, pH, uniformity |
| Absorbent pad | High absorption capacity to drive complete flow |
5. Calibrators / Standards¶
| Attribute | Specification |
|---|---|
| Purity | High-purity assigned material |
| Assigned value | Traceable to reference method |
| Stability | Validated over shelf life |
Data Notes¶
- Each incoming raw-material lot is tested against the table above before release to the production line.
- A material lot failing IQC is quarantined and does not enter production.
For the full supply-chain control 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.
Contact: Martin.Wong · Phone (WhatsApp): +86 13323237275 · Email: martinwang2024@gmail.com