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.
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Frequently Asked Questions
What is the difference between lateral flow and FIA? Lateral flow gives a visual, qualitative result; FIA uses a fluorescent label read by an analyzer for quantitative output.
Related knowledge
References
- Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno)assay: its strengths, weaknesses, opportunities and threats. Anal Bioanal Chem. 2009;393(2):569-582.
- Bahadır EB, Sezgintürk MK. Lateral flow assays: principles, designs and labels. TrAC Trends Anal Chem. 2016;82:286-306.
By Progene Bio Regulatory Affairs Team · Medical Device QA · Medical disclaimer · Last reviewed: 2026-09-12