Raw Materials & Supply Chain¶
The performance of a fluorescence immunochromatographic test is set at the raw-material level. This page documents the critical inputs, what quality attributes matter for each, and how Migibio controls the supply chain from incoming inspection to lot traceability.
Critical Raw Materials¶
| Material | Role in the strip | Critical quality attributes |
|---|---|---|
| Capture & detection antibodies | Bind the analyte at the T-line and label the signal | Affinity, specificity, lot-to-lot consistency |
| Fluorescent label (fluorophore / microsphere) | Generates the quantifiable signal | Quantum yield, size uniformity, stability |
| Nitrocellulose membrane | Migration substrate; carries T/C lines | Pore size, capillary speed, background |
| Conjugate pad (glass fiber) | Releases labeled antibody uniformly | Wicking rate, release efficiency |
| Sample pad | Buffers and pre-treats sample | Absorption capacity, pH, uniformity |
| Absorbent pad | Drives capillary flow to completion | Absorption capacity |
| Calibrators / standards | Set the standard curve | Purity, assigned values, stability |
Material-by-Material Requirements¶
Antibodies¶
Antibodies are the assay's specificity engine. Migibio sources and validates:
- Monoclonal antibodies for defined epitope specificity and reproducibility.
- Polyclonal antibodies where broad recognition is desirable.
- Validation: affinity, cross-reactivity screening, and lot-consistency testing before a new antibody lot is qualified for production.
Fluorescent Labels¶
FICT uses fluorescent labels that enable quantitative, instrument-read results. Two label families are used depending on the assay:
- Fluorescent microspheres — high signal, stable, photobleach-resistant.
- Organic fluorophores — smaller, faster kinetics for selected assays.
Label quality is controlled for size uniformity (CV of particle diameter) and conjugation efficiency.
Nitrocellulose Membrane¶
The membrane is the single most performance-critical consumable. Key attributes:
- Capillary speed (s/4 cm) — determines assay run time.
- Pore size — balances sensitivity vs. speed.
- Background fluorescence — must be low for quantitative readout.
Conjugate & Sample Pads¶
Glass-fiber and cellulose pads are validated for wicking rate, release efficiency, and uniformity before release to the production line.
Supply Chain Controls¶
| Control | What it ensures |
|---|---|
| Qualified supplier list | Only audited, approved suppliers feed production |
| Incoming inspection (IQC) | Every raw-material lot is tested against its specification before use |
| Lot traceability | Each finished kit lot maps to its raw-material lots |
| Change control | A material change triggers re-validation before production use |
Why This Matters to Buyers¶
- Consistent performance — controlled materials mean consistent lot-to-lot results.
- Regulatory defensibility — documented raw-material control supports product registration and audits.
- Supply security — dual-qualified suppliers for critical materials reduce disruption risk.
FAQ¶
Do you manufacture the antibodies yourselves? Antibodies are sourced from qualified partners and validated in-house; conjugation and assay assembly are done in our facility.
Can you support OEM assays with custom raw materials? Yes — OEM/ODM development can source and qualify assay-specific materials. See OEM/ODM Process.
For structured raw-material specifications, see the Data Hub.
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.