IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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MicroELISA

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Method & Line Sample & Target Product Package Info Product Package Info
MicroELISA Plasma,Serum EIAgen Anti-CORE 2 Steps Kit Tests per Package: 96
EIAgen Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis B core Antigen in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HBV-infected patients. Code: 071009 Package: 1 Microplate
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  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

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Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis B core Antigen in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HBV-infected patients. For “in vitro” diagnostic use only.

The World Health Organization (WHO) defines Hepatitis B as follows:

“Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. Hepatitis means inflammation of the liver, and the most common cause is infection with one of 5 viruses, called hepatitis A,B,C,D, and E. All of these viruses can cause an acute disease with symptoms lasting several weeks including yellowing of the skin and eyes (jaundice); dark urine; extreme fatigue; nausea; vomiting and abdominal pain. It can take several months to a year to feel fit again. Hepatitis B virus can cause chronic infection in which the patient never gets rid of the virus and many years later develops cirrhosis of the liver or liver cancer.

HBV is the most serious type of viral hepatitis and the only type causing chronic hepatitis for which a vaccine is available. Hepatitis B virus is transmitted by contact with blood or body fluids of an infected person in the same way as human immunodeficiency virus (HIV), the virus that causes AIDS. However, HBV is 50 to 100 times more infectious than HIV. The main ways of getting infected with HBV are: (a) perinatal (from mother to baby at the birth); (b) child- to-child transmission; (c) unsafe injections and transfusions; (d) sexual contact.

Worldwide, most infections occur from infected mother to child, from child to child contact in household settings, and from reuse of un-sterilized needles and syringes. In many developing countries, almost all children become infected with the virus. In many industrialized countries (e.g. Western Europe and North America), the pattern of transmission is different. In these countries, mother-to-infant and child-to-child transmission accounted for up to one third of chronic infections before childhood hepatitis B vaccination programmes were implemented. However, the majority of infections in these countries are acquired during young adulthood by sexual activity, and injecting drug use. In addition, hepatitis B virus is the major infectious occupational hazard of health workers, and most health care workers have received hepatitis B vaccine. Hepatitis B virus is not spread by contaminated food or water, and cannot be spread casually in the workplace. High rates of chronic HBV infection are also found in the southern parts of Eastern and Central Europe. In the Middle East and Indian sub-continent, about 5% are chronically infected. Infection is less common in Western Europe and North America, where less than 1% are chronically infected. Young children who become infected with HBV are the most likely to develop chronic infection. About 90% of infants infected during the first year of life and 30% to 50% of children infected between 1 to 4 years of age develop chronic infection. The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood. Chronic hepatitis B in some patients is treated with drugs called interferon or lamivudine, which can help some patients. Patients with cirrhosis are sometimes given liver transplants, with varying success. It is preferable to prevent this disease with vaccine than to try and cure it. Hepatitis B vaccine has an outstanding record of safety and effectiveness. Since 1982, over one billion doses of hepatitis B vaccine have been used worldwide. The vaccine is given as a series of three intramuscular doses. Studies have shown that the vaccine is 95% effective in preventing children and adults from developing chronic infection if they have not yet been infected. In many countries where 8% to 15% of children used to become chronically infected with HBV, the rate of chronic infection has been reduced to less than 1% in immunized groups of children. Since 1991, WHO has called for all countries to add hepatitis B vaccine into their national immunization programmes.” Hepatitis B core Antigen (or HBcAg) is the major component of the core particles of HBV. HBcAg is composed of a single polypeptide of about 17 kD that is released upon disaggregating the core particles; the antigen contains at least one immunological determinant. Upon primary infection, anti HBcAg antibodies are one of the first markers of HBV hepatitis appearing in the serum of the patient, slightly later than HBsAg, the viral surface antigen. Anti HBcAg antibodies are produced usually at high titers and their presence is detectable even years after infection. Isolated HBcAb, in absence of other HBV markers, have been observed in infected blood units, suggesting the use of this test for screening HBV, in addition of HBsAg. The determination of HBcAb has become important for the classification of the viral agent, together with the detection of the other markers of HBV infection, in sera and plasma.

The assay is based on the principle of competition where the antibodies in the sample compete with a monoclonal antibody for a fixed amount of antigen on the solid phase.

A purified recombinant HBcAg is coated to the microwells.

The patient’s serum/plasma is added to the microwell together with an additive able to block interferences present in the sample.

In the second incubation after washing, a monoclonal antibody, conjugated with Horseradish Peroxidase (HRP) and specific for HBcAg is added and binds to the free rec-HBcAg coated on the plastic.

After incubation, microwells are washed to remove any unbound conjugate and then the substrate TMB is added. In the presence of peroxidase enzyme the colorless substrate is hydrolyzed to a colored end-product.

The color intensity is inversely proportional to the amount of antibodies to HBcAg present in the sample.

The kit contains reagents for 96 tests (code 071009).

Microplate

Negative Control

Positive Control

Calibrator

Wash Buffer Concentrate 20x

Conjugate

Substrate TMB

Sample Diluent

Stop Solution

Plate sealing foils

1

1x1 mL/vial

1x1 mL/vial

2 vials

1x60 mL/vial

1x16 mL/vial

1x16 mL/vial

4x3 mL/vials

1x15 mL/vial

2

Number of tests

96

Code

071009

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