Cardiac & Tumor Markers

AFP Rapid Test

Detects Alpha-fetoprotein. colloidal-gold. Specimen: WB / S / P.

AFP Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteAlpha-fetoprotein
Disease / IndicationHepatocellular carcinoma
SeriesCardiac & Tumor Markers
Methodcolloidal-gold
SpecimenWB / S / P
RegulatoryNon-CE / registration in progress
OEM/ODMAvailable — private label & custom panel

Direct Answer

This rapid test detects Alpha-fetoprotein in WB / S / P to support Hepatocellular carcinoma. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of alpha-fetoprotein (AFP) for hepatocellular carcinoma screening support.

Clinical Context

AFP is a tumor marker associated with hepatocellular carcinoma; used in high-risk surveillance and monitoring.

Test Principle

Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.

Limitations

Not diagnostic alone — imaging and confirmatory testing required; elevated in other liver conditions.

Procurement

Specimen: whole blood / serum / plasma. Format: cassette. CE-marked line.

Interpretation

ResultLinesMeaning
PositiveTest + control lineTarget detected (presumptive positive)
NegativeControl line onlyBelow cut-off / not detected
InvalidNo control lineRepeat with a new device

Documentation & quotation — datasheet, IFU, MOQ and OEM/ODM options on request.

Request IFU / Spec Sheet Request Datasheet

Last reviewed: 2026-09-12