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Product description

  HBsAg One Step Rapid Test Cassette

 

Intruduction:

 

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. revious designations included the Australia or Au antigen 1. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute orchronic. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus.

 

The HBsAg One Step Rapid Test Cassette is a rapid test to qualitatively detect the presence of HBsAg in serum or plasma specimens. The test utilises a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in serum or plasma.

 

Principle:

 

The HBsAg One Step Rapid Test Cassette is a lateral flow chromatographic immunoassay based on the principle of the double antibody–sandwich technique. The membrane is pre-coated with anti-HBsAg antibodies on the test line region of the test. During testing, the serum or plasma specimen reacts with the particle coated with anti-HBsAg antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a coloured line.

 

The presence of this coloured line in the test region indicates a positive result, while its absence indicates a negative result.

 

To serve as a procedural control, a coloured line will always appear in the control line region indicating that the proper volume of specimen has been added and membrane wicking has occurred.

 

 Feature:

  1. It can detect 1.0ng/ml of HBsAg.
  2. HBsAg monoclonal antibody is used for coating. It excludes alien interference and has a high specificity.
  3. It is stored at room temperature. easy to carry and valid for 18months.
  4. Sensitivity:It can detect 1ng/ml HBsAg in 15min. 0.5ng /ml HBsAg in 30 min.
  5. specificity:It shows no cross reaction with clinical HAV-,HCV- RF- and VDRL-positive serum samples

Intended Use:

Infections resulting from Hepatitis B Virus bring us a fearful public hygiene problem. Maternal-neonatal transmission, sexual transmission and blood transmission are three main transmission routes. The earlier the infectious antigens are discovered, the more effectively the transmission of disease is decreased. This product is used for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in serum/plasma samples. It can be used to screen for HBsAg in the scene for blood donation and detect HBsAg before clinical emergency operation.

 

Package Details:

 

Formats

 strip, cassette

Specifications

strip(2.5mm,3.0mm, 4.0mm)

cassette(3mm, 4mm)

or according to the customers' requirements

Specimens

 serum

Specificity

 over 99.6%

Shelf Life

 24 months at room temperature

Packing Details

  Cassette

40pcs/bag, 50bags/carton.  500,000pcs/20'ft container

40pcs/box, 50boxes/carton, 550,000pcs/20’ft container

1pcs/box, 500boxes/carton, 120,000pcs/20’ft container
 Strip

100pcs/bag, 100bags/carton .1,300,000pcs/20'ft container

100pcs/box, 50boxes/carton, 1,700,000pcs/20’ft container

50pcs/box, 100boxes/carton, 1,600,000pcs/20’ft container

1pcs/box, 500boxes/carton, 120,000pcs/20’ft container

Others

 The kits can be made according to the customers' artwork or design

 

 

 

 

 

 

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