Infectious Disease

HBsAg Rapid Test

Detects Hepatitis B surface antigen. colloidal-gold. Specimen: WB / S / P.

HBsAg Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteHepatitis B surface antigen
Disease / IndicationHepatitis B
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 B surface antigen in WB / S / P to support Hepatitis B. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of Hepatitis B surface antigen (HBsAg) for HBV infection screening.

Clinical Context

HBsAg is the earliest serological marker of acute HBV and a marker of chronic infection. Widely used in blood-bank and antenatal screening.

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

Reactive results require confirmatory testing (neutralization / HBV DNA); does not distinguish acute from chronic.

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

Available SKUs (this series)

Cat. No.ProductSpecimenFormatKit SizeStatus
IHBC-325 HBsAg and HCV Combo Rapid Test Cassette S / P Cassette 25 T Non-CE
IHBC-425 HBsAg and HCV Combo Rapid Test Cassette WB/ S / P Cassette 25 T Non-CE
IBCH-335 HBsAg/HCV/HIV Combo Rapid Test Cassette S/ P Cassette 25 T Non-CE
IMID-345 HBsAg /HCV /HIV /Syphilis Combo Rapid Test Cassette S / P Cassette 25 T Non-CE
IMID-445 HBsAg /HCV /HIV /Syphilis Combo Rapid Test Cassette WB/S / P Cassette 25 T Non-CE

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

Request IFU / Spec Sheet Request Datasheet

Last reviewed: 2026-09-12