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|Method & Line||Sample & Target||Product||Package Info|
|MicroELISA||Whole blood,Plasma,Serum||EIAgen HBsAb||Tests per Package: 96|
|EIAgen||Enzyme immunoassay for the qualitative and quantitative detection of antibodies to Hepatitis B Surface Antigen (HBsAb) in human serum derived from HBV infected patients and vaccinated. For “in vitro” diagnostic use only.||Code: 071131||Package: 1 Microplate|
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Enzyme immunoassay for the qualitative and quantitative detection of antibodies to Hepatitis B Surface Antigen (HBsAb) in human serum derived from HBV infected patients and vaccinated.
For “in vitro” diagnostic use only.
The Hepatitis B Virus (HBV) is a human pathogen DNA virus with a word-wide distribution among geographic areas and population groups. He is one of the five strictly epatotropic viruses, together with the A, C, Delta and E viruses. All of these viruses can cause acute disease, with symphtoms that ranged between mild asymphtomatic infection to severe fulminant hepatitis1-3. The thpical symptoms are yellowing of the skin and eyes (jaundice), dark urine and extreme fatigue, nausea, vomiting and abdominal pain4. HBV can cause chronic infection when the patient never gets rid of the virus and many years later develops cirrhosis of the liver or liver cancer4, particularly if the infection was acquired in childhood than as an adult5,6. In this case the infection persists for more than six months. More than 90% of the infected adults will have an acute self-limiting infection1. Young children are the most likely to develop chronic hepatitis infection. 90% of the infants affected by HBV infection in the first year and 30-50% of the infants affected into the first 4 years can develop chronic hepatitis, and 25% of these patients will death for liver cancer or cirrhosis4. HBV is the most serious type of viral hepatitis and the only type causing chronic hepatitis for which a vaccine is available. Since 1991, WHO suggested to consider the hepatitis B vaccine into their national immunization programs. The therapy is mainly based on alfa-interferon to relieve symptoms5,6. The response to this treatment is between 40 and 50% of patients with chronic active HBV infection5,6. In the chronic HBV carriers there is no evidence of hepatic damage1,2, the infection persists and the patient maintains the ability to transmit the virus.
The transmission of the disease is mainly due to a parenteral contac (blood or blood products exchange, sexual contacts, perinatal spread from mother to newborn at the birth, unsafe injections and transfusions)4. The virus is not spread by contaminated food of water4. High prevalence of HBV infections are found ion southern areas of Eastern and Central Europe. Lower prevalence (5%) is detected in Middle and Far East, and less that 1% in Western Europe and North America4.
In the HBV infection three phases can be identify: incubation, acute and covalescent, on the basis of several serological markers results.
The first marker to appear in the serum is the hepatitis B surface antigen (HBsAg),m detectable after 4-12 weeks after the infection and before the onset of the symptoms1,2,5.
Upon infection, a strong immunological response develops firstly against the type specific determinants and in a second time against the “a” determinant.
Anti “a” antibodies are however recognized to be most effective in the neutralization of the virus, protecting the patient from other infections and leading it to convalescence.
The detection of HBsAb has become important for the follow up of patients infected by HBV and the monitoring of recipients upon vaccination with synthetic and natural HBsAg.
The “HBsAb” enzyme immunoassay is based on a microtiterplate wells coated with high-purified HBsAg that in the first incubation with sample specifically captures anti-HBsAg antibodies to the solid phase. After washing, captured antibodies are detected by an HBsAg labelled with peroxidase (HRP), that specifically binds the second available binding site of these antibodies. After the incubation, the chromogen/substrate (TMB) is then added and, in the presence of captured anti-HBs immunocomplex, the colourless substrate is hydrolyzed by the bound HRP conjugate to a colored end-product. After blocking the enzymatic reaction, its optical density is measured by an ELISA reader.
The amount of antibodies may be quantitated by means of a standard curve calibrated against the W.H.O reference preparation.
Samples are pre-treated in the well with a specimen diluent able to block interference present in vaccinated individuals.
Each kit contains sufficient reagents to perform 96 tests (code 071131).
Wash Buffer Concentrate 20x
Plate sealing foils
Plastic Sealable Bag
Number of tests
Evaluation of Performances has been conducted in accordance to what reported in the Common Technical Specifications or CTS (art. 5, Chapter 3 of IVD Directive 98/79/EC).