Infectious Disease

HCV Rapid Test

Detects Hepatitis C antibodies. colloidal-gold. Specimen: WB / S / P.

HCV Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteHepatitis C antibodies
Disease / IndicationHepatitis C
SeriesInfectious Disease
Methodcolloidal-gold
SpecimenWB / S / P
RegulatoryNon-CE / registration in progress
OEM/ODMAvailable — private label & custom panel

Direct Answer

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

Intended Use

Detection of antibodies to Hepatitis C virus.

Clinical Context

Anti-HCV indicates exposure (current or past infection). Standard first-line screen; active infection is confirmed by HCV RNA.

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

A positive antibody result does not confirm active infection — reflex to HCV RNA is required.

Procurement

Specimen: whole blood / serum / plasma. Format: cassette / strip. Registration in progress.

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