HBsAg Rapid Test description:

"Export Use Only"
Diagnostics Automation Inc. offers OneStep HBsAg RapiDip™ InstaTest. This HBsAg Rapid Test is a direct binding test for the visual detection of hepatitis B surface antigen (HBsAg) in Serum, Plasma, and Whole Blood. It is used as an aid in the diagnosis of hepatitis B infection and screening of blood donors or blood products.


Materials Provided with HBsAg Rapid Test Kit:

1. HBsAg Test device
2. Sample diluent
3. Instructions for use


HBsAg Rapid Test Background Information
Hepatitis B virus (HBV) is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family. HBV is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces acute or chronic liver diseases and in some cases that can lead to cirrhosis and carcinoma of the liver. Hepatitis B surface antigen or HBsAg, which was previously described as Australia antigen is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes, immunologically distinguished in two distinct subgroups (ay and ad). HBV has ten major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become atypical and 3 to 5 weeks before symptoms development.



HBsAg Rapid Test Principle
The One Step HBsAg Rapid Test is based on the principle of chromatographic immunoassay for qualitative detection of the surface antigen of hepatitis B virus (HBsAg) in human whole blood, serum, and plasma samples. Monoclonal and polyclonal antibodies are employed to identify HBsAg specifically. HBsAg Rapid Test is very sensitive and results can be read visually without any instrumentation. This HBsAg Rapid Test employs chromatographic lateral flow device. Colloidal gold conjugated monoclonal antibodies reactive to HBsAg (sAb-Au) are dryimmobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion trough the strip rehydrating the gold conjugate. If present, HBsAg will bind with the gold conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBs antibodies immobilized there and a visible red line appears.


HBsAg Rapid Test Performance & Characteristics
Using 3254 confirmed negative and 437 positive samples:
Sensitivity 99.54% (435/437)
Specificity 99.56% (3240/3254)
Accuracy 99% tested by a panel of analytical standards of HBsAg
Cross Reactivity No cross reactivity was observed with specimens from patients
infected with HAV, HCV, HIV, HTLV, CMV & TP


Notable features of the HBsAg Rapid Test:
a reliable and inexpensive
a easy-to-understand directions
a clear preparation procedures
a simple specimen collection directions
a safe and convenient packaging
a rapid and accurate test results


HBsAg Rapid Test Results Interpretation
One red line next to the Test Zone (T) indicates that HBsAg have been detected using this Rapid Test. For additional details please refer to the instructions for use.


HBsAg Related Tests:


Hepatitis Rapid Tests kits

http://www.rapidtest.com/index.php?product=Hepatitis-Panel&cat=27

Hepatitis ELISA Test Kits

http://www.rapidtest.com/index.php?product=Hepatitis-ELISA-kits&cat=119





Diagnostic Automation Inc. also provides other hepatitis related Rapid Test Kits:

http://www.rapidtest.com/index.php?product=Rapid-Tests&cat=3


For more information about Rapid Tests, ELISA Kits, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representative
at 818-591-3030.


*Not to be sold, shipped, or distributed in the United States.