Accurex HBsAg Card Test Kit

Accurex HBsAg Card Test Kit
Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic diseases. An estimated 240 million people are chronically infected with hepatitis B (defined as hepatitis B surface antigen positive for at least 6 months). Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg. Hepatitis B surface antigen (HBsAg) consists of lipid carbohydrate and protein elements; the protein moiety provides a marker for the identification of chronic, infectious BBV infections. Hepatitis B is transmitted sexually or intravenously and has an incubation period of six months. If not diagnosed properly and in time, it can develop into an acute or chronic infection, liver cirrhosis and fulminant hepatitis. This test is very useful for screening blood donors, to find out whether they are HBsAg positive before the collection of blood.

Uses:
The HBsAg test kit is a one-step immunochromatographic assay based on the antigen capture or Sandwich principle. HBsAg positive may include antiviral medications.

Product Specifications and Features:

• AccuTest HBsAg should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch

• AccuTest HBsAg is a qualitative test based on the immunochromatography sandwich principle

• The test card includes a combination of monoclonal antibody gold conjugate (colloidal gold) and polyclonal solid phase antibodies which selectively bind Hepatitis B surface antigen with a high degree of sensitivity

• The HBsAg test is a one-step immunochromatographic assay based on the antigen capture or Sandwich principle

• The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin
  line

• The test sample is introduced into the well and flows laterally through an absorbent pad where it mixes with the signal reagent. If the sample contains HBsAg, the colloidal gold-antibody (mouse) conjugate binds to the antigen, forming an antigen-antibody-colloidal
  gold complex

• The complexes then migrate through the nitrocellulose strip by capillary action, which is stopped by an immobilized antibody zone forming a purple band

• The formation of the first purple band (T zone) is indicative of hepatitis positive. To serve as a procedural control, an additional line of antibody antimouse IgG has been immobilized on the card

• If the test is performed correctly, this will result in the formation of purple and upon contact with the conjugate as a control line

Directions For Use:
Test Procedure:

• Allow the test, specimen and or control to room temperature before the testing

• Remove one test card from the pouch and place it on a clean flat surface

• Using the dropper provided one drop of serum/plasma or W. blood sample (25 ul), and wait for a few seconds till the Whole blood is absorbed by the sample pad (approx. 30 seconds)

• Add 2-3 drops of buffer (60 ul) into the sample well. (If needed add one more drop of assay buffer)

• Let the reaction proceed until the appearance of the positive line and control line or up to 20 minutes

• Read results after 20 minutes, the strong positive reaction may be visible within 5 minutes

• If negative or questionable results are obtained, the HBV infection is suspected, the test should be repeated on a fresh serum specimen

Safety Information:

• AccuTest HBsAg test kit is designed for the detection of Hepatitis B surface antigen in the specimen

• As with all diagnostic tests, it is recommended to interpret all the results in line with clinical manifestations, other lest results and clinicians' views colleclively

• If the last device is showing stagnancy in flow on chromatography, it is most likely due to a problem in the sample

• In this case, relist with a fresh sample or diluted sample