IVD Testing Methodologies
Direct answer: Rapid tests use one of two methodologies: colloidal-gold lateral flow (visual, qualitative) or fluorescence immunoassay (analyzer-read, quantitative). Lateral flow is instrument-free and lower-cost; FIA adds numeric results.
| Colloidal-gold lateral flow | Fluorescence immunoassay (FIA) | |
|---|---|---|
| Readout | Visual line (naked eye) | Fluorescent signal (analyzer-read) |
| Result type | Qualitative / semi-quantitative | Quantitative |
| Instrument | None | Fluorescence analyzer required |
| Cost | Lower | Higher |
Principle (lateral flow)
A labeled antibody captures the target analyte on a nitrocellulose membrane as the sample migrates by capillary action, producing a visible test line within minutes.
Browse products by methodology →
By Progene Bio Regulatory Affairs Team · Medical Device QA · Medical disclaimer · Last reviewed: 2026-09-12