Audited Supplier
HBV
IVD Instrument
2 Years
Strip and Cassette
Serum/Plasma/Whole Blood
David or Neutral
Carton
3mm/4.2mm
China
Product Description
One-Step HBsAg Rapid Test is a single use immunochromatographic assay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum, plasma.
It is intended to be used as a screening test and as an aid in the diagnosis of infection with Hepatitis B virus (HBV). The test is used for the evaluation of blood and blood products for the presence of HBsAg intended for transfusions and as an aid in the diagnosis of ongoing or previous hepatitis B viral infection.
PRINCIPLES OF THE TEST
One-Step HBsAg Rapid Test is based on the principle of agglutinating sera on membrane and utilizes the technique of a lateral flow chromatographic immunoassay. The test uses a double antibody " sandwich principle ".The test strip consists of: 1) a burgundy colored conjugate pad containing mouse anti-HBsAg monoclonal antibody conjugated with colloid gold (HBsAb conjugates) 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with nonconjugated anti-HBsAg polyclonal antibody, and the C band is pre-coated with goat anti-mouse IgG polyclonal antibody.
When an adequate volume of test specimen is dispensed into the sample pad of the strip, the specimen migrates by capillary action across the strip. As the test sample flows through the membrane assembly of the test device, the colored monoclonal anti-HBsAg-colloidal gold conjugate complexes with the HBsAg in the sample. HBsAg if present in the specimen will bind to the HBsAb conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-HBsAg antibody.This complex moves further on the membrane to the test region where it is immobilized by a polyclonal anti-HBsAg antiserum coated on the membrane leading to formation of a pink-purple colored band. A positive reaction is visualised by a pink/red band in the test region of the device. A negative reaction occurs in the absence of HBsAg in the analysed specimen. Consequently no visually detectable band develops in the test region of the device.
It is intended to be used as a screening test and as an aid in the diagnosis of infection with Hepatitis B virus (HBV). The test is used for the evaluation of blood and blood products for the presence of HBsAg intended for transfusions and as an aid in the diagnosis of ongoing or previous hepatitis B viral infection.
PRINCIPLES OF THE TEST
One-Step HBsAg Rapid Test is based on the principle of agglutinating sera on membrane and utilizes the technique of a lateral flow chromatographic immunoassay. The test uses a double antibody " sandwich principle ".The test strip consists of: 1) a burgundy colored conjugate pad containing mouse anti-HBsAg monoclonal antibody conjugated with colloid gold (HBsAb conjugates) 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with nonconjugated anti-HBsAg polyclonal antibody, and the C band is pre-coated with goat anti-mouse IgG polyclonal antibody.
When an adequate volume of test specimen is dispensed into the sample pad of the strip, the specimen migrates by capillary action across the strip. As the test sample flows through the membrane assembly of the test device, the colored monoclonal anti-HBsAg-colloidal gold conjugate complexes with the HBsAg in the sample. HBsAg if present in the specimen will bind to the HBsAb conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-HBsAg antibody.This complex moves further on the membrane to the test region where it is immobilized by a polyclonal anti-HBsAg antiserum coated on the membrane leading to formation of a pink-purple colored band. A positive reaction is visualised by a pink/red band in the test region of the device. A negative reaction occurs in the absence of HBsAg in the analysed specimen. Consequently no visually detectable band develops in the test region of the device.
